The European Centre for Disease Control and Prevention continues to advise against the vaccination of children for the prevention of seasonal influenza.
The "Factsheet for the general public on seasonal influenza" notes that few "EU countries recommend immunising children or offering vaccines to pregnant women. An expert panel convened by ECDC considered there was as yet insufficient evidence on the burden of infection in children to take any view for or against immunisation."
http://ecdc.europa.eu/en/healthtopics/seasonal_influenza/basic_facts/Pages/factsheet_general_public.aspx
Friday, December 2, 2011
Thursday, September 15, 2011
Preventing Killer Flu: Endothelial cells may be factor in preventing cytokine storm
A team from the Scripps Research Institute found that endothelial cells may act as a regulator in how the body reacts to the flu virus.
The scientists were looking at the S1P pathway (molecular control circuit) and gave rodents a substance to stimulate the S1P1 receptor. They learned that the treatment lessened severe cytokine response.
Details available on SCIENCE NOW:
http://news.sciencemag.org/sciencenow/2011/09/surprising-cells-rein-in-killer-.html
The scientists were looking at the S1P pathway (molecular control circuit) and gave rodents a substance to stimulate the S1P1 receptor. They learned that the treatment lessened severe cytokine response.
Details available on SCIENCE NOW:
http://news.sciencemag.org/sciencenow/2011/09/surprising-cells-rein-in-killer-.html
Wednesday, July 20, 2011
Thousands get flu in Australia, but few require medical care.
Thousands get the flu in Australia, but few require medical care.
Influenza monitoring systems are reporting nearly 8,000 cases, early in the Australia flu season.
Recent flooding and bad weather may be to blame, but it is not clear that this is either the main or sole reason for the high reported numbers. One theory is that there is simply more testing going on, another that fewer people are being vaccinated due to concerns about the safety of the flu shot.
Report in Brisbane Times: http://www.brisbanetimes.com.au/national/warnings-as-flu-cases-surge-20110719-1hn5m.html#ixzz1SeuevxIe
Report on “The Conversation”: http://theconversation.edu.au/flu-is-on-the-rise-australia-and-thats-not-to-be-sniffed-at-2414
Influenza monitoring systems are reporting nearly 8,000 cases, early in the Australia flu season.
Recent flooding and bad weather may be to blame, but it is not clear that this is either the main or sole reason for the high reported numbers. One theory is that there is simply more testing going on, another that fewer people are being vaccinated due to concerns about the safety of the flu shot.
Report in Brisbane Times: http://www.brisbanetimes.com.au/national/warnings-as-flu-cases-surge-20110719-1hn5m.html#ixzz1SeuevxIe
Report on “The Conversation”: http://theconversation.edu.au/flu-is-on-the-rise-australia-and-thats-not-to-be-sniffed-at-2414
Tuesday, July 19, 2011
Reuters reports potential tripling of flu vaccine production by 2015
Reuters is reporting that the World Health Organization (WHO) has announced 11 new producers of flu vaccine. The manufacturers could potentially provide up to 1.7 billion doses of season flu vaccine by 2015.
According to Marie-Paule Kieny, WHO assistant director-general, "what we are continuing to do is to make sure that not only will there be more pandemic vaccine if need be, but also that the sites where these vaccines will be produced will be more diverse geographically and more populations of the world will have earlier access to pandemic vaccine."
"We have to take influenza vaccine as a tool to combat influenza pandemic, not just a tool to maximise profit," said Dr. Pathom Sawanpanyalert, Thailand's chair of the WHO's Global Action Plan for Influenza Vaccines, the experts group that met. (Reporting by Stephanie Nebehay)
http://www.reuters.com/article/2011/07/14/health-flu-vaccine-idUSLDE76D0XD20110714
According to Marie-Paule Kieny, WHO assistant director-general, "what we are continuing to do is to make sure that not only will there be more pandemic vaccine if need be, but also that the sites where these vaccines will be produced will be more diverse geographically and more populations of the world will have earlier access to pandemic vaccine."
"We have to take influenza vaccine as a tool to combat influenza pandemic, not just a tool to maximise profit," said Dr. Pathom Sawanpanyalert, Thailand's chair of the WHO's Global Action Plan for Influenza Vaccines, the experts group that met. (Reporting by Stephanie Nebehay)
http://www.reuters.com/article/2011/07/14/health-flu-vaccine-idUSLDE76D0XD20110714
Thursday, May 19, 2011
CDC offers Zombie Apocalypse preparedness plan
If you previously took everything the CDC said with a grain of salt, their latest pronouncement is not likely to change your mind.
A tongue-in-cheek blog post describes what to do in case zombies strike.
http://emergency.cdc.gov/socialmedia/zombies_blog.asp
Excerpt:
"Zombie Apocalypse
There are all kinds of emergencies out there that we can prepare for. Take a zombie apocalypse for example. That’s right, I said z-o-m-b-i-e a-p-o-c-a-l-y-p-s-e. You may laugh now, but when it happens you’ll be happy you read this, and hey, maybe you’ll even learn a thing or two about how to prepare for a real emergency.
A Brief History of Zombies
We’ve all seen at least one movie about flesh-eating zombies taking over (my personal favorite is Resident EvilExternal Web Site Icon.), but where do zombies come from and why do they love eating brains so much? The word zombie comes from Haitian and New Orleans voodoo origins. Although its meaning has changed slightly over the years, it refers to a human corpse mysteriously reanimated to serve the undead. Through ancient voodoo and folk-lore traditions, shows like the Walking Dead were born."
Full blog post is here:
http://emergency.cdc.gov/socialmedia/zombies_blog.asp
A tongue-in-cheek blog post describes what to do in case zombies strike.
http://emergency.cdc.gov/socialmedia/zombies_blog.asp
Excerpt:
"Zombie Apocalypse
There are all kinds of emergencies out there that we can prepare for. Take a zombie apocalypse for example. That’s right, I said z-o-m-b-i-e a-p-o-c-a-l-y-p-s-e. You may laugh now, but when it happens you’ll be happy you read this, and hey, maybe you’ll even learn a thing or two about how to prepare for a real emergency.
A Brief History of Zombies
We’ve all seen at least one movie about flesh-eating zombies taking over (my personal favorite is Resident EvilExternal Web Site Icon.), but where do zombies come from and why do they love eating brains so much? The word zombie comes from Haitian and New Orleans voodoo origins. Although its meaning has changed slightly over the years, it refers to a human corpse mysteriously reanimated to serve the undead. Through ancient voodoo and folk-lore traditions, shows like the Walking Dead were born."
Full blog post is here:
http://emergency.cdc.gov/socialmedia/zombies_blog.asp
Friday, April 8, 2011
FDA refuses to approve Merck HPV treatment Gardasil for older women
Merck (NYSE: MRK) announced that it's Gardasil HPV (Human Papillomavirus) treatment is not effective in women over the age of 26 (specifically, ages 27-45). Although it had applied to the FDA to extend treatment for use by this age group, approval was denied.
Sales of Gardasil have been declining, as the market for this drug has been saturated. Gardasil is approved for young women (and also young men, aged 9-26). This is the second time that the FDA has disallowed wider use of the vaccine.
The full text of Merck's announcement can be found here:
http://bit.ly/gmcAeg
Sales of Gardasil have been declining, as the market for this drug has been saturated. Gardasil is approved for young women (and also young men, aged 9-26). This is the second time that the FDA has disallowed wider use of the vaccine.
The full text of Merck's announcement can be found here:
http://bit.ly/gmcAeg
Wednesday, April 6, 2011
Flu symptoms visits decrease for 6th straight week
Doctor visits for influenza-like illness decreased for the sixth straight week, as problems associated with the flu continue to fall.
According to the CDC's (Centers for Disease Control and Prevention) weekly Fluview update, only one state in their survey showed an increase in flu symptoms (Idaho).
From the weekly report: "# Visits to doctors for influenza-like illness (ILI) nationally decreased again for the sixth consecutive week, falling below the national baseline for the first time since the week ending December 25, 2010. However two of 10 U.S regions—Regions 2 and 10—continue to report ILI activity at or above baseline levels. One state (Idaho) had high ILI activity."
The full report can be found here: http://www.cdc.gov/flu/weekly/summary.htm
According to the CDC's (Centers for Disease Control and Prevention) weekly Fluview update, only one state in their survey showed an increase in flu symptoms (Idaho).
From the weekly report: "# Visits to doctors for influenza-like illness (ILI) nationally decreased again for the sixth consecutive week, falling below the national baseline for the first time since the week ending December 25, 2010. However two of 10 U.S regions—Regions 2 and 10—continue to report ILI activity at or above baseline levels. One state (Idaho) had high ILI activity."
The full report can be found here: http://www.cdc.gov/flu/weekly/summary.htm
Tuesday, March 22, 2011
FluCide drug candidate shows promise but the mouse gets it in the end. NanoViricides, Inc. (OTC BB: NNVC.OB)
NanoViricides, Inc. (OTC BB: NNVC.OB) announced that a recent animal study of it's FluCide drug candidate, showed a quadrupling in efficacy over a previous study.
In the study, mice were aspirated with one million virus particles of the H1N1 flu virus. The mice were treated with both FluCide and Tamiflu 24 hours later. The results show that the mice treated with Tamiflu survived only 8.3 days, while the FluCide treated mice were able to hold on for 20.2 to 22.2 days.
The full announcement is here:
http://www.businesswire.com/news/home/20110321005653/en/NanoViricides-Reports-Treatment-FluCide-Drug-Candidate-Achieves
In the study, mice were aspirated with one million virus particles of the H1N1 flu virus. The mice were treated with both FluCide and Tamiflu 24 hours later. The results show that the mice treated with Tamiflu survived only 8.3 days, while the FluCide treated mice were able to hold on for 20.2 to 22.2 days.
The full announcement is here:
http://www.businesswire.com/news/home/20110321005653/en/NanoViricides-Reports-Treatment-FluCide-Drug-Candidate-Achieves
Friday, March 11, 2011
Group calls for removal of mercury from all vaccines
In a press release Thursday, the Coalition for Mercury-Free Drugs (http://mercury-freedrugs.org/) points to new research that illustrates more reasons to avoid adding Thimerosal (THIM) to vaccines. Thimerosal is a mercury-based compound that is widely used as a preservative in flu vaccines.
Although some previous research on the relationship between mercury and autism has been widely discredited, a new paper, by Helen V. Ratajczak, "Theoretical aspects of autism: Causes—A review," published in the Journal of Immunotoxicology, provides fresh clues. While not "proving" a relationship, the paper points to some damning evidence:
1. "Not only is every major symptom of autism documented
in cases of mercury poisoning but also biological
abnormalities in autism are very similar to the side effects of
mercury poisoning itself (Bernard et al., 2001)."
2. Mercury poisoning & Autism symptoms (in parallel): "...include psychiatric disturbances (e.g., impairments in sociality, stereotypic behaviors, depression, anxiety disorder, and neuroses), increased incidences of allergies and asthma, increases in the presence of IgG autoantibodies against brain and myelin basic proteins, reductions in natural killer cell function, and increases in neopterin levels (indicative of immune activation). Autistic brains show neurotransmitter irregularities that are virtually identical to those arising from mercury exposure, i.e., changes in serotonin and dopamine concentrations, elevated epinephrine and norepinephrine levels in the plasma and brain, elevated serum glutamate levels, and an acetylcholine deficiency in the hippocampus (Bernard
et al., 2001)."
3. "More evidence linking autism with mercury poisoning is the timing of inclusion of Thimerosal in vaccines in the 1930s closely preceding the discovery of autism in 1943."
4. Toxicity of Thimerosal: "There are dangerous effects of Thimerosal on the immune
system, particularly on T-lymphocytes. Mercury induces glutathione depletion, increased oxidative stress, and apoptosis in these cells (Makani et al., 2002). In addition, Thimerosal causes toxic effects on brain cells (Baskin et al., 2003), inhibits glutamate transport (Mutkus et al., 2005), affects nerve differentiation (Parran et al., 2005), induces immunoproliferation and formation of autoantibodies to fibrillin proteins (Havarinasab and Hultman, 2005), and depletes glutathione (James et al., 2005)."
The full press release is here:
http://www.prnewswire.com/news-releases/researchers-urge-the-removal-of-mercury-from-flu-shots-117737828.html
Although some previous research on the relationship between mercury and autism has been widely discredited, a new paper, by Helen V. Ratajczak, "Theoretical aspects of autism: Causes—A review," published in the Journal of Immunotoxicology, provides fresh clues. While not "proving" a relationship, the paper points to some damning evidence:
1. "Not only is every major symptom of autism documented
in cases of mercury poisoning but also biological
abnormalities in autism are very similar to the side effects of
mercury poisoning itself (Bernard et al., 2001)."
2. Mercury poisoning & Autism symptoms (in parallel): "...include psychiatric disturbances (e.g., impairments in sociality, stereotypic behaviors, depression, anxiety disorder, and neuroses), increased incidences of allergies and asthma, increases in the presence of IgG autoantibodies against brain and myelin basic proteins, reductions in natural killer cell function, and increases in neopterin levels (indicative of immune activation). Autistic brains show neurotransmitter irregularities that are virtually identical to those arising from mercury exposure, i.e., changes in serotonin and dopamine concentrations, elevated epinephrine and norepinephrine levels in the plasma and brain, elevated serum glutamate levels, and an acetylcholine deficiency in the hippocampus (Bernard
et al., 2001)."
3. "More evidence linking autism with mercury poisoning is the timing of inclusion of Thimerosal in vaccines in the 1930s closely preceding the discovery of autism in 1943."
4. Toxicity of Thimerosal: "There are dangerous effects of Thimerosal on the immune
system, particularly on T-lymphocytes. Mercury induces glutathione depletion, increased oxidative stress, and apoptosis in these cells (Makani et al., 2002). In addition, Thimerosal causes toxic effects on brain cells (Baskin et al., 2003), inhibits glutamate transport (Mutkus et al., 2005), affects nerve differentiation (Parran et al., 2005), induces immunoproliferation and formation of autoantibodies to fibrillin proteins (Havarinasab and Hultman, 2005), and depletes glutathione (James et al., 2005)."
The full press release is here:
http://www.prnewswire.com/news-releases/researchers-urge-the-removal-of-mercury-from-flu-shots-117737828.html
Thursday, March 10, 2011
FDA & Justice Dept files consent decree against JNJ (NYSE: JNJ) division McNeil-PPC
The FDA today announced that a consent decree of permanent injunction has been filed against Tylenol producer McNeil-PPC (division of JNJ), for failing to comply with good manufacturing practices.
The FDA will assume control of three plants; located in Puerto Rico, Fort Washington, PA and Lancaster, PA.
The FDA announcement can be found here:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm246685.htm
Excerpt:
"Manufacturing deficiencies at McNeil’s facilities have resulted in several extensive recalls, including an April 30, 2010, recall of lots of several liquid products such as children’s Tylenol, Motrin, Zyrtec, and Benadryl products. In January 2010, the FDA issued a Warning Letter to McNeil’s Consumer Healthcare Division regarding violations identified at McNeil’s Las Piedras facility.
The decree, filed by the U.S. Department of Justice’s Office of Consumer Litigation and the U.S. Attorney’s Office for the Eastern District of Pennsylvania, requires McNeil to destroy all drugs under McNeil’s control that have been recalled from the Fort Washington, Las Piedras, and Lancaster facilities since December 2009. McNeil also must retain an independent expert to inspect the Fort Washington, Las Piedras, and Lancaster facilities to determine whether the violations have been corrected, and to ensure that adequate manufacturing processes are in place. After expert certification, the FDA will determine if the facilities are in compliance.
If the defendants violate the decree, the FDA may order McNeil to cease manufacturing, recall products, and take other corrective action, including levying fines of $15,000 for each day and an additional $15,000 for each violation of the law, up to $10 million annually."
The FDA will assume control of three plants; located in Puerto Rico, Fort Washington, PA and Lancaster, PA.
The FDA announcement can be found here:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm246685.htm
Excerpt:
"Manufacturing deficiencies at McNeil’s facilities have resulted in several extensive recalls, including an April 30, 2010, recall of lots of several liquid products such as children’s Tylenol, Motrin, Zyrtec, and Benadryl products. In January 2010, the FDA issued a Warning Letter to McNeil’s Consumer Healthcare Division regarding violations identified at McNeil’s Las Piedras facility.
The decree, filed by the U.S. Department of Justice’s Office of Consumer Litigation and the U.S. Attorney’s Office for the Eastern District of Pennsylvania, requires McNeil to destroy all drugs under McNeil’s control that have been recalled from the Fort Washington, Las Piedras, and Lancaster facilities since December 2009. McNeil also must retain an independent expert to inspect the Fort Washington, Las Piedras, and Lancaster facilities to determine whether the violations have been corrected, and to ensure that adequate manufacturing processes are in place. After expert certification, the FDA will determine if the facilities are in compliance.
If the defendants violate the decree, the FDA may order McNeil to cease manufacturing, recall products, and take other corrective action, including levying fines of $15,000 for each day and an additional $15,000 for each violation of the law, up to $10 million annually."
Wednesday, March 9, 2011
Coming soon: Flu Hysteria redux: H2N2. Calls for pre-vaccination for nonexistent threat
BBC reports that Dr. Gary Nabel and colleagues at the Vaccine Research Center (US) say that H2N2 poses a risk for a pandemic and that world governments should start a preemptive vaccine program now.
They suggest a worldwide vaccine program despite the fact that H2N2 does not currently pose a threat.
However, there was a major "oopsie" in 2004-2005, when "3,700 test kits of the 1957 H2N2 virus were accidentally spread around the world."
http://en.wikipedia.org/wiki/Influenza_A_virus_subtype_H2N2
http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00229
The full BBC report is here:
http://www.bbc.co.uk/news/health-12691894
Excerpts:
"The US authors say immunity to the H2N2 flu strain is very low in people under the age of 50. But a safe vaccine already exists after an H2N2 outbreak in the 1950s and '60s. They say that vaccinating now could save billions of dollars if a pandemic does develop."
"Between 2003 and 2007 they examined levels of immunity to H2N2 among a small group of 90 people.
"Our study suggests that people under the age of 50 have little or no immunity, and resistance dramatically increases for those older than 50. This was also the case for the 2009 H1N1."
They argue that the vaccine developed in the 1950s would still work today and that governments should use this to develop a pre-emptive vaccination programme.
"One approach would be to manufacture the vaccine licensed in 1957 and immunise enough of the world's population to provide 'herd immunity' to the rest.
"This could be achieved by a 'one-time' campaign to immunise most of the adult population worldwide - for example, as part of standard seasonal flu vaccinations - accompanied by an ongoing programme to administer the vaccine to children."
Cheaper option
The authors say this would be a much cheaper option than stockpiling the vaccine or waiting for a pandemic to strike before boosting production.
"Another major influenza pandemic is likely to cost far more and create a much greater health burden than a well-planned pre-emptive programme.
"The US Centres for Disease Control and Prevention estimates that a pandemic outbreak costs the United States between $71 billion and $167 billion."
Pretty amazing numbers being thrown around. Common sense seems to dictate that we spend millions now to save billions later. However, inquiring minds want to know which companies hold the patents for these vaccines? Somebody call Congress!
They suggest a worldwide vaccine program despite the fact that H2N2 does not currently pose a threat.
However, there was a major "oopsie" in 2004-2005, when "3,700 test kits of the 1957 H2N2 virus were accidentally spread around the world."
http://en.wikipedia.org/wiki/Influenza_A_virus_subtype_H2N2
http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00229
The full BBC report is here:
http://www.bbc.co.uk/news/health-12691894
Excerpts:
"The US authors say immunity to the H2N2 flu strain is very low in people under the age of 50. But a safe vaccine already exists after an H2N2 outbreak in the 1950s and '60s. They say that vaccinating now could save billions of dollars if a pandemic does develop."
"Between 2003 and 2007 they examined levels of immunity to H2N2 among a small group of 90 people.
"Our study suggests that people under the age of 50 have little or no immunity, and resistance dramatically increases for those older than 50. This was also the case for the 2009 H1N1."
They argue that the vaccine developed in the 1950s would still work today and that governments should use this to develop a pre-emptive vaccination programme.
"One approach would be to manufacture the vaccine licensed in 1957 and immunise enough of the world's population to provide 'herd immunity' to the rest.
"This could be achieved by a 'one-time' campaign to immunise most of the adult population worldwide - for example, as part of standard seasonal flu vaccinations - accompanied by an ongoing programme to administer the vaccine to children."
Cheaper option
The authors say this would be a much cheaper option than stockpiling the vaccine or waiting for a pandemic to strike before boosting production.
"Another major influenza pandemic is likely to cost far more and create a much greater health burden than a well-planned pre-emptive programme.
"The US Centres for Disease Control and Prevention estimates that a pandemic outbreak costs the United States between $71 billion and $167 billion."
Pretty amazing numbers being thrown around. Common sense seems to dictate that we spend millions now to save billions later. However, inquiring minds want to know which companies hold the patents for these vaccines? Somebody call Congress!
Adamis Pharmaceuticals (ADMP) files IND with FDA for APC-100 prostate cancer treatment
REALLY DANNY?
REALLY?
By the way, here is something for your Facebook page:
I hated every minute of training, but I said, 'Don't quit. Suffer now and live the rest of your life as a champion.'
Muhammad Ali
Adamis Pharmaceuticals announces the filings of an IND ("Investigational New Drug") application with the FDA for its APC-100 drug.
According to the announcement, "APC-100 is an orally available anti-androgenic/anti-inflammatory, signal transduction inhibitor drug. APC-100 has demonstrated to have higher therapeutic activity than the current marketed Standard of Care anti-androgens.
APC-100 has previously received the National Cancer Institute's (NCI) multi-year, multi-million dollar RAPID Award (Rapid Access to Preventative Intervention Development). Each year, this award is given by the NCI Division of Cancer Prevention, under the RAPID Program, to what it believes are the most promising new preventative/ therapeutic anti-cancer drugs.
Previously, development of APC-100 has been funded by Michael Milken's Prostate Cancer Foundation (PCF, formerly CapCure), the Department of Defense’s Congressionally Directed Medical Research Programs’ (CDMRP) Prostate Cancer Research Program (PCRP), as well as grants and contracts from the NCI."
The entire transcript can be found here:
http://www.businesswire.com/news/home/20110309005641/en/Adamis-Pharmaceuticals-Files-IND-Product-Candidate-Treat
Excerpt:
APC-100 is an orally available anti-androgenic/anti-inflammatory, signal transduction inhibitor drug. APC-100 has demonstrated to have higher therapeutic activity than the current marketed Standard of Care anti-androgens. Pre-clinical studies confirming the use of APC-100 for the treatment of prostate cancer were pioneered by Dr. George Wilding and his team. Dr. Wilding is the Assistant Dean for Oncology and Director of the University of Wisconsin Carbone Cancer Center. When tested side by side in the TRAMP prostate cancer mouse model (spontaneous prostate cancer model), APC-100 gave 90% efficacy versus the marketed Standard of Care giving 55% efficacy. In addition to increasing time to tumor progression and survival, APC-100 also induced a significant decrease in PSA production. Adamis believes these characteristics make APC-100 a first-in-class compound for the potential treatment of castrate-sensitive and castrate-resistant prostate cancer.
REALLY?
By the way, here is something for your Facebook page:
I hated every minute of training, but I said, 'Don't quit. Suffer now and live the rest of your life as a champion.'
Muhammad Ali
Adamis Pharmaceuticals announces the filings of an IND ("Investigational New Drug") application with the FDA for its APC-100 drug.
According to the announcement, "APC-100 is an orally available anti-androgenic/anti-inflammatory, signal transduction inhibitor drug. APC-100 has demonstrated to have higher therapeutic activity than the current marketed Standard of Care anti-androgens.
APC-100 has previously received the National Cancer Institute's (NCI) multi-year, multi-million dollar RAPID Award (Rapid Access to Preventative Intervention Development). Each year, this award is given by the NCI Division of Cancer Prevention, under the RAPID Program, to what it believes are the most promising new preventative/ therapeutic anti-cancer drugs.
Previously, development of APC-100 has been funded by Michael Milken's Prostate Cancer Foundation (PCF, formerly CapCure), the Department of Defense’s Congressionally Directed Medical Research Programs’ (CDMRP) Prostate Cancer Research Program (PCRP), as well as grants and contracts from the NCI."
The entire transcript can be found here:
http://www.businesswire.com/news/home/20110309005641/en/Adamis-Pharmaceuticals-Files-IND-Product-Candidate-Treat
Excerpt:
APC-100 is an orally available anti-androgenic/anti-inflammatory, signal transduction inhibitor drug. APC-100 has demonstrated to have higher therapeutic activity than the current marketed Standard of Care anti-androgens. Pre-clinical studies confirming the use of APC-100 for the treatment of prostate cancer were pioneered by Dr. George Wilding and his team. Dr. Wilding is the Assistant Dean for Oncology and Director of the University of Wisconsin Carbone Cancer Center. When tested side by side in the TRAMP prostate cancer mouse model (spontaneous prostate cancer model), APC-100 gave 90% efficacy versus the marketed Standard of Care giving 55% efficacy. In addition to increasing time to tumor progression and survival, APC-100 also induced a significant decrease in PSA production. Adamis believes these characteristics make APC-100 a first-in-class compound for the potential treatment of castrate-sensitive and castrate-resistant prostate cancer.
Tuesday, March 8, 2011
90 days in the life of an AID's patient (Topsy)
Unbelievable video -- from death's door to life. 90 days in the life of an AID's patient (in a minute and a half).
Video documents AIDs patients miraculous recovery. "Topsy" (by thetopsyfoundation).
Video documents AIDs patients miraculous recovery. "Topsy" (by thetopsyfoundation).
Aethlon Medical (AEMD) granted FDA approval to export Hemopurifier to India
Aethlon Medical, Inc. (AEMD) announced today that it has been granted FDA approval to export its Hemopurifier medical device to India.
Although not yet approved for sale in the US, the therapeutic filtration device was granted approval under section 801 (e) of the Federal Food, Drug, and Cosmetic Act for devices that are manufactured under the FDA's Good Manufacturing Practices.
According to the announcement, "Aethlon is currently conducting a clinical study entitled: "Use of the Aethlon Hemopurifier® in Treating Chronic HCV Infection in Combination with Standard of Care (SOC) Drug Therapy" at the Medicity Institute (Medicity) near Delhi, India. The Medicity is a $360 million multi-specialty medical institute recently established on a 43-acre campus to be a premier center of medical tourism in India. A clinical goal of the Aethlon-Medicity study will be to demonstrate that the Hemopurifier® is able to accelerate the benefit of HCV standard of care (SOC) drug regimens. Therapeutic filtration at the outset of SOC improves early virus reduction kinetics to levels associated with that of patients most likely to achieve a sustained viral response, which is the goal of HCV therapy. Additionally, lower quantities of HCV in circulation at the outset of SOC correlate with increased cure rates. Upon demonstration of treatment efficacy, Aethlon plans to commence commercialization of its Hemopurifier® in India."
Full report is here:
http://www.prnewswire.com/news-releases/aethlon-medical-receives-fda-approval-to-export-its-hemopurifier-to-india-117574578.html
Excerpt:
"Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
1. Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2. Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
3. Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4. Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats."
Although not yet approved for sale in the US, the therapeutic filtration device was granted approval under section 801 (e) of the Federal Food, Drug, and Cosmetic Act for devices that are manufactured under the FDA's Good Manufacturing Practices.
According to the announcement, "Aethlon is currently conducting a clinical study entitled: "Use of the Aethlon Hemopurifier® in Treating Chronic HCV Infection in Combination with Standard of Care (SOC) Drug Therapy" at the Medicity Institute (Medicity) near Delhi, India. The Medicity is a $360 million multi-specialty medical institute recently established on a 43-acre campus to be a premier center of medical tourism in India. A clinical goal of the Aethlon-Medicity study will be to demonstrate that the Hemopurifier® is able to accelerate the benefit of HCV standard of care (SOC) drug regimens. Therapeutic filtration at the outset of SOC improves early virus reduction kinetics to levels associated with that of patients most likely to achieve a sustained viral response, which is the goal of HCV therapy. Additionally, lower quantities of HCV in circulation at the outset of SOC correlate with increased cure rates. Upon demonstration of treatment efficacy, Aethlon plans to commence commercialization of its Hemopurifier® in India."
Full report is here:
http://www.prnewswire.com/news-releases/aethlon-medical-receives-fda-approval-to-export-its-hemopurifier-to-india-117574578.html
Excerpt:
"Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
1. Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2. Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
3. Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4. Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats."
Monday, March 7, 2011
More evidence why you might not want that flu shot (Hyman, Huff Post)
If you are paying attention, you should know by now that most of the recommendations for getting the flu vaccine are based on hype, hope and hysteria (along with a little industry propaganda, thrown in for good measure). But, Mark Hyman, of Huffington Post, knocks it out of the box, with his blog post: "Flu Shots: Panacea or Propaganda?"
Along with evidence provided by Flu Crazy (see: should you get the flu shot, probably not), Hymans note provides facts that show flu vaccines have NOT been proven to reduce person-to-person transmission of the flu or complications from pneumonia.
Also, research funded by industry paints a glowing picture of flu vaccines (and garners most of the attention), while publicly-funded research does just the opposite (and is widely ignored).
Our (easy) prediction: Hyman will be branded "crazy" and "dangerous." That's what he gets for citing the literature and providing a reasoned, non-hysteric analysis.
http://www.huffingtonpost.com/dr-mark-hyman/flu-shots-panacea-or-prop_b_831696.html
Along with evidence provided by Flu Crazy (see: should you get the flu shot, probably not), Hymans note provides facts that show flu vaccines have NOT been proven to reduce person-to-person transmission of the flu or complications from pneumonia.
Also, research funded by industry paints a glowing picture of flu vaccines (and garners most of the attention), while publicly-funded research does just the opposite (and is widely ignored).
Our (easy) prediction: Hyman will be branded "crazy" and "dangerous." That's what he gets for citing the literature and providing a reasoned, non-hysteric analysis.
http://www.huffingtonpost.com/dr-mark-hyman/flu-shots-panacea-or-prop_b_831696.html
Japan suspends use of pediatric vaccines from Pfizer & Sanofi
Bloomberg is reporting that the Japanese ministry of health has suspended the use of pediatric vaccines from Sanofi Aventis (SAN.PA) and Pfizer (NYSE: PFE), following the deaths of four children, between March 2 and March 4.
Pfizer's Prevenar and Sanofi's ActHIB have been suspended in Japan at least until tomorrow, until a panel can meet to discuss the deaths.
Prevnar is used to protect children from meningitis and pneumonia. While ActHIB is used to prevent Haemophilus influenzae type b.
The Bloomberg article can be found here:
http://www.bloomberg.com/news/2011-03-07/japan-stops-use-of-pfizer-sanofi-vaccines-on-four-deaths-1-.html
Pfizer's Prevenar and Sanofi's ActHIB have been suspended in Japan at least until tomorrow, until a panel can meet to discuss the deaths.
Prevnar is used to protect children from meningitis and pneumonia. While ActHIB is used to prevent Haemophilus influenzae type b.
The Bloomberg article can be found here:
http://www.bloomberg.com/news/2011-03-07/japan-stops-use-of-pfizer-sanofi-vaccines-on-four-deaths-1-.html
Sunday, March 6, 2011
About Allergan, Inc (NYSE: AGN)
About Allergan, Inc. (NYSE: AGN)
2525 Dupont Drive
Irvine, California, 92612
I.R.S. Employer Identification No.: 95-1622442
website: http://www.allergan.com/index.htm
Total Revenue: $ 4,919,400,000 (2010)
About Allergan (from Form 10-K):
We are a multi-specialty health care company focused on developing and commercializing innovative pharmaceuticals, biologics, medical devices and over-the-counter products that enable people to live life to its greatest potential — to see more clearly, move more freely and express themselves more fully. Our diversified approach enables us to follow our research and development into new specialty areas where unmet needs are significant.
We discover, develop and commercialize specialty pharmaceutical, biologics, medical device and over-the-counter products for the ophthalmic, neurological, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention, urological and other specialty markets in more than 100 countries around the world. Our diversified business model includes products for which patients may be eligible for reimbursement and cash pay products that consumers pay for directly. Based on internal information and assumptions, we estimate that in fiscal year 2010, approximately 71% of our net product sales were derived from reimbursable products and 29% of our net product sales were derived from cash pay products.
We are a pioneer in specialty pharmaceutical, biologic and medical device research and development, with global efforts targeting products and technologies related to eye care, skin care, neuromodulators, medical aesthetics, obesity intervention, urology and neurology. In 2010, our research and development expenditures were approximately 16.7% of our product net sales or approximately $804.6 million. We supplement our own research and development activities with our commitment to identify and obtain new technologies through in-licensing, research collaborations, joint ventures and acquisitions.
We were founded in 1950 and incorporated in Delaware in 1977. Our principal executive offices are located at 2525 Dupont Drive, Irvine, California, 92612, and our telephone number at that location is (714) 246-4500. Our Internet website address is www.allergan.com.
FDA Accused of going soft on Allergan (AGN)
http://flucrazy.blogspot.com/2011/03/fda-accused-of-going-soft-on-allergan.html
200 Largest Pharmaceutical Companies in the World
http://flucrazy.blogspot.com/2011/02/flucrazy-200-200-largest-pharmaceutical.html
2525 Dupont Drive
Irvine, California, 92612
I.R.S. Employer Identification No.: 95-1622442
website: http://www.allergan.com/index.htm
Total Revenue: $ 4,919,400,000 (2010)
About Allergan (from Form 10-K):
We are a multi-specialty health care company focused on developing and commercializing innovative pharmaceuticals, biologics, medical devices and over-the-counter products that enable people to live life to its greatest potential — to see more clearly, move more freely and express themselves more fully. Our diversified approach enables us to follow our research and development into new specialty areas where unmet needs are significant.
We discover, develop and commercialize specialty pharmaceutical, biologics, medical device and over-the-counter products for the ophthalmic, neurological, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention, urological and other specialty markets in more than 100 countries around the world. Our diversified business model includes products for which patients may be eligible for reimbursement and cash pay products that consumers pay for directly. Based on internal information and assumptions, we estimate that in fiscal year 2010, approximately 71% of our net product sales were derived from reimbursable products and 29% of our net product sales were derived from cash pay products.
We are a pioneer in specialty pharmaceutical, biologic and medical device research and development, with global efforts targeting products and technologies related to eye care, skin care, neuromodulators, medical aesthetics, obesity intervention, urology and neurology. In 2010, our research and development expenditures were approximately 16.7% of our product net sales or approximately $804.6 million. We supplement our own research and development activities with our commitment to identify and obtain new technologies through in-licensing, research collaborations, joint ventures and acquisitions.
We were founded in 1950 and incorporated in Delaware in 1977. Our principal executive offices are located at 2525 Dupont Drive, Irvine, California, 92612, and our telephone number at that location is (714) 246-4500. Our Internet website address is www.allergan.com.
FDA Accused of going soft on Allergan (AGN)
http://flucrazy.blogspot.com/2011/03/fda-accused-of-going-soft-on-allergan.html
200 Largest Pharmaceutical Companies in the World
http://flucrazy.blogspot.com/2011/02/flucrazy-200-200-largest-pharmaceutical.html
Report warns parents against over treating fever
A recent report in the journal "Pediatrics" may not prove to be very popular with parents and some caregivers. The authors contend that in most cases fever in children is a good thing and helps normalize body temperature, and in and of itself is not particularly dangerous.
Further, the study suggests that it is not a good idea to wake a child just to treat them with ibuprofen or acetaminophen.
"Fever" accounts for upwards of one-third of all trips to the pediatrician. Yet, parents may be over reacting to these symptoms and may be over treating their children (and are subject to "fever phobia"). The study asserts that the main goal in treating a fever is simply to make the child more comfortable, not to lower temperature.
The full report can be found here:
http://bit.ly/foAUE1
Excerpt:
SUMMARY
Appropriate counseling on the management of fever begins by helping parents understand that fever, in and of itself, is not known to endanger a generally healthy child. In contrast, fever may actually be of benefit; thus, the real goal of antipyretic therapy is not simply to normalize body temperature but to improve the overall comfort and well-being of the child. Acetaminophen and ibuprofen, when used in appropriate doses, are generally regarded as safe and effective agents in most clinical situations. However, as with all drugs, they should be used judiciously to minimize the risk of adverse drug effects and toxicity. Combination therapy with acetaminophen and ibuprofen may place infants and children at increased risk because of dosing errors and adverse outcomes, and these potential risks must be carefully considered. When counseling a family on the management of fever in a child, pediatricians and other health care providers should minimize fever phobia and emphasize that antipyretic use does not prevent febrile seizures. Pediatricians should focus instead on monitoring for signs/symptoms of serious illness, improving the child's comfort by maintaining hydration, and educating parents on the appropriate use, dosing, and safe storage of antipyretics. To promote child safety, pediatricians should advocate for a limited number of formulations of acetaminophen and ibuprofen and for clear labeling of dosing instructions and an included dosing device for antipyretic products.
Further, the study suggests that it is not a good idea to wake a child just to treat them with ibuprofen or acetaminophen.
"Fever" accounts for upwards of one-third of all trips to the pediatrician. Yet, parents may be over reacting to these symptoms and may be over treating their children (and are subject to "fever phobia"). The study asserts that the main goal in treating a fever is simply to make the child more comfortable, not to lower temperature.
The full report can be found here:
http://bit.ly/foAUE1
Excerpt:
SUMMARY
Appropriate counseling on the management of fever begins by helping parents understand that fever, in and of itself, is not known to endanger a generally healthy child. In contrast, fever may actually be of benefit; thus, the real goal of antipyretic therapy is not simply to normalize body temperature but to improve the overall comfort and well-being of the child. Acetaminophen and ibuprofen, when used in appropriate doses, are generally regarded as safe and effective agents in most clinical situations. However, as with all drugs, they should be used judiciously to minimize the risk of adverse drug effects and toxicity. Combination therapy with acetaminophen and ibuprofen may place infants and children at increased risk because of dosing errors and adverse outcomes, and these potential risks must be carefully considered. When counseling a family on the management of fever in a child, pediatricians and other health care providers should minimize fever phobia and emphasize that antipyretic use does not prevent febrile seizures. Pediatricians should focus instead on monitoring for signs/symptoms of serious illness, improving the child's comfort by maintaining hydration, and educating parents on the appropriate use, dosing, and safe storage of antipyretics. To promote child safety, pediatricians should advocate for a limited number of formulations of acetaminophen and ibuprofen and for clear labeling of dosing instructions and an included dosing device for antipyretic products.
China Vaccine Regulators Are Now WHO Certified
China's national regulatory authority, the "State Food and Drug Administration" (SFDA), has been found to meet requirements for a functional vaccine regulatory system, per published indicators. According to a report by the World Health Organization, Chinese vaccine manufacturers will now be eligible for prequalification of specific products. The addition of Chinese vaccines to the world market is expected to "have a significant, beneficial impact on global supply of vaccines of assured quality."
http://www.who.int/immunization_standards/vaccine_regulation/nra_china_functional/en/
Excerpts from the report:
"A WHO-led team concluded today, at the end of a comprehensive review by experts from six countries, that the national regulatory authority of China, the State Food and Drug Administration (SFDA), and affiliated institutions, meet WHO published indicators for a functional vaccine regulatory system."
"Effective regulatory oversight of vaccines is essential since vaccines are used on a population-wide basis, and are usually given to healthy infants. Furthermore, vaccines are produced in only a small number of countries and often exported from the country of manufacture to many countries. Countries importing vaccines need to be confident that the national regulatory authority in the country of origin is competent in its oversight. WHO has established benchmarks that define international expectations for a functional vaccine regulatory system. WHO also conducts regular external audits of national regulatory authorities, particularly in vaccine-producing countries, to ensure that the regulatory systems meet the necessary standards, and that the system is maintained and functions in a sustainable way."
"With a regulatory system for vaccines documented to comply with international standards, vaccine manufacturers in China are now eligible to apply for Prequalification of specific products. WHO prequalification, which is a guarantee that a specific vaccine meets international standards of quality, safety and efficacy, is a prerequisite for manufacturers to supply to countries through United Nations procuring agencies. Each application for prequalification of a specific product is independently evaluated by WHO. It is expected that vaccines from China could be prequalified 1-2 years from now. The eventual ability of United Nations procuring agencies to source vaccines from Chinese manufacturers is expected to have a significant, beneficial impact on global supply of vaccines of assured quality."
http://www.who.int/immunization_standards/vaccine_regulation/nra_china_functional/en/
Excerpts from the report:
"A WHO-led team concluded today, at the end of a comprehensive review by experts from six countries, that the national regulatory authority of China, the State Food and Drug Administration (SFDA), and affiliated institutions, meet WHO published indicators for a functional vaccine regulatory system."
"Effective regulatory oversight of vaccines is essential since vaccines are used on a population-wide basis, and are usually given to healthy infants. Furthermore, vaccines are produced in only a small number of countries and often exported from the country of manufacture to many countries. Countries importing vaccines need to be confident that the national regulatory authority in the country of origin is competent in its oversight. WHO has established benchmarks that define international expectations for a functional vaccine regulatory system. WHO also conducts regular external audits of national regulatory authorities, particularly in vaccine-producing countries, to ensure that the regulatory systems meet the necessary standards, and that the system is maintained and functions in a sustainable way."
"With a regulatory system for vaccines documented to comply with international standards, vaccine manufacturers in China are now eligible to apply for Prequalification of specific products. WHO prequalification, which is a guarantee that a specific vaccine meets international standards of quality, safety and efficacy, is a prerequisite for manufacturers to supply to countries through United Nations procuring agencies. Each application for prequalification of a specific product is independently evaluated by WHO. It is expected that vaccines from China could be prequalified 1-2 years from now. The eventual ability of United Nations procuring agencies to source vaccines from Chinese manufacturers is expected to have a significant, beneficial impact on global supply of vaccines of assured quality."
Thursday, March 3, 2011
British Members of Parliament react to swine flu hysteria created by Chief Medical Officer
Members of Parliament react to hysteria created by Chief Medical Officer
The House of Commons Science & Technology Committee (UK) released a report in which they questioned the methods with which the public was informed about the threat of the Swine Flu pandemic in 2009. The UK’s Chief Medical Officer held a press conference (on July 16, 2009) in which he suggested that up to 65,000 people in the UK could die during the pandemic.
According the to the report, “On 16 July 2009, the Chief Medical Officer, Sir Liam Donaldson, held a press briefing that led to media reports suggesting up to 65,000 people in the UK could die from swine flu in a worst case scenario. At that time, the number of actual deaths stood at around 30, and by the time the pandemic was over in April 2010, the total number of UK deaths was 460.
Dr Justin McCracken, Chief Executive of the Health Protection Agency (HPA), commented that: it shows how difficult communication is because it was not just the reasonable worst case scenario that was communicated to the press. It was, actually, the range of both the best and the worst. But, inevitably, I think the figure that the press focused on was the worst case scenario.”
Of course, the media ran with the report, and offered up scary headlines, which were echoed around the globe.
The committee’s recommendation:
“We recommend that there should be a single portal of information for every emergency, along the lines of flu.gov in the USA. This should be of use to members of the public as well as emergency responders and should be the primary source of all information, linking to other websites as necessary. We consider that maintaining this portal should be the responsibility of the Lead Government Department, and should be located within its departmental website.”
http://www.publications.parliament.uk/pa/cm201011/cmselect/cmsctech/498/49808.htm#a24
http://www.publications.parliament.uk/pa/cm201011/cmselect/cmsctech/498/49802.htm
The House of Commons Science & Technology Committee (UK) released a report in which they questioned the methods with which the public was informed about the threat of the Swine Flu pandemic in 2009. The UK’s Chief Medical Officer held a press conference (on July 16, 2009) in which he suggested that up to 65,000 people in the UK could die during the pandemic.
According the to the report, “On 16 July 2009, the Chief Medical Officer, Sir Liam Donaldson, held a press briefing that led to media reports suggesting up to 65,000 people in the UK could die from swine flu in a worst case scenario. At that time, the number of actual deaths stood at around 30, and by the time the pandemic was over in April 2010, the total number of UK deaths was 460.
Dr Justin McCracken, Chief Executive of the Health Protection Agency (HPA), commented that: it shows how difficult communication is because it was not just the reasonable worst case scenario that was communicated to the press. It was, actually, the range of both the best and the worst. But, inevitably, I think the figure that the press focused on was the worst case scenario.”
Of course, the media ran with the report, and offered up scary headlines, which were echoed around the globe.
The committee’s recommendation:
“We recommend that there should be a single portal of information for every emergency, along the lines of flu.gov in the USA. This should be of use to members of the public as well as emergency responders and should be the primary source of all information, linking to other websites as necessary. We consider that maintaining this portal should be the responsibility of the Lead Government Department, and should be located within its departmental website.”
http://www.publications.parliament.uk/pa/cm201011/cmselect/cmsctech/498/49808.htm#a24
http://www.publications.parliament.uk/pa/cm201011/cmselect/cmsctech/498/49802.htm
Wednesday, March 2, 2011
Baxter Intl’s (NYSE: BAX) Preflucel given EU approval
Baxter International (NYSE: BAX) announced that they have been approval by a European repeat mutual recognition procedure (rMRP), at the Austrian Agency for Health and Food Safety to begin providing it’s PREFLUCEL seasonal influenza vaccine for the 2011-12 flu season.
PREFLUCEL is manufactured via a patented cellular process (“Vero”), rather than the traditional embryonated chicken egg production process.
A study recently published in The Lancet showed a 78.5 percent protective efficacy.
The Baxter International release is here
http://www.baxter.com/press_room/press_releases/2011/03_02_11_preflucel_europe.html
PREFLUCEL is manufactured via a patented cellular process (“Vero”), rather than the traditional embryonated chicken egg production process.
A study recently published in The Lancet showed a 78.5 percent protective efficacy.
The Baxter International release is here
http://www.baxter.com/press_room/press_releases/2011/03_02_11_preflucel_europe.html
Tuesday, March 1, 2011
FDA accused of going soft on Allergan and Lap-Band
An article in the LA Times, takes the FDA to task for allowing Allergan (NYSE: AGN) to push it's Lap-Band for broader use, while still demanding further testing. Critics say that the testing should come first, then the approval, pointing to the companies shady marketing of Botox.
http://www.latimes.com/business/la-fi-hiltzik-20110222,0,376907.column
The article points out the glaring difference between today's FDA, which appears to be an industry cheerleader, rather than an industry watchdog, and the FDA of the 1960's when an inspector stood up to a company that tried to push through the drug thalidomide.
According to the LA Times, in "1960, a young inspector for the Food and Drug Administration faced down a powerful drug company by rejecting its application to sell a morning-sickness drug in the United States.
The company, Richardson-Merrell, griped about her repeated demands for more safety data. They complained to her superiors, branding her as a nitpicker. But she stood firm.
The drug in question was thalidomide, and worldwide as many as 12,000 children were born with severe birth defects after their mothers used it. In the U.S., where Frances Oldham Kelsey blocked Merrell from distributing the drug except to a few doctors for "experimental" trials, the toll was 17. Thanks to her, the FDA gained a reputation as a vigilant watchdog.
Today's FDA isn't that FDA.
Today's FDA just approved an application by the drug company Allergan to expand the target market of its Lap-Band weight-loss device potentially by tens of millions of patients. How much safety data did the FDA review before giving Allergan the green light? Mainly the results of one year of study of 149 patients, and partial data from a second year. Today's FDA evidently can be steamrollered.
Kelsey has said that she demanded more information from Merrell, thalidomide's U.S. manufacturer, because its history of conflicts with the agency made her suspicious. Is there any reason to mistrust Allergan? Let's look at the record.
In September, Allergan pleaded guilty to one criminal count and paid $600 million in fines and penalties to settle federal charges that it had illegally marketed its marquee product, Botox, for uses the FDA hadn't approved. The guilty plea was for "misbranding" Botox, a misdemeanor.
In accepting the plea bargain, the government charged that the company had made under-the-table payments to doctors who used Botox to treat unapproved conditions, created front groups and websites to push the broader uses of the drug while concealing Allergan's backing, and coached physicians to over-diagnose a condition for which Botox could be legally marketed so it could sell more product. Allergan says for the record that it doesn't believe there is merit to those allegations "factually or legally."
Allergan took these steps, the government contended, because the approved uses had meager sales potential. The most prevalent condition for which Botox treatment was approved, cervical dystonia, is a painful neck spasm that affects only about 27,000 people in the U.S. Allergan wanted doctors to prescribe Botox for headaches — not an approved use, but a potentially huge market — so it prodded them to diagnose their patients' headaches as symptoms of the very rare CD. (The use of Botox as a cosmetic wrinkle-remover wasn't at issue, but the typical injected dose for beauty treatment is tiny compared with that for a headache.)
Federal regulators were upset with Allergan because Botox derives from botulinum, one of the most toxic substances known to man. The high therapeutic doses, FDA officials say, increase the potential for the toxin to cause dangerous muscle weakness or paralysis.
Allergan's tactics worked fabulously. Between 1999 and 2006, the government says, Botox's headache sales grew by 1,407%. By 2007, total Botox sales exceeded $500 million. More than 70% of that was for unapproved uses.
This history didn't seem to enter into the FDA's review of Allergan's application to expand its marketing of the Lap-Band, a device that's surgically implanted around the stomach to suppress appetite. Up to now, the approved use has been for morbidly obese people who had failed to reduce with diet and exercise.
If you're 5 feet, 8 inches tall, you'd be eligible for the Lap-Band if you weighed 262, more than 100 pounds overweight, or 230 if you have an obesity-related condition such as diabetes. Under the newly approved standard, the latter figure drops to 197.
An FDA advisory panel, which gave preliminary approval to Allergan's application in December, wasn't entirely happy with the company's data supporting its safety and efficacy claims for the Lap-Band — its own 149-patient study and six other studies, at least three of which were conducted by researchers with financial links to Allergan.
"I chastised Allergan for the cherry-picking they had done in the data," says John Kral, a member of the panel and a surgery professor at the State University of New York. The panel felt that a study of 149 patients wasn't good enough to establish the device's safety and efficacy over the long haul. Kral says he and the rest of the panel majority favored approval of Allergan's application even so, because they felt that the Lap-Band's benefits outweighed the risks."
The article further points to aggressive marketing of the Lap-Band:
"Nor does the FDA action take into account the overheated marketing that already surrounds the Lap-Band, such as the 1-800-GET-THIN billboards promoting this surgery. (Just the other day, two published studies showed that more traditional weight-loss surgeries were more effective and no riskier than the band.) Do you think the GET-THIN gang might exploit the FDA approval to push their service even harder? My Magic 8-ball answers: "Signs point to yes."
Two weeks after Allergan pleaded out its criminal case, the FDA had a big ceremony honoring the now 96-year-old Kelsey. FDA Commissioner Margaret Hamburg pledged "to continue your great work here at the FDA."
Ironic, yes?
http://www.latimes.com/business/la-fi-hiltzik-20110222,0,376907.column
The article points out the glaring difference between today's FDA, which appears to be an industry cheerleader, rather than an industry watchdog, and the FDA of the 1960's when an inspector stood up to a company that tried to push through the drug thalidomide.
According to the LA Times, in "1960, a young inspector for the Food and Drug Administration faced down a powerful drug company by rejecting its application to sell a morning-sickness drug in the United States.
The company, Richardson-Merrell, griped about her repeated demands for more safety data. They complained to her superiors, branding her as a nitpicker. But she stood firm.
The drug in question was thalidomide, and worldwide as many as 12,000 children were born with severe birth defects after their mothers used it. In the U.S., where Frances Oldham Kelsey blocked Merrell from distributing the drug except to a few doctors for "experimental" trials, the toll was 17. Thanks to her, the FDA gained a reputation as a vigilant watchdog.
Today's FDA isn't that FDA.
Today's FDA just approved an application by the drug company Allergan to expand the target market of its Lap-Band weight-loss device potentially by tens of millions of patients. How much safety data did the FDA review before giving Allergan the green light? Mainly the results of one year of study of 149 patients, and partial data from a second year. Today's FDA evidently can be steamrollered.
Kelsey has said that she demanded more information from Merrell, thalidomide's U.S. manufacturer, because its history of conflicts with the agency made her suspicious. Is there any reason to mistrust Allergan? Let's look at the record.
In September, Allergan pleaded guilty to one criminal count and paid $600 million in fines and penalties to settle federal charges that it had illegally marketed its marquee product, Botox, for uses the FDA hadn't approved. The guilty plea was for "misbranding" Botox, a misdemeanor.
In accepting the plea bargain, the government charged that the company had made under-the-table payments to doctors who used Botox to treat unapproved conditions, created front groups and websites to push the broader uses of the drug while concealing Allergan's backing, and coached physicians to over-diagnose a condition for which Botox could be legally marketed so it could sell more product. Allergan says for the record that it doesn't believe there is merit to those allegations "factually or legally."
Allergan took these steps, the government contended, because the approved uses had meager sales potential. The most prevalent condition for which Botox treatment was approved, cervical dystonia, is a painful neck spasm that affects only about 27,000 people in the U.S. Allergan wanted doctors to prescribe Botox for headaches — not an approved use, but a potentially huge market — so it prodded them to diagnose their patients' headaches as symptoms of the very rare CD. (The use of Botox as a cosmetic wrinkle-remover wasn't at issue, but the typical injected dose for beauty treatment is tiny compared with that for a headache.)
Federal regulators were upset with Allergan because Botox derives from botulinum, one of the most toxic substances known to man. The high therapeutic doses, FDA officials say, increase the potential for the toxin to cause dangerous muscle weakness or paralysis.
Allergan's tactics worked fabulously. Between 1999 and 2006, the government says, Botox's headache sales grew by 1,407%. By 2007, total Botox sales exceeded $500 million. More than 70% of that was for unapproved uses.
This history didn't seem to enter into the FDA's review of Allergan's application to expand its marketing of the Lap-Band, a device that's surgically implanted around the stomach to suppress appetite. Up to now, the approved use has been for morbidly obese people who had failed to reduce with diet and exercise.
If you're 5 feet, 8 inches tall, you'd be eligible for the Lap-Band if you weighed 262, more than 100 pounds overweight, or 230 if you have an obesity-related condition such as diabetes. Under the newly approved standard, the latter figure drops to 197.
An FDA advisory panel, which gave preliminary approval to Allergan's application in December, wasn't entirely happy with the company's data supporting its safety and efficacy claims for the Lap-Band — its own 149-patient study and six other studies, at least three of which were conducted by researchers with financial links to Allergan.
"I chastised Allergan for the cherry-picking they had done in the data," says John Kral, a member of the panel and a surgery professor at the State University of New York. The panel felt that a study of 149 patients wasn't good enough to establish the device's safety and efficacy over the long haul. Kral says he and the rest of the panel majority favored approval of Allergan's application even so, because they felt that the Lap-Band's benefits outweighed the risks."
The article further points to aggressive marketing of the Lap-Band:
"Nor does the FDA action take into account the overheated marketing that already surrounds the Lap-Band, such as the 1-800-GET-THIN billboards promoting this surgery. (Just the other day, two published studies showed that more traditional weight-loss surgeries were more effective and no riskier than the band.) Do you think the GET-THIN gang might exploit the FDA approval to push their service even harder? My Magic 8-ball answers: "Signs point to yes."
Two weeks after Allergan pleaded out its criminal case, the FDA had a big ceremony honoring the now 96-year-old Kelsey. FDA Commissioner Margaret Hamburg pledged "to continue your great work here at the FDA."
Ironic, yes?
Monday, February 28, 2011
Should you get the flu shot? Probably not
There are good and valid reasons to get the annual seasonal flu shot, especially if you have an underlying medical condition such as asthma, heart disease, or a weakened immune system.
But, for the vast majority of healthy people (under the age of 65), there are also good and valid reasons NOT to get the annual influenza shot. Although some are distrustful of all vaccines, there are specific reasons to be wary of the influenza vaccine;
these include:
• Complications related to the flu shot. Many people report feeling sick after getting the flu shot, and children have been reported to suffer from febrile seizures. Reports of narcolepsy and adverse reactions to the flu shot appear to be on the rise.
• The flu shot is not entirely effective. You can still get the flu, even if you are vaccinated. So, while you incur the risks for adverse side effects you may still get the flu.
* The effectiveness of the anti-flu treatment Tamiflu has been called into question, and it appears that it does not lessen hospital stays. Further it appears some of the results of the trials were intentionally withheld when they painted a picture of doing exactly the opposite of the intended affect. There was one trial that seemed to suggest that Tamiflu lessened the ability of the immune system to fight influenza.
• Lack of legal recourse (civil) especially in the US if you are harmed by the flu shot. A US Supreme Court decision (BRUESEWITZ et al. v . WYETH LLC) sided with vaccine makers in a case involving a Pennsylvania girl who was denied a claim in vaccine court and was not allowed for file a claim in civil court. The fact is that if you lose your case in “vaccine court” you will have no further legal recourse. Some, including Supreme Court Justice Sotomayor, argue that there are now no serious consequences for vaccine manufacturers if they produce a faulty product and that no other industry in America has such a comprehensive “get out of jail free” card.
• Most healthy people do not require hospitalization for the flu, even though suffering from the flu is uncomfortable.
• Washing your hands frequently, eating healthy, and getting plenty of sleep are very good ways to avoid getting the flu.
• The majority of health care providers (approximately 60%) choose NOT to get the flu shot every year. Even the risk of termination of their job is not great enough of a threat to convince them to risk getting the flu shot. [ Edit note: in 2012, the numbers have improved. One study shows that 60% + of health care providers are now getting the flu shot. But, this improvement has happened after employers threatened termination for non-compliance. The fact that so many health care providers are still leery of getting the flu shot speaks volumes. ]
• Recommendations for getting the flu shot vary widely from country to country. For example, most countries in Europe only recommend those aged 65 or over get the flu shot (with no underlying medical condition).
• The odds of dying from the flu are minuscule. The CDC’s numbers for mortality are suspect, at best. Influenza is grouped with pneumonia statistics, thus blurring any meaningful comparisons. But, even the CDC admits that most deaths occur among the elderly population, yet still insist that everyone (over 6 months of age) get the flu shot. The is especially at odds with reality, given that pediatric deaths associated with flu are now at historically low levels.
• Valid reasons to mistrust government and pharmaceutical pronouncements, including the influence of money in the political process. The recent case of trial tests of the antibiotic drug “Trovan” on African children, allegedly without parental consent, illustrates problems with the industry. Recent news reports about past horrors amplify the point. *
• Valid reasons to mistrust media outlets. Many newspapers, web sites, and television news programs are beholden to vast pharmaceutical advertising dollars. Anyone who questions the necessity of flu shots is instantly branded a kook or “dangerous.” An outlet that does not follow the party line risks losing advertising dollars to other programs that are not so choosy about what they publish.
• Not all flu shot formulas are the same. Risks vary by formula. The nasal flu shot, Flumist, contains a live, albeit weakened, influenza virus.
So, we will continue to remain skeptical of the CDC's blanket recommendation that everyone over the age of 6 months get the flu shot.
As with all medical decisions, you should ask your doctor if you should get the flu shot. But, also ask him/her if they have gotten the flu shot themselves.
Hopefully they will be honest with you.
See also: Flu Shots: Panacea or Propaganda? http://www.huffingtonpost.com/dr-mark-hyman/flu-shots-panacea-or-prop_b_831696.html
*AP IMPACT: Past medical testing on humans revealed
http://www.washingtonpost.com/wp-dyn/content/article/2011/02/27/AR2011022700988.html
But, for the vast majority of healthy people (under the age of 65), there are also good and valid reasons NOT to get the annual influenza shot. Although some are distrustful of all vaccines, there are specific reasons to be wary of the influenza vaccine;
these include:
• Complications related to the flu shot. Many people report feeling sick after getting the flu shot, and children have been reported to suffer from febrile seizures. Reports of narcolepsy and adverse reactions to the flu shot appear to be on the rise.
• The flu shot is not entirely effective. You can still get the flu, even if you are vaccinated. So, while you incur the risks for adverse side effects you may still get the flu.
* The effectiveness of the anti-flu treatment Tamiflu has been called into question, and it appears that it does not lessen hospital stays. Further it appears some of the results of the trials were intentionally withheld when they painted a picture of doing exactly the opposite of the intended affect. There was one trial that seemed to suggest that Tamiflu lessened the ability of the immune system to fight influenza.
• Lack of legal recourse (civil) especially in the US if you are harmed by the flu shot. A US Supreme Court decision (BRUESEWITZ et al. v . WYETH LLC) sided with vaccine makers in a case involving a Pennsylvania girl who was denied a claim in vaccine court and was not allowed for file a claim in civil court. The fact is that if you lose your case in “vaccine court” you will have no further legal recourse. Some, including Supreme Court Justice Sotomayor, argue that there are now no serious consequences for vaccine manufacturers if they produce a faulty product and that no other industry in America has such a comprehensive “get out of jail free” card.
• Most healthy people do not require hospitalization for the flu, even though suffering from the flu is uncomfortable.
• Washing your hands frequently, eating healthy, and getting plenty of sleep are very good ways to avoid getting the flu.
• The majority of health care providers (approximately 60%) choose NOT to get the flu shot every year. Even the risk of termination of their job is not great enough of a threat to convince them to risk getting the flu shot. [ Edit note: in 2012, the numbers have improved. One study shows that 60% + of health care providers are now getting the flu shot. But, this improvement has happened after employers threatened termination for non-compliance. The fact that so many health care providers are still leery of getting the flu shot speaks volumes. ]
• Recommendations for getting the flu shot vary widely from country to country. For example, most countries in Europe only recommend those aged 65 or over get the flu shot (with no underlying medical condition).
• The odds of dying from the flu are minuscule. The CDC’s numbers for mortality are suspect, at best. Influenza is grouped with pneumonia statistics, thus blurring any meaningful comparisons. But, even the CDC admits that most deaths occur among the elderly population, yet still insist that everyone (over 6 months of age) get the flu shot. The is especially at odds with reality, given that pediatric deaths associated with flu are now at historically low levels.
• Valid reasons to mistrust government and pharmaceutical pronouncements, including the influence of money in the political process. The recent case of trial tests of the antibiotic drug “Trovan” on African children, allegedly without parental consent, illustrates problems with the industry. Recent news reports about past horrors amplify the point. *
• Valid reasons to mistrust media outlets. Many newspapers, web sites, and television news programs are beholden to vast pharmaceutical advertising dollars. Anyone who questions the necessity of flu shots is instantly branded a kook or “dangerous.” An outlet that does not follow the party line risks losing advertising dollars to other programs that are not so choosy about what they publish.
• Not all flu shot formulas are the same. Risks vary by formula. The nasal flu shot, Flumist, contains a live, albeit weakened, influenza virus.
So, we will continue to remain skeptical of the CDC's blanket recommendation that everyone over the age of 6 months get the flu shot.
As with all medical decisions, you should ask your doctor if you should get the flu shot. But, also ask him/her if they have gotten the flu shot themselves.
Hopefully they will be honest with you.
See also: Flu Shots: Panacea or Propaganda? http://www.huffingtonpost.com/dr-mark-hyman/flu-shots-panacea-or-prop_b_831696.html
*AP IMPACT: Past medical testing on humans revealed
http://www.washingtonpost.com/wp-dyn/content/article/2011/02/27/AR2011022700988.html
Friday, February 25, 2011
Flu Vaccine Recommendations for UK, Germany, France, Spain, Italy
Flu Vaccine Recommendations for UK, Germany, France, Spain, Italy
Unlike the US, where the CDC recommends that nearly everyone over 6 months of age get the annual seasonal influenza shot, many other countries only recommend the shot (or, "the jab" as it is known in the UK) for person's aged 60 or older. In fact, most reserve the recommendation for people over 65 (with no underlying medical condition).
The US stands in sharp contrast, where the recommendation is that "everyone 6 months and older should get a flu vaccine each year starting with the 2010-2011 influenza season."
http://www.cdc.gov/media/pressrel/2010/r100224.htm
By contrast, the Europeans suggest that only those with underlying medical conditions (and not as many as in the US) and those over 65 get the shot.
It is not clear what the leading driver is for this disparity. It could be a number of factors, including; influence of the large pharmaceutical companies, legal structures (in the US vaccine makers shielded from civil liability), structural and political reasons, or, perhaps just hysteria.
Source: www.eurosurveillance.org
http://www.eurosurveillance.org/images/dynamic/EE/V15N44/MERECKIENE_Tab1.jpg
Unlike the US, where the CDC recommends that nearly everyone over 6 months of age get the annual seasonal influenza shot, many other countries only recommend the shot (or, "the jab" as it is known in the UK) for person's aged 60 or older. In fact, most reserve the recommendation for people over 65 (with no underlying medical condition).
The US stands in sharp contrast, where the recommendation is that "everyone 6 months and older should get a flu vaccine each year starting with the 2010-2011 influenza season."
http://www.cdc.gov/media/pressrel/2010/r100224.htm
By contrast, the Europeans suggest that only those with underlying medical conditions (and not as many as in the US) and those over 65 get the shot.
It is not clear what the leading driver is for this disparity. It could be a number of factors, including; influence of the large pharmaceutical companies, legal structures (in the US vaccine makers shielded from civil liability), structural and political reasons, or, perhaps just hysteria.
Source: www.eurosurveillance.org
http://www.eurosurveillance.org/images/dynamic/EE/V15N44/MERECKIENE_Tab1.jpg
Sanofi-Aventis (NYSE: SNY) acquires BMP Sunstone (NASDAQ: BJGP) for $ 10/share
Sanofi-Aventis (SNY) announced the consummation of the previously announced merger with BMP Sunstone (BJGP), following a special meeting held today.
BMP Sunstone will provide a portfolio of products for the Chinese market, including pediatric and women’s health products sold in pharmacies throughout China.
According to the announcement, with “the closing of the merger, BMP Sunstone common stock will no longer trade on the NASDAQ Global Market following today's market close and will be delisted.
Morgan, Lewis & Bockius LLP served as counsel to BMP Sunstone. Stephens Inc. acted as financial advisor to BMP Sunstone. Shearman & Sterling LLP served as counsel to sanofi-aventis. Morgan Stanley acted as financial advisor to sanofi-aventis.”
The press release is available: here
BMP Sunstone will provide a portfolio of products for the Chinese market, including pediatric and women’s health products sold in pharmacies throughout China.
According to the announcement, with “the closing of the merger, BMP Sunstone common stock will no longer trade on the NASDAQ Global Market following today's market close and will be delisted.
Morgan, Lewis & Bockius LLP served as counsel to BMP Sunstone. Stephens Inc. acted as financial advisor to BMP Sunstone. Shearman & Sterling LLP served as counsel to sanofi-aventis. Morgan Stanley acted as financial advisor to sanofi-aventis.”
The press release is available: here
Wednesday, February 23, 2011
Gilead Sciences (NASDAQ: GILD) acquires privately-held bio-tech firm Calistoga Pharmaceuticals for $ 375 million.
Gilead Sciences (NASDAQ: GILD) acquires privately-held bio-tech firm Calistoga Pharmaceuticals for $ 375 million. Calistoga stands to earn an additional $ 225 million if certain milestones are achieved. Gilead will consummate the transaction with cash on hand.
Gilead will pick up a stable of cancer fighting compounds, including Calistoga's lead product candidate, CAL-101, a "first-in-class specific inhibitor of the PI3K delta isoform. PI3K delta is preferentially expressed in leukocytes involved in a variety of inflammatory and autoimmune diseases and hematological cancers. CAL-101 is currently in Phase II studies as a single agent in patients with refractory indolent non-Hodgkin's lymphoma (iNHL) and in combination with rituximab in treatment-naïve elderly patients with chronic lymphocytic leukemia (CLL). In addition to CAL-101, Calistoga Pharmaceuticals' product development pipeline includes other selective PI3K inhibitors that are in preclinical development, and may have application in both oncology and inflammatory diseases."
Advisors to the transaction:
"Calistoga Pharmaceuticals' exclusive financial advisor for the transaction was J.P. Morgan Securities LLC while Wilson Sonsini Goodrich & Rosati, P.C. was its legal advisor."
The full press release is: here
Gilead will pick up a stable of cancer fighting compounds, including Calistoga's lead product candidate, CAL-101, a "first-in-class specific inhibitor of the PI3K delta isoform. PI3K delta is preferentially expressed in leukocytes involved in a variety of inflammatory and autoimmune diseases and hematological cancers. CAL-101 is currently in Phase II studies as a single agent in patients with refractory indolent non-Hodgkin's lymphoma (iNHL) and in combination with rituximab in treatment-naïve elderly patients with chronic lymphocytic leukemia (CLL). In addition to CAL-101, Calistoga Pharmaceuticals' product development pipeline includes other selective PI3K inhibitors that are in preclinical development, and may have application in both oncology and inflammatory diseases."
Advisors to the transaction:
"Calistoga Pharmaceuticals' exclusive financial advisor for the transaction was J.P. Morgan Securities LLC while Wilson Sonsini Goodrich & Rosati, P.C. was its legal advisor."
The full press release is: here
Tuesday, February 22, 2011
Vaccine makers shielded from suits says Supreme Court
In a 6-2 vote, the Supreme Court today ruled that vaccine makers cannot be sued outside of a specially designated "vaccine court," created by National Childhood Vaccine Injury Act of 1986.
The justices apparently struggled with some ambiguities in the law, with Justice Scalia writing that the "lack of guidance for design defects [in the drugs] combined with the extensive guidance for the grounds of liability specifically mentioned in the act strongly suggests that design defects were not mentioned because they are not a basis for liability."
However, Justice Sotomayer (with Justice Ginsburg) dissented, saying that
to "pre-empt all design defect claims against vaccine manufacturers for covered vaccines, the majority’s decision leaves a regulatory vacuum in which no one—neither the FDA nor any other federal agency, nor state and federal juries—ensures that vaccine manufacturers adequately take account of scientific and technological advancements.
This concern is especially acute with respect to vaccines that have already been released and marketed to the public. Manufacturers, given the lack of robust competition in the vaccine market, will often have little or no incentive to improve the designs of vaccines that are already generating significant profit margins. Nothing in the text, structure, or legislative history remotely suggests that Congress intended that result."
Links to the Supreme Court decision can be found: here.
The ruling was in response to a case brought by the Bruesewitz family, against Wyeth (now owned by Pfizer, Inc), in which the Breusewitz's claimed that their infant daughter was harmed by toxins in a booster shot.
The justices apparently struggled with some ambiguities in the law, with Justice Scalia writing that the "lack of guidance for design defects [in the drugs] combined with the extensive guidance for the grounds of liability specifically mentioned in the act strongly suggests that design defects were not mentioned because they are not a basis for liability."
However, Justice Sotomayer (with Justice Ginsburg) dissented, saying that
to "pre-empt all design defect claims against vaccine manufacturers for covered vaccines, the majority’s decision leaves a regulatory vacuum in which no one—neither the FDA nor any other federal agency, nor state and federal juries—ensures that vaccine manufacturers adequately take account of scientific and technological advancements.
This concern is especially acute with respect to vaccines that have already been released and marketed to the public. Manufacturers, given the lack of robust competition in the vaccine market, will often have little or no incentive to improve the designs of vaccines that are already generating significant profit margins. Nothing in the text, structure, or legislative history remotely suggests that Congress intended that result."
Links to the Supreme Court decision can be found: here.
The ruling was in response to a case brought by the Bruesewitz family, against Wyeth (now owned by Pfizer, Inc), in which the Breusewitz's claimed that their infant daughter was harmed by toxins in a booster shot.
Pfizer Inc (NYSE: PFE) and plaintiffs settle lawsuits related to clinical trial of antibiotic Trovan
Pfizer Inc (NYSE: PFE) and plaintiffs in the cases related to the clinical trial of antibiotic Trovan, have settled the lawsuits.
Although the suits have been resolved, the tragedy continues for children affected by the trial. The suits alleged that Pfizer conducted clinical trials of the controversial antibiotic "Trovan" on some 200 children without the parents consent. Pfizer says that the 11 children who died during the trial were suffering from meningitis, but the parents disputed this.
Trovan has since been barred from pediatric use and is only available in the US for adult populations, due to side affects.
It looked like the plaintiffs in the case were destined to lose in their next court challenge (at the US Supreme Court), and decided to settle the case.
According to a report by Dow Jones Newswires, "Pfizer Inc. (PFE) said Tuesday it has settled lawsuits stemming from a 1996 clinical trial of the antibiotic Trovan in which 11 Nigerian children died and others suffered health problems.
The New York-based drug maker said the terms of the settlement were confidential. A plaintiffs' attorney in the settlement couldn't be reached.
Pfizer conducted the Trovan trial during in outbreak of cerebral spinal meningitis in Nigeria, with the goal of providing a medicine to treat the disease. Families of the children and the Nigerian government accused the company of experimenting on children without proper consent. Pfizer has maintained it conducted the trial in consultation with Nigerian authorities, and that the deaths were caused by meningitis.
Pfizer previously reached settlements with government bodies in Nigeria."
http://english.capital.gr/News.asp?id=1139967
There is more information about these cases via Law.com (ALM):
"According to Nigerian press reports, the trust fund can pay a maximum of $35,000 per family to those able to prove death or permanent disability due to the 1996 trial of Trovan, an antibiotic that has since been restricted to adult emergency care in America because of its damaging side effects.
Pfizer spokesman Christopher Loder said the settlement is confidential and he could not discuss if there were any other terms. Plaintiffs' lawyer Peter Safirstein of Milberg also declined comment beyond the statement.
The suit accused Pfizer of using the experimental drug without the consent of the parents, and of not telling the families that another acceptable drug was available and was being used by Doctors Without Borders in Nigeria to treat the epidemic. Pfizer denied their allegations.
The families battled Pfizer all the way to the U.S. Supreme Court and back after U.S. District Judge William H. Pauley, III, had dismissed the suit in 2005. As of a hearing on Friday, the case was still in the pre-trial motion stage.
But earlier this month the plaintiffs' cause took a bleak turn when the 2nd Circuit Court of Appeals ruled en banc in a different case that claims against a corporation cannot be brought under the Alien Tort Statute. Rather than risk another dismissal and another appeal that was destined to lose at the next level, the plaintiffs agreed on Friday to settle all claims both in the U.S. and Nigeria.
Pfizer established the $35 million Healthcare/Meningitis Trust Fund as part of settling a suit in 2007 brought by the Kano state government, where the drug trial took place. That settlement also is confidential."
http://www.law.com/jsp/cc/PubArticleCC.jsp?id=1202482854504&Pfizer_Settles_Lawsuits_Over_Drugs_Trials_on_Children_in_Nigeria_
200 Largest Pharmaceutical Companies in the World
http://flucrazy.blogspot.com/2011/02/flucrazy-200-200-largest-pharmaceutical.html
Although the suits have been resolved, the tragedy continues for children affected by the trial. The suits alleged that Pfizer conducted clinical trials of the controversial antibiotic "Trovan" on some 200 children without the parents consent. Pfizer says that the 11 children who died during the trial were suffering from meningitis, but the parents disputed this.
Trovan has since been barred from pediatric use and is only available in the US for adult populations, due to side affects.
It looked like the plaintiffs in the case were destined to lose in their next court challenge (at the US Supreme Court), and decided to settle the case.
According to a report by Dow Jones Newswires, "Pfizer Inc. (PFE) said Tuesday it has settled lawsuits stemming from a 1996 clinical trial of the antibiotic Trovan in which 11 Nigerian children died and others suffered health problems.
The New York-based drug maker said the terms of the settlement were confidential. A plaintiffs' attorney in the settlement couldn't be reached.
Pfizer conducted the Trovan trial during in outbreak of cerebral spinal meningitis in Nigeria, with the goal of providing a medicine to treat the disease. Families of the children and the Nigerian government accused the company of experimenting on children without proper consent. Pfizer has maintained it conducted the trial in consultation with Nigerian authorities, and that the deaths were caused by meningitis.
Pfizer previously reached settlements with government bodies in Nigeria."
http://english.capital.gr/News.asp?id=1139967
There is more information about these cases via Law.com (ALM):
"According to Nigerian press reports, the trust fund can pay a maximum of $35,000 per family to those able to prove death or permanent disability due to the 1996 trial of Trovan, an antibiotic that has since been restricted to adult emergency care in America because of its damaging side effects.
Pfizer spokesman Christopher Loder said the settlement is confidential and he could not discuss if there were any other terms. Plaintiffs' lawyer Peter Safirstein of Milberg also declined comment beyond the statement.
The suit accused Pfizer of using the experimental drug without the consent of the parents, and of not telling the families that another acceptable drug was available and was being used by Doctors Without Borders in Nigeria to treat the epidemic. Pfizer denied their allegations.
The families battled Pfizer all the way to the U.S. Supreme Court and back after U.S. District Judge William H. Pauley, III, had dismissed the suit in 2005. As of a hearing on Friday, the case was still in the pre-trial motion stage.
But earlier this month the plaintiffs' cause took a bleak turn when the 2nd Circuit Court of Appeals ruled en banc in a different case that claims against a corporation cannot be brought under the Alien Tort Statute. Rather than risk another dismissal and another appeal that was destined to lose at the next level, the plaintiffs agreed on Friday to settle all claims both in the U.S. and Nigeria.
Pfizer established the $35 million Healthcare/Meningitis Trust Fund as part of settling a suit in 2007 brought by the Kano state government, where the drug trial took place. That settlement also is confidential."
http://www.law.com/jsp/cc/PubArticleCC.jsp?id=1202482854504&Pfizer_Settles_Lawsuits_Over_Drugs_Trials_on_Children_in_Nigeria_
200 Largest Pharmaceutical Companies in the World
http://flucrazy.blogspot.com/2011/02/flucrazy-200-200-largest-pharmaceutical.html
Monday, February 21, 2011
FluGen raises $ 7.8 million for development of Flu Patch
As reported by the Milwaukee Wisconsin Journal Sentinel, FluGen a "Madison company that is trying to develop a safer flu vaccine, has landed $7.8 million of funding that should allow it to being one of its leading technologies into human clinical trials this year.
Knox LLC of Las Vegas, the investment vehicle for a wealthy University of Wisconsin-Madison alum, led the funding round.
FluGen will use the money to fund a Phase I clinical trial for its vaccine delivery device, a micro-needle skin patch the size of a poker chip the company says is more effective and less painful than standard needle injections. In the trial, FluGen will use a vaccine that already is on the market, said Paul Radspinner, the company's president and chief executive officer.
The patch promises to make vaccines more effective in older people because it delivers them into the skin, which is able to maintain immunity longer than the rest of the body, Radspinner said. It will also be less invasive, and therefore less scary, for children, he said."
The Journal Sentinel article also pointed out the encouraging business environment in Wisconsin.
"The climate for capital formation and investment in bioscience innovation in the state of Wisconsin is strong and likely to attract substantial additional outside investment interest in the months and years to come…" Mancheski said.
http://www.jsonline.com/business/116603133.html
#flu #pharma
Knox LLC of Las Vegas, the investment vehicle for a wealthy University of Wisconsin-Madison alum, led the funding round.
FluGen will use the money to fund a Phase I clinical trial for its vaccine delivery device, a micro-needle skin patch the size of a poker chip the company says is more effective and less painful than standard needle injections. In the trial, FluGen will use a vaccine that already is on the market, said Paul Radspinner, the company's president and chief executive officer.
The patch promises to make vaccines more effective in older people because it delivers them into the skin, which is able to maintain immunity longer than the rest of the body, Radspinner said. It will also be less invasive, and therefore less scary, for children, he said."
The Journal Sentinel article also pointed out the encouraging business environment in Wisconsin.
"The climate for capital formation and investment in bioscience innovation in the state of Wisconsin is strong and likely to attract substantial additional outside investment interest in the months and years to come…" Mancheski said.
http://www.jsonline.com/business/116603133.html
#flu #pharma
About Auxilium Pharmaceuticals, Inc (NASDAQ: AUXL)
About Auxilium Pharmaceuticals, Inc (NASDAQ: AUXL)
40 Valley Stream Parkway
Malvern, PA 19355
(484) 321-5900
23-3016883
(I.R.S. Employer
Identification No.)
Employees: 540 (Approx.)
Revenue: $ 164 Million
From Form 10-K,
"We are a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences, such as urologists, endocrinologists, certain targeted primary care physicians, hand surgeons, subsets of orthopedic, general, and plastic surgeons who focus on the hand, and rheumatologists. We currently have approximately 540 employees, including a sales and marketing organization of approximately 315 people. We reported revenues in 2009 of $164 million, an increase of 30.8% over the $125.4 million reported in 2008.
We currently market two products in the United States (“U.S.”):
Testim® is a proprietary, topical 1% testosterone once-a-day gel indicated for the treatment of hypogonadism. Hypogonadism is defined as reduced or absent secretion of testosterone which can lead to symptoms such as low energy, loss of libido, adverse changes in body composition, irritability and poor concentration. Testim has been approved in the U.S. by the U.S. Food and Drug Administration (“FDA”) and according to National Prescription Audit (“NPA”) data from IMS Health, Inc. (“IMS”), a pharmaceutical market research firm, Testim’s share of total prescriptions for the gel segment of the U.S. testosterone replacement therapy (“TRT”) market was 22.3% for the month of December 2009, and 22.0% for the full year 2009.
XIAFLEX™ (collagenase clostridium histolyticum) is a proprietary, injectable collagenase enzyme for the treatment of Dupuytren’s contracture (“Dupuytren’s”). XIAFLEX received approval from the FDA on February 2, 2010 for the treatment of adult Dupuytren’s patients with a palpable cord. Dupuytren’s is a condition that affects the connective tissue that lies beneath the skin in the palm. The disease is progressive in nature. Typically, nodules develop in the palm as collagen deposits accumulate. As the disease progresses, the collagen deposits form a cord that stretches from the palm of the hand to the base of the finger. Once this cord develops, the patient’s fingers contract and the function of the hand is impaired. Prior to approval of XIAFLEX, surgery was the only effective treatment. We expect to begin shipping XIAFLEX to our distribution partners in early March 2010 in advance of a launch planned for the end of March 2010.
We also have received marketing approval for Testim in Belgium, Canada, Denmark, Finland, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden and the United Kingdom (“U.K.”). Ferring International Center S.A. (“Ferring”) and Paladin Labs Inc. (“Paladin”) commercialize Testim on our behalf in certain European countries and Canada, respectively.
Our current product pipeline includes:
Phase II:
XIAFLEX for the treatment of Peyronie’s disease (“Peyronie’s”)
XIAFLEX for the treatment of Adhesive Capsulitis (“Frozen Shoulder syndrome”)
Phase I:
AA4010, treatment for overactive bladder using our transmucosal film delivery system
A Fentanyl pain product using our transmucosal film delivery system.
In addition to the above, we have the rights to develop other compounds for the treatment of pain using our transmucosal film delivery system and other products using our transmucosal film technology for treatment of urologic disease and for hormone replacement. We also have the option to license additional indications for XIAFLEX other than dermal products for topical administration.
200 Largest Pharmaceutical companies
http://flucrazy.blogspot.com/2011/02/flucrazy-200-200-largest-pharmaceutical.html
40 Valley Stream Parkway
Malvern, PA 19355
(484) 321-5900
23-3016883
(I.R.S. Employer
Identification No.)
Employees: 540 (Approx.)
Revenue: $ 164 Million
From Form 10-K,
"We are a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences, such as urologists, endocrinologists, certain targeted primary care physicians, hand surgeons, subsets of orthopedic, general, and plastic surgeons who focus on the hand, and rheumatologists. We currently have approximately 540 employees, including a sales and marketing organization of approximately 315 people. We reported revenues in 2009 of $164 million, an increase of 30.8% over the $125.4 million reported in 2008.
We currently market two products in the United States (“U.S.”):
Testim® is a proprietary, topical 1% testosterone once-a-day gel indicated for the treatment of hypogonadism. Hypogonadism is defined as reduced or absent secretion of testosterone which can lead to symptoms such as low energy, loss of libido, adverse changes in body composition, irritability and poor concentration. Testim has been approved in the U.S. by the U.S. Food and Drug Administration (“FDA”) and according to National Prescription Audit (“NPA”) data from IMS Health, Inc. (“IMS”), a pharmaceutical market research firm, Testim’s share of total prescriptions for the gel segment of the U.S. testosterone replacement therapy (“TRT”) market was 22.3% for the month of December 2009, and 22.0% for the full year 2009.
XIAFLEX™ (collagenase clostridium histolyticum) is a proprietary, injectable collagenase enzyme for the treatment of Dupuytren’s contracture (“Dupuytren’s”). XIAFLEX received approval from the FDA on February 2, 2010 for the treatment of adult Dupuytren’s patients with a palpable cord. Dupuytren’s is a condition that affects the connective tissue that lies beneath the skin in the palm. The disease is progressive in nature. Typically, nodules develop in the palm as collagen deposits accumulate. As the disease progresses, the collagen deposits form a cord that stretches from the palm of the hand to the base of the finger. Once this cord develops, the patient’s fingers contract and the function of the hand is impaired. Prior to approval of XIAFLEX, surgery was the only effective treatment. We expect to begin shipping XIAFLEX to our distribution partners in early March 2010 in advance of a launch planned for the end of March 2010.
We also have received marketing approval for Testim in Belgium, Canada, Denmark, Finland, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden and the United Kingdom (“U.K.”). Ferring International Center S.A. (“Ferring”) and Paladin Labs Inc. (“Paladin”) commercialize Testim on our behalf in certain European countries and Canada, respectively.
Our current product pipeline includes:
Phase II:
XIAFLEX for the treatment of Peyronie’s disease (“Peyronie’s”)
XIAFLEX for the treatment of Adhesive Capsulitis (“Frozen Shoulder syndrome”)
Phase I:
AA4010, treatment for overactive bladder using our transmucosal film delivery system
A Fentanyl pain product using our transmucosal film delivery system.
In addition to the above, we have the rights to develop other compounds for the treatment of pain using our transmucosal film delivery system and other products using our transmucosal film technology for treatment of urologic disease and for hormone replacement. We also have the option to license additional indications for XIAFLEX other than dermal products for topical administration.
200 Largest Pharmaceutical companies
http://flucrazy.blogspot.com/2011/02/flucrazy-200-200-largest-pharmaceutical.html
Pediatric flu deaths at low level, reports CDC
The CDC (Centers for Disease Control and Prevention) is reporting that pediatric mortality linked to influenza is at the lowest level in years, with 30 deaths so far this season.
According to the CDC's Morbidity and Mortality Weekly Report, as "of February 5, 2011, a total of 30 influenza-related pediatric deaths from 18 states (Arizona, Colorado, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, New Jersey, New York, North Carolina, North Dakota, Oklahoma, Pennsylvania, Texas, Utah, Virginia, and West Virginia) and New York City have been reported to CDC for the 2010--11 season.
Nine deaths were associated with influenza A (H3N2) virus infection, 12 deaths were associated with influenza B virus infection, three deaths were associated with influenza A (H1N1), and six were associated with an influenza A virus for which the subtype was not determined. Twenty of these deaths occurred during January 16--February 5, 2011.
During the 2009 pandemic, 329 pediatric deaths were reported during April 15, 2009--January 23, 2010.
Before the pandemic, 65 influenza-related pediatric deaths were reported for the 2008--09 season (through the week ending April 11, 2009), 88 pediatric deaths were reported for the 2007--08 season, and 77 pediatric deaths were reported for the 2006--07 season."
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6006a4.htm?s_cid=mm6006a4_w
According to the CDC's Morbidity and Mortality Weekly Report, as "of February 5, 2011, a total of 30 influenza-related pediatric deaths from 18 states (Arizona, Colorado, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, New Jersey, New York, North Carolina, North Dakota, Oklahoma, Pennsylvania, Texas, Utah, Virginia, and West Virginia) and New York City have been reported to CDC for the 2010--11 season.
Nine deaths were associated with influenza A (H3N2) virus infection, 12 deaths were associated with influenza B virus infection, three deaths were associated with influenza A (H1N1), and six were associated with an influenza A virus for which the subtype was not determined. Twenty of these deaths occurred during January 16--February 5, 2011.
During the 2009 pandemic, 329 pediatric deaths were reported during April 15, 2009--January 23, 2010.
Before the pandemic, 65 influenza-related pediatric deaths were reported for the 2008--09 season (through the week ending April 11, 2009), 88 pediatric deaths were reported for the 2007--08 season, and 77 pediatric deaths were reported for the 2006--07 season."
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6006a4.htm?s_cid=mm6006a4_w
Saturday, February 19, 2011
K-Mart lowers price of flu shot, joins the club of vaccine "pushers" despite slow flu season
Kmart, a wholly owned subsidiary of Sears Holdings Corporation (NASDAQ: SHLD) announced that they have lowered the price of the seasonal influenza vaccine to $ 15.
They join a host of other outlets, including Walmart (NYSE:WMT), Rite Aid (NYSE:RAD), CVS (NYSE:CVS), and Walgreens (NYSE:WAG) in aggressively "pushing" the flu shot this year, despite the low incidence of flu outbreaks this year.
K-Mart shamelessly cites the CDC's flaky "misconceptions" web site (http://www.cdc.gov/flu/about/qa/misconceptions.htm) in saying that the influenza disease can "occur as late as May" in urging people to get the shot. However, we are under no misconceptions about the real reason for the flu shot promotion: with no swine flu hysteria this year, sales of flu shots are lagging, hurting the bottom line.
K-Mart Press Release
http://www.searsholdings.com/pubrel/kmart/02182011.pdf
#flu #swineflu
They join a host of other outlets, including Walmart (NYSE:WMT), Rite Aid (NYSE:RAD), CVS (NYSE:CVS), and Walgreens (NYSE:WAG) in aggressively "pushing" the flu shot this year, despite the low incidence of flu outbreaks this year.
K-Mart shamelessly cites the CDC's flaky "misconceptions" web site (http://www.cdc.gov/flu/about/qa/misconceptions.htm) in saying that the influenza disease can "occur as late as May" in urging people to get the shot. However, we are under no misconceptions about the real reason for the flu shot promotion: with no swine flu hysteria this year, sales of flu shots are lagging, hurting the bottom line.
K-Mart Press Release
http://www.searsholdings.com/pubrel/kmart/02182011.pdf
#flu #swineflu
Friday, February 18, 2011
About Cipla (CIPL.BO)
About Cipla (CIPL.BO):*
Cipla Ltd.
Mumbai Central
Mumbai 400 008
India
91 22 2308 2891
Cipla laid foundations for the Indian pharmaceutical industry back in 1935 with the vision to make India self-reliant and self-sufficient in healthcare. Over the years Cipla has emerged as one of the most respected pharma names not just in India but worldwide. Its R&D centre has given the country and the world many firsts. This includes the revolutionary HIV/AIDS cocktail for less than a dollar a day. With over 40 state of the art manufacturing units across the country, Cipla manufactures over 1200 products in 80 therapeutic areas.
With a turnover of over US $ 1.2 billion, Cipla serves doctors and patients in over 180 countries. It has earned a name for maintaining one global standard across all its products and services. Cipla continues to support, improve and save millions of lives with its high-quality drugs and innovative devices.
* Source: www.cipla.com
200 Largest Pharmaceutical companies
http://flucrazy.blogspot.com/2011/02/flucrazy-200-200-largest-pharmaceutical.html
Cipla Ltd.
Mumbai Central
Mumbai 400 008
India
91 22 2308 2891
Cipla laid foundations for the Indian pharmaceutical industry back in 1935 with the vision to make India self-reliant and self-sufficient in healthcare. Over the years Cipla has emerged as one of the most respected pharma names not just in India but worldwide. Its R&D centre has given the country and the world many firsts. This includes the revolutionary HIV/AIDS cocktail for less than a dollar a day. With over 40 state of the art manufacturing units across the country, Cipla manufactures over 1200 products in 80 therapeutic areas.
With a turnover of over US $ 1.2 billion, Cipla serves doctors and patients in over 180 countries. It has earned a name for maintaining one global standard across all its products and services. Cipla continues to support, improve and save millions of lives with its high-quality drugs and innovative devices.
* Source: www.cipla.com
200 Largest Pharmaceutical companies
http://flucrazy.blogspot.com/2011/02/flucrazy-200-200-largest-pharmaceutical.html
Gilead Sciences says Natco Pharma is challenging patent for Tamiflu
Gilead Sciences (GILD) says that Natco Pharma is challenging its patent for the influenza drug "Tamiflu" calling it invalid.
Natco is seeking to offer a generic version of Tamiflu.
According to the report on Bloomberg:
"Gilead Sciences Inc. (GILD) said Monday that Natco Pharma Ltd. is challenging a patent on the flu drug Tamiflu.
Tamiflu was developed by Gilead, which receives royalties on the drug's sale from Roche Holding AG.
Gilead said Natco is seeking Food and Drug Administration approval to sell a generic version of Tamiflu and alleges that Gilead's patent on the drug is invalid.
Gilead said it is reviewing the notice it received from the FDA and has 45 days to file a lawsuit against Natco. If it does sue Natco, that would bar the FDA from allowing Natco to make the Tamiflu generic for two and half years or until the case is decided in Natco's favor, Gilead said."
http://www.bloomberg.com/news/2011-02-07/gilead-reports-patent-challenge-on-tamiflu.html
Natco is seeking to offer a generic version of Tamiflu.
According to the report on Bloomberg:
"Gilead Sciences Inc. (GILD) said Monday that Natco Pharma Ltd. is challenging a patent on the flu drug Tamiflu.
Tamiflu was developed by Gilead, which receives royalties on the drug's sale from Roche Holding AG.
Gilead said Natco is seeking Food and Drug Administration approval to sell a generic version of Tamiflu and alleges that Gilead's patent on the drug is invalid.
Gilead said it is reviewing the notice it received from the FDA and has 45 days to file a lawsuit against Natco. If it does sue Natco, that would bar the FDA from allowing Natco to make the Tamiflu generic for two and half years or until the case is decided in Natco's favor, Gilead said."
http://www.bloomberg.com/news/2011-02-07/gilead-reports-patent-challenge-on-tamiflu.html
CSL (ASX: CSL.AX ): profits hit by strong dollar, one-off contribution from sale of pandemic flu vaccine
CSL (ASX: CSL.AX ) : profits hit by strong dollar, one-off contribution from sale of pandemic flu vaccine
From the announcement:
"CSL Limited today announced a profit after tax of $500 million for the six months ended 31 December 2010.
This result included an unfavourable foreign exchange impact of
$47 million. Net profit after tax in the prior comparable period was $617 million, which included a one-off contribution from the sale of pandemic influenza vaccine (H1N1)."
According to Dr McNamee, CSL’s Managing Director, the "success of our novel A (H1N1) influenza or ‘swine flu’ vaccine, Panvax®, in the
prior comparable period was a one-off contribution and, as foreshadowed, resulted in a decline in our headline profit."
CSL Intermim release available via this link:
http://www.csl.com.au/s1/cs/auhq/1187378853299/news/1255925859621/prdetail.htm
From the announcement:
"CSL Limited today announced a profit after tax of $500 million for the six months ended 31 December 2010.
This result included an unfavourable foreign exchange impact of
$47 million. Net profit after tax in the prior comparable period was $617 million, which included a one-off contribution from the sale of pandemic influenza vaccine (H1N1)."
According to Dr McNamee, CSL’s Managing Director, the "success of our novel A (H1N1) influenza or ‘swine flu’ vaccine, Panvax®, in the
prior comparable period was a one-off contribution and, as foreshadowed, resulted in a decline in our headline profit."
CSL Intermim release available via this link:
http://www.csl.com.au/s1/cs/auhq/1187378853299/news/1255925859621/prdetail.htm
About Pfizer Inc (NYSE: PFE)
Pfizer, Inc (NYSE: PFE)
About Pfizer, Inc*
235 East 42nd Street, New York, New York 10017
(212) 733-2323
Reveune: $67.8 billion (2010)
I.R.S. Employer Identification Number:
13-5315170
Pfizer Inc. (which may be referred to as Pfizer, the Company, we, us or our) is a research-based, global biopharmaceutical company. We apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer health care products. Every day, we work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with other biopharmaceutical companies, health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.
The Company was incorporated under the laws of the State of Delaware on June 2, 1942.
On October 15, 2009, we completed our acquisition of Wyeth. The acquisition was a cash-and-stock transaction valued, based on the closing market price of Pfizer’s common stock on the acquisition date, at $50.40 per share of Wyeth common stock, or a total of approximately $68 billion.
In response to the challenging operating environment, we have taken many steps to strengthen our Company and better position ourselves for the future. The most important of these steps was the acquisition of Wyeth, which has transformed us into a more diversified health care company, with product offerings in human and animal health, including vaccines, biologics, small molecules and nutrition across developed and emerging markets. We believe that our acquisition of Wyeth meaningfully advances, in a single transaction, each of the strategic priorities that we have identified and pursued over the last two years, including:
• Enhancing the in-line and patent-protected pipeline portfolio in key “invest to win” areas of
research where there exist significant unmet medical needs and significant opportunities for innovation and market leadership, such as oncology, pain, inflammation, Alzheimer’s disease, psychoses and diabetes as well as the critical technologies of vaccines and biologics;
• Becoming a top-tier player in biotherapeutics by 2015;
• Accelerating growth in emerging markets;
• Creating new opportunities for established products;
• Investing in complementary businesses; and
• Creating a lower, more flexible cost base for the combined company.
*Source: Form 10-K
. . . . .
Pfizer and plaintiffs settle lawsuits
http://flucrazy.blogspot.com/2011/02/pfizer-inc-nyse-pfe-and-plaintiffs.html
200 Largest Pharmaceutical Companies in the World
http://flucrazy.blogspot.com/2011/02/flucrazy-200-200-largest-pharmaceutical.html
About Pfizer, Inc*
235 East 42nd Street, New York, New York 10017
(212) 733-2323
Reveune: $67.8 billion (2010)
I.R.S. Employer Identification Number:
13-5315170
Pfizer Inc. (which may be referred to as Pfizer, the Company, we, us or our) is a research-based, global biopharmaceutical company. We apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer health care products. Every day, we work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with other biopharmaceutical companies, health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.
The Company was incorporated under the laws of the State of Delaware on June 2, 1942.
On October 15, 2009, we completed our acquisition of Wyeth. The acquisition was a cash-and-stock transaction valued, based on the closing market price of Pfizer’s common stock on the acquisition date, at $50.40 per share of Wyeth common stock, or a total of approximately $68 billion.
In response to the challenging operating environment, we have taken many steps to strengthen our Company and better position ourselves for the future. The most important of these steps was the acquisition of Wyeth, which has transformed us into a more diversified health care company, with product offerings in human and animal health, including vaccines, biologics, small molecules and nutrition across developed and emerging markets. We believe that our acquisition of Wyeth meaningfully advances, in a single transaction, each of the strategic priorities that we have identified and pursued over the last two years, including:
• Enhancing the in-line and patent-protected pipeline portfolio in key “invest to win” areas of
research where there exist significant unmet medical needs and significant opportunities for innovation and market leadership, such as oncology, pain, inflammation, Alzheimer’s disease, psychoses and diabetes as well as the critical technologies of vaccines and biologics;
• Becoming a top-tier player in biotherapeutics by 2015;
• Accelerating growth in emerging markets;
• Creating new opportunities for established products;
• Investing in complementary businesses; and
• Creating a lower, more flexible cost base for the combined company.
*Source: Form 10-K
. . . . .
Pfizer and plaintiffs settle lawsuits
http://flucrazy.blogspot.com/2011/02/pfizer-inc-nyse-pfe-and-plaintiffs.html
200 Largest Pharmaceutical Companies in the World
http://flucrazy.blogspot.com/2011/02/flucrazy-200-200-largest-pharmaceutical.html
Thursday, February 17, 2011
Chimerix Awarded BARDA Contract for Development of Antiviral CMX001 Countermeasure Against Smallpox
Chimerix Awarded BARDA Contract for Development of Antiviral CMX001 Countermeasure Against Smallpox
According to the announcement, Chimerix, Inc, has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA) for advanced development of its antiviral drug candidate, CMX001, as a medical countermeasure in the event of a smallpox release.
Excerpt:
"RESEARCH TRIANGLE PARK, N.C., Feb. 16, 2011 /PRNewswire/ --
Chimerix, Inc., a pharmaceutical company developing orally available antiviral therapeutics, today announced that it has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA) for the advanced development of Chimerix's broad spectrum antiviral drug candidate, CMX001, as a medical countermeasure in the event of a smallpox release.
CMX001 is a potential dual-use therapeutic with evidence of antiviral activity against all five families of double-stranded DNA (dsDNA) viruses that cause morbidity and mortality in humans, including smallpox. Under the terms of the BARDA contract, Chimerix will receive committed funding of $24.8 million during the first year with subsequent option periods that, if completed, would bring the total contract value to $81.1 million.
The funding from BARDA builds upon the $37 million Chimerix previously received from the National Institute of Allergy and Infectious Diseases (NIAID) for development of CMX001 for smallpox, in addition to substantial private investment from top-tier venture capital firms for the development of CMX001 as a treatment for other life-threatening infections such as adenovirus and cytomegalovirus.
As part of progressing the clinical and non-clinical development of CMX001 for the smallpox indication, the BARDA contract will also support expanded human safety trials and the recently initiated CMX001-350 multicenter, open-label clinical study of CMX001 for the treatment of twelve life-threatening or serious conditions caused by dsDNA viruses. This represents Chimerix's first contract with BARDA and will position CMX001 for possible procurement as a medical countermeasure for the Strategic National Stockpile."
Read More at http://www.prnewswire.com/news-releases/chimerix-awarded-barda-contract-for-advanced-development-of-broad-spectrum-antiviral-cmx001-as-medical-countermeasure-against-smallpox-116318154.html
According to the announcement, Chimerix, Inc, has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA) for advanced development of its antiviral drug candidate, CMX001, as a medical countermeasure in the event of a smallpox release.
Excerpt:
"RESEARCH TRIANGLE PARK, N.C., Feb. 16, 2011 /PRNewswire/ --
Chimerix, Inc., a pharmaceutical company developing orally available antiviral therapeutics, today announced that it has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA) for the advanced development of Chimerix's broad spectrum antiviral drug candidate, CMX001, as a medical countermeasure in the event of a smallpox release.
CMX001 is a potential dual-use therapeutic with evidence of antiviral activity against all five families of double-stranded DNA (dsDNA) viruses that cause morbidity and mortality in humans, including smallpox. Under the terms of the BARDA contract, Chimerix will receive committed funding of $24.8 million during the first year with subsequent option periods that, if completed, would bring the total contract value to $81.1 million.
The funding from BARDA builds upon the $37 million Chimerix previously received from the National Institute of Allergy and Infectious Diseases (NIAID) for development of CMX001 for smallpox, in addition to substantial private investment from top-tier venture capital firms for the development of CMX001 as a treatment for other life-threatening infections such as adenovirus and cytomegalovirus.
As part of progressing the clinical and non-clinical development of CMX001 for the smallpox indication, the BARDA contract will also support expanded human safety trials and the recently initiated CMX001-350 multicenter, open-label clinical study of CMX001 for the treatment of twelve life-threatening or serious conditions caused by dsDNA viruses. This represents Chimerix's first contract with BARDA and will position CMX001 for possible procurement as a medical countermeasure for the Strategic National Stockpile."
Read More at http://www.prnewswire.com/news-releases/chimerix-awarded-barda-contract-for-advanced-development-of-broad-spectrum-antiviral-cmx001-as-medical-countermeasure-against-smallpox-116318154.html
FluCrazy 200 - The 200 Largest Pharmaceutical Companies in the World
FluCrazy 200
Updated list for 2012 is here:
http://flucrazy.blogspot.com/2012/03/flu-crazy-200-largest-pharmaceutical.html
2011
The 200 Largest Pharmaceutical Companies in the World
(Alphabetical Order)
Abbott Laboratories
Acrux Limited
Alexion
ALK-Abello AS
Alkermes
Allergan
Amarin Corporation plc
Amylin Pharmaceuticals
Ardea Biosciences
ARIAD Pharmaceuticals
Astellas Pharma Inc.
AstraZeneca Pharma India
Aurobindo Pharma
Auxilium
Bavarian Nordic A/S
Baxter International
Bayer
Beijing Double-Crane
Beijing Tongrentang Co
Biocon Limited
Biogen Idec
BioMarin Pharmaceutical
Boiron S.A.
Bristol-Myers Squibb
Cadila Healthcare
Celgene Corporation
Celltrion Inc
Cephalon
Chengdu Hoist
Chongqing Huapont Pharmaceutical
Chongqing Taiji Industry
Chugai Pharmaceutical
Cipla
Clinical Data Inc
Cubist Pharmaceuticals
Da An Gene Co Ltd of Sun Yat-Sen University
Daiichi Sankyo
Dainippon Sumitomo
Dendreon
Divi's Laboratories
Dong-A Pharmaceutical Co
Dr. Reddy's Laboratories
EGIS NyRt
Eisai
Eli Lilly
Emergent BioSolutions
Endo Pharmaceuticals
Enzon Pharmaceuticals
Euromayor S.A. De Inversiones
Exelixis
F. Reichelt AG
Financiere de Tubize
Forest Laboratories
Gansu Duyiwei Biological
Genomma Lab Internacional SAB de CV
Geron Corp
GlaxoSmithKline
Glenmark Pharmaceuticals
Green Cross Corp
Guangzhou Baiyunshan
Guangzhou Pharmaceutical
Guizhou Bailing Group
Guizhou Yibai
H. Lundbeck
Hainan Honz Pharmaceutical Co
Halozyme Therapeutics
Harbin Pharm Group Sanjing
Harbin Pharmaceutical
Henan Topfond Pharmaceutical
Hikma Pharmaceuticals
Hisamitsu
Hospira
Huadong Medicine Co
Hubei Biocause Pharmaceutical Co
ImmunoGen Inc
Impax Laboratories
Intermune, Inc.
IPCA Laboratories
Jazz Pharmaceuticals
Jiangsu Hengrui Medicine
Jiangsu Kanion Pharmaceutical
Jiangsu Nhwa Pharmaceutical
Jiangsu Sihuan Bioengineering
Jiangxi Jiangzhong Pharmaceutical
Jilin Aodong Medicine
Jinling Pharmaceutical
Jiuzhitang Co
Kaken Pharmaceutical
Kangmei
King Pharmaceuticals (acquired by Pfizer, Inc)
Kissei Pharmaceutical
Kobayashi Pharmaceutical Co
Krka, tovarna zdravil
Kunming Pharmaceutical
Kyorin
Kyowa Hakko Kirin
Lexicon Pharmaceuticals
LG Life Sciences
Livzon
Lupin
Max India
MaYinglong Pharmaceutical
Medicines Company
Medicis Pharmaceutical
Merck
Merck KGaA
Merro Pharmaceutical
Mitsubishi Tanabe Pharma
Mochida Pharmaceutical
Momenta Pharmaceuticals
Mylan
Myriad Genetics
Nektar Therapeutics
Nichi-iko Pharmaceutical
Nippon Shinyaku Co
North China Pharmaceutical
Northeast Pharmaceutical
Novo-Nordisk
Ono Pharmaceutical
ONYX Pharmaceuticals
Opko Health Inc
Orion Oyj
Par Pharmaceutical
Perrigo
Pfizer (India)
Pfizer Inc.
Pharmasset
Pharmstandard JSC
Piramal Healthcare
PKU International
Prestige Brands Holdings
Protek OAO
PT Kalbe Farma
Qingdao Huaren Pharmaceutical
Q-Med AB
Questcor Pharmaceuticals
Ranbaxy Laboratories
Recordati
Regeneron Pharmaceuticals
Richter Gedeon Nyrt
Rohto Pharmaceutical
Salix
Sanofi-Aventis
Santen Pharmaceutical
Savient Pharmaceuticals
Sawai Pharmaceutical
Seikagaku Corp
Shandong Luoxin Pharmacy
Shanghai Fosun
Shanghai Kaibao Pharmaceutical
Shanghai Modern Pharmaceutical
Shanghai RAAS Blood Products
Shanxi Yabao Pharmaceutical
Shenzhen Accord
Shenzhen Salubris Pharmaceuticals Co
Shionogi
Shire PLC
Sichuan Kelun
SIGA Technologies
Simcere Pharmaceutical
Square Pharmaceuticals
STADA Arzneimittel
Stallergenes
Sun Pharmaceutical
Swedish Orphan Biovitrum AB
Taisho Pharmaceutical
Takeda Pharmaceutical
Targacept
Tempo Scan Pacific
Theravance
Tianjin Chase Sun Pharmaceutical
Tianjin Zhong Xin
Tibet Cheezheng Tibetan Medicine
Tibet Urban Development & Investment
Torii Pharmaceutical
Torrent Pharmaceuticals
Towa Pharmaceutical
Tsumura & Co.
TTY Biopharm
Unisplendour Guhan Group
United Therapeutics
Valeant Pharmaceuticals
Vertex
Virbac SA
ViroPharma
Vivus Inc
Watson Pharmaceuticals
Wockhardt
Xiangxue Pharmaceutical
Xinjiang Tecon Animal Husbandry Bio-Technology
YuHan Corp
Zeria Pharmaceutical
Zhangzhou Pientzehuang
Zhejiang Hisoar Pharmaceutical
Zhejiang Hisun
Zhejiang Huahai
Zhejiang Jianfeng Group
Zhejiang Medicine Co., Ltd.
Zhejiang Xianju Pharmaceutical
Zhuzhou Qianjin Pharmaceutical
Updated list for 2012 is here:
http://flucrazy.blogspot.com/2012/03/flu-crazy-200-largest-pharmaceutical.html
2011
The 200 Largest Pharmaceutical Companies in the World
(Alphabetical Order)
Abbott Laboratories
Acrux Limited
Alexion
ALK-Abello AS
Alkermes
Allergan
Amarin Corporation plc
Amylin Pharmaceuticals
Ardea Biosciences
ARIAD Pharmaceuticals
Astellas Pharma Inc.
AstraZeneca Pharma India
Aurobindo Pharma
Auxilium
Bavarian Nordic A/S
Baxter International
Bayer
Beijing Double-Crane
Beijing Tongrentang Co
Biocon Limited
Biogen Idec
BioMarin Pharmaceutical
Boiron S.A.
Bristol-Myers Squibb
Cadila Healthcare
Celgene Corporation
Celltrion Inc
Cephalon
Chengdu Hoist
Chongqing Huapont Pharmaceutical
Chongqing Taiji Industry
Chugai Pharmaceutical
Cipla
Clinical Data Inc
Cubist Pharmaceuticals
Da An Gene Co Ltd of Sun Yat-Sen University
Daiichi Sankyo
Dainippon Sumitomo
Dendreon
Divi's Laboratories
Dong-A Pharmaceutical Co
Dr. Reddy's Laboratories
EGIS NyRt
Eisai
Eli Lilly
Emergent BioSolutions
Endo Pharmaceuticals
Enzon Pharmaceuticals
Euromayor S.A. De Inversiones
Exelixis
F. Reichelt AG
Financiere de Tubize
Forest Laboratories
Gansu Duyiwei Biological
Genomma Lab Internacional SAB de CV
Geron Corp
GlaxoSmithKline
Glenmark Pharmaceuticals
Green Cross Corp
Guangzhou Baiyunshan
Guangzhou Pharmaceutical
Guizhou Bailing Group
Guizhou Yibai
H. Lundbeck
Hainan Honz Pharmaceutical Co
Halozyme Therapeutics
Harbin Pharm Group Sanjing
Harbin Pharmaceutical
Henan Topfond Pharmaceutical
Hikma Pharmaceuticals
Hisamitsu
Hospira
Huadong Medicine Co
Hubei Biocause Pharmaceutical Co
ImmunoGen Inc
Impax Laboratories
Intermune, Inc.
IPCA Laboratories
Jazz Pharmaceuticals
Jiangsu Hengrui Medicine
Jiangsu Kanion Pharmaceutical
Jiangsu Nhwa Pharmaceutical
Jiangsu Sihuan Bioengineering
Jiangxi Jiangzhong Pharmaceutical
Jilin Aodong Medicine
Jinling Pharmaceutical
Jiuzhitang Co
Kaken Pharmaceutical
Kangmei
King Pharmaceuticals (acquired by Pfizer, Inc)
Kissei Pharmaceutical
Kobayashi Pharmaceutical Co
Krka, tovarna zdravil
Kunming Pharmaceutical
Kyorin
Kyowa Hakko Kirin
Lexicon Pharmaceuticals
LG Life Sciences
Livzon
Lupin
Max India
MaYinglong Pharmaceutical
Medicines Company
Medicis Pharmaceutical
Merck
Merck KGaA
Merro Pharmaceutical
Mitsubishi Tanabe Pharma
Mochida Pharmaceutical
Momenta Pharmaceuticals
Mylan
Myriad Genetics
Nektar Therapeutics
Nichi-iko Pharmaceutical
Nippon Shinyaku Co
North China Pharmaceutical
Northeast Pharmaceutical
Novo-Nordisk
Ono Pharmaceutical
ONYX Pharmaceuticals
Opko Health Inc
Orion Oyj
Par Pharmaceutical
Perrigo
Pfizer (India)
Pfizer Inc.
Pharmasset
Pharmstandard JSC
Piramal Healthcare
PKU International
Prestige Brands Holdings
Protek OAO
PT Kalbe Farma
Qingdao Huaren Pharmaceutical
Q-Med AB
Questcor Pharmaceuticals
Ranbaxy Laboratories
Recordati
Regeneron Pharmaceuticals
Richter Gedeon Nyrt
Rohto Pharmaceutical
Salix
Sanofi-Aventis
Santen Pharmaceutical
Savient Pharmaceuticals
Sawai Pharmaceutical
Seikagaku Corp
Shandong Luoxin Pharmacy
Shanghai Fosun
Shanghai Kaibao Pharmaceutical
Shanghai Modern Pharmaceutical
Shanghai RAAS Blood Products
Shanxi Yabao Pharmaceutical
Shenzhen Accord
Shenzhen Salubris Pharmaceuticals Co
Shionogi
Shire PLC
Sichuan Kelun
SIGA Technologies
Simcere Pharmaceutical
Square Pharmaceuticals
STADA Arzneimittel
Stallergenes
Sun Pharmaceutical
Swedish Orphan Biovitrum AB
Taisho Pharmaceutical
Takeda Pharmaceutical
Targacept
Tempo Scan Pacific
Theravance
Tianjin Chase Sun Pharmaceutical
Tianjin Zhong Xin
Tibet Cheezheng Tibetan Medicine
Tibet Urban Development & Investment
Torii Pharmaceutical
Torrent Pharmaceuticals
Towa Pharmaceutical
Tsumura & Co.
TTY Biopharm
Unisplendour Guhan Group
United Therapeutics
Valeant Pharmaceuticals
Vertex
Virbac SA
ViroPharma
Vivus Inc
Watson Pharmaceuticals
Wockhardt
Xiangxue Pharmaceutical
Xinjiang Tecon Animal Husbandry Bio-Technology
YuHan Corp
Zeria Pharmaceutical
Zhangzhou Pientzehuang
Zhejiang Hisoar Pharmaceutical
Zhejiang Hisun
Zhejiang Huahai
Zhejiang Jianfeng Group
Zhejiang Medicine Co., Ltd.
Zhejiang Xianju Pharmaceutical
Zhuzhou Qianjin Pharmaceutical
Forest Lab's (NYSE: FRX) Teflaro "one to watch"
Forest Lab's (NYSE: FRX) Teflaro is listed as a phase III "one to watch" by Thomson Reuters Pharma.
Teflaro is used to treat bacterial pneumonia.
From the report: "Teflaro is an injectable formulation of the broad-spectrum antibiotic ceftaroline fosamil from Forest Laboratories, which acquired the worldwide rights to the drug after its acquisition of Cerexa in 2007. Teflaro received approval from the FDA in October 2010 for the treatment of community-acquired bacterial pneumonia (CABP), including those cases caused by multidrug-resistant Streptococcus pneumoniae, and skin and skin structure infections (SSSIs), including those caused by methicillin-resistant Staphylococcus aureus.
Both bacterial CABP and SSSI are serious, potentially life-threatening
conditions, and new treatments are needed constantly, particularly as
bacteria resistance to existing antibiotics continues to increase.
Phase III trials showed that Teflaro had a similar response and cure rate
to ceftriaxone in CABP patients and was as effective as vancomycin plus
aztreonam against SSSIs."
Also mentioned in the report:
Haleven, from Eisai (Metastatic breast cancer)
Kombiglyze XR, from AstraZeneca/Bristol Myers Squibb (Type 2 diabetes)
Brilique, from AstraZeneca (Acute coronary syndrome)
Ruconest, from Pharming/Esteve (Hereditary angioedema)
The full report is available at
http://thomsonreuters.com/content/science/pdf/ls/pharma_matters/the_ones_to_watch.pdf
Teflaro is used to treat bacterial pneumonia.
From the report: "Teflaro is an injectable formulation of the broad-spectrum antibiotic ceftaroline fosamil from Forest Laboratories, which acquired the worldwide rights to the drug after its acquisition of Cerexa in 2007. Teflaro received approval from the FDA in October 2010 for the treatment of community-acquired bacterial pneumonia (CABP), including those cases caused by multidrug-resistant Streptococcus pneumoniae, and skin and skin structure infections (SSSIs), including those caused by methicillin-resistant Staphylococcus aureus.
Both bacterial CABP and SSSI are serious, potentially life-threatening
conditions, and new treatments are needed constantly, particularly as
bacteria resistance to existing antibiotics continues to increase.
Phase III trials showed that Teflaro had a similar response and cure rate
to ceftriaxone in CABP patients and was as effective as vancomycin plus
aztreonam against SSSIs."
Also mentioned in the report:
Haleven, from Eisai (Metastatic breast cancer)
Kombiglyze XR, from AstraZeneca/Bristol Myers Squibb (Type 2 diabetes)
Brilique, from AstraZeneca (Acute coronary syndrome)
Ruconest, from Pharming/Esteve (Hereditary angioedema)
The full report is available at
http://thomsonreuters.com/content/science/pdf/ls/pharma_matters/the_ones_to_watch.pdf
Baxter (NYSE: BAX) International reports that Preflucel vaccine, using cell-based manufacturing is as effective as conventional chicken egg vaccines
Baxter International's cell-based Preflucel vaccine has been shown to be at least as effective as vaccines manufactured using the conventional method of fertilized chicken eggs.
Fox News reports "Baxter International's seasonal flu vaccine made using quicker cell-based manufacturing methods was at least as effective at preventing flu as conventional vaccines grown in chicken eggs, company researchers said on Tuesday.
They said Baxter's vaccine Preflucel prevented flu in 78.5 percent of people who got the vaccine. That compared to egg-based vaccines, which historically protect 73 percent of people who get the vaccine.
"At 78.5 percent, we certainly would not claim superiority to egg-derived vaccines, but we are at least as protective as vaccines produced by historical manufacturing process involving the use of eggs," said Dr. Noel Barrett of Baxter's Bioscience unit in Austria, whose findings were published in Lancet.
Read more: http://www.foxnews.com/health/2011/02/16/baxters-cell-based-flu-vaccine-effective-study-says/#ixzz1EELCJiV3
The use of cell-based methods holds the promise of quicker turnaround time in the development of seasonal flu vaccines, versus the current method.
The NY Times points out that "[using] animal cells, which are grown in enclosed steel tanks, also reduces the risk of bacterial contamination, which has led to shortages of seasonal vaccines in some years.
“I just think it’s an improvement in vaccine production that has been warranted for a long time,” said Dr. W. Paul Glezen, an influenza expert at the Baylor College of Medicine who wrote a commentary to accompany the report, which was published online Tuesday by The Lancet. “I just feel we’ve been sort of slow in implementing it.”
Dr. Glezen said shorter production times would allow health officials to wait longer before deciding which strains to include in the next winter’s flu vaccine, a decision that now has to be made around February. That would increase the chance that the strains in the vaccine match the strains in circulation."
http://www.nytimes.com/2011/02/16/health/research/16flu.html
The Baxter International press release is here
Excerpt:
Baxter International Inc. announced today results of a study published in this week’s issue of The Lancet that demonstrate effectiveness and tolerability of Baxter’s PREFLUCEL in protecting against seasonal influenza. The study data show nearly 80 percent protective efficacy against the influenza strains contained in the vaccine and a low adverse event profile. PREFLUCEL is manufactured using Vero cell technology, offering an innovative method of vaccine production compared to conventional embryonated chicken egg production, which has been used for decades.
Fox News reports "Baxter International's seasonal flu vaccine made using quicker cell-based manufacturing methods was at least as effective at preventing flu as conventional vaccines grown in chicken eggs, company researchers said on Tuesday.
They said Baxter's vaccine Preflucel prevented flu in 78.5 percent of people who got the vaccine. That compared to egg-based vaccines, which historically protect 73 percent of people who get the vaccine.
"At 78.5 percent, we certainly would not claim superiority to egg-derived vaccines, but we are at least as protective as vaccines produced by historical manufacturing process involving the use of eggs," said Dr. Noel Barrett of Baxter's Bioscience unit in Austria, whose findings were published in Lancet.
Read more: http://www.foxnews.com/health/2011/02/16/baxters-cell-based-flu-vaccine-effective-study-says/#ixzz1EELCJiV3
The use of cell-based methods holds the promise of quicker turnaround time in the development of seasonal flu vaccines, versus the current method.
The NY Times points out that "[using] animal cells, which are grown in enclosed steel tanks, also reduces the risk of bacterial contamination, which has led to shortages of seasonal vaccines in some years.
“I just think it’s an improvement in vaccine production that has been warranted for a long time,” said Dr. W. Paul Glezen, an influenza expert at the Baylor College of Medicine who wrote a commentary to accompany the report, which was published online Tuesday by The Lancet. “I just feel we’ve been sort of slow in implementing it.”
Dr. Glezen said shorter production times would allow health officials to wait longer before deciding which strains to include in the next winter’s flu vaccine, a decision that now has to be made around February. That would increase the chance that the strains in the vaccine match the strains in circulation."
http://www.nytimes.com/2011/02/16/health/research/16flu.html
The Baxter International press release is here
Excerpt:
Baxter International Inc. announced today results of a study published in this week’s issue of The Lancet that demonstrate effectiveness and tolerability of Baxter’s PREFLUCEL in protecting against seasonal influenza. The study data show nearly 80 percent protective efficacy against the influenza strains contained in the vaccine and a low adverse event profile. PREFLUCEL is manufactured using Vero cell technology, offering an innovative method of vaccine production compared to conventional embryonated chicken egg production, which has been used for decades.
Wednesday, February 16, 2011
Study shows no drop in rate of childhood pneumonia after vaccine
A study on the rates of childhood pneumonia shows no difference in the number of cases after the vaccine became available. Pfizer's (PFE) vaccine "Prevnar" cited.
According to Reuters, in "the first study to provide national estimates of childhood pneumonia, they found rates of the lung infection had stayed more or less constant between 1994 and 2007.
At the beginning of that period, 19 in 1,000 children got a pneumonia diagnosis at the doctor's office or at an emergency department, compared to 22 in 1,000 at the end.
But that doesn't mean the vaccine -- Pfizer's Prevnar, or PCV7 -- has been useless.
For instance, earlier work found the number of kids who had to be treated for pneumonia at the hospital dropped by more than half after the vaccine became available.
"It's possible that the vaccination has had a major impact on the more serious complications of pneumonia," said Dr. Samir S. Shah of the University of Pennsylvania School of Medicine in Philadelphia, who led the work.
Prevnar protects against a type of bacteria called Streptococcus pneumoniae, or just pneumococcus, which causes several kinds of infections -- including pneumonia, meningitis and middle ear infections.
"If you look at how effective the vaccine was in reducing meningitis and blood infections, it has done a phenomenal job," said Shah, whose study was supported by the National Institutes of Health.
While Pfizer said Prevnar is not licensed to prevent pneumonia in the U.S., it stressed the new study's design might be shrouding possible effects of the vaccine on the disease."
#flu #pharma "pfizer"
According to Reuters, in "the first study to provide national estimates of childhood pneumonia, they found rates of the lung infection had stayed more or less constant between 1994 and 2007.
At the beginning of that period, 19 in 1,000 children got a pneumonia diagnosis at the doctor's office or at an emergency department, compared to 22 in 1,000 at the end.
But that doesn't mean the vaccine -- Pfizer's Prevnar, or PCV7 -- has been useless.
For instance, earlier work found the number of kids who had to be treated for pneumonia at the hospital dropped by more than half after the vaccine became available.
"It's possible that the vaccination has had a major impact on the more serious complications of pneumonia," said Dr. Samir S. Shah of the University of Pennsylvania School of Medicine in Philadelphia, who led the work.
Prevnar protects against a type of bacteria called Streptococcus pneumoniae, or just pneumococcus, which causes several kinds of infections -- including pneumonia, meningitis and middle ear infections.
"If you look at how effective the vaccine was in reducing meningitis and blood infections, it has done a phenomenal job," said Shah, whose study was supported by the National Institutes of Health.
While Pfizer said Prevnar is not licensed to prevent pneumonia in the U.S., it stressed the new study's design might be shrouding possible effects of the vaccine on the disease."
#flu #pharma "pfizer"
Monday, February 14, 2011
Approx 40% of health care workers get the flu shot (the rest don't).
Approx 40% of health care workers get the flu shot (the rest don't).
Survey after survey reveals that in large, consistent numbers, healthcare professionals of all stripes refuse to get the flu shot.
Doctors, nurses, and facility workers all shun the vaccine.
Although New York State tried to mandate the flu shot for medical workers, this was blocked by a judge.
http://cityroom.blogs.nytimes.com/2009/10/16/judge-halts-mandatory-flu-vaccines-for-health-care-workers/
According to the CDC web site "Coverage levels during the 2009 pandemic were higher for seasonal vaccine, but remained low for the 2009 pandemic vaccine. By mid–January 2010, estimated vaccination coverage among HCP was 37% for 2009 pandemic influenza A (H1N1) and 62% for seasonal influenza, based on a RAND Corporation–conducted telephone survey that used a somewhat different methodology than NHIS."
What do healthcare providers know that the rest of us don't?
http://www.cdc.gov/flu/professionals/acip/coveragelevels.htm#tab3
Study: Influenza vaccination of healthcare workers
http://www.ncbi.nlm.nih.gov/pubmed/9090547?dopt=AbstractPlus&holding=f1000,f1000m,isrctn
Wall Street Journal - Blog
http://blogs.wsj.com/health/2009/07/13/who-put-health-workers-first-in-line-for-swine-flu-vaccine/
Survey after survey reveals that in large, consistent numbers, healthcare professionals of all stripes refuse to get the flu shot.
Doctors, nurses, and facility workers all shun the vaccine.
Although New York State tried to mandate the flu shot for medical workers, this was blocked by a judge.
http://cityroom.blogs.nytimes.com/2009/10/16/judge-halts-mandatory-flu-vaccines-for-health-care-workers/
According to the CDC web site "Coverage levels during the 2009 pandemic were higher for seasonal vaccine, but remained low for the 2009 pandemic vaccine. By mid–January 2010, estimated vaccination coverage among HCP was 37% for 2009 pandemic influenza A (H1N1) and 62% for seasonal influenza, based on a RAND Corporation–conducted telephone survey that used a somewhat different methodology than NHIS."
What do healthcare providers know that the rest of us don't?
http://www.cdc.gov/flu/professionals/acip/coveragelevels.htm#tab3
Study: Influenza vaccination of healthcare workers
http://www.ncbi.nlm.nih.gov/pubmed/9090547?dopt=AbstractPlus&holding=f1000,f1000m,isrctn
Wall Street Journal - Blog
http://blogs.wsj.com/health/2009/07/13/who-put-health-workers-first-in-line-for-swine-flu-vaccine/
Medivation (MDVN) and Astellas Pharma (YPH.BE) to present Follow-Up Data From Phase 1-2 Trial of MDV3100
Via biospace.com ...
SAN FRANCISCO, CA--(Marketwire - February 14, 2011) - Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. today announced that new, long-term, follow-up data from the Phase 1-2 trial of MDV3100 in patients with advanced prostate cancer will be presented in a poster session at the American Society of Clinical Oncology's Genitourinary Cancers Symposium (ASCO-GU) in Orlando, Fla. MDV3100 is a novel, triple-acting, oral androgen receptor antagonist.
The abstract (#177), titled "Antitumor activity of MDV3100 in pre- and post-docetaxel advanced prostate cancer: long-term follow-up of the Phase 1-2 study" will be available tomorrow, Tuesday, February 15, at 6:00 p.m. ET on the ASCO website at www.ASCO.org. The full poster (poster board #A71) will be presented on Thursday, February 17, from 4:50 - 6:20 p.m. ET during the General Poster Session B: Prostate Cancer in the Exhibit Hall at the Orlando World Center Marriott. The poster will include the most up-to-date data from this trial and will expand upon the results originally submitted in the abstract.
"We look forward to presenting promising new efficacy data from the Phase 1-2 trial of MDV3100," said Lynn Seely, M.D., chief medical officer of Medivation. "As part of these data, we will be sharing results of median time to prostate specific antigen (PSA) progression. We will be presenting PSA progression data calculated using three distinct reporting criteria: the criteria specified in the Phase 1-2 trial protocol; the most recent published PSA reporting consensus criteria (the Prostate Cancer Clinical Trials Working Group 2, or PCWG2, criteria)(1); and an older commonly used reporting method (the Prostate-Specific Antigen Working Group 1, or PSAWG1, criteria)(2)."
http://www.biospace.com/news_story.aspx?StoryID=210603&full=1
SAN FRANCISCO, CA--(Marketwire - February 14, 2011) - Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. today announced that new, long-term, follow-up data from the Phase 1-2 trial of MDV3100 in patients with advanced prostate cancer will be presented in a poster session at the American Society of Clinical Oncology's Genitourinary Cancers Symposium (ASCO-GU) in Orlando, Fla. MDV3100 is a novel, triple-acting, oral androgen receptor antagonist.
The abstract (#177), titled "Antitumor activity of MDV3100 in pre- and post-docetaxel advanced prostate cancer: long-term follow-up of the Phase 1-2 study" will be available tomorrow, Tuesday, February 15, at 6:00 p.m. ET on the ASCO website at www.ASCO.org. The full poster (poster board #A71) will be presented on Thursday, February 17, from 4:50 - 6:20 p.m. ET during the General Poster Session B: Prostate Cancer in the Exhibit Hall at the Orlando World Center Marriott. The poster will include the most up-to-date data from this trial and will expand upon the results originally submitted in the abstract.
"We look forward to presenting promising new efficacy data from the Phase 1-2 trial of MDV3100," said Lynn Seely, M.D., chief medical officer of Medivation. "As part of these data, we will be sharing results of median time to prostate specific antigen (PSA) progression. We will be presenting PSA progression data calculated using three distinct reporting criteria: the criteria specified in the Phase 1-2 trial protocol; the most recent published PSA reporting consensus criteria (the Prostate Cancer Clinical Trials Working Group 2, or PCWG2, criteria)(1); and an older commonly used reporting method (the Prostate-Specific Antigen Working Group 1, or PSAWG1, criteria)(2)."
http://www.biospace.com/news_story.aspx?StoryID=210603&full=1
Sunday, February 13, 2011
Cold F-X producer, Afexa Life Sciences (TSX: FXA) announces third quarter results, and fewer colds.
Cold F-X producer Afexa Life Sciences (TSX: FXA) announces third quarter results, and fewer colds.
Afexa reports earnings of one penny a share.
"As we have stated previously, revenue from our lead product, COLD-FX is highly dependent on the frequency and severity of colds and flu experienced in Canada," commented Jack Moffatt, Afexa's Chairman and CEO. "The incidence of cold and flu will continue to fluctuate and contribute to quarter-to-quarter volatility in our revenue. This year retailers entered calendar 2010 well stocked with product, in anticipation of a normal cold and flu season. However, in calendar 2010 incidence of colds and flu were much lower than the prior year. In particular, the January to April 2010 period, post H1N1, was very light and continued to be light well into the fall 2010 cold and flu season."
http://www.tradingmarkets.com/news/stock-alert/afxsf_fxa_afexa-announces-2011-third-quarter-results-1485736.html
Afexa reports earnings of one penny a share.
"As we have stated previously, revenue from our lead product, COLD-FX is highly dependent on the frequency and severity of colds and flu experienced in Canada," commented Jack Moffatt, Afexa's Chairman and CEO. "The incidence of cold and flu will continue to fluctuate and contribute to quarter-to-quarter volatility in our revenue. This year retailers entered calendar 2010 well stocked with product, in anticipation of a normal cold and flu season. However, in calendar 2010 incidence of colds and flu were much lower than the prior year. In particular, the January to April 2010 period, post H1N1, was very light and continued to be light well into the fall 2010 cold and flu season."
http://www.tradingmarkets.com/news/stock-alert/afxsf_fxa_afexa-announces-2011-third-quarter-results-1485736.html
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