Monday, February 28, 2011
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;
• 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
Friday, February 25, 2011
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."
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.
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 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-naÃ¯ve 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
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
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."
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."
200 Largest Pharmaceutical Companies in the World
Monday, February 21, 2011
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.
40 Valley Stream Parkway
Malvern, PA 19355
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:
XIAFLEX for the treatment of Peyronie’s disease (“Peyronie’s”)
XIAFLEX for the treatment of Adhesive Capsulitis (“Frozen Shoulder syndrome”)
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
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."
Saturday, February 19, 2011
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
Friday, February 18, 2011
Mumbai 400 008
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
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."
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:
About Pfizer, Inc*
235 East 42nd Street, New York, New York 10017
Reveune: $67.8 billion (2010)
I.R.S. Employer Identification Number:
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
200 Largest Pharmaceutical Companies in the World
Thursday, February 17, 2011
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.
"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
Updated list for 2012 is here:
The 200 Largest Pharmaceutical Companies in the World
Amarin Corporation plc
Astellas Pharma Inc.
AstraZeneca Pharma India
Bavarian Nordic A/S
Beijing Tongrentang Co
Chongqing Huapont Pharmaceutical
Chongqing Taiji Industry
Clinical Data Inc
Da An Gene Co Ltd of Sun Yat-Sen University
Dong-A Pharmaceutical Co
Dr. Reddy's Laboratories
Euromayor S.A. De Inversiones
F. Reichelt AG
Financiere de Tubize
Gansu Duyiwei Biological
Genomma Lab Internacional SAB de CV
Green Cross Corp
Guizhou Bailing Group
Hainan Honz Pharmaceutical Co
Harbin Pharm Group Sanjing
Henan Topfond Pharmaceutical
Huadong Medicine Co
Hubei Biocause Pharmaceutical Co
Jiangsu Hengrui Medicine
Jiangsu Kanion Pharmaceutical
Jiangsu Nhwa Pharmaceutical
Jiangsu Sihuan Bioengineering
Jiangxi Jiangzhong Pharmaceutical
Jilin Aodong Medicine
King Pharmaceuticals (acquired by Pfizer, Inc)
Kobayashi Pharmaceutical Co
Krka, tovarna zdravil
Kyowa Hakko Kirin
LG Life Sciences
Mitsubishi Tanabe Pharma
Nippon Shinyaku Co
North China Pharmaceutical
Opko Health Inc
Prestige Brands Holdings
PT Kalbe Farma
Qingdao Huaren Pharmaceutical
Richter Gedeon Nyrt
Shandong Luoxin Pharmacy
Shanghai Kaibao Pharmaceutical
Shanghai Modern Pharmaceutical
Shanghai RAAS Blood Products
Shanxi Yabao Pharmaceutical
Shenzhen Salubris Pharmaceuticals Co
Swedish Orphan Biovitrum AB
Tempo Scan Pacific
Tianjin Chase Sun Pharmaceutical
Tianjin Zhong Xin
Tibet Cheezheng Tibetan Medicine
Tibet Urban Development & Investment
Tsumura & Co.
Unisplendour Guhan Group
Xinjiang Tecon Animal Husbandry Bio-Technology
Zhejiang Hisoar Pharmaceutical
Zhejiang Jianfeng Group
Zhejiang Medicine Co., Ltd.
Zhejiang Xianju Pharmaceutical
Zhuzhou Qianjin Pharmaceutical
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
Baxter (NYSE: BAX) International reports that Preflucel vaccine, using cell-based manufacturing is as effective as conventional chicken egg vaccines
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."
The Baxter International press release is here
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
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
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.
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?
Study: Influenza vaccination of healthcare workers
Wall Street Journal - Blog
Medivation (MDVN) and Astellas Pharma (YPH.BE) to present Follow-Up Data From Phase 1-2 Trial of MDV3100
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)."
Sunday, February 13, 2011
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."
"Dottie had a heart condition and she died."
Swine flu video (funny, sort of).
Friday, February 11, 2011
BioCryst Pharmaceuticals (BCRX) posts 4th quarter loss. Most revenue came from US government contract for development of flu drug peramivir
According to the announcement, “fourth quarter 2010 total revenues of $17.8 million consisted primarily of reimbursement of collaboration expenses, including $14.9 million from the contract with the Department of Health and Human Services (HHS) for the continued development of i.v. peramivir and the recognition of $1.1 million in grant income from the U.S. Government's QTDP program. Fourth quarter 2009 total revenues of $54.9 million were boosted by exceptional items related to the H1N1 pandemic and peramivir development, including $22.9 million in emergency use product sales of peramivir, primarily to HHS, and a $7.0 million milestone payment from Shionogi & Co., Ltd. (Shionogi) related to the filing of a New Drug Application (NDA) for i.v. peramivir in Japan. Fourth quarter 2009 revenue also included reimbursement of $21.5 million in i.v. peramivir development expenses from HHS.
In January, BioCryst completed its Phase 3 study (303) of the safety, tolerability and anti-viral activity of i.v. peramivir administered either as a once-daily infusion of 600 mg or a twice-daily infusion of 300 mg to adult and adolescent subjects hospitalized with confirmed or suspected influenza infection. Both dose regimens of i.v. peramivir were generally safe and well-tolerated. The frequency and severity of adverse events was similar in the two groups and was consistent with the profile of influenza patients hospitalized during the 2009-2010 pandemic.”
The Department of Health initially resisted requests for the information with flimsy claims of commercial confidentiality. As we now know, the swine flu “pandemic” was vastly over hyped, and much of the swine flu vaccine had to be discarded (at taxpayer’s expense).
Rosenbaum reports that GlaxoSmithKline (GSK) received the lion share of the bounty for its Pandemrix vaccine, with the rest going to Baxter Int’l (BAX) for Celvapan.
Still, it wasn’t easy getting the information. At first DOH refused to respond to a freedom of information request. BBC then had to appeal to the information commissioner. As Rosenbaum points out, this “case illustrates the limits of commercial confidentiality under FOI. It shows how claims sometimes made by public authorities about possible damage to commercial interests are not necessarily strong enough grounds for refusing freedom of information requests.“
Thursday, February 10, 2011
As reported by CNBC, “the company began in the late 1980s as a home drug-infusion business. And as they processed drug claims with the government, they found something odd, says Patrick Burns, a spokesman for the non-profit group Taxpayers Against Fraud, who calls the founders of Ven-A-Care “American heroes.”
"What they discovered was that they were buying drugs for a buck and Uncle Sam was paying $5 for 'em,” Burns says. “Five-hundred percent markups, 1,000 percent markups, 2,000 percent markups that Uncle Sam was paying.”
Armed with that information, Ven-A-Care filed whistleblower suits against drug companies. And since 2001, the four men have forced drug companies to pay the federal government more than $1.3 billion dollars. Of that, the Ven-A-Care founders, known as “relators” in whistleblower jargon, got to keep $280 million dollars for themselves.”
Report says Pfizer (NYSE: PFE) will pay approx $ 330 million to settle claims related to the Prempro menopause drug.
"The drugmaker faced more than 10,000 claims that its menopause drugs caused breast cancer prior the settlements, which were reached during the past five months, the people said. That number included more than 8,000 cases consolidated in federal court in Arkansas and other cases in state courts in Pennsylvania, Nevada and Minnesota."
Pfizer is facing numerous suits claiming that its hormone replacement therapy caused breast cancer.
"The virus that would trigger the H1N1/A pandemic in the spring of 2009 emerged in Mexico, and appeared to jump not from birds but from pigs. (Hence the term "swine flu.") It was as if the world's epidemiologists has been preparing for an invasion from the east only to be hit in our soft underbelly. While the Mexican government should be applauded for reacting to the new virus relatively well — and more importantly, in an open fashion — the fact that it emerged in a medical blind spot almost certainly slowed the international reaction to the new pandemic. Luckily, H1N1/A ended up being fairly weak, but if the virus had been a killer on level with the 1918 pandemic, that lost time could have meant lost lives.
Read more: http://healthland.time.com/2011/02/08/a-new-project-to-track-animal-disease-before-they-infect-humans/#ixzz1DZfWwtbr"
The Global Viral Forecasting project http://www.gvfi.org/ is trying to predict and prevent future pandemics.
Sanofi-Aventis provided guidance that earnings per share could drop 5-10 % this year.
“Despite the absence of A/H1N1 vaccines sales and the impact of generic competition, double digit sales increase(6) of growth platforms and cost control should lead to 2011 business EPS(1) 5% to 10% lower at CER than 2010 business EPS(7), barring major unforeseen adverse events. This guidance does not assume a return of generics of Eloxatin® in the U.S. and does not include any benefit from a possible acquisition of Genzyme.”
Wednesday, February 9, 2011
"In the past week, the number of number of GP consultations in England has fallen to 24.1 per 100,000, down from 40.7 per 100,000 the previous week. The baseline level is 30 per 100,000 and the peak level was 124.4 per 100,000 in the flu report dated 30 December."
The CDC's "Morbidity and Mortality Weekly Report" provides an interesting, if eerie, glimpse into the weekly death rate in 122 cities in the United States.
Pneumonia and Influenza deaths are grouped together. This continues to be a troublesome feature of CDC's reporting as the pneumonia death statistics inflate the scope of flu deaths overall.
Utica, New York, and Gary, Indiana, are among the places where no flu or pneumonia deaths were reported in the last week. The Gary is number is interesting, given the CDC's assessment that flu activity is "widespread" in Indiana.
A Flu Crazy Exclusive!
ILINet (“Influenza-like illness”) numbers on the CDC’s weekly flu page, show that the majority of states and territories are experiencing low or minimal flu outbreaks for the week ending January 29.
• “New York City and 10 states (California, Idaho, Kansas, Kentucky, Missouri, Nevada, New York, Ohio, West Virginia, and Wyoming) experienced low ILI activity.
• Minimal ILI activity was experienced by the District of Columbia and 19 states (Alaska, Connecticut, Delaware, Iowa, Maine, Massachusetts, Michigan, Minnesota, Montana, Nebraska, New Hampshire, North Dakota, Oregon, Rhode Island, South Dakota, Utah, Vermont, Washington, and Wisconsin).”
In addition, four states (Delaware, Hawaii, Oregon, and Utah) reported only sporadic flu activity.
Tuesday, February 8, 2011
The campaign is promoting the vitamin C content of its drinks. However, the National Consumers League is not amused and has filed a complaint with the Federal Trade Commission asking vitaminwater to cease and desist with the ads, calling them "dangerously misleading," according to a report by the Atlanta Journal Constitution.
I think I am going to call "foul" on the National Consumers League (NCL) for lacking a sense of humor. Seriously, don't they have anything better to do? There have to be greater threats to consumers then a silly ad campaign. And, I ask the NCL to perhaps check up on the Centers for Disease Control (CDC) for their "dangerously misleading" hysteria.
Monday, February 7, 2011
"Seoul confirmed its first outbreak of the virulent H5N1 strain on Dec. 31 after some poultry farms reported sudden deaths of animals earlier in the month. It has since ordered the culling of more than 5.41 million birds to stop the spread of the contagious disease."
"The latest outbreak is the fourth to hit the country, with previous cases reported in the winter months of 2003-04, 2006-07 and spring of 2008.
In the 2003-04 period, Seoul destroyed 5.28 million birds while in the subsequent outbreaks, 2.8 and 3.45 million birds were culled, respectively."
According the to report on the medical site, WebMD, "such a vaccine could also help prevent pandemics such as the recent outbreaks of H1N1 swine flu.
Traditional flu vaccines target proteins that sit on the virus’s outside coat and harness the body’s existing antibodies to fight infection. However, these proteins tend to mutate, meaning that manufacturers have to develop new vaccines.
The new treatment targets proteins inside the flu virus that are common across all strains and use existing antiviral T cells to attack the virus."
Longer article about this research via The Guardian: http://www.guardian.co.uk/society/2011/feb/06/flu-universal-vaccine-test-success?CMP=twt_gu
Wednesday, February 2, 2011
Dr. Lorraine Smith, and ear, nose and throat doc at Osborne Head and Neck Institute says, ""That product is actually supposed to kill 99.9 percent of the viruses and bacteria that you get exposed to, and it lasts about eight hours,"
Tuesday, February 1, 2011
Of course, they still link pneumonia and flu together in their statistics, so we still don't have a "real" number of flu cases. But, this report confirms what many have long suspected: flu hysteria is just that: hysteria.
Scientists have discovered that the swine flu was transmitted to the same gender at three times the rate of opposite gender infections, according to a story in the Milwaukee Wisconsin Journal Sentinel (http://www.jsonline.com/blogs/news/115036389.html).
"Researchers in the U.S. and England are reporting that in the 2009 swine flu pandemic, boys most often infected other boys, while girls tended to infect other girls.
The study examining how swine flu spread in an elementary school was conducted by scientists at Imperial College London, the U.S. Centers for Disease Control and Prevention and the Pennsylvania Department of Health and appears in the journal Proceedings of the National Academy of Sciences.
The researchers looked at how social networks influenced the way in which the H1N1 pandemic spread through an elementary school in Pennsylvania. Their findings could help health officials plan responses to future epidemics.
The scientists found that children were three times more likely to transmit the flu to children of the same gender than to children of the opposite gender. They also found that the rate of flu transmission was five times higher between children in the same class than it was between children in the same grade but different classes. The rate of transmission was 25 times high between children in the same class than between children in different grades.
However, the scientists found that a child's risk of catching the flu did not rise significantly when he or she sat next to a child with the flu.
In all, 370 children were involved in the study. They attended a school that closed 18 days after the swine flu outbreak began. At the time, 27% of the students were showing symptoms.
"The data from this study will help us make more accurate models, which can help public health officials to handle epidemics effectively," said Simon Cauchemez, who works at Imperial College London and led the study. "For example, these new models could help us better understand whether and when it would be appropriate to close a school, or whether it might be better to close individual classes or grades.""