FDA and Genentech, a member of the Roche Group, have issued warnings about counterfeit versions of the injectable cancer drug, Avastin, circulating in the US. According to the FDA safety alert,  the counterfeit version of Avastin does not contain the medicine’s active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy. FDA issued letters to 19 medical practices that purchased unapproved cancer medications from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products. Read more »

A report released on Feb. 8, 2012 from the California Healthcare Institute, BayBio and PwC shows that the shrinking economy, changes in investment strategies, and pressures on the pharmaceutical market have put the brakes on one of the US’s most robust biotechnology centers. California had enjoyed steady growth in its biotech sector for the past two decades, and according to the report, is the source of 28% of the country’s biomedical pipeline. More recently, as with the rest of the world, the slowdown in the global economy has taken its toll on this area. The industry lost approximately 6,300 jobs, or about 2.3% of its life-sciences workforce since 2008, returning employment levels to those seen in 2006. Read more »

As part of Ranbaxy’s recently announced consent decree, the company is required to set up a program whereby whistleblowers can come forward with information related to potential violations of the Food, Drug, and  Cosmetic Act. According to the decree, available through Pharmalot’s post, Ranbaxy must, within 75 days, establish a phone line and a system to receive and maintain submissions from individuals wishing to report suspected violations. The submissions are required to be confidential, there should be no retaliation, and a good-faith effort must be made to investigate any allegations. Read more »

When should there be restrictions on the dissemination of basic research results? This question has arisen in the context of papers from independent laboratories submitted to the journals Science and Nature. Ron Fouchier and colleagues from the Erasmus Medical Center in Rotterdam, the Netherlands and a team headed by Yoshihiro Kawaoka of the University of Wisconsin-Madison, were both studying the H5N1 strain of flu virus, which causes avian flu. Avian flu can decimate flocks of poultry, but is rarely transmissible to humans. Nevertheless, because of the close proximity in which humans and poultry reside, there is concern that the virus could someday acquire the ability to infect mammals, and become the source of a pandemic. Both laboratories, working independently, identified mutations in H5N1 that allowed mammal-to-mammal transmission, using ferrets as the experimental model. Read more »

A newly released report from Jones Lang LaSalle, a financial and professional services firm specializing in real estate services and investment management, looks at the world in terms of life-sciences investment, and finds some not-so-surprising trends over the past 10 years. The report ranked areas of the world according to how much direct investment they received in life sciences, and compared the rankings made between 2003–2006 with those made between 2007–2010. Those time periods were chosen to represent periods before and after the world-wide economic slowdown. Not surprisingly, on both lists, the US was number one, with Ireland, China, and Singapore also in the top 5 in both analyses. However, there have been some changes over the past few years. Puerto Rico, which ranked number 8 on the 2003–2006 list, failed to make the top 10 ranking in the 2007–2010 list. And Canada and Brazil, two non-European countries, replaced Sweden and France as top 10 recipients of life-sciences investments. India, ranked at number 9 in the 2003–2006 analysis, moved up to number 4 in the more recent ranking. Read more »

If a clinical trial is run, but the results are never published, what benefit is there to patients, physicians, or the public? Read more »

According to a recent press release from the Department of Justice, the government has reached record highs in the recovery of fines settled under the False Claims Act. In 2011, over $3 billion were collected, bringing the total since January 2009 to $8.7 billion. This year’s total included $2.4 billion in recoveries involving fraud committed against federal health care programs. Read more »

This week’s announcement of a public meeting to discuss a user fee structure for biosimilars marks another step towards implementation of the Biologics Price Competition and Innovation Act of 2009, which mandates that FDA establish an approval pathway for biosimilars. The question on everyone’s mind regarding the definition of a biosimilar has yet to be answered, but the fee announcement and the accompanying proposed review of performance goals and procedures provides some welcome information about what the approval process will look like. Read more »

On Nov. 30, 2011, the patent for Lipitor, the cholesterol-lowering drug that defined the term “blockbuster,” expired. Over its lifetime, it is estimated that Lipitor generated over $100 billion in sales for its parent company, Pfizer, since its introduction in 1997. Read more »

Geron announced earlier this week that it was discontinuing its clinical trial evaluating the use of embryonic stem cells for the treatment of spinal cord injury. The company said it planned to discontinue its embryonic stem cell research program, and focus instead on its oncology pipeline. The reason given was economic. According to the company press release, “The decision to narrow Geron’s technology and therapeutic focus was made after a strategic review of the costs, value inflection timelines and clinical, manufacturing and regulatory complexities associated with the Company’s research and clinical-stage assets.” In other words, the company did not expect to recover enough revenue soon enough from the therapy to justify the expense of the remaining trials and the expense of continuing development. Read more »