President Barack Obama announced on Monday that he plans to appoint Harold Varmus, a former director of the National Institutes of Health (NIH) and co-recipient of the 1989 Nobel Prize in Physiology or Medicine, as director of the National Cancer Institute (NCI). Varmus would replace current director John E. Niederhuber, who became NCI head in 2006. The move follows recent criticism of NCI’s clinical-trial program by the Institute of Medicine (IOM), the health arm of the National Academy of Sciences. Read more »

The dust has partly settled since President Obama signed the “Health Care and Education Affordability Reconciliation Act of 2010.” By now, analysts have had a chance to examine the act’s details and get a sense of what practical effects the legislation will have. So what will healthcare reform mean for pharmaceutical manufacturers? Read more »

Big biopharmaceutical companies likely struck up a chorus of “We’re in the Money” upon hearing Ernst and Young’s report that the world’s established biotechnology markets achieved profitability in 2009 for the first time ever. Mostly by dint of cost cutting, major players such as Genzyme (Cambridge, MA) moved out of the red and into the black. Making a profit was no small feat during the economic downturn, and large biopharmaceutical companies have a right to celebrate. Small companies and startups, however, are more likely to sing along with Bob Dylan, “It’s not dark yet, but it’s gettin’ there.” Read more »

Last week the US Food and Drug Administration approved Provenge (sipuleucel-T), an autologous cellular immunotherapy for treating advanced prostate cancer, developed by the biotechnology company Dendreon (Seattle). If commercially successful, the approval of this cancer immunotherapy, a cancer vaccine, which uses a patient’s own immune system to combat the disease, may offer a new treatment paradigm for cancer. Key questions going forward, however, are how the product will fare commercially against existing anticancer therapies and the long-term financial viability of producing a personalized medicine. Read more »

The other night, I was watching this great cable show hosted by Penn and Teller, the former magicians, in which they set out to prove wrong popular myths and beliefs. The hosts interview academics, scientists, and even perform their own social experiments. For example, one recent show focused on whether the playing of violent video games can translate into actual violent behavior (the answer they reached: no). Read more »

Legislators and regulators on both sides of the Atlantic have spent the past decade trying to improve access to safe and effective pediatric formulations and drug products—but it’s unclear whether pharma companies are taking notice. Read more »

This afternoon, FDA Commissioner is expected to help launch the Critical Path to TB Drug Regimens (CPTR)—an initiative aimed at accelerating the development and approval of new treatments for tuberculosis (TB). Supporting the initiative are the TB Alliance, the Bill & Melinda Gates Foundation, the Critical Path Institute (C-Path), and 10 pharmaceutical companies: Johnson & Johnson, sanofi-aventis, Pfizer, AstraZeneca, GlaxoSmithKline, Bayer, Otsuka, Novartis, Sequella and Anacor Pharmaceuticals.
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This morning I read about a public–private collaboration that reflects many of the latest trends in the drug industry today. The project began when the University of Pittsburgh Medical Center (UPMC) created the 21st Century Biodefense (21CB) initiative to enhance the nation’s biosecurity. Robert J. Cindrich, who is leading the initiative, said in a press release that the project’s goal was to foster advances in vaccine development and manufacturing. Battelle (Columbus, OH), a research and development organization, IBM (Armonk, NY), Merck (Whitehouse Station, NJ), and GE Healthcare (Waukesha, WI) have all joined the collaboration so far. Read more »

These days, mandatory furloughs and staff cuts have employees in all industries nervously glancing over their shoulders. The pharmaceutical industry is no exception. Last week, Merck (Whitehouse Station, NJ) revealed plans to reduce its workforce by 15% by the end of 2012. Read more »

Handling the vast amount of data that can be generated from scientific research, including pharmaceutical research such as genome sequencing, can be a formidable task. Researchers may not be able to efficiently manage this task through the use of personal computers (PCs) alone, nor do they have access to supercomputers or other advanced information-technology (IT) systems. The emerging model of cloud computing, an advance in computational computing, seeks to address researchers’ difficulties by creating a community resource of computational and processing power accessible on demand through PCs. Last week Microsoft and the National Science Foundation (NSF) announced a partnership to increase access to cloud computing for NSF-supported researchers.

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