This week, vaccine manufacturers won increased protection from liability in a closely watched case before the US Supreme Court. In Bruesewitz v. Wyeth, the Court ruled that federal law prohibits patients who claim to have been injured by a vaccine from suing the manufacturer. Pfizer hailed the decision as a victory for public health, but its effect is to diminish patients’ recourse when they suffer harm from taking faulty products. Read more »

A possible link between cases of the chronic sleep disorder narcolepsy and GlaxoSmithKline’s H1N1 pandemic vaccine, Pandemrix, has led to a call from the World Health Organization (WHO) for further investigation. Narcolepsy is a rare condition with no currently available cure. Read more »

Earlier this week I took a trip to Liverpool (UK) to the Downstream Processing Day hosted by SAFC and Sartorius Stedim Biotech. A lot of interesting topics were discussed, including vaccine manufacture, which is a particularly hot issue both inside and outside of the industry at the moment. Read more »

Journalists continue to comb through the latest batch of diplomatic cables released by WikiLeaks, seeking to interpret the mass of raw information. Until now, the cables’ significance has seemed to be limited to political circles. But one cable turns out to contain the 2008 version of the Critical Foreign Dependencies Initiative (CFDI) list, which names international facilities that could be considered crucial for American security. Perhaps not surprisingly, the list cites several pharmaceutical and biopharmaceutical facilities. Read more »

Does federal law shield the makers of vaccines from product-liability lawsuits? Last week, the US Supreme Court began considering this question, which is the heart of a lawsuit against Wyeth, now a part of Pfizer (New York). Read more »

Johnson & Johnson (J&J New Brunswick, NJ) announced last week that it was in “advanced negotiations” for a potential public offer for the Dutch biopharmaceutical company Crucell (Leiden, The Netherlands). Although not yet making a formal bid, J&J said it would consider an offer of EUR 24.75 ($32.49) per share for Crucell in an all-cash transaction of approximately EUR 1.75 billion ($2.30 billion) to acquire all the shares of Crucell that it does not already own. J&J now holds a 17.9% stake in the company. If the deal proceeds as planned, the move would enable J&J to develop a vaccine business, something the company is seeking to build within its biopharmaceutical capabilities. Read more »

The global recession is still prompting a lot of belt tightening. Patients and healthcare payers are looking for ways to cut costs, and drugmakers are trying to boost their manufacturing efficiencies. Developing countries naturally are feeling the squeeze more keenly. Budget constraints in those nations could keep patients from receiving necessary vaccines, which often are produced from recombinant proteins in a multistep process that is complicated and expensive. Read more »

Patients who take biological drugs traditionally have had little choice but to submit to injections. Yet needlephobes should take heart. Several partnerships are developing other ways to deliver large molecules that seem to show promise. Read more »

A new clinical trial for an AIDS vaccine will take place in Africa and the United States. The program, announced this week, is a collaboration between the International AIDS Vaccine Initiative (IAVI), which will lead the trial, biopharmaceutical company Crucell (Leiden, Netherlands), Harvard Medical School’s Beth Israel Deaconess Medical Center, and the Ragon Institute, an organization dedicated to HIV/AIDS research. Read more »

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 »