FDA approves GlaxoSmithKline/Genmab’s Arzerra (ofatumumab) for refractory chronic lymphocytic leukemia, just what Genmab needed to pick itself up after the anti-CD20 monoclonal antibody disappointed in a non-Hodgkin’s lymphoma trial in August.
Supreme Court will take up securities fraud litigation against Merck related to Vioxx Nov. 30. Question comes down to when investors had enough information to file a suit against Merck.
One year after partnering dimebon with Pfizer, Medivation has found another deep-pocketed big pharma partner in Astellas. The Japanese pharma will pay $110 million to Medivation upfront for rights to a Phase III prostate cancer candidate.
ZymoGenetics’ Phase II start for the hepatitis C candidate PEG-interferon lambda triggers a significant $70 million payout from partner Bristol-Myers Squibb. The next generation interferon is one of Bristol’s “string of pearls” and one of several hepatitis C candidates the drug maker has in the pipeline.
Anti-Infective Drugs Advisory Committee recommends FDA use Clinical and Laboratory Standards Institute guidelines to update susceptibility test information in systemic antibacterial drug labeling to avoid mammoth undertaking and waste of resources.
