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POPSAnother Blow For Cancer Vaccines An independent committee stops a study of Cell Genesys' GVAX because more patients died with the therapy than without. Cell Genesys shares drop below $1. This is yet another blow to a field that has been beset by trouble. Still in the game: the controversial Dendreon, with another ongoing study in prostate cancer, and GlaxoSmithKline, which has a huge cancer immunotherapy effort.
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POPSCan't Always Believe The Briefing Docs Ligand got hammered because FDA scientists were doubtful about its Promacta. But a panel says the data support its use. Of course, the FDA doesn't have to follow the advice of its panels. Still, things are looking a lot better for Ligand -- proof that even scathing briefing documents don't have to sink a drug. It ain't over 'til it's over.
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POPSGlaxo Buys Sirtris For $720 Million A bit unexpected, as big pharma's have been mostly involved in buying up drugs that are close to market. Sirtris' medicines, famously based on a supposedly life-prolonging chemical in red wine, are very early stage. Still, this emphasizes the trend of foreign-based pharmaceutical firms buying up U.S. companies, which are cheap because of the weakness of the dollar.
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POPSFinally. Who would have thought a combo of two already marketed drugs would take forever and a day to approve?
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POPSDear Dr. Garnier Glaxo gets a warning letter from the FDA, which says the company didn't provide full and timely information about Avandia. "We take these findings seriously, and corrective steps to make sure we file periodic reports completely and promptly have been taken or are underway," said Dr. Ronald Krall, Chief Medical Officer at GlaxoSmithKline said in a prepared statement. "These omissions did not interfere with the timely reporting of adverse event information to the FDA."
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POPSBad For Glaxo, Good For Merck The run of good luck Merck has had with regard to potential rivals has really been amazing. First, it's Januvia benefited from a regulatory delay of Novartis' Galvus. Then the safety controversy over Avandia further boosted Januvia sales. Now the main rival to Merck's Gardasil vaccine, Cervarix from GSK, faces another regulatory delay.
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POPSMerck's Big Risk: High Expectations So much has gone so right for so long. Merck has executed well, but it has also gotten very lucky. For instance, its diabetes pill Januvia would not be such a big product were it not for both the safety problems plaguing GlaxoSmithKline's Avandia and the regulatory delay of Novartis' Galvus. Earnings forecasts have just kept going up. Should investors start to feel cautious? Or can Merck really keep delivering when other drug stocks are not?
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POPSAvandia: Hanging By A Thread? Senator Charles Grassley said in a letter to the Food and Drug Administration that he has heard an FDA panel voted in private to keep Avandia on the market. The margin: One vote.
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POPSA Golden Age Of Vaccines? My colleague Robert Langreth has a fantastic story about the cutting edge of vaccine development, including this striking story of a researcher who volunteered to be part of a test for a new malaria vaccine.
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POPSAvandia May Get Black Box It wouldn't be a surprise if Avandia does get a black box warning. But it is interesting to her that the battle is going on behind the scenes at the FDA.
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