Prasugrel – the saga continues. Gets approval to launch in the EU; positive study results versus Plavix for a certain group of patients; but controversy swirls around FDA approval process.
Synta‘s Phase III trial for melanoma drug fails badly. In a devastating blow to the company, Synta Pharmaceuticals has halted a Phase III melanoma drug trial after a greater number of people taking elesclomol died than those receiving standard care. The findings were so bad that the company also suspended other ongoing studies of the drug, including a study a trial for metastatic prostate cancer and a monotherapy dose escalation study.
Wearisome to report – more scandals. AstraZeneca buried some Seroquel data? Ranbaxy falsified records and gets major smackdown. Forest accused of off-label marketing practices (anti-depressants for children). And, from Peter Rost’s blog, here’s an interesting chart showing who paid the most/least in government fines and settlements since 2000 (the winner on the “least” scale: Novartis!)
Sanofi gets US clearance to market Apidra pen. Sanofi-Aventis has won U.S. approval to market its Apidra Solostar injection pen which contains insulin to treat diabetes, the world’s third-biggest drugmaker said on Thursday. The disposable pen is prefilled with Apidra, which is indicated to improve glycemic control in adults and children of at least four years with type 1 diabetes or adults with type 2 diabetes, the most common form of the disease.
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