Lilly/Daiichi Sankyo's antiplatelet agent Effient (prasugrel) took 18 months to approve, and the unexplained lack of effect for ticagrelor in North American patients in AstraZeneca's PLATO study is a sure bet for FDA scrutiny. read more
Committee finds clinical trial safety results more compelling than meta-analysis, and is undeterred by the lack of statistical significance in the study's primary endpoints. read more
Firms air good Phase III data for generic combo in PE, while Vivus tackles more mature erectile dysfunction market. read more
Support for merged Senate bill will be tested in Saturday evening cloture vote. read more
A rebound in the Indian stock market and two recent high-value takeovers sparked "irrational hope" in overvalued mid-size companies. read more
Protein Sciences "Dumbfounded" After Committee Votes Down FluBlok
Cell-based seasonal influenza vaccine needs both additional safety data in general and considerably more efficacy data in older patients, FDA advisory panel says. read more
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