For the First Time, the FDA Takes Back a Breakthrough Therapy Designation
Insights - Merck (MRK) revealed on Wednesday that the U.S. FDA has rescinded a Breakthrough Therapy Designation for its investigational Hepatitis C treatment.
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Your 30-Second Primer on this Week’s Hottest IPO, Spark Therapeutics
Insights - Spark Therapeutics (ONCE) lists publicly today, joining companies like bluebird bio (BLUE) and Avalanche (AAVL) as yet another emerging gene therapy player.
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Conatus’ Recent Data were so Damn Confusing; Sometimes That’s the Best Thing for Investors
Research - Conatus (CNAT) was punished 2 weeks ago with the release of results from 3 phase I/II studies. Thankfully, we suggested taking profit beforehand at +60%.
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Regeneron’s New Cholesterol Drug is a Month Ahead of Amgen’s: Is that Worth $70 Million?
Insights - That's what Regeneron (REGN) and Sanofi (SNY) paid for a FDA Priority Review Voucher that will shorten the review time for the PCSK9 inhibitor, alirocumab.
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Medivation Reports Success in Latest Cancer Trial
Insights - The trial was successful, with enzalutamide improving progression-free survival (PFS) meaningfully compared to bicalutamide.
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What Does it Mean When EVERYONE’s Optimistic About Biotech Stocks?
Tekmira Just Became a Must-Own Stock for 2015
Research - Tekmira Pharmaceuticals (TKMR) is merging with privately held OnCore Biopharma, which develops drugs targeting the Hepatitis B virus (HBV).
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