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Investment in the biotechnology sector stagnated in the third quarter of 2015, raising $2.1 billion, according to the latest MoneyTree Report from PricewaterhouseCoopers and the National Venture Capital Association. Read More
A U.S. district court judge handed PhRMA a major victory when he vacated an HHS rule requiring Medicaid discounts on orphan drugs in certain healthcare settings, calling it “arbitrary, capricious, [and] an abuse of discretion.” Read More
The FDA Wednesday placed another Indian active pharmaceutical ingredient maker on its import alert list, adding one of Megafine Pharma sites to 46 other India-based finished drug and API sites whose products are banned from entering the U.S. Read More
Valeant Pharmaceuticals is reviewing subpoenas by federal prosecutors from two states regarding drug pricing decisions, following criticism from Democratic lawmakers last month over massive price increases in two of its heart disease drugs. Read More
The European Commission released new rules clarifying the responsibilities of qualified persons overseeing global, multisite manufacturing operations and the data they need to collect. Read More
Just days after the Trans-Pacific Partnership pact cut exclusivity protections for drugmakers outside the U.S., a proposal that would extend a waiver allowing poor countries to ignore drug patent laws is raising more ire. Read More
The FDA handed Galena Biopharma a 10-item Form 483 for lapses in adverse drug event reporting — some of them repeat observations — following a reinspection of its Portland, Ore., facility. Read More