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Democratic presidential candidate Hillary Clinton joined the growing chorus of lawmakers and others outraged over Turing Pharmaceuticals’ price hike on Daraprim, pressing the FDA and FTC Monday to broaden access to less expensive drugs. Read More
The FDA’s Office of Planning is calling for better coordination and communications between CDER and CDRH to facilitate reviews of a growing tide of combination therapies. Read More
A federal appeals court refused to rehear the biosimilars case pitting Sandoz against Amgen, letting stand a July decision allowing Sandoz to launch its Zarxio biosimilar of Amgen’s cancer therapy Neupogen (filgrastim) in September. Read More
A consumer watchdog group is urging the FDA to hold drugmakers to a higher standard when it comes to data to support NDAs, saying the agency’s review of Boehringer Ingelheim’s blockbuster bloodthinner Pradaxa was flawed and dangerous. Read More
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