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For the second time this year, Otsuka has sued the FDA for loss of patent protection for its schizophrenia drug Abilify — this time to reverse the agency’s approval of Alkermes’ Aristada. Read More
The FDA dealt Shire’s promising dry eye treatment lifitegrast a setback, requesting an additional clinical study and more product quality information just days before the drug’s anticipated approval date. 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
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
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