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A drug compounder not approved by the FDA says it is mixing pyrimethamine — the active ingredient in Daraprim — with another drug, folic acid-derivative leucovorin, at a cost of $99 per 100-count bottle to counter Turing Pharmaceuticals’ $750 per pill price on the blockbuster AIDS drug. Read More
Facing calls for congressional inquiries and investigations by prosecutors in New York and Massachusetts, Valeant Pharmaceuticals officials say the outlook for the drug industry in 2016 is for lower price increases. Read More
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