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Biosimilars makers must have FDA approval of their product before giving the reference product manufacturer 180-day notice of first commercial marketing, the Federal Circuit Court of Appeals ruled Tuesday — in a decision that bars Sandoz from marketing its Neupogen biosimilar until Sept. 2. Read More
Bristol-Myers Squibb has received breakthrough therapy designation from the FDA for its first-in-class investigational BMS-663068 compound for use in preventing HIV infection. Read More
The FDA continues to crack down on generic drugmakers that owe GDUFA fees, hitting Indian drugmaker Vista Pharmaceuticals with a warning letter for failing to pay fees for the last three fiscal years. Read More
Exelixis’ Cometriq improved patient outcomes in a pivotal Phase 3 trial for metastatic kidney cancer — signaling new life for the drug, which failed another study last fall. Read More
Regulators in the EU have cleared the way for Amgen to market its cholesterol-lowering drug Repatha, marking the world’s first approval of a PCSK9 inhibitor. Read More
Two institutional buyers of Gleevec want to stop its manufacturer, Novartis, from delaying generic competition of the blockbuster leukemia drug, saying a patent litigation settlement between the brandmaker and generics maker Sun Pharma was construed solely for that purpose. Read More
The FDA is revoking general safety test requirements that are duplicative in biologics licensing applications and proposing to remove two obsolete regulations for the review and reclassification of biologics licensed before July 1972. Read More
The FDA published dozens of product-specific draft guidance documents offering recommendations on the design of bioequivalence studies to support ANDAs. Read More