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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The FDA published dozens of product-specific draft guidance documents offering recommendations on the design of bioequivalence studies to support ANDAs.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
The House of Representatives approved the 21st Century Cures Act by a vote of 344 to 77 on July 10, moving focus to the Senate where efforts have begun to develop comparable legislation. Read More
Relying on a U.S. Supreme Court precedent involving Actavis, the Third Circuit Court of Appeals ruled June 26 that patent settlements in pay-for-delay cases can face antitrust scrutiny even if they do not include cash. Read More
The Federal Circuit Court of Appeals has ruled that two of The Medicines Company’s patents for its anticlotting drug Angiomax are invalid — a win for Hospira, which is planning a generic version of the treatment. Read More
Early notice of production shutdowns by manufacturers of life-supporting and life-sustaining drugs and biologics have allowed the FDA to avert more than 550 potential drug shortages in the last three years, the agency says in a final rule mandating early notice. Read More
The European Commission says it does not have the authority to issue compulsory licenses to allow the manufacture of generic drugs during a health emergency, noting those decisions are made by member states on an individual basis. Read More