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By a two to one vote, a Federal Circuit Court of Appeals panel cleared the way for Sandoz’s launch of Zarxio, the first FDA-approved biosimilar, as early as today. Read More
Valeant Pharmaceuticals will pay up to $445 million for the rights to AstraZeneca’s investigational psoriasis drug brodalumab, which is set for regulatory submissions in the U.S. and EU in the fourth quarter. Read More
EU biopharma groups have lodged a complaint with the European Commission opposing a French law that promotes off-label use of medicines, saying it put cost ahead of patient safety. Read More
Actavis must remove its generic version of Endo’s noncrush-resistant painkiller Opana from the U.S. market by Oct. 13, a New York federal judge ruled Aug. 14, citing infringement of Opana’s patents. Read More
The Federal Trade Commission has reached a settlement with Par Pharmaceuticals and Concordia Pharmaceuticals that, if finalized, would prohibit them from restraining trade in the sale of generic Kapvay, an attention deficit hyperactivity disorder drug. Read More
Amgen made a last-ditch effort to block competition for its chemotherapy product Neupogen, asking the Federal Circuit to stop Sandoz’s Sept. 2 launch of its Zarxio biosimilar. Read More
Mylan continues to breathe down Perrigo’s neck, announcing that two-thirds of votes cast during Friday’s shareholders meeting support the hostile takeover of the Dublin-based company. Read More
Amarin is asking a New York federal court judge to halt further litigation with the FDA over off-label promotion of its cholesterol-lowering drug Vascepa until Oct. 30, while the parties discuss possible settlement options. Read More