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The FDA released long-awaited draft guidance on Aug. 27 on naming biological products, proposing that both reference products and biosimilars have nonproprietary names comprised of the core drug substance name and a different four-letter suffix. Read More
All sponsors planning to conduct clinical trials in Saudi Arabia for the first time must register their studies through the Saudi Clinical Trials Registry, under new guidance released Sunday. 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
Bristol-Myers Squibb has agreed to pay up to $1.25 billion to acquire Promedior and its lead asset, PRM-151 — currently in Phase 2 development for the treatment of idiopathic pulmonary fibrosis and myelofibrosis. Read More
As Zarxio’s Sept. 3 launch date nears, Sandoz is urging the Federal Circuit to dismiss Amgen’s last-ditch effort to block the Neupogen biosimilar, saying the brandmaker’s request for an emergency injunction doesn’t meet the required standard. Read More