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The FDA released long-awaited draft guidance on Aug. 27 on naming biological products, proposing that both reference products and biosimilars have nonproprietary names comprised of the core drug substance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
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
The PTAB found Acorda’s mention of the posters in information disclosure statements didn’t constitute an admission that the posters were printed publications. Read More
The FDA Thursday released long-awaited draft guidance on naming biological products, proposing that both reference products and biosimilars have nonproprietary names comprised of the core drug substance name and a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
Just days before Sandoz is expected to launch Zarxio, its biosimilar of Amgen’s chemotherapy drug Neupogen, the FDA issued a proposed rule changing both drugs’ official names, at least temporarily. Read More
Mylan scored a potential win from the U.S. Patent and Trademark Office when it agreed to review challenges to two patents on Teva’s blockbuster multiple schlerosis drug Copaxone. Read More