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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
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
A California judge has halted a lawsuit against five manufacturers of prescription opioids, pending the outcome of postmarket safety studies the FDA is requiring on the drugs. Read More
Amgen made a last-ditch effort to block competition for its chemotherapy product Neupogen, asking the Federal Circuit to stop Sandoz’s Thursday launch of its Zarxio biosimilar. Read More
The FDA is requiring manufacturers of DDP-4 inhibitors to add a label warning that the type 2 diabetes drugs may cause severe and disabling joint pain. Read More
Swiss regulators have approved Exelixis’ cobimetinib for use in combination with Genentech’s Zelboraf to treat advanced melanoma — allowing the company to begin marketing the drug while it awaits regulatory decisions in the U.S. and EU. Read More