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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
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
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
The FDA approved Amgen’s Repatha late Thursday for some patients who are not able to control low-density lipoprotein cholesterol using standard treatment options, making it the second PCSK9 inhibitor to receive the agency’s blessing. Read More
A federal judge Wednesday said AbbVie and Teva can continue an arrangement that delays the launch of generic versions of the testosterone drug Androgel — rejecting the FTC’s request that he reconsider his earlier decision that the agreement was not pay-for-delay. Read More
The FDA handed Baxter Healthcare a six-observation FDA Form 483 for lapses in sterile process controls and failure to review batch discrepancies at its Puerto Rico manufacturing plant. The drugmaker has been plagued in recent months over recalls of sterile IV solutions. Read More