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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
Danish insulin maker Novo Nordisk is expanding its footprint in the U.S., acquiring two privately held biopharmaceutical research companies in Indiana and investing in a new manufacturing plant in North Carolina. 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
Last month, the FDA zapped seven more compounders in Tennessee, California, Florida, Arkansas, Montana and Washington over sterility issues. The FDA handed out three warning letters, three Form 483s and one facility issued a recall following an inspection. Read More