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The Association of the British Pharmaceutical Industry found four drugmakers — Celgene, Takeda, Vifor Pharma and Pierre Fabre — violated the group’s code of practice by engaging in activities ranging from inadequate quality management to deceptive drug promotion. Read More
New Jersey federal judges validated patents on Sunovion Pharmaceuticals’ schizophrenia drug Latuda and Helsinn’s nausea therapy Aloxi, dealing a blow to sponsors looking to launch generic versions of the drugs. Read More
In a loss for Shire, a three-judge panel for the U.S. Court of Appeals for the Federal Circuit ruled Actavis did not infringe a patent covering the ulcerative colitis drug Lialda, reversing a lower court decision. Read More
The U.S. solicitor general, the biosimilar industry, and several generics makers have filed U.S. Supreme Court briefs in support of reversing a Federal Circuit ruling that orders sponsors to wait six months after an FDA approval to launch a biosimilar. Read More
Twenty states have joined an antitrust lawsuit accusing six generics makers of colluding to fix the price of generic versions of antibiotic doxycycline hyclate and the diabetes drug glyburide. Read More
Mylan reached a settlement with Roche and Genentech that paves the way for the generic drugmaker to market a biosimilar version of the blockbuster drug Herceptin. Read More
The USPTO's Patent Trial and Appeal Board validated four of Acorda’s patents on the multiple sclerosis drug Ampyra, but a federal court still has to determine whether five of the drug’s patents are valid before generic drugmakers can market versions of Ampyra. Read More
Amgen is calling on the U.S. Supreme Court to rule that biosimilar makers must wait six months after an FDA approval to market their therapy. Read More
PhRMA urged the HHS inspector general to create a new safe harbor in anti-kickback regulations to directly address value-based payments and rebates. Read More