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Generics maker Glenmark might have infringed on Merck’s Indian patent covering type II diabetes drugs Januvia and Janumet, the Delhi High Court in India said recently in an interim ruling. Read More
The U.S. Supreme Court has declined to hear one of three petitions submitted over a Pennsylvania appellate decision refusing to recognize generic drugs as largely immune from product liability lawsuits. Read More
A federal appeals court has affirmed a lower court ruling that Allergan’s Zymar eye drop patent is invalid because the process is obvious for others to try. Read More
A federal court agreed March 17 to hear Mylan’s appeal in patent infringement litigation with AstraZeneca, in a case that could determine in which states brandmakers can file lawsuits against generic firms. Read More
An EU-level court has established a precedent that would allow drugmakers to protect orphan drugs from generic competition by developing and patenting a similar drug for the same orphan indications while the original therapy still enjoys market exclusivity. Read More
Sun Pharma completed its $4 billion purchase of fellow Indian generics maker Ranbaxy March 25, shortly after the FTC signed off on a divestiture order allowing the merger as long as the companies relinquish rights to the antibiotic minocycline. Read More
Amgen, in an expected move, is appealing a federal judge’s decision that cleared the way for Sandoz to launch Zarxio, its biosimilar of Amgen’s chemotherapy product Neupogen. Read More
Drugmakers sparred with consumer and patient advocates at a March 27 public hearing on the FDA’s proposed rule to give generics makers the ability to update label safety information independently — with generics firms opposing the rule and advocacy groups supporting it. Read More
Biosimilars makers are not required to share their applications and manufacturing processes with the biologics company whose product they are copying, the FDA says, rejecting Amgen’s argument that the law that created the biosimilars pathway mandates disclosure of that information. Read More
With the FDA beginning to approve biosimilars, the next major hurdle for the emerging sector will be in the courts, where brandmakers and would-be competitors are arguing over how they will approach patent infringement lawsuits, especially when it comes to sensitive manufacturing data. Read More
Sponsors of brand, generic and biosimilar drugs applying for marketing authorization through the EU’s centralized procedure must begin including facility inspection information in their applications. Read More