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Sandoz’s application to produce a biosimilar of Amgen’s bone marrow drug Neulasta has been rebuffed by the agency, according to Sandoz’s parent company, Novartis. Read More
In a blow to the biosimilars industry, the federal appellate court has reiterated its position that biosimilars makers must give reference product holders six months’ notice before going to market. Read More
A Delaware federal court ruled that Mylan’s efforts to develop a generic version of Forest Laboratories’ Savella infringed on three of the company’s patents. Read More
An FDA advisory committee recommended FDA approve Amgen’s biosimilar of the AbbVie’s blockbuster drug Humira and Sandoz’s biosimilar of Amgen’s Enbrel. Read More
Horizon Therapeutics has filed suit against Par Pharmaceutical, alleging infringement of three patents for its urea cycle disorders drug Ravicti. Read More
Mylan has agreed to shed two generics that treat muscle pain and epilepsy to allay FTC antitrust concerns, clearing the way for its $7.2 billion acquisition of Meda. Read More
The FDA approved eight ANDAs for AstraZeneca’s blockbuster cholesterol drug Crestor after a federal judge denied the company’s bid to stave off the approvals. Read More
The FDA has shot down three citizen petitions seeking agency action on biosimilar labeling, arguing that a draft guidance issued in April is sufficient to address most of their concerns. Read More
The FDA is advising generic drugmakers looking to revise their labels without the fallback of a reference product that they have only one route: supplemental submissions. Read More
Forest Laboratories has decided to bury the hatchet with Teva Pharmaceuticals USA and Mayne Pharma, settling a two-and-a-half year-long patent dispute for undisclosed terms. Read More