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Three of four generics makers prevailed in a patent infringement lawsuit by Eli Lilly as a federal judge ruled that they either did not infringe on Eli Lilly & Co.’s patents or proved them to be invalid. Read More
A judge ruled that two patents covering Vanda Pharmaceuticals’ schizophrenia drug Fanapt were valid and one was infringed on by Roxane Laboratories. Read More
Nestle Skin Health and Galderma Laboratories have filed a patent lawsuit against Perrigo and Perrigo UK over patents related to the topical gel Mirvaso, which clears up facial redness. Read More
Earlier this summer the FDA recommended a five-point scale to measure topical patch adhesion for drugmakers submitting ANDAs. However, the recommendations have only raised more questions. Read More
Industry continues to be divided on whether to include interchangeability statements on biosimilar labels, with Amgen taking the lead in support and Merck taking the lead against in comments on the FDA’s March draft biosimilar labeling guidance. Read More
Applications for generics of Johnson & Johnson’s Risperdal should contain characterization data on the reference product and the copycat version, the FDA says. Read More
The U.S. Judicial Panel on Multidistrict Litigation is consolidating price-fixing suits against generics maker Covis Pharmaceuticals for its heart drug Lanoxin. Read More
In a move that may hinder companies looking to develop generic Tyvaso, the combination product’s developer is asking the FDA to impose stringent approval requirements on generic competitors. Read More
Drugmakers seeking approval of fidaxomicin generics to treat Clostridium difficile-associated diarrhea have two options for demonstrating bioequivalence, the FDA said. Read More