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The FDA will revise its recommendations for the submission of quality metrics and provide advice on comparative analyses for drug-device generics before the year ends. Read More
The U.S. Department of Justice issued grand jury subpoenas to Taro Pharmaceuticals and two of the company’s senior officials over the pricing of its generics, the drugmaker revealed in an SEC filing. Read More
A federal judge rendered Janssen’s composition patent for Remicade invalid, marking a loss for the company engaged in ongoing efforts to block biosimilar competition. Read More
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
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