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Bad news came on Good Friday for Incyte Corp. and Eli Lilly and Co. in the form of a CRL from the FDA related to once-daily, oral baricitinib for moderate to severe RA.

Being the first to market and having commercial success do not prove novelty, the U.S. Court of Appeals for the Federal Circuit ruled Wednesday in affirming that the PTAB rightly invalidated one of four patents protecting Novartis AG's Gilenya from generic competition.

"It's a lab-ready system – that's really critical," Geraldine Hamilton, president and chief scientific officer of Emulate Inc., told BioWorld Today, detailing the firm's cooperative research and development agreement with the FDA.

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