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Latest From CymaBay Therapeutics, Inc.
Early Strides for Takeda’s Qdenga In Brazil, India Deal Adds New Dimension
Takeda’s head of multi-country organization, India and Southeast Asia, Dion Warren, tells Scrip how things are shaping for Qdenga in Brazil’s public vaccination program and outlines the contours, including pricing aspects, of the deal with Biological E for the dengue vaccine. The US IND application for the jab is still open.
NASH: Madrigal Files Resmetirom In EU While US Action Date Closes In
Resmetirom, which could become the first approved treatment for non-alcoholic steatohepatitis, is among 11 new drugs that the European Medicines Agency has started to review for potential EU approval. Meanwhile, a decision on whether to approve the drug in the US is due on 14 March.
Inventiva Gets OK To Resume Phase III MASH Study
Inventiva can resume screening and randomizing for its Phase III trial of lanifibranor in MASH, about three weeks after pausing the study due to a suspected unexpected serious adverse event.
Breakthrough Designation Binge In February By US FDA Didn’t Extend To Approvals
Six new breakthrough therapy designations have been announced, all for novel agents, but approvals were fewer and limited to new indications and formulations.
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