NIH Move To Consolidate Translational Programs Is Not The Big Shakeup It's Made Out To Be, Agency Says
The National Institutes of Health's proposed National Center for Advancing Translational Sciences reflects neither a shakeup of existing NIH programs nor any intent to create an agency that functions like a drug company, NIH officials say.
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While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.