FDA will update vaccines advisory committee on GlaxoSmithKline's Lymerix during the afternoon of May 21. The company withdrew the lyme disease vaccine Feb. 25, citing low demand. The committee had previously reviewed reports of safety problems with the vaccine (11"The Pink Sheet" March 4, p. 23). The meeting will be held at the Hilton in Silver Spring, Md., at 8:30 a.m...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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.
