Pfizer Spiriva production: Boehringer-Ingelheim "has sufficient manufacturing capacity already in Germany" to meet demand for the chronic obstructive pulmonary drug Spiriva (tiotropium) "for out as far as we can see," Pfizer CEO Henry McKinnell tells Oct. 17 conference call. Pfizer will copromote the BI agent, with launch expected in 2002 or 2003. BI's Columbus, Ohio facility "was to come on stream for production in 2005," McKinnell noted. The plant was the subject of an FDA warning letter in July (1"The Pink Sheet" July 30, p. 10)...
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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.
