Merck will not file an application for regulatory approval of rolofylline in 2009 as initially planned because a pivotal study of the adenosine A1 receptor antagonist failed to meet its primary or secondary efficacy endpoints. Merck had thought the drug had potential to be the first major acute heart failure therapy that preserves renal function and improves outcomes after an earlier pilot study showed an overall trend toward efficacy (1Start-Up, September 2007). Merck said June 5 that rolofylline did no better than placebo in the 2,033-patient PROTECT study in improving symptoms of acute heart failure, nor did it reduce the risk of death or cardiovascular or renal re-hospitalization versus placebo by 60 days after treatment. Merck plans to present more explicit results at a meeting later this year. Rolofylline was not expected to be a big seller, but the loss of yet another Phase III compound, particularly a cardiovascular drug, is a blow for Merck - and drives home the rationale for its merger with Schering-Plough (2"The Pink Sheet," March 16, 2009, p. 18)
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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.
