Higher regulatory hurdles for anti-arrhythmic drugs have pushed Merck to discontinue the development of Cardiome’s oral vernakalant.
Vancouver-based biotech Cardiome Pharma Corp.’s future seems unclear, even to its own management, following the decision on March 17 of its partner, Merck & Co. Inc., to discontinue development of its lead project, an oral version of the anti-arrhythmic drug vernakalant.
Cardiome’s share price plummeted by more than 50% and the status of the development project fell into limbo after it...
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.’
The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.
The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
