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 UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges
