You would have to go back a quarter century to find a year with as few new drug approvals as 2007. There may be no one more concerned with the sinking approval rate of new molecular entities than FDA's Office of New Drugs Director John Jenkins. The RPM Report asked Jenkins why the stream of NMEs coming on to the market has slowed to a trickle.
Ramsey Baghdadi
Q:The RPM Report: With new molecular entity approvals at the lowest number since 1983 and the drug industry spending about 11 times more on R&D than it did 25 years...
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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.’
If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.
With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
