European Notebook: Clinical Trial Fatality; Affordable Medicines Debate; Physician Payment Disclosure
One death and five healthy volunteers hospitalized in a Phase I study in France; EU Council looks set to debate patient access to medicines; and the two Mercks set to continue litigation in Europe and the US over use of the Merck word, straining their 60-year-old agreement. Generics/biosimilar trade group adopts physician payment disclosure policy.
You may also be interested in...
Brexit vote creates uncertainty about biopharma policies in the UK and how local companies interact with the rest of the world;; antibiotic use decreases in several countries; high prices prompt European Commission review of industry incentives.
Review will consider whether study fatality and serious injuries were a matter of "scientific chance" or "faults of a criminal nature"; separate evaluations will inform guidelines on first-in-human trials.
European Notebook: All Change In The C-Suites; EMA PRIME Starts; French Experts Recommend Phase I Changes
Once-in-a-decade leadership changes stack up in Europe’s big pharma companies as the region aims for quicker and more certain drug development, although following a recent fatality an expert committee is advising caution during dose-escalation in Phase I studies.