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.
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Leveraging the brain power behind the first approved IPF drug, Esbriet, small companies Antegrin and Cascadia merge to form the fibrosis-centered Indalo Therapeutics. Gedeon Richter in-licenses a biosimilar of Roche’s Herceptin.
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: Bayer Bids For Monsanto; Biosimilar Uptake Still Sluggish; EMA Enters Drug Pricing Debate
The restructuring of business portfolios occupies Europe's big pharma companies, while the region's health providers look to improve the uptake of biosimilars, and European regulators suggest ways to use greater market competition to tame high drug prices. Plus Brexit, trade agreements, pharmacovigilance and more in this month's column.