Comparing EU Vs. US Accelerated Pathway Approval Times Makes Senior UK Regulator 'Slightly Defensive'
This article was originally published in The Pink Sheet Daily
Record-setting US Blincyto approval is case in point for discussion; EMA/MHRA official Robert Hemmings says EU review structure taps into expertise from "the whole of the continent," plus rapporteurs' independent views.
You may also be interested in...
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.
FDA's John Jenkins discusses concerns about return of the "drug lag" during IoM meeting on drug safety.
Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.