Half Of All EU Fast-Track Requests Fail; AZ’s Imfinzi Among Latest
The European Medicines Agency recently denied AstraZeneca’s pre-filing request for accelerated assessment of Imfinzi in Stage III NSCLC, an indication the company is hoping to make its own. It’ll be no consolation that the EMA this year seems to have rejected as many fast-track requests as it has granted.
You may also be interested in...
Shire and Regeneron/Sanofi are among the companies that have recently submitted investigational new treatments for approval across the EU.
Ammtek, Pfizer, Portola and Roche are among the companies that are likely to find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are nearing the end of the review pathway. Questions are likely to be in store for the sponsor of a biosimilar version of pegfilgrastim.
Lilly’s migraine prevention therapy, galcanezumab, is among the nine new products that companies have submitted to the European Medicines Agency for evaluation in recent weeks.