Biosimilar User Fee Collections Climb; Application Growth Less Clear
Executive Summary
FDA plans to send out 57 invoices for annual biosimilar product development fees in fiscal year 2016, 10 more than were sent last year, but agency remains mum on how many 351(k) submissions it expects.
You may also be interested in...
Biosimilar Pathway Quickly Becoming Crowded In U.S.
Interactive chart of growing 351(k) pipeline shows that while Phase III is dominated by big players, pure-play biosimilar companies are beginning to emerge.
BrainStorm’s Phase III Data Do Not Support Clinical Benefit Of NurOwn In ALS, US FDA Says
Agency’s unusual public statement about an investigational product's development status may be aimed at countering bullish comments from the sponsor; FDA cites failure of pivotal trial on the primary and secondary endpoints and ‘modest excess in deaths’ with the cell therapy.
ACIP Shies Away From COVID-19 Vaccine Comparative Efficacy And Safety Evaluations
The CDC panel’s mandate is to make recommendations for each specific vaccine brought forward, not ‘comparing two, three or four vaccines, and coming up with specific recommendations for each one independent of the other,’ chairman Jose Romero says as ACIP recommends use of Janssen’s COVID-19 vaccine under EUA.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: