Orphan Drugs Dominate EU Fast-Track Request Decisions In July
The European Medicines Agency decided this month whether to grant fast-track review for planned marketing authorization applications for three potential new orphan treatments.
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EU Accelerated Assessment Tracker
In the first half of 2021, just six requests from companies seeking accelerated assessment of their planned EU marketing authorization applications were granted; 11 were rejected. The outcomes of five decided on in July and August are still unknown.
10 US Approval Decisions To Look Out For In Q3
This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.
Amicus Pompe Disease Combo’s Approvability In Question As Key Trial Misses Mark
The company hopes to score a nod from the US FDA based on a secondary endpoint that won approval for Sanofi’s Lumizyme.