Rejection of Sarepta’s golodirsen has become latest flashpoint in debate over release of complete response letters. In this case, though, FDA’s reasoning seems fairly obvious, based on the prior eteplirsen review.
The rejection of Sarepta Therapeutics Inc.’s proposed Duchenne muscular dystrophy therapy golodirsen caught investors and patients very much by surprise, and has thus become the latest rallying point for calls to make US Food and Drug Administration “complete response” letters public.
As is usually the case, Sarepta is declining to release the letter – though the company’s explanation that it would...
Sponsor of psychedelic PTSD treatment will try rarely successful formal dispute resolution process after receiving a complete response letter.
US FDA would need to approve 44 novel agents by year-end to match 2023’s big total, but only 40 candidates are known to have user fee goals in the second half of 2024.
A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.
<p>Executive Summary</p> <p>Zanidatamab, Jazz and BeiGene’s investigational treatment for biliary tract cancer, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.</p>
<p>Executive Summary</p> This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
