March 18 Quick Takes: Amylyx launches expanded access for ALS therapy

With an FDA advisory committee scheduled to meet late this month ahead of a June 29 PDUFA date for amyotrophic lateral sclerosis treatment AMX0035, Amylyx Pharmaceuticals Inc. (NASDAQ:AMLX) has begun an expanded access program in the U.S. for the combination of sodium phenylbutyrate and tauroursodeoxycholic acid. The program will run in parallel to the ongoing Phase III PHOENIX trial. Patient groups have advocated for the therapy’s swift approval by FDA.

All adults could soon be able to receive a fourth dose of Spikevax vaccine from Moderna Inc. (NASDAQ:MRNA) after the company submitted an EUA amendment to FDA. Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) submitted an EUA for their Comirnaty vaccine on March 15 for the over 65-year-old population only; Moderna said its much broader request was made so CDC and healthcare providers had the flexibility to determine Spikevax’s appropriate use. ...