Oct. 1 Quick Takes: Setback at FDA for Mesoblast; plus AMAG, Solid, COVID updates from Gilead, AZ and more 

Bucking ODAC recommendation, FDA wants another trial from Mesoblast
Mesoblast Ltd. (ASX:MSB; NASDAQ:MESO) said FDA issued a complete response letter to a BLA for remestemcel-L to treat pediatric steroid-refractory acute GvHD. FDA’s Oncologic Drugs Advisory Committee had voted 9 to 1 to back approval of the therapy, but the company said FDA wants at least one more randomized, controlled trial in adults or children to provide more evidence of efficacy. The company will request a Type A meeting with the agency, expected within 30 days, to discuss a potential accelerated approval with a postapproval condition for an additional study.

Gilead assumes responsibility for remdesivir distribution
The U.S. government is no longer controlling domestic allocation of Veklury remdesivir from Gilead Sciences Inc. (NASDAQ:GILD). Recent trends on Veklury orders indicate the supply now outweighs demand, according to HHS Assistant Secretary for Preparedness and Response CMO John Redd. Gilead Chief Commercial Officer Johanna Mercier said the company has “enough supply on hand to treat every existing COVID-19 hospitalization in the U.S. and ample supply for future patients even if the incidence surges. Healthcare providers may continue to order the therapy through AmerisourceBergen Corp. (NYSE:ABC), the sole U.S. distributor. ...