Drugmakers ask FDA to approve another Alzheimer’s drug, similar to Aduhelm
By
Alicia Lasek
Sep 29, 2021
Drugmakers Eisai and Biogen are putting the Food and Drug Administration to the test with a request to approve a second Alzheimer’s drug that works like aducanumab (Aduhelm), the new, yet controversial,...
Clinical briefs for Thursday, Nov. 18
By
Alicia Lasek
Nov 18, 2021
OSHA suspends implementation of COVID-19 vaccine mandate for businesses … Feds expected to OK Pfizer’s COVID vaccine boosters for all adults; Moderna requests the same for its shot … 12 more...
Becerra orders CMS to rethink $22 Medicare Part B premium price hike tied to Aduhelm
By
Alicia Lasek
Jan 11, 2022
With the 50% price drop of Aduhelm on January 1, there is good reason for CMS to reassess a hefty proposed premium hike for 2022, the U.S. health secretary said. On Wednesday, CMS is expected to announce...
CMS restricts coverage of Alzheimer’s drug Aduhelm to clinical trials
By
Alicia Lasek
Apr 08, 2022
Coverage of aducanumab (Aduhelm) is officially limited to clinical trials only, the agency announced Thursday. Most stakeholders have called for restricted use while more efficacy and safety data is gathered,...
U.S. lawmakers ramp up scrutiny of FDA following agency’s approval of controversial Alzheimer’s drug
By
Alicia Lasek
Sep 07, 2021
The FDA is being asked to help explain how Aduhelm (aducanumab) met accelerated approval criteria when so many experts — including internal advisers — have flagged insufficient safety and efficacy...