Biogen in up to $1.8 bln deal as rare diseases take center stage
Ever since the controversial approval of Biogen and Eisai's Aduhelm, debate has swirled around the strength of the link between amyloid reduction and the cognitive benefits of potential Alzheimer's disease treatments. The FDA appears to have stepped back into this arena as part of fresh updates to its guidance on these drugs.
Biogen drops Alzheimer`s drug Aduhelm, ending a 17-year chapter
Biogen hasn’t had many wins with its failed Alzheimer’s disease drug Aduhelm, but now the company can chalk up a courtroom victory.
The Veterans Health Administration will cover Eisai and Biogen’s new Alzheimer’s drug Leqembi (lecanemab), reversing on an earlier decision to not pay for veterans to access Biogen’s other amyloid-targeted drug Aduhelm (aducanumab).
Billy Dunn is leaving his post leading the FDA’s neuroscience team after an 18-year career that in recent years has included the controversial accelerated approval of Biogen’s Alzheimer’s med Aduhelm.
The FDA last week signed off on a safety-related change to the label of Biogen’s controversial Alzheimer’s drug Aduhelm, which has barely mustered any sales since its approval because payers have refused to cover it.
Biogen's Biologic ADUHELM (Aducanumab) Receives Approval in the U.S.
Jan 10 (Reuters) - Japanese drugmaker Eisai Co Ltd (4523.T) said on Tuesday it had submitted a marketing application to the European health regulator for review of its Alzheimer's drug lecanemab, which was recently granted accelerated approval in the United States.
Eisai nabbed an accelerated FDA approval last week for its new Alzheimer’s disease drug, and we now have a new entry into the drug name world in Leqembi.