Four senior #FDA leaders forged close ties with #Biogen ahead of #Aduhelm's approval. Now they've all left FDA. Three of those four senior officials, who managed and worked closely with the clinical and biostats reviewers assigned to the Aduhelm application, have now ended up working at drugmakers
https://endpts.com/four-senior-fda-leaders-forged-close-ties-with-biogen-ahead-of-aduhelms-approval-now-theyve-all-left-fda/ #revolvingdoor #quidproquo

GSK nixes next-gen COVID-19 antibody collaboration, leaving Vir to fly solo — FDA adds warning of 'larger areas of bleeding' in brain to Biogen's Aduhelm label —Roivant ex-CEO Ramaswamy may be considering US Presidential run-- See more on our front page news http://bit.ly/w28kSd #gsk #vir #fda #aduhelm #biogen #alzheimers #roivant #vivekramaswamy #2024election #pharma #pharmanews #biotech #biotechnology #biopharma #cafepharma

Trio of biotech buyouts jumpstarts J.P. Morgan healthcare meeting — Eisai learns from Biogen’s Aduhelm disaster —5 FDA decisions to watch in the first quarter -- See more on our front page news http://bit.ly/w28kSd #mergersandacquisitions #ipsen #astrazeneca #chiesi #jpm2023 #jpm23 #biogen #eisai #aduhelm #alzheimers #fda #pharma #pharmanews #biopharma #biotech #biotechnology #cafepharma

Congressional inquiry raises serious questions about irregularities behind #aduhelm approval. #aging #alzheimers https://www.nytimes.com/2022/12/29/health/alzheimers-drug-aduhelm-biogen.html?action=click&module=Well&pgtype=Homepage&section=Health

"The 18-month investigation, initiated by two congressional committees after the F.D.A. approved the drug, also strongly criticized Biogen, Aduhelm’s manufacturer. Internal documents showed the company set “an unjustifiably high price” of $56,000 a year for Aduhelm because it wanted a history-making “blockbuster” to “establish Aduhelm as one of the top pharmaceutical launches of all time,” even though it knew the high price would burden Medicare and patients, the report found."

#Aduhelm #MonoclonalAntibody #Alzheimer #AlzheimersDisease #Aducanumab

https://www.nytimes.com/2022/12/29/health/alzheimers-drug-aduhelm-biogen.html?action=click&module=Well&pgtype=Homepage&section=Health

#aduhelm #alzheimers #biogen #fda #bigpharma

The congressional review of the highly flawed FDA approval of aduhelm
has some gems
Biogen was going to spend **500 million dollars* to develop a sales force !!!!!!!!
https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/Final%20Aduhelm%20Report_12.29.22.pdf

House Committees Release Internal Documents from #FDA and Biogen Related to #Alzheimers drug #Aduhelm's Review & Accelerated Approval https://energycommerce.house.gov/newsroom/press-releases/maloney-and-pallone-release-staff-report-on-review-approval-and-pricing-of

House Committees Release Internal Documents from #FDA and Biogen Related to #Alzheimers drug #Aduhelm's Review & Accelerated Approval https://energycommerce.house.gov/newsroom/press-releases/maloney-and-pallone-release-staff-report-on-review-approval-and-pricing-of

"Biogen was prepared to spend up to several billion dollars — more than two-and-a-half times what it spent developing the drug — on aggressive marketing to counter expected 'pushback' over whether Aduhelm was worth its price." Damning article about FDA approval process for #Aduhelm https://www.nytimes.com/2022/12/29/health/alzheimers-drug-aduhelm-biogen.html

#Aduhelm never should have been approved by the #FDA. This was a blatant case of #RegulatoryCapture. Of course #Biogen's credibility was damaged; they DESERVED for their credibility to be damaged damaged.
#alzheimers #MediFedi #MedMastodon
(Free link, no paywall)
https://www.washingtonpost.com/science/2022/12/29/alzheimers-fda-biogen-aduhelm/?pwapi_token=eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWJpZCI6IjI5Nzk3NjciLCJyZWFzb24iOiJnaWZ0IiwibmJmIjoxNjcyMzQzMzcxLCJpc3MiOiJzdWJzY3JpcHRpb25zIiwiZXhwIjoxNjczNTUyOTcxLCJpYXQiOjE2NzIzNDMzNzEsImp0aSI6ImY0MmNhN2ZiLTA0NTQtNGYzMC1iNTg4LTYwMzMwN2Y4N2JkZiIsInVybCI6Imh0dHBzOi8vd3d3Lndhc2hpbmd0b25wb3N0LmNvbS9zY2llbmNlLzIwMjIvMTIvMjkvYWx6aGVpbWVycy1mZGEtYmlvZ2VuLWFkdWhlbG0vIn0.J6PDbNGZIotZYPlvsEcggNUmZSXrq3BK7YB9tZYJyNM&itid=gfta

Despite unproven efficacy, #Alzheimer's drug set to cost $56,000/year per patient Flushed face Current trends in medicine lean to #biologics: it's profits & patents as tantalizing as it is frighteningly expensive.
#Aduhelm #Medicine #BigPharma #Pharma #news

https://arstechnica.com/science/2021/06/controversial-alzheimers-drug-could-cost-us-334b-nearly-half-of-dod-budget/