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Biogenのアルツハイマー薬の承認に至るまでのBiogenとFDAのやり取りを取り調べるよう、FDA委員長代理のDr. Janet Woodcockが監察総監室に依頼。BIIBは2.95%下落。https://t.co/3Jb71Bsjov
— 今村咲 (@saki_imamura) July 9, 2021
The head of the FDA has called for an investigation into the recent approval of Biogen's Alzheimer’s drug, Aduhelm. @megtirrell reports. https://t.co/z19UKjVH47 pic.twitter.com/OAxY7qFJOR
— CNBC (@CNBC) July 9, 2021
Biogen stock falls after FDA calls for federal investigation into Alzheimer's drug approval https://t.co/HOGfkqMX34
— CNBC (@CNBC) July 9, 2021
BREAKING: FDA calls for federal investigation into its controversial Alzheimer’s drug approval https://t.co/4azLLYwOD9
— STAT (@statnews) July 9, 2021
FDA calls for federal investigation into its controversial Alzheimer’s drug approval - impact reporting by @statnews https://t.co/jIzu8VXkY3 via @statnews
— Charles Piller (@cpiller) July 9, 2021
. @DrWoodcockFDA wants to limit @OIGatHHS investigation to just focus on relationship btwn @Biogen, @US_FDA staff. She wants to take them off the trail of the larger scandal here, the regulatory capture of the agency, the problems with the approval itself. https://t.co/R2mXfyU5Yw
— Gregg Gonsalves (@gregggonsalves) July 9, 2021
No, @DrWoodcockFDA, this isn't just about the relationship between you & @Biogen, but the entire approval process for #Aduhelm. You lose confidence when you ignore your own statisticians and your entire external advisory committee. Nice try. https://t.co/R2mXfyU5Yw via @statnews
— Gregg Gonsalves (@gregggonsalves) July 9, 2021
FDA calls for federal investigation into its controversial Alzheimer’s drug approval https://t.co/P25tfICfvo via @statnews.
— Jason Karlawish (@jasonkarlawish) July 9, 2021
BiogenのAduhelm、なんかヤバそう…?!
— ラピュタロボ (@azanstain) July 9, 2021
FDA calls for federal investigation into its controversial Alzheimer’s drug approvalhttps://t.co/Wpd6gjyu0U pic.twitter.com/ff7BGwhO6G
Aduhelmに関してFDAのコミッショナーがOffice of Inspector General(連邦監察総監)に対して、承認プロセスに対する調査を依頼。BiogenとFDAスタッフの非公式な関係等が調査される。
— 小林宏彰@VC (@KobyMd) July 9, 2021
コミッショナーの自己保身とも見えるが、各所からの風当たりは強いですね。
https://t.co/lw4sSApJou
BREAKING: FDA calls for investigation of its Aduhelm approval, citing STAT’s reporting that agency officials worked hand in hand with Biogen executives to get the #Alzheimers drug on the market https://t.co/YjipQfJk4k via @statnews pic.twitter.com/Sty72TgeU5
— Gideon Gil (@GideonGil) July 9, 2021
Breaking: Acting @US_FDA Commissioner @DrWoodcockFDA calls for an independent investigation into how agency staff interacted with Biogen in the lead up to FDA's controversial approval of of the #Alzheimer's drug, Aduhelm. https://t.co/BoBtu7VZzl pic.twitter.com/aHg8Nx6KBL
— Helen Branswell (@HelenBranswell) July 9, 2021
"I believe it is critical that the events at issue be reviewed by an independent body," Janet Woodcock wrote to HHS OIG... https://t.co/fcHHf1nuCy #pharma #FDA #Alzheimer $BIIB
— pharmalot (@pharmalot) July 9, 2021
FDA calls for federal investigation into its controversial Alzheimer’s drug approval.
— Matthew Herper (@matthewherper) July 9, 2021
With lots of commentary.https://t.co/u1u4dkXsxd
BREAKING: In wake of STAT's coverage, FDA calls for federal investigation into its controversial Alzheimer’s drug approval.
— Rick Berke (@rickberke) July 9, 2021
By @adamfeuerstein @damiangarde https://t.co/I8UViQyA5W via @statnews
FDA calls for federal investigation into its controversial Alzheimer’s drug approval https://t.co/k8fmFxZ9FD via @statnews
— Joseph Ross (@jsross119) July 9, 2021
$SAVA: price move reversed from uptrend to downtrend as $BIIB is called by the interim FDA for its AD drug approval investigations.https://t.co/7PUUDKKIMK
— Luosheng Peng (@LuoshengPeng) July 9, 2021
BREAKING: FDA calls for federal investigation into its controversial $BIIB Alzheimer’s drug approval https://t.co/PMBGyGV4Zy via @statnews
— Adam Feuerstein ? (@adamfeuerstein) July 9, 2021
this is not normal https://t.co/pPtrnEGEEG
— Nicholas Bagley (@nicholas_bagley) July 9, 2021
@US_FDA & @DrWoodcockFDA calls for federal investigation by @OIGatHHS into its controversial @biogen Alzheimer’s drug approval https://t.co/nY1gYoTehD via @adamfeuerstein & @NicholasFlorko & @matthewherper & @damiangarde
— Ash Paul (@pash22) July 9, 2021
Wow!!!!!#FDA calls for investigation into controversial Alzheimer’s drug approval https://t.co/Na2B0Q0TZ7
— Dr. Alison Bateman-House (@ABatemanHouse) July 9, 2021
FDA calls for federal investigation into its controversial Alzheimer’s drug approval
— Mela Storm #Resistance! NO SURRENDER (@StormMela) July 9, 2021
It is quite unusual for the FDA to call for an IG investigation of an approval. https://t.co/vmAkqQsCgp via @statnews
FDA calls for federal investigation into its controversial Alzheimer’s drug approval https://t.co/1K1Tz6yJ6A via @statnews
— Laffy (@GottaLaff) July 9, 2021
Thank goodness the foxes will be investigating who ate the hens.https://t.co/yvmo9q7Kn1
— James Lyons-Weiler (@lifebiomedguru) July 10, 2021
The head of the FDA has called for a wide-ranging federal investigation into the approval of Biogen’s treatment for Alzheimer’s disease just one month after a decision that sparked the ire of lawmakers, doctors, and public health advocates. https://t.co/NICCUlTZdx
— STAT (@statnews) July 10, 2021
FDA calls for investigation into controversial Alzheimer’s drug approval https://t.co/O8cFlFKSUq
— Maria T. Carney MD, FACP (@MCarneyMD) July 9, 2021
FDA calls for investigation of FDA. https://t.co/MRg2URLZPx
— Leigh Turner (@LeighGTurner) July 10, 2021
.@gregggonsalves nails it. Don't let the agency to be investigated dictate the scope of the investigation. To paraphrase, there is much potentially rotten in the state of Denmark. https://t.co/IRHxKwTbdW pic.twitter.com/BWPz9Xufm2
— Ameet Sarpatwari (@AmeetSarpatwari) July 9, 2021
#FDA のトップ Woodcockが、なんと自分の組織FDAによる #Aduhelm 承認過程での、配下スタッフと #Biogen との不適切関係に関し連邦OIGに調査を要求。Woodcockは現在長官代理ポジション、正ポジションをかけた行為。https://t.co/sr2oUaNWsZ
— silex知の文献サービス (@silex_transl) July 9, 2021