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House investigation finds FDA, drug firm Biogen ignored internal concerns for Alzheimer's drug

Sarah Silbiger/Getty Images, FILE(WASHINGTON) A congressional investigation into the Food and Drug Administration's review process for an Alzheimer's treatment found that the agency "deviated" from its standard procedures to approve the Aduhelm drug with inconsistent data. Aduhelm is notable for being the first drug in recent years approved to treat the underlying cause of Alzheimer's, a disease with no known cure that is characterized by progressive dementia that affects more than six million Americans, according to the Alzheimer's Association. The joint 18-month investigation between the House's Oversight and Reform Committee and Energy and Commerce Committee, released on Thursday, criticizes the FDA for "atypical collaboration and interactions" with Biogen, the drug's manufacturer. In statements, Biogen and the FDA both said their interactions prior to Aduhelm's green light were appropriate in the context of the approval proce ....

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House investigation finds FDA, drug firm Biogen ignored internal concerns for Alzheimer's drug

The Food and Drug Administration's review process for an Alzheimer's treatment found that the agency "deviated" from its standard procedures to approve the Aduhelm drug. ....

United States , Carolyn Maloney , Centers For Medicare Medicaid Services , Approval Program , Reform Committee , Commerce Committee , Alzheimer Association , Drug Administration , Committee On Oversight , House Oversight , Accelerated Approval Program , Medicaid Services ,

Intensity Therapeutics, The Ottawa Hospital and Ontario Institute for Cancer Research Report INT230-6 Demonstrates Tumor Necrosis and Immune Activation in Early Stage Breast Cancers

Significant Necrosis Demonstrated in Invasive Ductal and Lobular Cancers, Which are Normally Resistant to Chemotherapy. Significant Necrosis from a Single. ....

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Cui Bono when FDA Fast Tracks Products?

Cui bono is Latin for "Who benefits?" It s the sister phrase of "sequi pecuniam/follow the money" and the orphan of "plebes/the people." All roads used to lead to Rome. Today, they lead to chosen industry. There are many sayings about. ....

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TRICIDIA INVESTIGATION CONTINUED BY FORMER LOUISIANA ATTORNEY GENERAL: Kahn Swick & Foti, LLC Continues to Investigate the Officers and Directors of Tricida, Inc.

/PRNewswire/ Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC ("KSF"), announces that. ....

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