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发帖数: 43471 | 1 2 FDA committee members resign over Biogen Alzheimer's drug approval | d********f
发帖数: 43471 | 2 看来有些人太着急发财了
Fallout over the FDA’s recent decision to grant Biogen’s Alzheimer’s drug
accelerated approval has seen two advisory panel members resign. The agency
’s decision, which was met with mixed reviews and marked the first approval
of an Alzheimer’s drug in nearly two decades, came after the Peripheral
and Central Nervous System Drugs Advisory Committee said in November that it
was not reasonable to consider clinical benefit of the drug based on one
successful study.
One of the members who resigned, Dr. David Knopman, is a Mayo Clinic
neurologist who according to Reuters had been recused from the November
meeting because he was an investigator in Biogen’s clinical trials.
"I was very disappointed at how the advisory committee input was treated by
the FDA," Knopman told the outlet. "I don’t wish to be put in a position
like this again."
FDA OK'S BIOGEN'S ALZHEIMER'S DRUG: WHAT IS ACCELERATED APPROVAL?
The other member is Dr. Joel Perlmutter, a neurologist of Washington
University in St Louis, who told STAT that his resignation on Monday was "
due to this ruling by the FDA without further discussion with our advisory
committee."
In a statement regarding Biogen’s approval, Dr. Patrizia Cavazzoni, FDA
Center for Drug Evaluation and Research director, said that when the panel
had said there was not enough data to consider benefit of the drug, it had
not discussed the option of Accelerated Approval in November. Accelerated
Approval allows for drugs targeted at serious conditions that fill an unmet
medical need to be approved "based on a surrogate endpoint," which is a
marker thought to predict clinical benefit but is not itself a measure of
clinical benefit."
WHO SHOULD TAKE NEW ALZHEIMER'S DRUG? EXPERT WEIGHS IN
But according to STAT, the panelists were not asked to consider that
possibility as the committee had determined they would not use the amyloid "
as a surrogate for efficacy."
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"After the Advisory Committee provided its feedback, our review and
deliberations continued, and we decided that the evidence presented in the
Aduhelm application met the standard for Accelerated Approval," Cavazzoni
said. "We thank the Advisory Committee for its independent review of the
data and valuable advice."
The FDA is not mandated to follow the advice of the advisory committee, but
often issues decisions similar to their recommendations.
The agency's ruling was celebrated by others, including the Alzheimer's
Association which called the approval "the beginning of a completely new
future for Alzheimer's treatments."
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: 2 FDA committee members resign over Biogen Alzheimer's drug approval
| I********8
发帖数: 1 | | d****o
发帖数: 32610 | 4 反正吃不死人就行
当脑白金卖也能暴赚
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: 看来有些人太着急发财了
: Fallout over the FDA’s recent decision to grant Biogen’s Alzheimer’s drug
: accelerated approval has seen two advisory panel members resign. The agency
: ’s decision, which was met with mixed reviews and marked the first approval
: of an Alzheimer’s drug in nearly two decades, came after the Peripheral
: and Central Nervous System Drugs Advisory Committee said in November that it
: was not reasonable to consider clinical benefit of the drug based on one
: successful study.
: One of the members who resigned, Dr. David Knopman, is a Mayo Clinic
: neurologist who according to Reuters had been recused from the November
| d********f
发帖数: 43471 | 5 一年5万7，反正medicare买单
【在 d****o 的大作中提到】
: 反正吃不死人就行
: 当脑白金卖也能暴赚
:
: 提到: 】
| d****o
发帖数: 32610 | 6 属实
爽
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: 一年5万7，反正medicare买单
| N*****d
发帖数: 9872 | | W***n
发帖数: 11530 | 8 don't damn care
can't short | r*****e
发帖数: 7853 | 9 22m shares available to short
：don't damn care
：can't short
【在 W***n 的大作中提到】
: don't damn care
: can't short
| P****R
发帖数: 22479 | 10 在业界臭名昭著。
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: 一年5万7，反正medicare买单
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发帖数: 700 | |
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