Author Topic: Two members of FDA panel resign in protest over Alzheimer's drug approval  (Read 417 times)

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Offline thackney

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Two members of FDA panel resign in protest over Alzheimer's drug approval
https://www.nbcnews.com/health/health-news/two-members-fda-panel-resign-protest-over-alzheimer-s-drug-n1270300
June 10, 2021

Two members of a panel of outside advisors to the U.S. Food and Drug Administration have resigned in protest at the agency's decision to approve Biogen Inc's Aduhelm for treatment of Alzheimer's disease despite the committee’s recommendation against doing so.

Mayo Clinic neurologist Dr. David Knopman, a panel member who had been recused from the advisors’ November meeting to review the drug because he was an investigator in clinical trials of Biogen’s drug, said he resigned on Wednesday.

"I was very disappointed at how the advisory committee input was treated by the FDA," Dr. Knopman told Reuters. "I don't wish to be put in a position like this again.”

The 11-member committee voted nearly unanimously in November that Biogen's drug should not be approved, citing inconclusive evidence that the drug was effective. Due to his recusal, Knopman did not participate in the vote....
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Offline thackney

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Biogen CEO says $56,000 annually for Alzheimer’s drug is ‘fair,’ promises not to hike price for at least 4 years
https://www.cnbc.com/2021/06/07/biogen-ceo-says-56000-annually-for-alzheimers-drug-is-fair-promises-not-to-hike-price-for-at-least-4-years.html

Biogen CEO Michel Vounatsos told CNBC on Monday that the list price of $56,000 per year for the company’s FDA-approved Alzheimer’s disease drug aducanumab is “fair.”...
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Offline thackney

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Biogen, awaiting FDA nod for $2B Swiss plant, plans to ship initial Aduhelm doses from North Carolina factory
https://www.fiercepharma.com/manufacturing/countdown-to-aducanumab-biogen-looks-to-start-shipments-alzheimer-s-drug-two-weeks-as

Biogen has been beefing up manufacturing on both sides of the Atlantic ahead of a green light for its Alzheimer's disease drug aducanumab. Flush with an approval—and a label that could tee up millions of patients for treatment—it's ready to hit the ground running, the company's head of global manufacturing and technical operations said.

To gear up for the launch, the company has spent the past several years kitting out its facility in North Carolina's Research Triangle Park and building a bioprocessing plant in Solothurn, Switzerland, hiring more than 500 new employees along the way, manufacturing exec Nicole Murphy told Fierce Pharma. Biopharmaceutical manufacturing, which is complex, pricey and time-consuming, "takes a bit of an army," she explained.

Biogen will initially call on its facility at Research Triangle Park to supply the drug in the U.S., though it hopes to quickly bring its Swiss plant into the mix. There, the company figures it’s built enough capacity to supply the drug to more than 1 million patients per year, Murphy said....
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Offline thackney

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$56,000 x 1,000,000 = $56 Billion

Biogen Annual Report, 2020
https://investors.biogen.com/static-files/0b109c48-3d3c-4554-8249-74b06c09797e

Total Revenues = $13.4 Billion
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Offline PeteS in CA

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Quote
The 11-member committee voted nearly unanimously in November that Biogen's drug should not be approved, citing inconclusive evidence that the drug was effective.

This FDA approval is WTH-grade!
If, as anti-Covid-vaxxers claim, https://www.poynter.org/fact-checking/2021/robert-f-kennedy-jr-said-the-covid-19-vaccine-is-the-deadliest-vaccine-ever-made-thats-not-true/ , https://gospelnewsnetwork.org/2021/11/23/covid-shots-are-the-deadliest-vaccines-in-medical-history/ , The Vaccine is deadly, where in the US have Pfizer and Moderna hidden the millions of bodies of those who died of "vaccine injury"? Is reality a Big Pharma Shill?

Millions now living should have died. Anti-Covid-Vaxxer ghouls hardest hit.