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ICER: FDA failed to protect patients from unproven Alzheimer's treatment with known harms


Food and Drug Administration (FDA) drew criticisms after granting Alzheimer’s disease drug Aduhelm a conditional approval. It allows the drug scientifically known as aducanumab to be prescribed and used while its maker Biogen conducts a post-marketing, phase 4 confirmatory study that could take years to complete.
Aduhelm is the first Alzheimer’s medication approved by the FDA since 2003.
According to the influential Institute for Clinical and Economic Review (ICER), the FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Aduhelm.
ICER questions Aduhelm’s effectiveness
The FDA, which announced the approval on June 7, said that the drug was the first to treat the underlying mechanism in Alzheimer’s. But ICER didn’t see it that way. ....

United States , Alessio Brunello , Michel Vounatsos , Robert Howard , University College London , Veterans Health Administration , Institute For Clinical , National Association Of Free , Alzheimer Association , Drug Administration , Natural News , Economic Review , National Association , Charitable Clinics , Alzheimers Disease , Veterans Health Care , Bad Medicine , Big Pharma , Clinical Outcomes , Conditional Approval , Mild Cognitive Impairment , Mild Dementia , Prescription Drugs , ஒன்றுபட்டது மாநிலங்களில் , Alessio புருனெல்லோ , ராபர்ட் ஹோவர்ட் ,

BIOPHYTIS Completed Recruitment of 155 Participants to the COVA Phase 2-3 Study with Sarconeos ...


Press release content from Globe Newswire. The AP news staff was not involved in its creation.
BIOPHYTIS Completed Recruitment of 155 Participants to the COVA Phase 2-3 Study with Sarconeos .
BIOPHYTIS SAMay 12, 2021 GMT
This 2nd interim analysis is to be performed by the independent DMC (Data Monitoring Committee) based on safety and efficacy data
The Company is to report the recommendation from the DMC based on its review of second interim analysis by end of Q2 2021, subject to any COVID-19-related delays
PARIS and CAMBRIDGE, Mass., May 12, 2021 (GLOBE NEWSWIRE) BIOPHYTIS SA (Nasdaq CM: BPTS, Euronext Growth Paris: ALBPS), (“BIOPHYTIS” or the “Company”), a clinical-stage biotechnology company focused on the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients sufferin ....

United States , France General , United Kingdom , Sophie Baumont Chris Maggos , Evelyne Nguyen , European Medicines Agency , Drug Administration , Data Monitoring Committee , Euronext Growth Paris , Emergency Use Authorization , Conditional Approval , Latin America , Duchenne Muscular Dystrophy , Euronext Growth , Nasdaq Capital Market , Interim Analysis , Investor Relations , Globe Newswire , Coronavirus Pandemic , ஒன்றுபட்டது மாநிலங்களில் , பிரான்ஸ் ஜநரல் , ஒன்றுபட்டது கிஂக்டம் , ஏவெளிய்னே ஂக்யந் , தகவல்கள் கண்காணிப்பு குழு , அவசரம் பயன்பாடு அங்கீகாரம் , நிபந்தனை ஒப்புதல் ,

BIOPHYTIS Completed Recruitment of 155 Participants to the COVA Phase 2-3 Study with Sarconeos (BIO101) in COVID-19 allowing the 2nd Interim Analysis


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interim analysis is to be performed by the independent DMC (Data Monitoring Committee) based on safety and efficacy data
The Company is to report the recommendation from the DMC based on its review of second interim analysis by end of Q2 2021, subject to any COVID-19-related delays
PARIS and CAMBRIDGE, Mass., May 12, 2021 (GLOBE NEWSWIRE) BIOPHYTIS SA (Nasdaq CM: BPTS, Euronext Growth Paris: ALBPS), ( BIOPHYTIS or the Company ), a clinical-stage biotechnology company focused on the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, today announces it has recruited the 155th participant for Part 2 of its COVA Phase 2-3 study of Sarconeos (BIO101) in patients infected with COVID-19. ....

United States , France General , United Kingdom , Ligia Vela Reid , Sophie Baumont Chris Maggos , Evelyne Nguyen , Lifesci Advisors , European Medicines Agency , Drug Administration , Data Monitoring Committee , Euronext Growth Paris , Emergency Use Authorization , Conditional Approval , Latin America , Duchenne Muscular Dystrophy , Euronext Growth , Nasdaq Capital Market , Interim Analysis , Sci Advisors , ஒன்றுபட்டது மாநிலங்களில் , பிரான்ஸ் ஜநரல் , ஒன்றுபட்டது கிஂக்டம் , லிகியா வேலா ரீட் , ஏவெளிய்னே ஂக்யந் , தகவல்கள் கண்காணிப்பு குழு , அவசரம் பயன்பாடு அங்கீகாரம் ,