Monthly Archives: December 2022

US Congressional report faults FDA and Biogen for Alzheimer’s drug approval

      Btobioinnovation.com  Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com     SPECIAL REPORT #22.12.5     US Congressional report faults FDA and Biogen for Alzheimer’s drug approval     You will find below the Executive Summary of the US Congressional Report on the Investigation into FDA’s Atypical Review Process and Biogen’s Aggressive Launch […]

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Additional Comments on the CTAD annual conference

      Btobioinnovation.com  Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com       Additional Comments on the CTAD annual conference     In the four previous reports presented this week at the Clinical Trials in Alzheimer’s Disease (CTAD) annual conference in San Francisco, we had focussed on rather positive data from the large study […]

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TauRx reports confusing results with HMTM in Alzheimer’s disease treatment

      Btobioinnovation.com  Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com     TauRx reports confusing results with HMTM in Alzheimer’s disease treatment     An odd and confusing result in the 3 Lucidity trial obtained with hydromethylthionine mesylate (HMTM), a tau inhibitor, in Alzheimer’s disease patients, was reported at the Clinical Trials on Alzheimer’s […]

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A commentary on lecanemab’s recent results published in Science

Dear readers   Attached is a commentary published today in the journal Science casting doubt on the clinically meaningful effect of lecanemab and commenting on the New England Journal of Medicine article of November 29, 2022.   Have a nice read   ………………………………………………………………… Jean-Claude Muller Ph.D.  Executive Editor phone: 33 6 76 84 71 60 […]

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Eli Lilly announced that Donanemab reduces brain amyloid clearance in a Phase 3 study.

Dear Readers,   More positive news announced at the Clinical Trials on Alzheimer(s disease (CTAD) conference in San Francisco yesterday. Eli Lilly  announced that donanemab met all primary and secondary endpoints for the 6-month primary outcome analysis in the Phase 3 TRAILBLAZER-ALZ 4 study, providing the first active comparator data on amyloid plaque clearance in […]

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Eisai’s lecanemab shows positive cognitive effects in Alzheimer’s disease.

Dear Readers   You will find attached results presented yesterday on lecanemab Clarity AS study at the Clinical Trials on Alzheimer’s disease (CTAD) conference in San Francisco. Eisai, BioArtic and Biogen have confirmed that the Phase III lecanemab data look strong on efficacy (27% on decline) and safety on Amyloid -related imaging abnormalities (ARIA) a […]

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