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FDA head seeks probe of Aduhelm approval

FDA head seeks probe of Aduhelm approval

WASHINGTON _  Acting Food and Drug Administration commissioner Janet Woodcock on Friday sought a federal probe into the agency’s approval last month of Biogen Inc.’s controversial Alzheimer’s disease drug Aduhelm. In a letter to the Office of Inspector General, Woodcock requested that the independent watchdog investigate the interactions between the drugmaker and the FDA  during

FDA narrows indication for Aduhelm

FDA narrows indication for Aduhelm

SILVER SPRING, Md. _ The Food and Drug Administration has narrowed the indication for Biogen and Eisai Co.’s controversial Alzheimer’s disease drug Aduhelm (aducanumab-avwa), recommending it only for patients with mild symptoms. The FDA approved an updated label to align it with the disease stages studied in clinical trials. Approved wording includes, “Treatment with Aduhelm

Biogen teaming with CVS and Cigna

Biogen teaming with CVS and Cigna

CAMBRIDGE, Mass — Today following the FDA’s approval of Aduhelm (aducanumab) for Alzheimer’s disease, Biogen announced it it working with CVS Health and the intention to enter into a value-based contract with Cigna. Starting in September, CVS will make cognitive screenings available through its Project Health program, which aims to narrow care disparities. The program

J&J’s Joaquin Duato tabbed as PhRMA chairman

J&J’s Joaquin Duato tabbed as PhRMA chairman

WASHINGTON — The Pharmaceutical Research and Manufacturers of America has named Joaquin Duato, worldwide chairman of pharmaceuticals as Johnson & Johnson, as chairman of the PhRMA board of directors. Duato previously was chairman-elect on the PhRMA board and succeeds George Scangos, who has stepped down as chief executive officer of Biogen. “In the words of

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