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Aduhelm

Biogen, having scrapped Aduhelm, tries to convince investors of turnaround plan

Biogen’s drug for Alzheimer’s disease, once considered a blockbuster-in-waiting, has run into so many obstacles since gaining approval last June that the company is now …

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Aduhelm

Biogen pulls European application for Aduhelm in another setback for the Alzheimer’s drug

Dive Brief: Biogen has withdrawn a request to start selling its Alzheimer’s disease drug in Europe, marking the latest setback in the company’s efforts to …

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Aduhelm

Roche, nearing major trial readouts, starts new Alzheimer’s drug study

Dive Brief: Roche is expanding clinical testing of its experimental Alzheimer’s disease drug gantenerumab, announcing Thursday the start of a late-stage trial in people with …

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Aduhelm

Biogen reserves four years for trial meant to confirm its Alzheimer’s drug works

A crucial study evaluating Biogen’s approved drug for Alzheimer’s disease is set to begin in May, the company disclosed Thursday, and if enrollment goes as …

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Aduhelm

Biogen seeking more information in investigation of Aduhelm patient’s death

Aduhelm has come under intense scrutiny since the Food and Drug Administration’s controversial June approval of the drug, the first new Alzheimer’s treatment in decades …

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Aduhelm

Anticipating Aduhelm’s costs, Medicare plans big jump in premiums

The decision affects Medicare Part B, which pays for health care services typically received outside of institutional settings like hospitals and nursing homes. The planned …

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Aduhelm

With approval plans underway, Lilly’s next move is to test its Alzheimer’s drug against Biogen’s

With few treatment options and millions of patients in the U.S. alone, Alzheimer’s has long been one of the biggest targets for drug developers. Yet, …

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Aduhelm

Lilly, preparing Alzheimer’s drug plans, forms new neuroscience unit in company restructure

After numerous setbacks in Alzheimer’s disease, Lilly has high hopes for a breakthrough with donanemab. When the FDA controversially approved Biogen’s Aduhelm in June, it …

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Aduhelm

HHS watchdog to review FDA accelerated approval process after Aduhelm controversy

The U.S. health department’s inspector general will review how the Food and Drug Administration grants accelerated approvals of new drugs, announcing a broad investigation Wednesday …

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