Biogen Inc
FDA grants accelerated approval for Biogen ALS drug that treats rare form of the disease
A pedestrian walks past Biogen Inc. headquarters in Cambridge, Massachusetts, on Monday, June 7, 2021. Adam Glanzman | Bloomberg | Getty Images The Food and Drug Administration on Tuesday granted accelerated approval for Biogen‘s drug tofersen, which treats a rare and aggressive form of the disease known as ALS. Accelerated approval is an FDA designation […]
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Alzheimer’s patients retain the benefits of Leqembi even when they stop the drug, Eisai says
Research at Biogen Source: Biogen Alzheimer’s patients who take Leqembi retain the benefits of the treatment even when they stop taking it, new research by Eisai shows. The Japanese drugmaker and its partner Biogen last week released an additional analysis of clinical trials of the monoclonal antibody drug, which is also known as lecanemab. Alzheimer’s disease continued to progress at a slower rate […]
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Eli Lilly says experimental Alzheimer’s drug reduces brain plaque in early study
Medical bottles and syringe are seen with Eli Lilly and Company logo displayed on a screen in the background in this illustration photo taken in Krakow, Poland on November 10, 2022. Jakub Porzycki | Nurphoto | Getty Images Eli Lilly‘s experimental Alzheimer’s drug lowered levels of brain plaque in patients who are in the earliest […]
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FDA advisors vote against effectiveness of Biogen’s ALS drug for rare and aggressive form of the disease
A pedestrian walks past Biogen Inc. headquarters in Cambridge, Massachusetts, U.S., on Monday, June 7, 2021. Adam Glanzman | Bloomberg | Getty Images The Food and Drug Administration’s independent panel of advisors on Wednesday voted against the effectiveness of Biogen’s investigational ALS drug for a rare and aggressive form of the disease. The drug tofersen […]
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FDA advisors reject Biogen’s ALS drug for rare and aggressive form of the disease
A pedestrian walks past Biogen Inc. headquarters in Cambridge, Massachusetts, U.S., on Monday, June 7, 2021. Adam Glanzman | Bloomberg | Getty Images The Food and Drug Administration’s independent panel of advisors on Wednesday declined to endorse accelerated approval of Biogen’s investigational ALS drug for a rare and aggressive form of the disease. The drug […]
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FDA staff says Biogen’s ALS drug may have a ‘clinical benefit’ on a rare form of the disease
U.S. Food and Drug Administration staff on Monday said Biogen’s investigational ALS drug may have a “clinical benefit” on a rare and aggressive form of the disease, despite failing a broader late-stage clinical trial last year. The staff made the conclusion in briefing documents ahead of a meeting on Wednesday when a panel of external […]
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Veterans Health Administration will cover Alzheimer’s treatment Leqembi, Eisai says
The Veterans Health Administration will cover Eisai and Biogen‘s Alzheimer’s treatment Leqembi, the companies announced Monday. In a statement, drugmaker Eisai said veterans in the early stages of the disease who meet VHA criteria are eligible for coverage of Leqembi. The decision by VHA stands in contrast with Medicare, which has declined to cover the […]
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FDA will review Eisai’s and Biogen’s Alzheimer’s treatment Leqembi with decision on full approval expected in early July
Andrew Brookes | Image Source | Getty Images The Food and Drug Administration will make a decision on whether to fully approve Eisai‘s and Biogen‘s Alzheimer’s treatment Leqembi by July 6, the companies announced on Monday. Leqembi is an antibody treatment that targets brain plaque associated with the mind-robbing disease. It is administered intravenously twice […]
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Medicare rejects Alzheimer’s Association request for unrestricted coverage of treatments like Leqembi
Medicare will not provide broader coverage of the Alzheimer’s drug Leqembi until it receives more evidence that the treatment is reasonable and necessary, according to the federal agency that runs the program for seniors. The Centers for Medicare and Medicaid Services rejected a request from the Alzheimer’s Association for unrestricted coverage of antibody treatments approved […]
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Stocks making the biggest moves midday: Deere, Airbnb, AutoNation, Moderna and more
Deere’s autonomous 8R tractor Deere Check out the companies making the biggest moves midday: Deere — Shares rose 7.7% after the company reported earnings-per-share of $6.55 for its fiscal first quarter, topping the $5.57 expected by analysts polled by Refinitiv. The agricultural machinery maker’s revenue came in at $11.4 billion, versus the $11.28 billion expected. […]
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