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Eli Lilly Alzheimer’s drug FDA approval delayed

Eli Lilly headquarters in Indianapolis, Indiana, US, on Wednesday, May 3, 2023. Eli Lilly & Co.'s shares climbed in early US trading after its experimental drug for Alzheimer's slowed the progress of the disease in a final-stage trial, paving the way for the company to apply for US approval.AJ Mast | Bloomberg | Getty ImagesEli Lilly said Friday that the Food and Drug Administration has pushed back its approval decision deadline for the drugmaker's experimental Alzheimer's treatment donanemab in a surprise move.The…

Biogen (BIIB) earnings Q4 2023

A Biogen facility in Cambridge, Massachusetts.Brian Snyder | ReutersBiogen on Tuesday reported fourth-quarter revenue and profit that shrank from a year ago, as it recorded charges related to dropping its controversial Alzheimer's drug Aduhelm and as sales slumped in its multiple sclerosis therapies, the company's biggest drug category.Biogen booked sales of $2.39 billion for the quarter, down 6% from the same period a year ago. Revenue from multiple sclerosis products fell 8% to $1.17 billion as the therapies face…

Biogen drops Alzheimer’s drug Aduhelm to focus on Leqembi, others

The Biogen headquarters in Cambridge, Massachusetts, on Oct. 24, 2023.Vanessa Leroy | Bloomberg | Getty ImagesBiogen on Wednesday said it will discontinue the sale and development of its older and highly controversial Alzheimer's drug Aduhelm to refocus the company's efforts to treat the memory-robbing disease. The biotech company will focus on rolling out Leqembi, a newly approved Alzheimer's drug it developed with Japanese drugmaker Eisai. It also plans to work on a slate of experimental treatments for the disease.…

Pharma had a year full of firsts

Soumyabrata Roy | Nurphoto | Getty ImagesDrugmakers are closing out a year when they achieved several historic firsts that will shape the pharmaceutical industry in 2024 and beyond. The weight loss drug market transformed into the pharmaceutical industry's newest gold rush this year, as demand for costly but highly effective treatments from Novo Nordisk and Eli Lilly surged. Patients and investors also saw that the benefits of the medicines could extend beyond their original purposes.The Alzheimer's disease space also got…

Pfizer weight loss pill joins list of obesity drug flops

Sopa Images | Lightrocket | Getty ImagesPfizer's twice-daily version of its experimental weight loss pill has now joined a long list of other scrapped drugs that aimed to treat obesity but came with unintended consequences. The drugmaker on Friday said it will stop developing the twice-daily treatment, danuglipron, after obese patients taking the drug lost significant weight but experienced high rates of adverse side effects in a midstage clinical trial. Pfizer noted that it will release data on a once-daily version of…

Eli Lilly expects FDA decision on donanemab by year-end

Eli Lilly and Company, Pharmaceutical company headquarters in Alcobendas, Madrid, Spain.Cristina Arias | Cover | Getty ImagesEli Lilly on Monday said it applied for full U.S. Food and Drug Administration approval of its Alzheimer's treatment, donanemab, and expects the agency to make a decision by the end of the year.Eli Lilly is among the pharmaceutical companies racing to market new treatments for the mind-robbing disease after Eisai and Biogen's drug Leqembi won FDA approval this month. The agency's signoff was a…

What patients and doctors should know

The Alzheimer's drug Leqembi is seen in this undated handout image obtained by Reuters on January 20, 2023.Eisai | via ReutersMedicare has agreed to pay for the Alzheimer's treatment Leqembi, a major turning point for patients who are diagnosed with the early stages of the disease.Leqembi is the only drug on the market right now that has demonstrated the ability to slow the progression of early stages of Alzheimer's disease in a clinical trial. The monoclonal antibody, administered twice monthly through intravenous means,…

Alzheimer’s drug Leqembi sales may be slow at first: Analysts

Jay Reinstein, who suffers from Alzheimer's, receives an injection so he can have a PET scan at MedStar Georgetown University Hospital in Washington, DC on June 20, 2023. Michael Robinson Chávez | The Washington Post | Getty ImagesSales of the Alzheimer's drug Leqembi may be slow initially due to logistical requirements but could pick up in 2024, analysts said after the groundbreaking treatment won approval in the U.S. Wall Street is chewing over the Food and Drug Administration's Thursday approval of Leqembi – a…

FDA approves Alzheimer’s drug Leqembi from Eisai, Biogen

The Food and Drug Administration on Thursday approved the Alzheimer's treatment Leqembi, a pivotal decision that is expected to expand access to the expensive drug for older Americans.Medicare has promised to start covering Leqembi, with some conditions, on the same day the FDA approves the antibody treatment. Leqembi is made by Japanese pharmaceutical company Eisai and its Cambridge, Massachusetts, partner, Biogen. Leqembi is the first Alzheimer's antibody treatment to receive full FDA approval. It is also the first such…

Leqembi could cost Medicare $5 billion per year

The Alzheimer's drug Leqembi is seen in this undated handout image obtained by Reuters on Jan. 20, 2023.Eisai | ReutersThe new Alzheimer's antibody treatment Leqembi could cost Medicare up to $5 billion per year, according to research published in a leading medical journal this week.Medicare would spend about $2 billion per year if around 85,700 patients test positive for the disease and are treated with the Eisai and Biogen product Leqembi, according to the research published in JAMA Internal Medicine on Thursday.The…