Sage Therapeutics and Biogen announced positive and consistent results from their ongoing clinical trials on the efficacy and safety of zuranolone in treating major depressive disorder (MDD) and postpartum depression (PPD).
The U.S. Food and Drug Administration on Sept. 20 approved South Korean drugmaker Samsung Bioepis Co. Ltd. and Biogen Inc.’s biosimilar rival to Roche Holding AG’s blockbuster eye medicine Lucentis.
U.S. lawmakers requested data and documents from the Food and Drug Administration related to the regulatory agency’s accelerated approval of Biogen Inc.’s new Alzheimer’s drug, mounting further pressure on the FDA that has come under fire for clearing Aduhelm.
Biogen Inc. is providing the company’s controversial and expensive new Alzheimer’s drug free of charge for some patients amid slow claim reviews by Medicare, according to sources familiar with the situation, including a doctor treating patients with the drug.
The U.S. Veterans Health Administration will not include Aduhelm, the $56,000-a-year Alzheimer’s drug made by Biogen Inc. and Eisai Co. Ltd., on the VHA’s list of approved products due to a lack of evidence that the medicine is effective as well as safety concerns, the agency said on Aug. 11.
Massachusetts-based biotechnology firm Biogen and its Tokyo-based partner Eisai are seeking a speedy approval from the U.S. Food and Drug Administration for a second Alzheimer’s disease drug, lecanemab.
Biogen Inc. and partner Eisai Co. Ltd. on July 29 revealed the design of an upcoming study of their controversial Alzheimer’s treatment, Aduhelm.
Biogen reportedly withdrew a paper that analyzed data from the clinical trials of the Alzheimer’s drug Aduhelm that the company submitted to JAMA after the medical journal requested edits before publication.
One of the eagerly anticipated presentations at the 2021 Alzheimer’s Association International Conference in Denver and virtually is Biogen and the company’s partner Eisai on their controversial drug Aduhelm (aducanumab). Biogen is also presenting new data on a different Alzheimer’s drug with another partner, Ionis Pharmaceuticals.
Anthem Inc. is closely watching for guidance from the U.S. Food and Drug Administration and all available clinical evidence on Biogen Inc.’s Aduhelm to determine the health insurance provider’s coverage policy on the newly approved Alzheimer’s drug.
