Tag Archive for: Biogen

The FDA’s decision to decline the drug’s approval for a much larger cohort of patients with clinical depression, along with strict safety warnings for its use in PPD, is still a “strike against (Biogen’s) management”, Baird analyst Brian Skorney said.

Five major U.S. health systems said they would offer Eisai and Biogen’s promising new Alzheimer’s drug Leqembi after working out payment and administrative policies, and how to assess and monitor patients, most likely in the next month or two.

Having access to an oral medication will be a beneficial option for many of women coping with PPD and having extreme, and sometimes life-threatening, feelings, says the FDA.

The deal is the first large acquisition under new CEO Christopher Viehbacher as he seeks to return the drugmaker to growth.

The company said today that it expects to slash about 1,000 jobs, or about 11% of its workforce, under a fresh cost-cutting program as the company ramps up the launch of a new Alzheimer’s disease drug in efforts to return to growth.

Eisai intends to pair Leqembi with other drugs in its pipeline. Still, it is also open to partnering with other companies to advance treatments for the disease.

Previously, the CMS only covered a single round of PET imaging for patients enrolled in clinical studies. Yesterday’s proposal seeks to remove this cap and leave it up to CMS contractors to determine which patients should be covered by the health insurance program.

Yesterday Leqembi won a coveted standard approval nod from the U.S. Food and Drug Administration, the first Alzheimer’s treatment to achieve that goal, clearing the way for wider insurance coverage of the drug. The agency’s decision marks a new milestone for a fatal disease that has eluded drugmakers’ efforts for decades.

The company announced Monday its shareholders elected Susan Langer, current president of Souffle Therapeutics, to its board of directors, replacing her reputed romantic partner Alex Denner.

The U.S. Medicare health plan on Thursday offered details of plans to collect patient data as a condition for reimbursement for Eisai Co. Ltd. and Biogen Inc.’s new Alzheimer’s drug Leqembi, should it win traditional U.S. approval as expected by July 6.