The development comes after a health ministry panel recommended the drug’s approval in August, followed by standard approval from the U.S. Food and Drug Administration (FDA) in July.
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Interim data from the Phase III innovaTV 301 trial showed that Genmab and Seagen’s antibody-drug conjugate Tivdak (tisotumab vedotin-tftv) met its primary endpoint, leading to significant survival benefit in patients with metastatic cervical cancer, the companies announced Monday.
Sage Therapeutics said on Thursday it plans to lay off about 188 people, or about 40% of its workforce, weeks after the U.S. health regulator declined to approve its drug to treat major depressive disorder.
The FDA on Thursday approved Sandoz’s Tyruko (natalizumab-sztn), a biosimilar of Biogen’s blockbuster treatment Tysabri (natalizumab), a monotherapy for the treatment of adults with relapsing forms of multiple sclerosis.
A Japanese health ministry panel on Monday recommended approval of the Alzheimer’s disease treatment Leqembi, following standard approval for the drug granted by U.S. regulators last month.
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.
