Phase III
Perhaps the last big hope for a successful Alzheimer’s drug just died. Biogen and its collaboration partner, Eisai, announced they were discontinuing the global Phase III clinical trials of aducanumab in patients with mild cognitive impairment from Alzheimer’s.
Shares of Jazz Pharmaceuticals are climbing in premarket trading following a late Wednesday announcement that the U.S. Food and Drug Administration granted approval for Sunosi, a treatment for people with narcolepsy.
The trial, which paired a checkpoint inhibitor and PARP inhibitor, was not likely to hit endpoints. It was the second ovarian cancer trial failure for the two companies in six months.
The approval of Zulresso marks the first and only treatment for postpartum depression (PPD) approved by the U.S. Food and Drug Administration.
March is National Kidney Month, with March 14 designated as World Kidney Day. The kidneys are called the body’s chemical factories. Their job is to filter waste and perform specific important jobs like controlling red blood cell production and blood pressure.
The company announced positive topline results from its Phase III EMPOWUR trial of viregron in patients with overactive bladder.
In a Phase III trial, a higher proportion of deaths was observed in the venetoclax arm compared to the control arm of the trial.
Esperion, based in Ann Arbor, Mich., announced results from its Phase III Study 2 of bempedoic acid at the American College of Cardiology (ACC) annual meeting.
UK-based Allergy Therapeutics markets three allergy “jabs” for tree pollen, dust mites, and grass pollen. Later this year it is planning results from a Phase I trial of a dust mite vaccine. But the company’s results from its trial for a birch pollen vaccine are a bit puzzling—the vaccine flunked the trial, but appeared to show positive results.
This approval marks the first new initial treatment option for this difficult-to-treat type of lung cancer in more than 20 years.
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