Eisai Co. on Sept. 27 began the application process for the Japanese drugmaker’s experimental drug lecanemab for early Alzheimer’s disease using an accelerated approval pathway, the same path that helped Eisai’s development partner Biogen Inc. win U.S. approval of its medication in June.
The U.S. Food and Drug Administration granted breakthrough therapy designation to Japanese company Eisai and partner Biogen’s experimental therapy lecanemab for patients with early Alzheimer’s.
Eli Lilly and Co. on March 14 said the company’s experimental Alzheimer’s drug slowed the rate of decline in a measure of cognition and function by 32 percent compared with a placebo in a mid-stage trial of patients at an early stage of the mind wasting disease.
AMO Pharma, a British biopharmaceutical company, is targeting a pathway most often associated with cancer to treat people with genetic encephalopathy (GE).
Dr. Ann McKee of Boston University studies the brains of deceased football players at the world’s largest brain bank, hoping to learn about the long-term impact of repeated head traumas for people ranging from professional athletes to victims of domestic abuse.
Roche Holding and partner AC Immune called a halt to two late-stage studies of the companies’ crenezumab drug for early Alzheimer’s, the latest in a string of failures to find a treatment for the progressive brain disease.
Indivior’s experimental drug to help fight America’s growing opioid addiction crisis was approved by the U.S. Food and Drug Administration, boosting the company’s sales prospects as competitors threaten revenues from an older product.
Indivior PLC announced that the U.S. FDA approved Sublocade (buprenorphine extended-release) injection for subcutaneous use (CIII), the first and only once-monthly injectable buprenorphine formulation for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by dose adjustment for a minimum of seven days.
Staines-Upon-Thames, UK-based Mallinckrodt agreed to buy Redwood City, Calif.-based Ocera Therapeutics in a deal that could hit $117 million.
The U.S. FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18-to-1 to recommend Indivior’s RBP-6000 to treat opioid use disorder.