Yesterday the agency published a revised draft guidance document, aimed at helping sponsors and pharmaceutical companies to develop therapies for Alzheimer’s disease, particularly in its early stages before the onset of overt dementia.
Tag Archive for: Alzheimer’s disease
In a neurology update for investors, Roche touted data from a small Ib/IIa trial for trontinemab, an investigational therapy for Alzheimer’s disease which demonstrated “rapid and robust” amyloid plaque reduction.
The FDA will convene its Peripheral and Central Nervous System Drugs Advisory Committee to discuss Eli Lilly’s application for its Alzheimer’s disease antibody donanemab, the company announced today.
The company expects to reach 90% of its target for integrated delivery networks (IDNs) used to administer the drug in the U.S. in the fiscal year ending this month, its CEO stated.
Otsuka Pharmaceuticals on Monday announced that its investigational drug candidate AVP-786 fell short of its primary efficacy endpoint in a Phase III trial evaluating its effects as a treatment for agitation in Alzheimer’s disease.
During yesterday’s third-quarter fiscal year 2023 earnings report, Eisai revealed that the launch of its Biogen-partnered Alzheimer’s disease treatment Leqembi (lecanemab) has not been going according to plan, making the company’s goal of treating 10,000 patients by the end of March 2024 appear out of reach.
Today Biogen said it would terminate a post-approval study of its Alzheimer’s drug, Aduhelm, after failing to find a partner or external financing for the controversial treatment.
The two companies are preparing to launch the drug in the second quarter of Eisai’s 2024/25 business year starting in April.
Iovance’s lifileucel for advanced melanoma and Madrigal’s resmetirom for nonalcoholic steatohepatitis are just a couple of the key decisions on the FDA’s docket this quarter.
The acquisition announced on Friday will give Bristol Myers Squibb ownership of Karuna Therapeutics’ investigational antipsychotic KarXT, which is being tested for schizophrenia and Alzheimer’s disease psychosis.