FDA

Eisai and Biogen completed the rolling submission of a Biologics License Application for their proposed Alzheimer’s disease drug to the U.S. Food and Drug Administration.

People who die of severe COVID-19 have brain abnormalities that resemble changes seen in Alzheimer’s disease – accumulation of a protein called tau inside brain cells, and abnormal amounts of the protein beta-amyloid that accumulates into amyloid plaques – small studies found. In other news, seniors can safely get the high-dose flu vaccine and an mRNA COVID-19 booster dose at the same time, a new study confirms.

Cassava Sciences announced top-line results Sept. 22 from a 12-month interim analysis of the company’s Alzheimer’s drug candidate simufilam.

In a roundup review of scientific studies recently published, a study out of RCSI University of Medicine and Health Sciences and the HSE Health Protection Surveillance Centre (HPSC) in Ireland further defined the association between comorbidities and poor outcomes with Covid-19.

Eli Lilly

A small trial of Eli Lilly’s donanemab showed the experimental Alzheimer’s drug slowed by about a third the rate of decline in a combined measure of cognition and function in patients at an early stage of the mind-wasting disease.

Biogen announced the widely awaited submission of a U.S. marketing application for the experimental Alzheimer’s therapy aducanumab, sending the company’s shares up more than 8 percent before the bell.

Biogen Inc. and partner Eisai Co. Ltd. are ending two late-stage trials for the experimental Alzheimer’s drug aducanumab, in a setback to efforts to find treatments for the disease and for Biogen’s stock, which lost more than $17 billion of the company’s value.

Otsuka Pharmaceutical and Lundbeck announce that the two companies’ third clinical Phase 3 study of brexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer’s type will commence in June 2018.

Merck announced that it has entered into an exclusive worldwide license agreement with Teijin Pharma for the development, manufacture and commercialization of an investigational preclinical antibody candidate targeting the protein tau. Changes in tau are associated with a number of diseases affecting the nervous system, including Alzheimer’s disease (AD).

Healthcare promotion strikes me as a cozy little business sometimes, with our webs of contacts and clients, strongly strung in a specialized space. Nowhere did I feel this more than at Cannes, where Lions Health, in its own building at the Palais, gave us a chance to renew friendships and make new contacts easily, fueled by the appropriately sized venue and the gallons of pink wine.