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.

Bruised and battered by its failings with the controversial Alzheimer’s drug Aduhelm, Biogen is looking to right the ship with a new helmsman. The company is on the hunt for a new chief executive officer. 

Cassava Sciences President and CEO Remi Barbier is hitting back at The New York Times, calling out the venerable newspaper for an alleged one-sided article that he claims misrepresented the research of his company by only using sources who were critical of Cassava.

Biogen filed a lawsuit against a New York life sciences company over alleged patent infringements related to the experimental Alzheimer’s disease treatment aducanumab.

Powered by Xconomy, November 2019’s What’s Next in Neuroscience Therapies event brought together scientists, entrepreneurs and biotech executives at the Hyatt Regency San Francisco to discuss their work developing next-generation neuroscience therapies and technologies in areas such as spinal-cord injuries, precision mental health, dementia and Alzheimer’s disease.

Roche is testing the company’s “brain shuttle” in humans, with the Swiss drugmaker hoping to rejuvenate the theory that removing amyloid plaques from the brains of patients with Alzheimer’s disease will prove effective despite repeated failures.

Allergan will pay $750 million to settle a class action lawsuit from a group of direct purchasers of the Alzheimer’s disease therapy Namenda in a resolution to the litigation that was set to face trial.

The pharma industry’s R&D concentration has been shifting towards specialty therapy areas as research and development returns decline for some leaders.

Dayton, N.J., October 22, 2015 – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Memantine Hydrochloride Tablets USP, 5 mg and 10 mg. […]