The FDA’s stunning accelerated approval for Biogen’s Alzheimer’s drug Aduhelm, with limited clinical evidence supporting the decision, will have repercussions across the entire biopharma industry.

From companies now digging into new post-hoc analyses of failed trials, to others that can return to searching for amyloid beta-targeted drugs in search of a similar accelerated approval — when the bar is lowered for everyone, it’s the companies that put in the hard work to truly prove their drugs are safe and effective that will be hurt.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,300+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,300+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,300+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

Eli Lilly is teaming up with Roche to help develop a blood test to detect early signs of Alzheimer’s disease and determine whether a patient should go for further confirmatory testing.

Roche’s Elecsys Amyloid Plasma Panel (EAPP) measures pTau 181 protein assay and APOE E4 assay in human blood plasma – elevations in pTau 181 are present in the early stages of Alzheimer’s, while the presence of APO E4 is the most common genetic risk factor for the disease.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,300+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,300+ biopharma pros reading Endpoints daily — and it's free.

SIGN UP LOG IN