News
Under the temporary reign of top food executive Kyle Diamantas, the FDA will sustain programs initiated by former Commissioner Marty Makary, including the Commissioner’s National Priority Voucher initiative.
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Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care.
The tragic tale of TIGIT is well known. However, RIPK1, myc, STING and alpha-synuclein have also left a trail of failed clinical trials, canceled partnerships and sunk investments in their wake.
Analysts homed in on Duchenne muscular dystrophy and myotonic dystrophy type 1 assets during first quarter earnings as major players like REGENXBIO and Novartis as well as Dyne, Wave, Solid and Sarepta near the regulatory finish line.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
THE LATEST
The FDA approved Eisai and Biogen’s lecanemab (Leqembi) Friday afternoon. It is the second anti-amyloid antibody to be approved for Alzheimer’s disease in two years.
PCN-101, a ketamine-based candidate for treatment-resistant depression being developed by Atai’s Perception Neuroscience, fell short in a Phase II trial.
Thursday, Fate Therapeutics announced it terminated the 2020 collaboration agreement with Johnson & Johnson’s biopharma subsidiary Janssen.
Graphite Bio announced it is voluntarily pausing the Phase I/II study of its lead candidate nula-cel in sickle cell disease.
Moderna and CytomX ink a cancer partnership.
In another early high-value deal, Amgen inked a licensing agreement with Synaffix for the development of next-generation antibody-drug conjugates.
NovoCure’s novel cancer-fighting platform hits the mark in non-small cell lung cancer.
Metagenomi announced a Series B extension financing round led by Moderna, Leaps by Bayer and several others.
A letter published Wednesday in the NEJM links a stroke patient’s death to lecanemab. Eisai investigators respond.
Galmed announces positive late-stage results in biopsy-proven NASH patients.