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Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
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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.
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Ipsen bolsters rare disease portfolio with acquisition of liver disease specialist Albireo.
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.