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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.
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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.
Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotech’s heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerability—and more time for patients.
The recent approval of Regeneron’s Otarmeni underscores the maturation of gene therapies across a range of diseases. Here, BioSpace reviews genetic medicines in development for the central nervous system, retinal, cardiac and neuromuscular diseases.
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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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Both the White House and Congress have proposed legislation for the appropriate use of AI while the FDA continues to serve as the gatekeeper for patient privacy and safety.
While Amgen and Mirati are widely viewed as frontrunners to win the first front line approval, analysts—and competitors—say the field is still wide open.
Quotient Therapeutics, co-located in Cambridge, Mass. and Cambridge, U.K., will receive $50 million over two years from Flagship to study somatic genomics with an eye to finding new targets for gene therapies.
The buy brings three small molecules in preclinical development for Parkinson’s disease, amyotrophic lateral sclerosis and lysosomal storage diseases into Merck’s pipeline.
The biotech company has bought the global rights to an investigational oral CDK2 inhibitor from Ensem Therapeutics in a licensing agreement valued at up to $1.33 billion if all milestones are met.
The regulator has decided to hold an advisory committee meeting regarding BMS and 2seventy bio’s bid to move the CAR-T cell therapy into earlier lines of treatment, missing its previous target action date of Dec. 16.
Vorasidenib decreased tumor volume by a mean of 2.5% every six months, compared to growth of 13.9% for placebo over the same time span. The candidate is also being tested in a regimen with Keytruda.
As companies clamor for a piece of the antibody-drug conjugate pie, experts pose the question: is it possible to replicate the success of Enhertu?
Bayer’s investigational factor XIa inhibitor asundexian was inferior to BMS’ and Pfizer’s blockbuster blood thinner Eliquis (apixaban) in the Phase III OCEANIC-AF study.
Armed with a pipeline of obesity and diabetes hopefuls, Carmot Therapeutics joins the small group of biotechs to attempt a Nasdaq debut this year.