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Analysts are extremely encouraged by Phase 2 trial results for Relay Therapeutics’ PI3KA inhibitor in treating vascular malformations (VM), prompting the biotech to eye a potential path to accelerated approval.
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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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AstraZeneca reported Tuesday that its Phase III MESSINA trial hit one primary endpoint but missed the other. The study was evaluating Fasenra in eosinophilic esophagitis.
Novartis’ positive-third quarter growth report was slightly marred by several clinical setbacks that resulted in the termination of studies in liver transplant and non-small cell lung cancer.
Taysha Gene Therapies has entered into a strategic equity investment and licensing deal with Astellas. The latter stands to gain access to Taysha’s gene therapy development programs for Rett syndrome and GAN.
Data from two Phase I trials indicate Gritstone Bio’s samRNA vaccine can safely induce a strong and durable immune response against COVID-19.
In the near future, painful jabs and muscle soreness that persists for days could be replaced by new immunization approaches including intradermal delivery, edible and intranasal vaccines.
Mirum Pharmaceuticals announced that Livmarli oral solution met its primary endpoint in the Phase III MARCH study in young patients with progressive familial intrahepatic cholestasis.
BioMed X and Sanofi have inked an R&D collaboration to use digital data and artificial intelligence to predict the efficacy of first-in-class drug candidates using virtual patient populations.
PhaseBio plans to file Chapter 11 bankruptcy and sell off its bentracimab assets under a stalking horse arrangement with an unnamed “large pharmaceutical company.”
The FDA greenlit AstraZeneca’s tremelimumab in combination with its checkpoint inhibitor Imfinzi as a treatment for patients with unresectable hepatocellular carcinoma.
Alpine Immune Sciences has voluntarily terminated enrollment in two clinical trials of its immuno-oncology asset, davoceticept, after a second patient death.