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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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Lifting the clinical hold will allow Ocugen to continue to assess the vaccine in its ongoing study and potentially support its efforts to achieve EUA or full approval.
A small research study published in Jama shows people with a lower body mass index (BMI) tended to maintain immunity against COVID-19 longer.
Regeneron Pharmaceuticals shared positive results from its Phase III trial of an evinacumab for children with homozygous familial hypercholesterolemia.
Vir Biotechnology terminated a two-year-old COVID-19-related antibody collaboration with Wuxi Biologics that included sotrovimab, which lost EUA in the U.S. earlier this year.
Based on topline data, Pfizer stated that three doses of the COVID-19 vaccine met all immunobridging criteria required for EUA. The FDA’s advisory committee will meet June 15 to discuss the matter.
Sunday night, U.S. health authorities announced that they may have found the third documented case of monkeypox in a patient in South Florida.
Elicio Therapeutics published data on the preprint server bioRxiv, describing preclinical research into its cancer vaccine that shows a lot of promise.
Alnylam Pharmaceuticals shared 18-month results from its phase III Helios-A clinical study demonstrating that vutrisiran improves clinical cardiac symptoms in patients with hATTR.
Two experimental drugs from Seres Therapeutics and Vera Therapeutics celebrate clinical trial wins in hard-to-treat disease areas.
The compact and portable nasal spray means it can be used directly before an anxiety-provoking trigger or at the beginning of an episode.