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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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The Biotechnology Innovation Organization, Passage Bio and Palisade Bio saw leadership shakeups at the top, while Maze Therapeutics, Cerecin and more appointed new chief medical officers.
Pfizer and BioNTech released early data Thursday morning from a Phase II/III trial assessing an Omicron-specific booster that showed it provided significant protection, confirming early research.
Tiziana Life Sciences plans to submit an Investigational New Drug Application for a Phase I trial studying intranasal formulab, a breakthrough treatment option for Alzheimer’s Disease.
GSK’s RSV vaccine candidate met its primary endpoint in a pivotal Phase III trial, proving to be highly effective against RSV-associated lower respiratory tract disease.
One year after BridgeBio won accelerated approval for liver cancer drug Truseltiq (infigratinib), the company is pulling a planned Phase III program due to its partner’s decision to discontinue the drug.
Relmada Therapeutics’ RELIANCE III trial studying REL-1017 as a treatment for Major Depressive Disorder failed to hit the primary endpoint, the company reported Thursday.
Odyssey Therapeutics raised $168 million in a Series B financing round, which will be used to advance its portfolio of immunomodulators and oncology therapies.
The internet and “common wisdom” aren’t always right. Here are some of the top myths about three common conditions, and the truth from leading experts in their fields.
As part of a realignment, GreenLight Biosciences is cutting staff by about 25%, the company announced Wednesday.
Terray Therapeutics and Calico Life Sciences struck a research and development collaboration focused on the development of small-molecule therapeutics for age-related diseases.