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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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Pfizer apparently hasn’t begun any combination trials in human beings of Paxlovid, and no reported human tests are using the drug in combination with other therapies.
The American Society of Gene and Cell Therapy annual meeting continues to see companies showcasing promising therapeutics for multiple disease indications.
The current president, CEO and board member, Keith Kendall, is departing Aquestive. He will be replaced by Daniel Barber, its current chief operating officer.
Greece’s Health Minister Thanos Plevris announced plans to sue Novartis over what he alleges are illegal practices. In addition to demanding compensation, the country is implementing a three-point plan.
Hengrui Pharma is seeking to make medicines more available and affordable worldwide with the launch of Luzsana that opens up access to treatment for hundreds of illnesses.
Axsome Therapeutics announced that it published the results of its Ascend Phase-II clinical trial of AXS-05 to treat Major Depressive Disorder in The American Journal of Psychiatry.
Scientists in New Zealand have found that mRNA-based COVID-19 vaccines produce greater antibody levels compared to adenovirus vector-based ones across major COVID-19 variants.
ShouTi believes many targets addressed by biologic and peptide therapeutics can be reached by innovative, rationally-designed, best-in-class small molecules that don’t need refrigeration or injection.
Cytokinetics filed with the SEC reporting that the FDA planned to hold an advisory committee meeting to review its New Drug Application (NDA) for omecamtiv mecarbil.
Avrobio presented clinical data on Tuesday at the 25th Annual Meeting of the American Society for Gene and Cell Therapy (ASGCT) from its trial of AVR-RD-04, and preliminary results are promising.