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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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Bristol Myers Squibb has returned the rights for interleukin-12 immunotherapy program DF6002 back to its original owner, Dragonfly Therapeutics, the companies announced Monday.
Data from a Phase III study show Genentech’s crovalimab is non-inferior to AstraZeneca’s Soliris, the current standard of care in paroxysmal nocturnal hemoglobinuria (PNH).
Merck and Nectin Therapeutics announced a research collaboration agreement to study the safety and efficacy of Nectin’s investigational antibody in locally advanced and metastatic solid tumors.
Industry leaders say the second generation of interventions for nonalcoholic steatohepatitis is likely to succeed where first-generation approaches stumbled.
Janssen reported positive topline data from a Phase II proof of concept study assessing nipocalimab in severe hemolytic disease of the fetus and newborn.
Biogen and its partner, Sage Therapeutics, announced the FDA has accepted the New Drug Application for zuranolone and granted it priority review in two mental health indications.
Astellas named a new president and CEO and announced additional changes to its leadership structure in an effort to accelerate growth and chart its long-term business trajectory.
The FDA placed 4D Molecular Therapeutics’ gene therapy program, 4D-310, on clinical hold, the company announced Thursday.
The discovery of novel Alzheimer’s biomarkers is enabling better trial selection, earlier pipeline decision making and new targets for therapeutics.
Sanofi is discontinuing its Phase III study of tolebrutinib, an investigational BTK inhibitor for myasthenia gravis.