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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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Francis deSouza resigned from Illumina’s helm after strong campaigning from activist investor Carl Icahn and the ongoing regulatory roadblocks facing the company’s acquisition of GRAIL.
Unlimited paid time off may seem like a way to prevent burnout, but for many, it has the opposite effect.
The company paid $85 million upfront to Quell Therapeutics to develop Treg therapies for Type 1 diabetes and inflammatory bowel disorder, with the deal potentially worth more than $2 billion.
The Centers for Medicare & Medicaid Services announced Friday it will impose inflation penalties on 43 Medicare Part B drugs in the third quarter of 2023. The action follows fines on 27 drugs in March.
Data show the potential of Editas’ sickle cell disease and transfusion-dependent beta thalassemia gene therapy candidate, but it might not be enough to overtake Vertex and CRISPR Therapeutics.
The FDA has launched a new super office to prepare for myriad decisions on cell and gene therapies, including the potential first CRISPR therapy and the first gene therapy for Duchenne muscular dystrophy.
The FDA’s Antimicrobial Drugs Advisory Committee voted 21–0 that the companies’ respiratory syncytial virus antibody, nirsevimab, has a favorable benefit-risk profile in infants and young children.
The FDA has four target action dates this week for three supplemental approvals and one New Drug Approval.
The company said Thursday it has closed $200 million in Series B financing—on top of last year’s $200 million Series A haul—to help initiate a registrational Phase II study for its lead candidate UPB-101.
A total of nine U.S. cities stood out in terms of total NIH funding in 2022.