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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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On Monday, the Biden administration got an early victory in pharma’s legal challenge to the Inflation Reduction Act, with a Texas judge dismissing a complaint from the Pharmaceutical Research and Manufacturers of America.
On Friday, the regulator greenlit Iovance’s lifileucel to treat advanced melanoma. Prior to the approval, experts told BioSpace that tumor-infiltrating lymphocytes therapies also hold the potential to treat several other solid tumors.
Gilead Sciences announced Monday it will purchase CymaBay Therapeutics and its investigational treatment seladelpar for primary biliary cholangitis, a type of liver disease that causes bile-duct damage.
CSL’s investigational cholesterol efflux enhancer CSL112 failed to reduce major adverse cardiovascular events within 90 days in patients who had just suffered a heart attack.
Shares of preclinical genetic medicines company Metagenomi tanked more than 30% on Friday afternoon in a disappointing debut for its initial public offering, bucking the trend of positive IPOs so far this year.
Merging six of its portfolio biotechs, Medicxi on Monday unveiled Alys Pharmaceuticals, an immuno-dermatology focused company seeking to deliver up to 10 proof-of-concept readouts by the end of 2026.
Two Florida courts have sided with Novo Nordisk against Ekzotika and Effinger Health, agreeing that their compounded versions of semaglutide are against the law. The Danish pharma has reached confidential settlements with both companies.
Madrigal Pharmaceuticals announced late-stage results published Thursday in The New England Journal of Medicine for resmetirom as it awaits a March 14 PDUFA date.
Biopharma’s latest earnings season was, in a word, predictable. Companies are consistently beating Wall Street earnings and revenue estimates as they set low expectations for investors.
Despite not having a single candidate in the clinical stage, the Moderna-backed biotech is offering 6.25 million shares for $15 apiece in an initial public offering. Shares are expected to begin trading Friday.