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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 investment arm of the Novo Nordisk Foundation is acquiring contract development and manufacturing organization Catalent to help meet high demand for Ozempic and Wegovy.
The biotech is taking a synergistic approach to obesity with two muscle-preserving antibodies set to enter a Phase II study in mid-2024 in combination with existing incretin-based treatments.
Topline results from a mid-stage study show that 4D Molecular Therapeutics’ investigational gene therapy cut annual rates of Eylea injections by 85% and 89% for the low and high doses, respectively.
The FDA’s Oncologic Drugs Advisory Committee will meet on March 15 to discuss BMS and J&J applications for their CAR T-cell therapies Abecma and Carvykti, respectively.
The Japanese pharma’s financial numbers showed a drop in operating revenue as it signed a $300 million license and collaboration agreement with Protagonist Therapeutics.
The company’s blockbuster cancer treatment Keytruda continues to be a significant boon to its bottom line, according to Merck’s fourth quarter and full-year 2023 financial results.
With one disease-modifying therapy already reaching patients and another expected to soon, several biopharma companies anticipate key data for novel assets in the coming 12 months.
While AbbVie beat revenue expectations in the fourth quarter of 2023, the company reported Friday that its overall sales last year declined as it faced biosimilar competition for its blockbuster Humira.
The pharma Friday reported in-line and new product revenue growth of 9%, bringing in $9.8 billion for the fourth quarter of 2023. Eliquis and Opdivo remain top sellers but BMS is facing the loss of exclusivity.
The British pharma expects “meaningful” sales and earnings growth in 2024 and is upgrading its growth outlooks for 2026 and 2031, according to GSK CEO Emma Walmsley.