News
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.
FEATURED STORIES
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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
The U.S. Department of Health and Human Services on Thursday released new data showing that Americans pay three times more for prescription drugs than other developed countries and nearly 10 times more for insulin.
Alto Neuroscience and Fractyl Health provided further momentum to the recent spate of biotech initial public offerings, with both companies going public on Friday morning in respective $128 million and $110 million IPOs.
Kyverna Therapeutics, the fifth biotech with plans for an initial public offering this year, will use the proceeds to support the development of its anti-CD19 CAR-T therapies for autoimmune diseases.
The Centers for Medicare and Medicaid Services on Thursday sent its opening price proposals to drugmakers, which now have 30 days to either approve the offers or submit counteroffers.
Biotech companies are exploring multiple targets in the fight against neuroinflammation. Experts say these projects could yield the next breakthrough in treating Alzheimer’s disease.
The Swiss pharma on Thursday projected mid-single-digit sales growth for 2024, culling eight assets and looking to acquisitions and collaborations for de-risked assets with “significant potential.”
During a Wednesday webinar, FDA Commissioner Robert Califf said the agency is working on “systemic” changes to its advisory committee process.
Positive Phase III results for VX-548 could signal a new chapter in the fight against opioid addiction, but experts say there is still room to do better.
The first hearing on a potential injunction came the day before CMS is to release pricing proposals on 10 drugs.
Despite strong sales of its blockbuster drug Dupixent, Sanofi on Thursday reported that its fourth-quarter 2023 operating income dropped 5% due to a weaker U.S. dollar, high expenses and generic competition.