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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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After the unexpected success of their PHOENYCS GO study for dapirolizumab pegol in lupus earlier this fall, Biogen and UCB are planning a second late-stage trial by the end of the year to support a drug application.
Investigational CAR T therapies stole the spotlight at the American College of Rheumatology Convergence as data presented by Bristol Myers Squibb, Kyverna Therapeutics and more highlighted their potential to effectively treat lupus.
After failing to receive the RMAT designation from the FDA for its early-stage Batten disease gene therapy, Neurogene tells investors that it’s evaluating options for the program.
Analysts are split on whether the positive trial results will help Merck stem future Keytruda losses as the mega-blockbuster goes off patent in 2028.
Regenxbio is pushing its Duchenne muscular dystrophy gene therapy into pivotal development, with a BLA planned for 2026—potentially posing a threat to Sarepta’s Elevidys.
Incyte’s pipeline updates on Monday bring into question the value of its $750 million Escient acquisition in April 2024—and further erode confidence that the biotech can effectively mitigate the impacts of Jakafi’s loss of exclusivity in the coming years, according to analysts.
Lilly’s muvalaplin is the first oral drug to show positive Phase II findings for Lp(a) reduction, eliciting up to an 86% drop in the biomarker after 12 weeks.
In this deep dive BioSpace explores the opportunities and challenges presented by the FDA’s accelerated approval program.
The deal has secured Novartis the chance to work with Ratio Therapeutics on a novel drug candidate that could fortify the Big Pharma against competition from would-be radiopharmaceutical rivals such as BMS and Lilly.
Phase II results for Cybin’s psilocin therapy showed remission rates of 71%, but just eight patients made it to the 12-month milestone.