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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 company’s investigational electric field therapy was unable to elicit significant survival benefits in patients with platinum-resistant ovarian cancer.
The British drugmaker filed a lawsuit on Friday in the U.S. District Court for the District of Delaware claiming the Inflation Reduction Act conflicts with the goals of the Orphan Drug Act.
The late-stage results for acoramidis, BridgeBio’s transthyretin amyloid cardiomyopathy candidate, indicate significant survival, functional and biomarker improvements over placebo.
Following a countersuit by Amgen and Horizon Therapeutics, the Federal Trade Commission has temporarily suspended its challenge to the multi-billion dollar merger between the two companies.
The Swiss pharma is returning the anti-TGFβ antibody NIS793 to Xoma Corporation, from which it bought the asset in 2015 for $37 million upfront.
While an initial analysis showed improvements in progression-free survival and objective response rate, a second analysis saw no improvement in overall survival.
A second trial shows Novo Nordisk’s Wegovy improves heart health. Meanwhile, many other drugs are beginning to face generic competition, including from newly approved biosimilars.
Following a late-stage victory on Monday, Exelixis on Thursday reported another Phase III win for its tyrosine kinase inhibitor Cabometyx—this time in advanced neuroendocrine tumors.
Wegovy’s highest dose significantly improved physical function and quality of life in obese patients with heart failure, according to results published Friday in The New England Journal of Medicine.
Amid one of the industry’s steepest patent cliffs, the regulator Thursday approved Sandoz’s Tyruko, the first biosimilar for treating relapsing multiple sclerosis in adults. Sandoz is a division of Novartis.