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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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Clay Siegall resigned his role as president, CEO and a member of the board of directors of Seagen following domestic violence allegations. Roger Dansey will serve as interim CEO.
The changes are unlikely to help people in developing countries but could reduce innovation among biopharma companies and ultimately do more harm than good.
In addition to lowering of blood sugar, Mounjaro also enabled patients to lower their weight by 15 to 23 pounds. The drug compared well to other diabetes medications including Novo Nordisk’s semaglutide.
U.S. Food and Drug Administration(FDA) has granted Orphan Drug designations to Editas Medicine and Neurocrine Biosciences.
The U.S. Food and Drug Administration (FDA) has approved Mitsubishi Tanabe Pharma America’s oral alternative to its own treatment for amyotrophic lateral sclerosis (ALS).
Achilles dosed the first patient in a Phase I/IIa advanced NSCLC trial, Logic Bio’s pediatric methylmalonic acidemia study is back up and running and another look at Roche’s TIGIT flop.
Genentech’s flop of its anti-TIGIT drug has cast a shadow of doubt over the numerous companies in the process of developing their own anti-TIGIT drugs.
New research from the Allen Institute for Immunology in Seattle has identified inflammatory proteins as a potential driver of the long COVID.
The rejection appears to be related to pre-approval inspection issues that need to be resolved before it can be approved.
Since the COVID-19 pandemic, there has been increased interest in developing a universal antiviral that would stop a pandemic in its tracks. Now some companies are in the testing phase for just that.