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A month after reporting that its RAS inhibitor daraxonrasib doubled survival in advanced pancreatic cancer, Truist said Revolution Medicines “is evolving into a major revenue-generating oncology company,” and projects an approval in second-line disease by the end of the third quarter.
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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.
The FDA has introduced models intended to accelerate rare disease drug development, but recent reversals of guidance from the agency speak to a lack of clarity in its implementation. AI can help focus this process.
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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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According to reports citing “people familiar with the matter,” Kyowa Kirin, a specialty pharma company, could be lining up the sale of $1 billion worth of assets on the international market.
The trial evaluated crenezumab’s ability to slow Alzheimer’s disease in cognitively unimpaired people with a specific gene mutation that causes early-onset Alzheimer’s disease.
Covis announced that the U.S. Food and Drug Administration has granted the company a hearing for its controversial drug Makena, which is intended to reduce preterm births.
This week sees Exelixis, BioInvent, ImmunoGen and Oxford BioTherapeutics coming together to develop antibody-based therapies for cancer.
Biogen has terminated its asset purchase agreement with Karyopharm Therapeutics, putting a halt to the development of KPT-350 (BIIB100), which was being evaluated as a treatment for ALS.
An FDA advisory committee voted Wednesday to recommend both the Pfizer-BioNTech and Moderna COVID-19 vaccines for children as young as six months old.
Dr. Soon-Shiong and ImmunityBio are on the final leg of what they hope will be the FDA approval of their drug N-803 (anktiva) for the treatment of bladder cancer.
Clover dosed the first participants in a Phase III study of its COVID-19 booster shot, while Global Access Diagnostics, Orbit Discovery, Proximie and more provide business and pipeline updates.
Representation of women in biotech is nearing parity, but this is not reaching the executive level, where there is still stark disparity.
A recent study found that over a span of ten years, the FDA approved cancer drugs approximately eight months earlier than the same drugs were greenlit by the European Commission (EC).