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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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For people with, or at risk for, SOD1-ALS, the FDA’s approval of Qalsody is an important step toward advancing gene-specific research for this uniformly fatal disease.
Vowst, the first-ever oral fecal microbiome-based therapeutic, is indicated for preventing C. diff recurrence in adults following antibacterial treatment.
Merck and AstraZeneca are seeking broad approval for Lynparza in mCRPC regardless of BRCA status.
During its Q1 earnings call Tuesday, Biogen announced a handful of program pauses and cuts and touted the potential of anticipated approvals.
Orbital will use Series A funds to advance RNA-based vaccines, immunomodulators and protein replacement therapies.
The proposed drug pricing legislations follow the Inflation Reduction Act, passed in August 2022.
Novartis is scaling back its pipeline to focus on higher-value assets with stronger commercial potential.
The regulatory filing puts the company alongside Vertex and CRISPR, which also await FDA approval for their SCD gene therapy.
Vedanta will use the funds to advance its lead asset VE303 in clostridioides difficile infection and support the development of another candidate in ulcerative colitis.
Tuesday, the FDA approved Qalsody—formerly tofersen—on a conditional basis to treat SOD1-ALS.