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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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Black/African American hematological cancer patients tend to have the worst outcomes. This is partly driven by a lack of access to allogeneic hematopoietic stem cell transplant and available donors.
The model has been validated against clinically relevant IBD therapies to demonstrate efficacy and mechanism of action, enabling drug developers to gain more accurate therapeutic insights.
Dren Bio announced the completion a of $65M Series B financing round. New investors include Pfizer, ArrowMark Partners and Revelation Partners.
Despite geopolitical tensions, the pharmaceutical industry sees China as a land of opportunity and some largely surmountable challenges.
In a unanimous vote, a panel of FDA advisors voted to recommend the approval of Moderna’s COVID-19 vaccine for children between the ages of six and 17 years old.
MorphoSys U.S. Inc., Pfizer and Incyte are teaming up to test Pfizer’s TTI-622 in conjunction with Monjuvi plus lenalidomide in patients with lymphoma.
Day One Biopharmaceuticals announced positive early data assessing tovorafenib as a once-a-week treatment in people aged six months to 25 years with relapsed or progressive pediatric low-grade glioma.
On Tuesday, Stealth Biotherapeutics announced that it plans to meet with the FDA to discuss a potential NDA for its therapeutic, elamipretide, which is intended to treat Barth syndrome.
The FDA has approved Alnylam Pharmaceuticals’ Amvuttra (vutrisiran) for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy in adults.
Evotec SE has inked a deal with Janssen Pharmaceutical hat showcases its end-to-end integrated drug discovery and development platform.