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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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Looking for a biopharma job in Pennsylvania? Check out the BioSpace list of six companies hiring life sciences professionals like you.
The Trump administration’s recently announced fee for new H-1B visa petitions is “completely unreasonable,” an immigration attorney told BioSpace. Attorneys and talent acquisition experts discuss how the fee could impact biopharma and confusion around the proclamation.
Truist analysts called the results “encouraging” while pointing out certain unknowns in the data. Immuneering plans to kick off a registrational trial for atebimetinib later this year.
The decision to stop the Phase IIb study was driven by “strategic business reasons,” according to a federal clinical trials database.
Three draft recommendation documents published on Wednesday are intended to guide drug sponsors and accelerate the development of cell and gene therapies.
While Harmony management has not disclosed future plans for ZYN002, Jefferies analysts expect the asset to be shelved.
Talent acquisition leaders at leading pharma and biotech organizations are leveraging technologies, including automation, to develop internal talent marketplaces and systems that support upskilling and reskilling their workforce. BioSpace spoke to leaders at Pfizer and Bayer about their evolving approach to resourcing.
Acadia Pharmaceuticals was testing the drug, an intranasal formulation of the oxytocin analogue carbetocin, for its potential to ease hyperphagia in the rare neurological condition.
Sanofi Ventures, which now has $1.4 billion in total assets, will focus its investment efforts on early players working in immunology, rare diseases, neurology and vaccines.
If approved, uniQure’s gene therapy AMT-130—which slowed disease progression by 75%—would be the first genetic treatment for Huntington’s disease. A BLA submission is planned for the first quarter of 2026.