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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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Structure Therapeutics is offering over nine million shares on the heels of mid-stage data for its oral GLP-1 receptor agonist, which showed weight loss of 6.2% in overweight or obese patients.
Amgen’s CD19-directed antibody Uplizna in a late-stage study showed it can suppress the risk of flares by nearly 90% in patients with IgG4-related disease, the company announced Wednesday.
Novo Nordisk will face strong generic competition from at least 15 companies in China for its blockbuster GLP-1 receptor agonist products Wegovy and Ozempic, according to Reuters.
Telix Pharmaceuticals is looking to cash in on radiopharmaceuticals, which have emerged as one of the hottest spaces in oncology, with an initial public offering to help support its pipeline of targeted radiation products.
Moderna on Thursday said its investigational mRNA-based therapy for methylmalonic acidemia has been selected for the FDA’s accelerator program for rare diseases, dubbed START.
Securing top talent in research and development and manufacturing will remain challenging for life sciences companies in 2024, according to a new report by CBRE.
Gilead Sciences’ primary biliary cholangitis candidate seladelpar and Ipsen’s PBC asset elafibranor both showed encouraging Phase III results Wednesday, as they face looming FDA decision dates.
There are multiple ways biopharmas create inclusive workplaces for LGBTQ+ employees, and they go beyond employee resource groups and benefits.
Vir Biotechnology reported Wednesday that its monoclonal antibody tobevibart, as a monotherapy and in combination with Alynylam-partnered elebsiran, achieved high rates of virologic response at week 24 in patients with chronic hepatitis delta.
More than 50% of nonalcoholic steatohepatitis patients treated with Eli Lilly’s tirzepatide saw at least a one-stage improvement in fibrosis, according to the pharma’s latest mid-stage readout.