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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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The biotech company is looking to forge a path to profitability by scaling up the commercial uptake of Zynteglo and winning the FDA’s approval for its lovo-cel gene therapy for sickle cell disease.
The vaccine maker cut 25% of staff amid post-pandemic business challenges in May, but resurgent sales and an updated COVID-19 shot may prove a turning point.
Eli Lilly reported second-quarter revenue of over $8.3 billion, a 28% increase versus Q2 2022, beating estimates of $7.58 billion. The company Tuesday raised its full-year guidance by $2.2 billion.
Data from a Phase III study released Tuesday found that Novo Nordisk’s Wegovy lowered the risk of cardiovascular complications and death by 20% versus placebo in overweight and obese adults.
Last month, the agency hired a new director for the Office of Therapeutic Products, but both leadership and support staff positions remain open.
As biopharma companies look to prove price setting provisions in the Inflation Reduction Act are unconstitutional, lawmakers unveil legislation to further reduce drug costs.
The new legislation could increase healthcare spending overall while reducing biopharma’s return on investment on biologic drugs.
Despite failing a previous late-stage study, VistaGen’s fasedienol finally scored a win by meeting its primary endpoint and strongly easing distress among patients with social anxiety disorder.
Following a handful of clinical failures and changes to its leadership, FibroGen is trying to chart a more positive path forward by focusing on four strategic areas.
The Danish company’s vaccine candidate met all co-primary endpoints in a late-stage study in adults and adolescents just months after publishing trial data for elderly patients, as it seeks to challenge Valneva.