News
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.
FEATURED STORIES
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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
After finally getting the green light from the Federal Trade Commission last month, Amgen has completed the buyout and expects to provide updated fiscal year 2023 guidance during its third-quarter earnings call.
Keytruda’s winning streak in bladder continues with positive data from the Phase III AMBASSADOR study, showing significantly better disease-free survival in muscle-invasive urothelial carcinoma.
Data from a confirmatory study could not be reliably interpreted, according to the Oncologic Drugs Advisory Committee, which voted against Amgen’s request for full approval of its G12C KRAS inhibitor.
In this job market report we’re reviewing life sciences job market movement in Q3 and what to expect for Q4 and beyond.
This labor market report examines Q3 life science job market trends and the recruitment outlook for Q4 and beyond.
Recent FDA approvals of novel drugs based on less-than-stellar clinical evidence point to a trend toward regulatory flexibility—particularly in indications with very high unmet need.
The Japan-based pharma is acquiring Orchard Therapeutics for approximately $477.6 million, if all conditions are met. Orchard’s pediatric gene therapy has a PDUFA date set for March 2024.
Following a fatality due to the rare blood disease hemophagocytic lymphohistiocytosis, the regulator slapped a partial clinical hold on two studies of Innate Pharma’s investigational therapy lacutamab.
Despite the lack of a randomized controlled trial for US WorldMeds’ investigational drug, an FDA advisory committee found that the company provided adequate data to support its benefit in high-risk neuroblastoma.
Patients with treatment-resistant depression treated with Johnson & Johnson’s Spravato were significantly more likely to reach remission and stay relapse-free for up to 32 weeks.