Dive Brief: Illumina’s board of directors has approved a spinoff of Grail, targeting June 24 as the date the cancer blood test maker will regain its independence. Illumina agreed to divest the business it bought for $8 billion in 2021 after facing pressure from U.S and European antitrust regulators and activist investor Carl Icahn. Illumina,…
Medical experts who advise the Food and Drug Administration are not convinced MDMA is ready for general use to help treat post-traumatic stress disorder, recommending at a meeting Tuesday the agency hold off on an approval. The experts convened at the request of the FDA, which is reviewing a new drug application from Lykos Therapeutics,…
Dive Brief: An experimental GLP-1 pill helped people with obesity lose significantly more weight than a placebo over three months, according to summary results revealed by developer Structure Therapeutics Monday. In the Phase 2a study, which enrolled 64 healthy individuals who were obese or overweight, Structure’s drug led to an average reduction in body weight…
BioPharma Dive is testing out a new format rounding up smaller updates from around the industry. Have thoughts on what could make this type of story better? Drop us a line! Over the weekend at the American Society of Clinical Oncology’s annual meeting in Chicago, cancer researchers and doctors detailed fresh findings from hundreds of…
Liquid biopsy has emerged as a revolutionary tool for clinical trials, offering cellular and cell-free methods that provide valuable insights into disease progression and treatment response. Circulating tumor cells (CTCs) and cell-free DNA and cell-free RNA (cfDNA/cfRNA) allow for detecting cancer-specific genetic alterations and monitoring tumor heterogeneity over time and upon treatment. Despite their strengths,…
Two years ago, a drug called Enhertu changed the way doctors thought about treating an aggressive form of breast cancer, making it important to know not only whether their patients’ tumors express a protein known as HER2, but how much. New study results presented Sunday at the American Society of Clinical Oncology may further shift…
An accelerated approval for Gilead Sciences’ cancer drug Trodelvy could be in question after the company disclosed Thursday afternoon that a confirmatory trial failed to meet its main objective. In the trial, called TROPiCS-04, Trodelvy did not significantly extend survival versus chemotherapy among people with locally advanced or metastatic bladder cancer. Gilead noted the data numerically…
The Food and Drug Administration on Friday approved a third vaccine for respiratory syncytial virus, clearing a shot from biotechnology company Moderna one year after granting a green light to vaccines from GSK and Pfizer. The vaccine, dubbed mResvia, is for the prevention of disease caused by respiratory syncytial virus, or RSV, in adults 60…
BioPharma Dive is testing out a new format rounding up smaller updates from around the industry. Have thoughts on what could make this type of story better? Drop us a line! Today, a brief rundown of news from Regeneron, Summit Therapeutics and Verve Therapeutics, as well as updates from Bristol Myers Squibb and Neurocrine Biosciences…
Food and Drug Administration scientists have reservations about a potential new treatment for post-traumatic stress disorder that’s currently up for approval. Developed by an unusual company called Lykos Therapeutics, the ecstasy-based treatment has been tested across a handful of clinical trials, including two late-stage, placebo-controlled studies that are serving as the main evidence to support…
