Top-line results of a phase III trial testing sulbactam-durlobactam, a combination beta-lactam antibiotic and beta-lactamase inhibitor, in patients with carbapenem-resistant Acinetobacter baumannii infections, found the novel combo to be statistically noninferior to colistin in 28-day all-cause mortality, the study's primary endpoint.
Phase II results from Atea Pharmaceuticals Inc. with AT-527 in COVID-19 treatment had pundits scrambling to stack the odds of success for the direct-acting oral antiviral against those of Merck & Co. Inc.’s molnupiravir, though cross-trial comparisons are beset by the usual hurdles, with two especially dramatic ones.
A genetic biomarker-based diagnostic test developed by Inbiomotion SL to identify treatment for early-stage
breast cancer could significantly improve patient survival, a study has found. Data from the phase III NSABP-B34 study published in the Journal of the National Cancer Institute Cancer Spectrum, showed that in patients with MAF-negative (mutation biomarker) tumors – determined with Inbiomotion’s MAF Test – adjuvant treatment with clodronate was associated as having the greatest benefit compared to placebo-treated control patients receiving the same standard of care.
Thanks to positive phase III data from Phathom Pharmaceuticals Inc.’s Phalcon-EE study of patients with erosive esophagitis, the company is prepping to file an NDA with the FDA for its lead compound, vonoprazan.
Biogen Inc.’s phase III trial of tofersen in a form amyotrophic lateral sclerosis (ALS) has missed its main goal, but the company said it is still talking with regulators after seeing positive trends in the data.
LONDON – Valneva SA’s COVID-19 vaccine, VLA-2001, prompted a stronger immune response with fewer side effects than Astrazeneca plc’s product, according to headline data from the phase III trial. Shares in Valneva (NASDAQ:VALN) shot up by nearly 40% to close Oct. 18 at $39.21 when the data were announced, partly repairing the damage on Sept. 13 when the U.K. government cancelled a $1.65 billion contract with the French vaccines specialist for 100 million doses.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akeso, Astrazeneca, Eli Lilly, Medigen, Merck, Protalix, RDIF, TG.
In trials name-checking some of the world’s highest peaks, longest rivers and most famous seas, Astrazeneca plc has long sought the best use of its CTLA4 inhibitor tremelimumab. Now, after a disappointing cruise along the first-line bladder cancer trial Danube and travails in non-small-cell lung cancer with the trials Mystic, Neptune and Arctic, a trek to the endpoint of its phase III trial Himalaya has yielded top-line success. A single, high priming dose of tremelimumab added to the company's immune checkpoint inhibitor, Imfinzi (durvalumab), led to a statistically significant overall survival (OS) benefit vs. Nexavar (sorafenib, Bayer AG and Amgen Inc.) in the first-line treatment for patients with unresectable hepatocellular carcinoma.
Fabric Genomics Inc.’s Gem artificial intelligence algorithm plus whole genome and whole exome data detected more than 90% of disease-causing variants in infants with rare diseases, a study in Genome Medicine demonstrated. The full process from blood sample to shortlist of causative variants and likely diseases takes just a matter of hours and the time to interpret whole genomes is condensed to about 15 minutes.
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