China’s Center for Drug Evaluation and South Korea’s Ministry of Food and Drug Safety cleared Transcenta Holdings to begin phase III pivotal trials of osemitamab (TST-001) in combination with nivolumab and chemotherapy for first-line treatment of HER2-negative, Claudin 18.2 expressing locally advanced or metastatic gastric or gastroesophageal cancer.
Theralase Technologies Inc. has pioneered technology said to selectively infiltrate and kill non-muscle invasive bladder cancer (NMIBC) at the cellular level. Bladder cancer generally is the 10th most common cancer in the world (6th in men and 17th in women), and gradually showing up in greater numbers in other patient groups.
Parasym Ltd.’s neuromodulation technology significantly decreased postural tachycardia syndrome (POTS) and has the potential to be a safe and effective treatment for individuals living with the condition, according to a recent study. The result from the trial represents a substantial breakthrough for people with POTS, as there are no U.S. FDA approved treatments for the condition, Nathan Dundovic, co-founder at Parasym, told BioWorld.
Microba Life Sciences Ltd. has started dosing patients in a phase I trial of its gut microbiome-derived therapeutic, MAP-315, for ulcerative colitis, the major form of inflammatory bowel disease (IBD).
Aslan Pharmaceuticals Pte. Ltd. announced variegated results from its phase IIb TREK-AD trial testing eblasakimab, its biologic tested for moderate to severe atopic dermatitis (AD), that drew an equally mixed reaction from the market.
Moderna Inc. may have risen to prominence during the pandemic with its messenger RNA (mRNA)-based COVID-19 vaccine, but it’s now casting a net far larger and wider. The company said on July 5 that it is readying international approval for its second mRNA vaccine called mRNA-1345 for respiratory syncytial virus (RSV)-associated acute respiratory disease based on positive interim data from the ongoing Conquer RSV study in individuals 60 and older.
China’s Center for Drug Evaluation has cleared Jacobio Pharmaceuticals Group Co. Ltd.’s KRAS G12C inhibitor, glecirasib (JAB-21822), to begin a phase III pivotal study for pancreatic cancer.
The mortality rate of patients with kidney failure can be significantly reduced if they are treated with high-dose hemodiafiltration compared with the more commonly used high-flux hemodialysis, according to a study recently published in the New England Journal of Medicine. The results from the CONVINCE trial pave the way for the increased adoption of hemodiafiltration as a therapeutic option to treat patients with end-stage kidney disease.
A non-invasive retinal exam may soon enable clinicians to visualize the future for patients at risk of chronic kidney disease (CKD). When combined with an artificial intelligence algorithm, an exam accurately predicted CKD prior to symptom onset in a study published in Digital Medicine.
Sequana Medical NV has reported additional data on safety, survival and quality of life from its POSEIDON pivotal study in North America, evaluating its Alfapump device used in the treatment of patients with recurrent or refractory ascites caused by liver cirrhosis. The data were recently presented at the European Association for the Study of the Liver 2023 congress in Vienna.