Argá Medtech SA said patients in the first stage of enrollment for a first-in-human clinical trial have been safely and effectively treated with an ablation system for treating atrial fibrillation (AF). The Coherent Sine Burst Electroporation (CSE) system uses a pulsed field ablation (PFA) sine waveform and single, configurable (circular, linear, and focal) ablation catheter to better treat patients suffering from AF.
The debate over medical management versus percutaneous coronary intervention (PCI) for patients with chronic coronary artery disease took a new twist thanks to data that PCI plus medical management was better than medical management alone for cardiovascular mortality.
Radiopharmaceutical company Telix Pharmaceuticals Ltd’s TLX250-CDx (Zirconium (89Zr) TX250) met both primary and secondary endpoints in the phase III Zircon study in clear cell renal cell carcinoma, according to top-line data.
Verve Therapeutics Inc.’s heart disease candidate, VERVE-101, is the latest gene editing-based therapy to hit a snag at the FDA, which issued a clinical hold, delaying the start of phase I testing in the U.S. News of the hold, which followed preclinical presentations over the weekend at the American Heart Association 2022 meeting, sent shares of Verve (NASDAQ:VERV) falling 30.5% to close Nov. 7 at $21.75.
There are doubts about the future of GSK plc’s multiple myeloma drug Blenrep (belantamab mafodotin) after it failed to meet its goal of improving progression-free survival compared with standard chemotherapy in a confirmatory trial, placing its conditional approvals in the U.S. and Europe at risk.
Given Bioatla Inc.’s positive update from the study testing mecbotamab vedotin (BA-3011) in metastatic non-small-cell lung cancer sharpened investor thirst for more data by the end of this year, and Wall Street wanted to know how good the findings need to be in order to advance further.
At the end of September, C4 Therapeutics Inc. disclosed the U.S. FDA’s green light for the phase I/II trial with CFT-1946 in solid tumors, but the firm has piqued Wall Street’s interest more with another program due to face off with Bristol Myers Squibb Co. (BMS) in multiple myeloma (MM) and non-Hodgkin lymphoma (NHL).
New research presented by the University of Michigan revealed groundbreaking results for Certa Therapeutics Pty Ltd.’s lead candidate, FT-011, for serious inflammatory and fibrotic diseases. The results of a chronic kidney disease study presented at the American Society of Nephrology meeting on Nov. 4 concluded that FT-011 reverses the activation of molecular markers associated with fibrosis.
Once pharma’s great hope to replace opioid painkillers, it looks like the end for nerve growth factor (NGF) inhibitors after Regeneron Pharmaceuticals Inc. quietly axed fasinumab, the late-stage painkilling injection it was developing in partnership with Teva Pharmaceuticals Ltd. and Mitsubishi Tanabe Pharma Corp.
Femasys Inc. revised the design for its Femaseed pivotal trial to focus on couples experiencing male factor infertility, which accounts for about half of all cases of infertility today. Femaseed delivers sperm directly to the fallopian tube where an egg is released. As a result of the redesign, the Femaseed trial will need just one-quarter the number of treatment cycles originally anticipated.