Europe is losing its innovative edge in biopharma, especially when it comes to advanced therapy medicinal products, including tissue, gene and cell therapies used to prevent, treat and cure rare conditions and some cancers.
Innovent Biologics Inc. said that, compared to a placebo, both doses of its anti-PCSK-9 monoclonal antibody tafolecimab tested in a phase III trial “yielded significant and durable reductions” in low-density lipoprotein cholesterol levels and showed a favorable safety profile in Chinese patients with non-familial hypercholesterolemia.
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.
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.
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.