Haisco Pharmaceutical Group Co. Ltd. has synthesized soluble guanylate cyclase (sGC) activators reported to be useful for the treatment of cardiovascular, renal and respiratory disorders.
The U.S. FDA has cleared Artrya Ltd.’s 510(k) for its Salix coronary plaque (SCP) module that is a bolt-on module to the company’s Salix coronary anatomy platform.
The U.K. National Institute for Health and Care Excellence has recommended that physicians in the U.K. use the least expensive, clinically appropriate TAVR device when possible, concluding a pricing review that commenced roughly a year ago.
Cardiac hypertrophy is a main contributor to heart failure, where therapeutic options are limited. Increasing evidence exists regarding up-regulation of histone lysine-specific demethylase 4A (KDM4A) in patients with cardiac hypertrophy as a risk factor, although the mechanisms behind are not well understood.
Calcific aortic valve disease (CAVD) is the most prevalent acquired valve heart disorder in aging populations. Its most severe form in aortic valve stenosis (AVS), with an average survival of 2-3 years once symptoms appear. The early diagnosis of AVS based on circulating biomarkers is crucial to label high-risk patients before they progress to the severe form.
With a few tweaks to the protocol, Rocket Pharmaceuticals Inc.’s phase II trial testing RP-A501 in Danon disease is expected to resume following the lifting of the clinical hold, issued by the U.S. FDA in May in response to the death of a patient in the pivotal gene therapy study.
Vasthera Co. Ltd. has received IND clearance from the U.S. FDA, enabling it to initiate a phase I trial for VTB-10 for pulmonary arterial hypertension (PAH). Vasthera identified a deficiency of the enzyme peroxiredoxin (PRX) in PAH lesions and used its Redoxizyme platform to develop VTB-10, a small-molecule enzyme that precisely replicates PRX function.
Medtronic plc posted nearly 50% year-over-year growth in its cardiac ablation business this quarter, with a 72% increase in revenue in the U.S., largely driven by pulsed field ablation. With significant opportunity in renal denervation and a new committee to look at growth including M&A and divestitures and another to review operations, analysts think the company stands a good chance of shedding its “chronic underperformer” image.
Onward Medical NV secured U.S. FDA investigational device exemption (IDE) approval for a pivotal study to assess the safety and efficacy of its implantable spinal stimulation technology, the ARC-IM system. The Empower study BP study will focus on addressing blood pressure instability in patients with spinal cord injury (SCI).
Superluminal Medicines Inc. and Eli Lilly and Co. are collaborating in a deal to develop cardiometabolic disease and obesity therapies by aiming at undisclosed G protein-coupled receptor targets. The deal could bring Superluminal as much as $1.3 billion, including up-front and near-term investments, an equity investment, development and commercial milestones, plus tiered royalties on net sales.
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