Danish pharma giant Novo Nordisk A/S is set to launch its blockbuster glucagon-like peptide-1 therapy, Wegovy (semaglutide), in South Korea’s growing obesity therapeutics market next week, a company official confirmed to BioWorld.
Edwards Lifesciences Corp. made a splash recently with the U.S. FDA approval of the Evoque tricuspid valve replacement device, but is also pressing Centers for Medicare and Medicaid Services to provide a coverage framework for this class of devices.
The recent uptick in med-tech deals is a sign technologies that are solving unmet clinical needs are finally coming to fruition, Antoine Papiernik, chairman and managing partner at Sofinnova Partners, told BioWorld in an interview.
Researchers from Johns Hopkins University have filed for protection of their Optimal Target Identification via Modelling of Arrhythmogenesis technology – a method that builds a model of a patient’s heart from a cardiac MRI.
Neurobo Pharmaceuticals Inc., of Cambridge, Mass., reported top-line phase Ia study results of its obesity drug candidate, DA-1726, Sept. 30, causing the company’s shares to lose 11.7% of their value over two days.
Cereno Scientific AB’s positive top-line results from the phase IIa trial of histone deacetylase inhibitor CS1 in pulmonary arterial hypertension provide a “clear path forward” in the debilitating, fatal disease, the company said.
The Pi-Cardia Ltd. Shortcut — the catheter-based, leaflet modification solution for treating heart valves — received U.S. FDA clearance. The device was granted breakthrough device designation from the regulatory agency and is designed to split bioprosthetic aortic valve leaflets in patients undergoing valve-in-valve transcatheter aortic valve replacement (TAVR) procedures who are at risk of coronary obstruction.
Repair Biotechnologies Inc. and Genevant Sciences Corp. have entered into a collaboration and nonexclusive license agreement to combine Repair’s Cholesterol Degrading Platform (CDP) mRNA technology with Genevant’s proprietary lipid nanoparticle (LNP) technology in the development of a potential novel treatment for atherosclerosis.
Route 92 Medical Inc. sped past its series F goal, raising an additional $50 million in an extension to the oversubscribed round. The extension brings the total for the series F to $82 million, which the company plans to use to accelerate commercialization of its neurovascular reperfusion and access systems.
Researchers from UCLA’s Department of Cardiac Surgery filed for protection of a smart multistage peripherally inserted cannula with active fixation for temporary cardiopulmonary support which simultaneously drains both sides of the heart.
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