The history of Medicare coverage of transcatheter aortic valve replacement (TAVR) devices has not lacked for controversy despite the massive positive impact on outcomes. Ashwin Nathan, of Hospital of the University of Pennsylvania, said a new analysis made clear that the expansion of centers qualified to perform TAVR procedures has been nearly all in high population density areas with an existing TAVR program, thus leaving out the still-forgotten rural patient.
Edwards Lifesciences Corp. reported good news this week, with its third-quarter results exceeding expectations. Sales came in at $1.1 billion, an increase of 4%, and CEO Mike Mussallem highlighted the success of transcatheter aortic valve replacement (TAVR), with the Sapien valve platform performing well. Mussallem noted that TAVR sales were $745 million, up 6%, with Europe showing strength.
HONG KONG – Huya Bioscience International LLC, which has a special interest in China-developed assets, has obtained an exclusive global license, bar China, for the SHP2 inhibitor HBI-2376 from Suzhou-based Genhouse Pharmaceutical Co. Ltd. Financial terms were not disclosed.
Keeping you up to date on recent developments in cardiology, including: Assessing who’s at risk for heart rhythm disorders; Rewiring the heart to prevent recurrent fainting spells; Understanding link between COVID-19, cardiovascular diseases.
A U.S. district court in Nevada ruled in favor of two ANDA filers in Amarin Corp. plc.’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), increasing the possibility of generics crowding Amarin’s U.S. sales.
Novo Nordisk A/S' Ozempic, a once-weekly injectable version of the company's glucagon-like peptide-1 (GLP-1) receptor agonist, semaglutide, first FDA-approved in late 2017, has won the agency' approval for a new indication: reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes (T2D) and known heart disease.
With a label broadened by the FDA in December and two aspiring competitors apparently picked off via late-stage trial blowups, Amarin Corp. plc finds itself in strong position with fish oil therapy Vascepa (icosapent ethyl) – at least pending the outcome of court proceedings that involve challengers to patents for the cardiovascular (CV) drug.
DUBLIN – Novartis AG is making a $9.7 billion bet that the economics of an siRNA-based drug can better those of monoclonal antibodies and thus provide it with a dominant position in a major but still emerging cardiovascular drug market. The Basel, Switzerland-based pharma made an $85 per share offer for The Medicines Co., which has taken inclisiran, an siRNA-based inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9) to the brink of an approval in reducing the risk of a cardiovascular event – heart attack or stroke – in high-risk patients with cardiovascular disease or high levels of low-density lipoprotein cholesterol (LDL-C) who are inadequately controlled on current therapies.
SAN FRANCISCO – As the transcatheter aortic valve replacement (TAVR) field matures, it is becoming increasingly difficult to develop a new implant that can distinguish itself vs. competitors. The incremental benefits are narrowing rapidly, making it tough to distinguish new iterations from one another using standard, randomized trials.
