Damage to the left ventricle may be more common than damage to its cousin on the other side, but right heart failure is still a unique syndrome with its own specific needs. Chuck Simonton, the chief medical officer at Abiomed Inc., told BioWorld that both the company and the U.S. FDA are keen to remind cardiologists that early detection and treatment of right heart failure vastly improves outcomes, including a huge reduction in mortality in these desperately ill patients.
The move away from in-clinic testing continues, with another company offering a convenient, at-home sensor that gathers critical health information without requiring any change on the part of the patient, which may provide even more accurate, real-world data on patient health than the tests they replace.
As the Feb. 28, 2023 PDUFA date for the compound nears, Cytokinetics Inc. CEO Robert Blum insisted that his firm is not mulling withdrawal of the marketing application for heart failure drug omecamtiv mecarbil, nor is the company now considering another study, after an unfavorable vote on the drug Dec. 13 by the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee.
Even though Cytokinetics Inc. received applause for testing its heart failure drug, omecamtiv mecarbil, in the second largest global heart disease clinical trial ever, the drug didn’t get a standing ovation from the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Dec. 13.
Severe toxicities associated with immune checkpoint inhibitor (ICI) therapy are a major challenge of this anticancer therapy approach. While myocarditis is a rare immune-related adverse event in patients receiving ICIs, it has a nearly 50% mortality rate and its pathogenesis is poorly understood. In the current study, researchers from Vanderbilt University and affiliated organizations published data from a study that evaluated a novel mouse model recapitulating clinical and pathological features of ICI-associated myocarditis (ICI-MC).
Boston Scientific Corp. offered $523 million in cash for 65% of Acotec Scientific Holdings Ltd., a manufacturer of vascular intervention devices. The acquisition would significantly expand Boston Scientific’s presence in China, which the company expects to account for about 25% of the global med-tech market by the end of the decade. The transaction is expected to close in the first half of 2023, subject to shareholder approval. The offer price of HK$20 or US$2.57 per share represents a premium of more than 31% over its close on Friday, Acotec reported.
What could be Cytokinetics Inc.’s first approved drug will take center stage Dec. 13 at a meeting of the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee. But judging from the FDA’s briefing document for the meeting, the spotlight on the heart failure drug, omecamtiv mecarbil, could be harsh.
Gossamer Bio Inc. shares (NASDAQ:GOSS) fell 74.6% to $2.36 Dec. 6 after the disclosure of phase II results that, while meeting the study's primary endpoint of reducing pulmonary vascular resistance vs. placebo, failed to show the company's pulmonary arterial hypertension (PAH) candidate, seralutinib, holding its own against the performance of Merck & Co. Inc.'s PAH candidate, sotatercept, in separate PAH studies.
The age-old separation of dentistry from medicine is deeply embedded in education and professional practice. Given the great advances in both disciplines in recent decades, there is a reasonable argument to be made for maintaining the divide.
The ability to inexpensively predict events such as stroke and heart attack is something of a holy grail for cardiologists, and a new study presented at this year’s annual meeting of the Radiological Society of North American (RSNA) provides just that capability. A study of an algorithm developed to examine a single chest X-ray suggests that the data generated by the algorithm can be as effective in establishing the patient’s risk of these events as a standard approach that relies on information that isn’t always readily available to the clinician.
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