After passing on one skinny label case a few years ago, the U.S. Supreme Court agreed to delve into the dark hole the Federal Circuit has dug for drug label carveouts that allow generic drugs and biosimilars to come to market even though some indications of the reference drug may still be protected by exclusivities or patents. The high court granted cert Jan. 16 to Hikma Pharmaceuticals v. Amarin Pharma Inc., which revolves around Hikma’s marketing of its generic version of Amarin’s blockbuster drug, Vascepa (icosapent ethyl).
Brain-derived tau, a protein that is exclusive to the brain and detectable in the blood, could serve as an indicator of brain damage after an ischemic stroke. The analysis of this special form of tau has revealed a relationship between high levels of the protein and extensive brain injury, a higher risk of complications, and poorer outcomes.
The Centers for Medicare & Medicaid Services has cracked open its coverage policy for transcatheter aortic valve replacement devices a second time, and a wide range of stakeholders are providing feedback. Where the agency will land on questions such as the need for continued evidence development is difficult to predict, however, given that the agency is hearing anything but unanimity on the question.
Once it was considered to be more or less a passive energy-storing device that could double as a cushion. But increasingly, fat is conceptualized as an endocrine organ as much as a tissue type. Now, separate research groups have reported new insights into the functional roles of different fats based on their anatomical location and functional characteristics.
Boston Scientific Corp. looked ready to keep steamrolling down the acquisition path, carrying the momentum from last year, with the news that it is acquiring Penumbra Inc., a company that makes devices for interventional therapies to treat vascular conditions such as stroke and aneurysm, for a whopping $14.5 billion.
Lexeo Therapeutics Inc.’s phase I/II data – characterized by Oppenheimer analyst Leland Gershell as “heroic” – this week with gene therapy LX-2020 in PKP2-associated arrhythmogenic cardiomyopathy pushed the New York-based firm’s shares (NASDAQ:LXEO) down 35% to a low of $6.90 Jan. 12, following a $10.54 close the previous trading day.
Boston Scientific Corp.'s Farapoint, its latest pulsed field ablation catheter, received U.S. FDA approval for use as an adjunctive device when treating persistent atrial fibrillation that requires cavotricuspid isthmus ablation, CEO Mike Mahoney reported at the J.P. Morgan Healthcare Conference in San Francisco. The newest member of the popular Farapulse family of PFA catheters provides a focal point option for creation of straight line or focal lesions, complementing the larger, single-shot Farawave catheter that has dominated the PFA market since its U.S. approval in early 2024.
Affluent Medical SAS is becoming Carvolix after it entered into binding agreements to acquire Caranx Medical SAS for €16.6 million (US$19.34 million) and Artedrone SAS for €11.4 million. The aim is to create an integrated med tech company which will focus on revolutionizing cardiac valve replacement and stroke treatment through AI-driven autonomous mini-robots and innovative implants.
Edwards Lifesciences Corp. said it is scrapping plans to acquire Jenavalve Technology Inc. for $945 million after a federal court ruled against the company in a case brought by the U.S. Federal Trade Commission (FTC) to block the deal.
Jiangsu Deyuan Pharmaceutical Co. Ltd. has described cytochrome P450 11B2, mitochondrial (CYP11B2; aldosterone synthase; ALDOS) inhibitors reported to be useful for the treatment of hypertension.
RSS
