While the Biden administration continues applauding the savings it claims will be delivered by the first round of Medicare negotiations, many U.S. patients and their families are worried about the cost of the biopharma price-setting program – a cost they measure not in dollars and cents, but in worsening illness and lives that may be lost to a downturn in innovation and an upturn in barriers to access.

Johnson & Johnson aims to add a fourth cardiac business to its portfolio in less than two years with the acquisition of V-W aveLtd., which makes the Ventura interatrial shunt system for the treatment of heart failure. J&J will pay $600 million up front and an additional $1.1 billion contingent on meeting specified regulatory and commercial milestones. The deal is slated to close before the end of the year.

Johnson & Johnson (J&J) aims to add a fourth cardiac business to its portfolio in less than two years with the acquisition of V-Wave Ltd., which makes the Ventura interatrial shunt system for the treatment of heart failure. J&J will pay $600 million up front and an additional $1.1 billion contingent on meeting specified regulatory and commercial milestones. The deal is slated to close before the end of the year.

Despite the U.S. FDA’s tentative approval of Liquidia Corp.’s Yutrepia (treprostinil) for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, the company is stuck in the starting gate. Liquidia said it disagrees with the agency’s stance of simultaneously granting regulatory exclusivity in both indications to United Therapeutics Corp.’s powdered formulation of treprostinil, branded Tyvaso, until May 23, 2025. That means full approval for the inhalation powder won’t come until after that date and neither will a Yutrepia launch.

The COVID-19 pandemic drove a large volume of in vitro diagnostic test efforts toward the SARS-CoV-2 virus, such as the Biofire respiratory panel by Biofire Diagnostics LLC, of Salt Lake City, a test for which the U.S. FDA released the special controls.

Privacy legislation was passed and implemented in the European Union, but the picture in the U.S. is pockmarked by state legislation, a scenario that raises concerns about a fractured and impracticable compliance regime.

An implanted deep brain stimulator that calibrates its electrical pulses based on changes in brain activity reduced patients’ most bothersome symptoms of Parkinson’s disease 50%, a small feasibility study published in Nature Medicine found.

Edwards Lifesciences Corp. continued its recent acquisition streak with its buy of JC Medical Inc., a subsidiary of Genesis Medtech International. The sale included the intellectual property and commercial rights for the J-Valve system, a transcatheter aortic valve replacement for the treatment of severe aortic regurgitation.

The year 2024 squeaked through another IPO this week, that of Actuate Therapeutics Inc., which raised $22.4 million becoming the 15th biopharma company to debut on U.S. exchanges this year. Out of 17 companies total, including one listing on the Hong Kong Stock Exchange and another on the SIX Swiss Exchange, the industry has raised a total of $4.8 billion through IPOs.

Label comparisons began promptly with the accelerated U.S. FDA clearance of Gilead Sciences Inc.’s oral peroxisome proliferator-activated receptor (PPAR)-delta drug, Livdelzi (seladelpar), for primary biliary cholangitis (PBC). The space includes Ipsen Pharma SA’s dual PPAR alpha/delta agonist, Iqirvo (elafibranor), licensed from Genfit SA and cleared in June 2024, as well as Ocaliva (obeticholic acid), the first-in-class farnesoid X receptor agonist from Intercept Pharmaceuticals Inc., greenlighted for PBC in May 2016.