Cardiovascular

Semaglutide 7.2mg bests placebo for weight loss at 72 weeks, but with efficacy lower than seen with Novo Nordisk’s CagriSema or Lilly’s Zepbound.

Will Novartis’ monopoly on Entresto, one of the biggest-selling small molecule drugs in the US, last until its proffered mid-2025 date? An unfavorable decision by the US Court of Appeals for the Federal Circuit that has handed victory to ANDA sponsor MSN Labs could upend the originator’s projection.

The proposal states that Part D plans could define "obesity" for coverage determination, but CMS said overly restrictive criteria would be inconsistent with formulary review requirements and step-therapy would not be allowed.

Much anticipated Phase II results in obesity for Amgen’s GLP-1 agonist/GIP antagonist showed up to 20% weight loss, but without detailed data the drug’s competitiveness is hard to ascertain.

Deal Snapshot: Novo is partnering with Ascendis on less frequently dosed drugs for metabolic diseases, committing up to $285m for a lead program, a once-monthly GLP-1 receptor agonist.

With its two biggest sellers losing exclusivity in 2028, the pressure is on for Bristol Myers Squibb to grow revenue through new products, which made meaningful contributions in Q3.

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

Members of the Cardiovascular and Renal Drugs Advisory Committee repeatedly challenged Stealth’s assertion that a new randomized trial in Barth syndrome was not possible, but also said potential functional unblinding and other challenges could compromise a new study.

Tricuspid valve innovation has taken off since the US FDA’s 2023 authorizations of Edwards' Evoque and Abbott's TriClip systems. Whether to repair or replace tricuspid valves remains an open, nuanced question among cardiologists. Dr. Henrik Treede of University Hospital Mainz and TriCares CEO Ahmed Elmouelhi offer views on the evolving space.

The Cardiovascular and Renal Drugs Advisory Committee voted 10-6 that efficacy had been shown for the ultra-rare disease, but even panelists in the majority questioned whether the product satisfied the threshold requirement for an adequate and well-controlled study.