Cardiovascular

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.

Country Life Vitamins launches healthy aging support line as it announces less than half of US consumers in a recent survey were aware of biological processes that affect aging. Groupe Berken and Arctic Biosciences partner to bring to North America herring caviar oil extract in a supplement designed to support optimal health across all life stages.

The Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.

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.

The $100m upfront deal help AZ to fill out its cardiovascular, renal and metabolism portfolio, now joining Lilly in seeking to develop an oral Lp(a)-targeting therapy.