Metabolic Disorders

The complex landscape of clinical trials, fraught with pressures and risks, and exacerbated by the adoption of new technologies, regulatory burdens, and drug pricing negotiations, is rebounding with aplomb.

The financial macroenvironment may be looking more favorable for 2025 but will pharma growth be muted by elements beyond its control? In Vivo discusses the headwinds and drivers for pharma in the coming 12 months.

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.

After emerging with $290m in April and announcing Phase I data for its lead asset in September, Metsera raised another $215m to fund clinical trials for three obesity drug candidates.

The Denmark-based major intends to build on its heritage in diabetes and is keen to hear from innovators in a space where prevalence is on the rise but is not being served by improved new products.

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.

Amgen’s product sales grew 24% to $8.15bn in Q3 and its gains are being reinvested in R&D and manufacturing, including for MariTide, which will report Phase II obesity data in late 2024.

Since taking on the CEO role at Theratechnologies in 2020, Paul Lévesque has made it his priority to beef up the company’s commercial portfolio and look for partnerships on potentially high-value programs. Now, the Canadian biotech is turning a profit for the first time in many years.

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.