Metabolic

Repatha was not an overnight success, but the work Amgen has done to turn its PCSK9 inhibitor into a blockbuster is informing its strategy for Lp(a)-reducing olpasiran and obesity drug MariTide.

Manu Chakravarthy, Roche’s head of the resurrected cardiometabolic division, lays out his four-pillared strategy to place the company in direct competition with Eli Lilly and Novo Nordisk.

Despite the stellar success of the class so far, biotech is now looking past GLP-1s to more tolerable, sustainable approaches to obesity.

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.

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.

US FDA has greenlighted Senseonics’ Eversense 365 continuous glucose monitor. The fully implantable device is replaced once a year, lasting 185 days longer than the Eversense E3 sensor and outstripping competing CGMs, which last only for 10-14 days.

Dexcom announced the launch of Stelo, the first non-prescription continuous glucose monitoring system to hit the US market, but is likely going to face competition soon from Abbott.

During a tour of Truvian’s San Diego headquarters, Medtech Insight spoke with the company’s top executives about their unique three-in-one blood-testing benchtop system, plans for FDA regulatory filing, and marketing strategy.