Metabolic Disorders

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.

Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.

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 International Trade Commission looks set to ban the importation of Ascletis's THRβ agonist into the US for use in clinical trials due to an initial legal determination on potential infringement of trade secrets related to Viking's same-class candidate VK2809.

NHS England says it is proposing a “realistic but challenging uptake trajectory” that will make “this clinically and cost-effective drug” available to as many patients as possible without overwhelming health care providers.

CEO Chris Cargill talks to Scrip about Sosei Heptares’ new identity as Nxera, the ups and downs of being big pharma’s go-to small-molecule drug hunter and its move into commercialization in Japan.

The Swiss group’s head of cardiovascular, renal and metabolism aims to speed its incretins to market, and tackle the plateauing of weight loss and muscle wastage through combinations.    

A new contender emerges in obesity with pipeline assets from Jiangsu Hengrui, including a Phase III dual agonist, and an experienced team already focused on commercial hurdles.

Sharon Barr, AstraZeneca’s executive vice president, biopharmaceuticals R&D, in an interview with Scrip, outlines how the company is using a holistic approach to define a new competitive landscape in the weight loss sector. She also sees new frontiers for the firm and its potential partners both in China and beyond to jointly explore aimed at maintaining healthy muscle mass while decreasing body fat.

At an investor meeting in London, the Swiss company sets out plans for more disciplined decision-making to help it launch a new wave of blockbuster drugs.