Browse by category

Novo Nordisk has submitted a New Drug Application (NDA) to the FDA for once-weekly CagriSema (cagrilintide 2.4 mg and semaglutide 2.4 mg) injection, to be used with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight in the presence of at least one weight-related comorbid condition. CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2

The first patient has been treated in Nitinotes’ US Investigational Device Exemption (IDE) EASE Clinical Trial evaluating the EndoZip Automated Suturing System for endoscopic sleeve gastroplasty (ESG). The procedure was performed at Lenox Hill Hospital | Northwell Health in New York, NY, the trial's first activated US site. The EASE Clinical Trial is a prospective, multi-centre, randomised, two-arm, blinded pivotal study designed to evaluate the safety and effectiveness of th

Transoral outlet reduction (TORe) and anastomotic reduction techniques are gaining momentum as minimally invasive alternatives to surgical revision for managing post-surgical complications such as weight regain and dumping syndrome.(1) BARS® — a novel endoscopic platform developed by Ovesco Endoscopy AG — is among the emerging technologies in this field. As clinical experience with BARS® grows, early data on weight regain management and targeted treatment approaches for enlar

Just a few months after the world’s first gastric mucosal ablation (GMA) case using MOVIVA (Erbe Elektromedizin) at the Policlinico Universitario Agostino Gemelli in Rome, clinical experience is rapidly expanding across Europe. With around 80 procedures performed within a short timeframe in eight countries, MOVIVA is helping to establish a new era of endoscopic bariatric treatment – offering a less invasive option as obesity rates continue to rise worldwide. Gastric mucosal a

Novo Nordisk announced the submission of a sNDA to the FDA for a higher dose of semaglutide injection 7.2 mg, to be used along with a reduced calorie diet and increased physical activity for chronic weight management in adults with obesity. Under the CNPV expedited program, review is expected within 1–2 months following the FDA's acceptance of the filing. The sNDA includes results from STEP UP, a 72-week phase 3, randomised, double-blind, placebo-controlled and active-control

Eli Lilly and Company has announced an agreement with the US government to expand access to its obesity medicines and reduce patient costs. In 2020, Lilly partnered with the Trump Administration on a pilot programme that paved the way for Lilly to be the first company to cap out-of-pocket insulin costs at $35 per month. Lilly will now improve access to nearly 40 million Americans living with obesity on government insurance programmes and millions more who pay out-of-pocket. U

Nitinotes has received CE Mark approval for the EndoZip System, the first fully automated suturing platform for endoscopic sleeve gastroplasty (ESG). The milestone clearance enables the company to begin commercialisation across the European Union and other CE Mark-accepting markets. Nitinotes will launch EndoZip in select European centres of excellence, building clinical adoption and real-world data to support broader market penetration. In parallel, the company is preparing

Novo Nordisk has received FDA approval for Rybelsus for reducing the risk of major adverse cardiovascular events (MACE) such as cardiovascular (CV) death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events, whether they've had a prior CV event or not (primary and secondary prevention). Results of the SOUL trial reinforce the clinical profile of the semaglutide molecule, which has been studied across a variety of therapeutic areas. "Ev

Medtimo, a wholly owned subsidiary of Biorad Medisys Private Limited, has filed a patent infringement complaint in the US District Court of the District of Delaware against Allurion Technologies. Medtimo’s complaint claims Allurion's gastric balloon system infringes upon Medtimo's intellectual property. This definitive action follows Allurion’s recent unsuccessful challenge of Medtimo’s patent rights in the US Patent and Trademark Office (USPTO). The complaint alleges that Al

Pfizer and Metsera have entered into a definitive agreement under which Pfizer will acquire Metsera, a clinical-stage biopharmaceutical...