| |SEPTEMBER 20259NOVO NORDISK GETS NOD FOR RYBELSUS'S BENEFITS IN TYPE 2 DIABETESSUN PHARMA SECURES INTERIM COURT ORDER ON URSOCOLNovo Nordisk's Rybelsus (oral semaglutide) received an updated label from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in a significant regulatory victory, based on evidence of cardiovascular benefit from the SOUL trial.The 387-participant phase 3b SOUL study examined Rybelsus among adults with type 2 diabetes with atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). SOUL found a 14% reduction in major adverse cardiovascular events (i.e., cardiovascular-related death, heart attacks, and stroke) in patients taking Rybelsus when compared with patients taking placebo.Rybelsus is now the first and only oral GLP-1 receptor agonist in the EU approved to support weight reduction when prescribed for patients with type 2 diabetes who also have proven cardiovascular benefit. Rybelsus also already has established clinical and real-world evidence for its efficacy in reducing blood sugar and weight."Heart problems are the leading cause of disability and death for people living with type 2 diabetes. Therefore, treatments that also address heart problems are key to improving not only health outcomes, but also quality of life ­ and this approval will help do just that," said Emil Kongshøj Larsen, executive vice president, International Operations at Novo Nordisk. Novo Nordisk states additional SOUL trial data, specifically regarding hospitalization reductions, will be released later this week at EASD-2025. At the same time, the company has filed applications with the U.S. Regulatory Authority for a cardiovascular indication extension for Rybelsus and for a once-daily 25 mg oral formulation of semaglutide for chronic weight management in adult patients with obesity or overweight and cardiovascular disease. Decisions on the U.S. applications are expected later this year. POThe Bombay High Court has given an interim injunction to Sun Pharma Laboratories Limited, which will stop Rambo Lifesciences Pvt. Ltd. and their associates to use the trademarks URSOCAL and URSOCAL-300 as it is stated that these marks are of the deceptive similarity to Sun Pharma's registered liver drug brand URSOCOL.Sun Pharma filed the suit stating that Rambo Lifesciences has come up with these products and promoted these in such a way that confusion is likely to be caused in the minds of the doctors, chemists, and patients. Indeed, according to the order dated 20 August 2025, Justice Arif S Doctor endorsed the view of Sun Pharma and pointed out that the issue of confusion of pharmaceutical products is very alarming and hence the reaction of the judiciary is necessarily quick.The Court at this instance prohibited Rambo Lifesciences, its promoters, proprietors Dr. Meera Jadhav, directors, partners, affiliates, sister/group companies, employees, distributors, stockists, super-stockists, e-commerce and warehouse aggregators, retailers, franchisees, licensees, importers, exporters, custodians, and all other related entities from trespassing upon Sun Pharma's rights.Previously, on 16 July 2025, the Court gave a wide-ranging powers to the Court Receiver to seize infringing goods, packaging materials, and documents. The order was carried out on 6 August 2025, and the Receiver submitted Report No. 371 of 2025.The Court gave the adjournment, in this case, till 29 August 2025 as the service on Defendant No. 1 was incomplete, and thus, the interim relief in favor of Sun Pharma, which will operate up to the time of the final adjudication, shall be maintained to ensure the protection of the established brand URSOCOL. PO
< Page 8 | Page 10 >