Industry News

In a landmark development for dengue prevention, the Drug Controller General of India (DCGI) has granted market authorization to Takeda Biopharmaceuticals India's QDENGA (Dengue Tetravalent Vaccine [Live, Attenuated]), making it the first dengue vaccine approved in India. The vaccine is approved for the prevention of dengue in individuals 4 to 60 years of age and can be administered regardless of prior dengue infection, eliminating the need for pre-vaccination screening.

Novo Nordisk has announced that the European Commission (EC) has approved Wegovy® (semaglutide) tablets for chronic weight management, making it the first oral GLP-1 receptor agonist authorized in the European Union for the treatment of obesity and overweight. The approval also includes a single, ready-to-use 7.2 mg Wegovy injection pen, providing healthcare professionals and patients with additional treatment options.

Sanofi has filed a patent infringement lawsuit against Moderna in the U.S. District Court for the District of New Jersey, alleging that Moderna's mRNA vaccine technologies infringe a portfolio of patents originally developed by Translate Bio, a biotechnology company acquired by Sanofi in 2021. The complaint names Translate Bio, Translate Bio MA, Sanofi Vaccines US, and VaxServe as plaintiffs, while Moderna, ModernaTX, and Moderna US are listed as defendants.

Emcure Pharmaceuticals Limited has announced a major strategic restructuring of its biopharmaceutical business by acquiring the remaining 12.05% minority stake in Gennova Biopharmaceuticals Limited, making it a wholly owned subsidiary. The company also announced a leadership transition, appointing Samit Mehta to lead Gennova as it sharpens its focus on biologics, biosimilars, and next-generation therapeutic platforms.

Evonik, one of the world's leading specialty chemicals companies, is making a significant investment to strengthen manufacturing capabilities at its Tippecanoe Labs site in Lafayette, Indiana. The site is home to one of the world's largest facilities for the production of active pharmaceutical ingredients (APIs), the industry's biggest high-potency API operation, and a major employer in the Greater Lafayette region.

The Subject Expert Committee (SEC) on Oncology has declined Roche Products (India) Private Limited's request for a waiver of local Phase III and Phase IV clinical trials for Glofitamab and has instead recommended that the company conduct Phase III clinical trials in India before the drug can be considered for marketing approval.

AstraZeneca and its partner Ionis Pharmaceuticals have announced that the Phase III CARDIO-TTRansform trial evaluating Wainua (eplontersen) for adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) did not meet its primary efficacy endpoint, marking a significant setback for the investigational indication.