Pharma News

Researchers from Ruhr University Bochum, Germany, have uncovered new evidence showing that the hepatitis E virus (HEV) begins evolving much earlier during infection than previously understood. The findings, published in the journal mBio, reveal that although the virus exhibits relatively low genetic diversity during the acute phase, it rapidly acquires specific recurring mutations within just a few weeks of infection. The discovery offers new insights into how HEV adapts inside the human body and could help guide future antiviral research.

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.

In a significant move to strengthen the regulation of certain medicinal products, the Ministry of Health and Family Welfare has notified the Drugs (Tenth Amendment) Rules, 2026, bringing specific high-alcohol oral formulations under the stricter provisions of Schedule H1 of the Drugs Rules, 1945.

Danish pharmaceutical giant Novo Nordisk has launched Awiqli (insulin icodec) in India, introducing the world's first once-weekly basal insulin for adults with Type 1 and Type 2 diabetes. The launch marks a major advancement in diabetes care by reducing the number of insulin injections from 365 per year to just 52, potentially improving treatment adherence among millions of patients.

The U.S. Food and Drug Administration (FDA) has proposed a major overhaul of its drug establishment registration and drug listing regulations, aiming to modernize oversight of pharmaceutical manufacturing and improve visibility across global supply chains. If finalized, the rule would introduce a new regulatory framework for distributed manufacturing and expand registration requirements for certain foreign drug manufacturing establishments that currently fall outside existing regulations.

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.

The U.S. Food and Drug Administration (FDA) has issued a Letter to Lundbeck Seattle Biopharmaceuticals, alleging that promotional materials for its migraine treatment Vyepti (eptinezumab-jjmr) contained false or misleading claims that overstated the drug's benefits.