Pharma News

The U.S. Food and Drug Administration (FDA) has announced a Class I recall, its most serious recall category, for certain Medtronic Harmony™ Delivery Catheter Systems (DCS) used to implant transcatheter pulmonary valves. The recall follows concerns that a manufacturing defect could cause the catheter's distal tip to detach during implantation, potentially leading to serious complications, including emergency surgery or death.

The U.S. Food and Drug Administration (FDA) has approved the first at-home starting dose for an Alzheimer's disease treatment, marking a significant advancement in the management of early Alzheimer's disease. The approval allows eligible patients to begin therapy using a subcutaneous (under-the-skin) injection at home, either by self-administration or with the assistance of a caregiver, reducing the need for hospital or infusion-center visits.

The Indian Pharmacist Association (IPA) has written to the Lieutenant Governor of Delhi seeking a high-level independent inquiry into the functioning of the Delhi Pharmacy Council (DPC). In a letter dated 12 July 2026, the association requested immediate intervention, alleging that administrative shortcomings and prolonged registration delays are adversely affecting pharmacy students and registered pharmacists.

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.