Pharma News

The U.S. Food and Drug Administration (FDA) has approved Tregzi, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult patients with blood cancers undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Canadian biotechnology company Zymeworks Inc. has signed a definitive agreement to acquire Theravance Biopharma in an all-cash transaction valued at approximately 929 millionUSD , marking a major strategic expansion beyond oncology into respiratory medicine.

Under the terms of the agreement, Theravance shareholders will receive 17.00 USD per share in cash. In addition, they will receive a Contingent Value Right (CVR) that entitles them to 80% of the net proceeds from any future licensing, divestiture, or monetization of ampreloxetine over the next ten years.

Merck has inaugurated its new Merck Global Capability Centre (MGCC) in Bengaluru, marking a significant expansion of its global digital and technology operations in India. The new facility, located in Electronic City, is designed to accelerate the company's digital transformation while strengthening India's position as a strategic innovation hub.

The Central Drugs Standard Control Organization (CDSCO) has issued a major clarification regarding the regulatory approval process for formulation intermediates, including directly compressible granules, taste-masked granules, modified-release granules, pellets, and similar intermediates used in pharmaceutical manufacturing. The clarification aims to establish uniform licensing practices across India and eliminate confusion among manufacturers.

AstraZeneca and Daiichi Sankyo have achieved a significant regulatory milestone after the European Commission approved Enhertu (trastuzumab deruxtecan) for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have no satisfactory treatment options.

US Food and Drug Administration (US FDA) has accepted two Abbreviated New Drug Applications (ANDAs) of Sandoz for review, marking an important milestone in the company's efforts to introduce generic versions of tirzepatide in the United States.

The applications cover generic tirzepatide autoinjectors developed entirely through Sandoz's in-house research and development program. If approved, the products could become among the first generic alternatives to Mounjaro® and Zepbound®, expanding access to one of the fastest-growing classes of medicines used for diabetes and obesity.