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  • Glenmark Expands Phase 3 Study of Trastuzumab Rezetecan

    Glenmark Specialty S.A, a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark) announced the advancement of its multi-country Phase 3 clinical trial for Trastuzumab rezetecan (SHR-A1811), a HER2-targeted antibody drug conjugate (ADC), for patients with platinum-resistant ovarian cancer (PROC).

  • Scientists Transform Human Cells into Living Biocomputers, Opening New Path for Precision Cancer Therapy
    Researchers at the Hebrew University of Jerusalem have developed an innovative genetic programming system that enables human cells to process information and make autonomous decisions, functioning much like miniature biological computers.
  • AbbVie’s Chemotherapy-Free Lymphoma Regimen Achieves Major Phase 3 Success, Significantly Delaying Disease Progression
    AbbVie has announced positive topline results from the Phase 3 EPCORE DLBCL-4 clinical trial, demonstrating that a chemotherapy-free combination of epcoritamab and lenalidomide significantly improved progression-free survival (PFS) in adults with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) compared with the current standard-of-care regimen.
  • FDA Approves Tregzi, First Regulatory T-Cell Therapy to Reduce Chronic GVHD After Stem Cell Transplant

    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).

  • Zymeworks to Acquire Theravance Biopharma in 929 Million USD Deal, Expanding Into Respiratory Care

    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 Opens AI-Powered Global Capability Centre in Bengaluru

    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.

  • CDSCO Restricts Supply of IVF Media and Reagents to Registered ART Centres Only
    The Central Drugs Standard Control Organization (CDSCO) has issued a public interest circular directing all stakeholders to ensure that In-Vitro Fertilization (IVF) media, reagents, and related consumables are supplied only to centres registered under the Assisted Reproductive Technology (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021.
  • CDSCO Clarifies Approval Pathway for Formulation Intermediates, Modified Release Granules and Pellets

    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.

  • EU Approves AstraZeneca’s Enhertu as First Tumour-Agnostic HER2-Targeted ADC for Advanced Solid Tumours

    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.

  • Sandoz Moves Closer to Generic Tirzepatide Launch as US FDA Accepts ANDA Applications

    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.

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