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  • Government Expands licensing Rules to Cover Cell & Gene Therapies, Stem Cell Products and Xenografts

    In a significant move to strengthen the regulation of advanced biological therapies in India, the Ministry of Health and Family Welfare has notified the Drugs (Eighth Amendment) Rules, 2026, expanding the scope of the Central Licence Approving Authority (CLAA) under the Drugs Rules, 1945. Through this amendment, Cell or Stem Cell Derived Products, Gene Therapeutic Products, and Xenografts have been formally included alongside Recombinant DNA (r-DNA) derived drugs within the CLAA licensing framework.

  • Mankind Pharma Partners with Denovo Sciences to Accelerate AI-Driven Drug Discovery and Innovation

    Mankind Pharma has announced a strategic collaboration with Denovo Sciences to strengthen its drug discovery capabilities through artificial intelligence (AI), marking a significant step toward technology-enabled pharmaceutical research. The partnership aims to accelerate the identification of promising drug candidates while reducing the time and cost associated with early-stage drug development.

  • Lonza to Expand HPAPI Manufacturing Capacity in Switzerland to Meet Rising ADC Demand

    Global contract development and manufacturing organization (CDMO) Lonza has announced a major expansion of its highly potent active pharmaceutical ingredient (HPAPI) and payload-linker manufacturing capabilities at its Visp, Switzerland facility. The investment aims to strengthen the company's integrated support for the rapidly growing antibody-drug conjugate (ADC) market.

  • 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.
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