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  • Study Paves the Way for an Active Agent Against Hepatitis E

    At present, there is no specific active substance against hepatitis E. As the disease kills 70,000 people every year, researchers are actively searching for one. The team from the Department of Molecular and Medical Virology at Ruhr University Bochum, Germany, may have found what they’re looking for.
  • Lupin Achieves Significant Milestone with ISO 14001 and ISO 45001 Certification Across All its Indian Manufacturing Sites, R&D Center and Corporate Office

    Global pharma major Lupin Limited announced that all 12 of its manufacturing sites, its R&D Center and corporate office in India have successfully completed rigorous audits and been certified by DNV for ISO 14001 Environment Management Systems (EMS), and ISO 45001 Occupational Health and Safety Management System (OHSMS). This achievement marks a significant milestone in acknowledging Lupin’s commitment to safe and sustainable operations.

  • WHO prequalifies new dengue vaccine
    WHO recommends the use of TAK-003 in children aged 6–16 years in settings with high dengue burden and transmission intensity. The vaccine should be administered in a 2-dose schedule with a 3-month interval between doses.
  • Merck Provides Update on Phase 3 KeyVibe-010 Trial Evaluating

    Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial. The trial is evaluating the investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, compared to KEYTRUDA alone, as adjuvant treatment for patients with resected high-risk melanoma (Stage IIB-IV). 

  • Plant Virus Treatment Shows Promise in Fighting Metastatic Cancers in Mice

    An experimental treatment made from a plant virus is effective at protecting against a broad range of metastatic cancers in mice, shows a new study from the University of California San Diego.

  • New Molecule Mimics the Anti-Clotting Action of Blood-Sucking Organisms

    Nature gave ticks, mosquitos and leaches a quick-acting way to keep blood from clotting while they extract their meal from a host.

    Now the key to that method has been harnessed by a team of Duke researchers as a potential anti-clotting agent that could be used as an alternative to heparin during angioplasty, dialysis care, surgeries and other procedures.

  • Zydus receives final approval from USFDA for Dapsone Gel, 7.5%

    Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as Zydus) has received final approval from the United States Food and Drug Administration (USFDA) to market Dapsone Gel, 7.5%, (USRLD : Aczone® Gel 7.5%). 

    Dapsone Gel is used to treat acne and will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad (India). 

    Dapsone Gel, 7.5% had annual sales of USD 35.8 mn in the United States (IQVIA MAT March 24).

  • FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer
    Patients were randomized (1:1) to receive either tisotumab vedotin 2 mg/kg intravenously every 3 weeks or investigator’s choice of chemotherapy consisting of topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed, until unacceptable toxicity or disease progression.
  • Alembic Pharma received EIR for its Oncology Facility

    Alembic Pharmaceuticals Limited received an Establishment Inspection Report (EIR) for its Oncology (Injectable and Oral Solid) Formulation Facility at Panelav.

    On 8th March, 2024, US FDA Inspection at Alembic Pharmaceuticals Limited’s Oncology (Injectable and Oral Solid) Formulation Facility at Panelav.

  • Gland Pharma receives approval for Edaravone Injection

    Gland Pharma Limited, a generic injectable-focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for Edaravone Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL), Single-Dose Bags. 

    The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Radicava Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL) of Mitsubishi Tanabe Pharma Corporation. 

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