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    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Catalent acquires cell and gene therapy-focused MaSTherCell for $315m

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    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma's VP3 Nasal Spray System

    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma’s VP3 Nasal Spray System

    Cryoport and Cell Matters Enter into Strategic Partnership

    Cryoport and Cell Matters Enter into Strategic Partnership

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19

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Merck Provides Update on European Medicines Agency Marketing Authorization Application for Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir

Yuvraj_pawp by Yuvraj_pawp
22nd December 2015
in Facilities & Operation

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has responded to the company’s marketing authorization application (MAA) for elbasvir/grazoprevir (50mg/100mg), which is under review for the treatment of adult patients with chronic hepatitis C (HCV) infection. The CHMP advised Merck that the application will now be reviewed on a standard timetable, rather than the accelerated assessment timeline previously announced. Under the revised timeline, Merck anticipates a European Commission decision in mid-2016.

“We are excited about the potential of elbasvir/grazoprevir and look forward to continuing our discussions with the European Medicines Agency to bring this important medicine to appropriate patients with chronic hepatitis C in the European Union,” said Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories.

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