MSD Licenses Molnupiravir In India
Nuances, Local Data In Focus
MSD India outlines further specifics around the just-announced voluntary licensing deal for molnupiravir with Indian firms, noting an expectation to discuss local data needs with the country’s regulator. All eyes are also on whether non-licensee Natco will stay the course for its application for the investigational antiviral.
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As India sees a consistent rise in daily cases and deaths due to COVID-19, the off-patent industry is stepping up to make drugs affordable and available. Zydus Cadila is seeking approval for virafin, while Natco has applied for molnupiravir approval. Vaccine production and availability has also come under focus.
Natco seeks emergency approval in India for investigational therapy molnupiravir, currently being developed by Merck & Co for the treatment of non-hospitalized COVID-19 patients. The firm has linked its request to compassionate use amid a ferocious surge in COVID-19 cases in India, posing a potentially delicate choice for the regulator.
The new chief of the Indian Society for Clinical Research, Sanish Davis, tells Scrip how the Indian trials segment coped amid pandemic upheaval, emphasizing the need for stakeholder “sensitization and socialization” of the concepts of virtual/hybrid trials as part of efforts to mainstream these. The executive also shared his views on India’s trial waiver clause.