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India saw a raft of vaccine and drug approvals in 2021, backed by pandemic-related accelerated regulatory processes, and outlined its intent to step up biopharma innovation in the country. Pharma wants some of the regulatory flexibility to stay, though experts are seeking increased transparency in the overall approach.
The vaccines segment continues to draw the interest of participants beyond those firms with a traditional core presence, with new players largely building partnered capabilities around COVID-19 inoculations. Are these merely opportunistic forays or will the competitive landscape for vaccines stand altered more widely?
Merck and Lilly tackle some early challenges before striking voluntary licensing deals for COVID-19 therapies with Indian firms. Data around the use of these drugs in low- and middle-income countries could also potentially make them ‘more acceptable’ elsewhere, experts say.
India authorizes molnupiravir for restricted emergency use in COVID-19, marking the arrival of around a dozen “affordable” generics of Merck & Co. and Ridgeback Biotherapeutics' oral antiviral. Physicians say data are “pretty compelling” notwithstanding the narrow FDA nod.