India’s first indigenous CAR T therapy is selling at around $50,000 per shot, nearly one-tenth of the price of top-selling CAR Ts in the U.S., and Immunoact founder and CEO Rahul Purwar told BioWorld he anticipates bringing the price down to as low as $20,000 per shot.
India’s first indigenous CAR T therapy is expected to cost around $50,000, nearly one-tenth of the price of top-selling CAR Ts in the U.S. India President Droupadi Murmu officially launched Immunoadoptive Cell Therapy’s (Immunoact) NexCAR19 (actalycabtagene autoleucel), a CD19-targeted CAR T, and dedicated it to the nation in April 2024.
India’s first indigenous CAR T therapy is expected to cost around $50,000, nearly one-tenth of the price of top-selling CAR Ts in the U.S. India President Droupadi Murmu officially launched Immunoadoptive Cell Therapy’s (Immunoact) NexCAR19 (actalycabtagene autoleucel), a CD19-targeted CAR T, and dedicated it to the nation in April 2024.
Through a series of notifications, India’s drug regulator has classified a new batch of medical devices as well as a range of software used in medical devices according to risk, taking another step to strengthen regulatory oversight and shore up the domestic med-tech sector.
India’s drug regulator has approved 31 fixed-dose combination (FDC) drugs out of more than 300 banned products, after an assessment by its drugs technical advisory board. It has also asked for more phase IV postmarketing data for 19 others.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: U.S. FDA provides updates on power morcellation; FDA seeks nominations for advisory committee; CDSCO suspends import notification requirements.
HONG KONG – Indian authorities have apparently given medical device manufacturers a one-year extension to register for market authorization that was originally to be done by the New Year.
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