Eyestem Research Pvt Ltd announced the completion of its phase one study for its investigational retinal pigment epithelium (RPE) cell therapy, Eyecyte-RPE. The clinical study report of the study has been submitted to the Central Drugs Standard Control Organisation (CDSCO) for permission to start the phase 2 study. The
The Indian medical device industry is set to undergo significant transformation as regulatory authorities introduce a new classification system aimed at simplifying approval processes. This initiative is expected to enhance efficiency, reduce time-to-market for medical devices, and bolster the growth of the healthcare sector. The Central
Gaurav Agarwal, Co-Chair of the Medical Devices Committee at PHDCCI, highlights the balanced approach of India’s Central Drugs Standard Control Organisation (CDSCO) in eliminating clinical trial waivers for in-vitro diagnostics (IVDs). This decision ensures both patient safety and fosters innovation within the healthcare sector. India's
COVAXINÒ is the one of the first COVID-19 vaccines in the world to generate data in 2-18 year age group. Phase II/III, Open-Label, Multi-centre Study was conducted to evaluate the Safety, Reactogenicity, and Immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®) in healthy children
Johnson & Johnson (J&J) on Friday said it has submitted an application to the Indian drug regulator to conduct a study of its Covid-19 vaccine in adolescents aged 12-17 years. The US-based pharmaceutical company noted that it is committed to facilitating global equitable access to
