India has brought AI-based diagnostic software under medical device regulations, mandating government licences and clinical validation. The move subjects AI tools to safety standards similar to medical equipment and is expected to impact health-tech start-ups using AI in clinical care.
Hyderabad: Pharma player Hetero announced that its biologics arm ‘Hetero Biopharma’ has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture Sputnik Light. Hetero is the first biopharmaceutical company in India to receive manufacturing and marketing (M&M) approval for the product manufactured locally for the prevention of COVID-19 in adults aged over […]
Hyderabad: Bharat Biotech International Limited (BBIL), on Thursday announced that BBV152 (Covaxin), its whole-virion inactivated COVID-19 vaccine candidate, has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study. Bharat Biotech had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children […]
Hyderabad: The shelf life of Hyderabad-based Bharat Biotech’s Covid-19 vaccine, Covaxin, has been extended to 12 months from the present nine months by the Central Drugs Standard Control Organisation (CDSCO). “The CDSCO has approved the extension of shelf life of Covaxin up to 12 months, from the date of manufacture. This approval of shelf life […]
The American pharma J&J said in a statement that it had submitted its application on Tuesday, and that it is "imperative" to ensure all sections of the population, including children, are vaccinated against the coronavirus as quickly as possible to stop the virus.
Ortho’s latest Covid-19 can run up to 130 tests per hour and immediately help hospitals and reference labs address testing backlogs, supply shortages, and delayed results
