The US drug regulator has stepped up its inspection activity in India, and plans to have more surprise or ‘short notice’ inspections, ending the two-year reprieve from ‘warning letters’ and other regulatory measures that Indian drug makers have enjoyed since…
Could cancer be diagnosed from the sound of a voice?
A $14 million research project is getting underway in the US to see whether cancer and other diseases can be diagnosed by picking up subtle changes in a person’s voice patterns. The National Institutes of Health (NIH)-funded project is being…
CHMP says yes to Sanofi/AstraZeneca antibody for RSV prevention
Sanofi and AstraZeneca are closing in on EU approval of nirsevimab, their long-acting antibody for the protection of newborns and infants from respiratory syncytial virus (RSV) infections. The EMA’s human medicines committee – the CHMP – has recommended approval of…
ObvioHealth launches new decentralised clinical trial platform
ObvioGo incorporates real-world data, AI, digital instruments, and integration with clinical systems through APIs and interfaces. ObvioHealth has introduced a next-generation decentralised clinical trial (DCT) platform and mobile application called ‘ObvioGo’ to provide robust therapeutic efficacy and safety evidence. The…
