Latest from Eliza Slawther
Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.
The UK will require all antibiotic manufacturers looking to apply for funding under its subscription payment model to demonstrate they are meeting waste discharge standards in a bid to reduce antimicrobial resistance.
Pharmaceutical companies should only use AI in evidence generation and reporting where there is “demonstrable value from doing so,” according to England’s health technology assessment body, NICE.
It is “absolutely fundamental” that manufacturers of cell and gene therapies interact with inspectors from regulatory agencies to understand their expectations around good manufacturing practice, a compliance consultant at CDMO eXmoor pharma says.
Brexit has been cited as a cause of the UK’s 2020 decline in clinical trials, but research suggests that other global trends including the pandemic also had a large impact. Meanwhile, the MHRA’s efforts to incentivize sponsors could boost trial figures “substantially,” an expert says.
Regulators can help companies to determine which biomarker is right for their development program before starting clinical trials, boosting the chances of success, Ipsen’s head of early development says.