Draft tracks ICH document, which touts the ‘efficiency, agility, and flexibility’ of continuous manufacturing while acknowledging the challenges around the developing practice, ‘particularly for products intended for commercialization internationally.’

Private Company Edition: The industry raised $28bn in venture capital through the third quarter, breaking the record $27.4bn raised last year. Also, big pharmas backed a start-up lab in Israel, plus mega-rounds for CinCor Pharma ($143m) and Rectify Pharmaceuticals ($100m), while Cerecin raises $40m.

Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium and Oxford BioMedica aim to get their CFTR gene therapy into the clinic soon, confident it could offer a long-lasting option for patients with cystic fibrosis.

Amgen’s former chief information officer Diana McKenzie highlights the inroads made by technology firms in health care and how life science companies can adapt from them while leveraging core capabilities at scale.