Manufacturing and Production

Enhertu, manufactured by AstraZeneca and Daiichi Sankyo, has been accepted for the treatment of adult patients in the US with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen. The application has also been granted Priority Review.

The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.

Daiichi Sankyo and AstraZeneca have announced that the SMC has accepted Enhertu® for use within NHS Scotland for the treatment of HER2 positive unresectable or metastatic breast cancer. The cancer treatment is approved for adults who have received two or more prior anti-HER2 based therapies, in line with its conditional marketing authorisation.

Almirall and IRB Barcelona (the Institute for Research in Biomedicine) have announced a research collaboration to identify the new oral treatments for immune-inflammatory skin diseases with remaining high unmet medical needs.

The collaboration aims to meet these needs using a novel therapeutic modality, called molecular glue degraders. These could represent an opportunity to expand the scope of druggable targets with small, drug-like molecules, that can reprogram natural cellular mechanisms to selectively remove disease driving proteins from human tissues.

Abbisko Therapeutics announced that it has entered into a partnership and exclusive licensing agreement with Eli Lilly and Company. This collaboration is focused on the further discovery, development, and potential commercialisation of novel molecules against an undisclosed target for cardiometabolic diseases with critical unmet needs.