? Top themes this week: personalised mRNA cancer therapy, recent drug approvals and a drug trial

? Personalised mRNA cancer therapy shown to boost immune response

An investigational, individualised neoantigen therapy, with personalised encoded mRNA, has demonstrated potential to enable patient’s immune system to target cells that cause cancer.

Researchers from the related study highlighted that it has been challenging to develop engineering therapies that give the immune system enough training to identify a patient’s neoantigens.

? Regulating therapies for rare diseases – recent approvals

This article summarises some of the recent notable drug approvals in the EU and US, including an innovative gene therapy for NHS use, treatment options for rare kidney disease and an enzyme replacement therapy.

? HDFN drug trial shows capability for alloimmune diseases

Clinical data indicates that nipocalimab could provide benefit to foetuses, newborns and pregnant mothers at risk for a rare blood disorder.?Findings from the Phase II UNITY study show that the treatment has potential to delay or prevent anaemia and the need for intrauterine blood transfusions in babies who are at high risk for haemolytic disease of the foetus and newborn (HDFN).

Discover more about the trial, the potential of nipocalimab for HDFN and the findings below.

Our latest webinar with West Pharmaceutical Services explores the key considerations in component selection when moving from a vial to a prefilled syringe during biologic drug development.

Discover how collaboration with your packaging supplier early in the drug development process can help the navigation of increased complex regulatory requirements and help reduce time in your packaging development work.