Latest from Eliza Slawther
More than 90% of companies have submitted new medicines packaging artwork to the UK’s drug regulator, the MHRA. The agency urges the remaining marketing authorization holders of its 31 December deadline to comply with the new Windsor Framework arrangements.
The European Commission’s proposed pharma legislation overhaul could expand the definition of a gene therapy medicinal product, posing challenges both from a regulatory and public perception perspective.
The European Parliament proposed introducing joint procurement for orphan medicinal products in the EU pharma legislation overhaul – a move that the new CEO of EURORDIS says could lead to “faster and more equitable” access to drugs for rare diseases.
Greater transparency around EU health technology assessment processes “can only be a good thing” for innovative rare disease therapies, Virginie Bros-Facer, the new CEO of the EU network of rare disease patient organizations, EURORDIS, tells the Pink Sheet.
While annual fees for marketing authorization applications and annual payments to the European Medicines Agency are set to increase from 2025, micro-sized companies and SMEs that make orphan drugs will still benefit from full reductions.
NICE, England’s health technology assessment institute, says it was unable to reach a price agreement for AstraZeneca/Daiichi Sankyo’s HER2-low breast cancer drug Enhertu, breaking a line of 21 positive recommendations for breast cancer therapies.