uniQure has become the third company to get accepted on the European Medicines Agency’s PRIME (priority medicines) scheme for a gene therapy for hemophilia, making hematology-hemostaseology the most common therapeutic areas for products on the scheme.
Blood disorders have overtaken cancer as most common therapeutic area being targeted by drugs on the European Medicines Agency's PRIME scheme for the priority review of medicines for unmet medical need.
A gene therapy that uniQure is developing for severe hemophilia B has become the latest product to make it on...
EU trilogs on the new pharmaceutical legislation will finalize the role patients will take in influencing the development of a new definition of unmet medical need.
Revision of the EU’s pharmaceutical legislation will include a new definition of unmet need, but getting it wrong could have unintended consequences for pricing and reimbursement.
European regulators could investigate alternative ways of offering early advice to companies in relation to the Health Technology Assessment Regulation, given that official scientific advice slots are limited, a senior figure at EUCOPE says.
While drug regulators are “conservative” by nature, the European Medicines Agency wants to help companies rather than rip their dossiers “into little pieces,” a senior regulatory assessor says.
Claims for the dermatological appearing on websites and social media were challenged by Dupixent marketer Sanofi. Galderma said it would comply with the National Advertising Division’s recommendations, a move that underscores the challenging times for DTC advertisers.
India rolls out amended R&D financial assistance plan targeting certain ‘priority areas’ and calls for proposals from industry and startups. While the corpus is modest, the scheme hopes to enable the ‘Innovate in India’ ecosystem and includes a co-funding provision.
Revision of the EU’s pharmaceutical legislation will include a new definition of unmet need, but getting it wrong could have unintended consequences for pricing and reimbursement.
