InnoSkel Targets Rapid UK Patient Access For Gene Therapy
INS-101 Is Intended For Rare Bone Disorder
The number of “innovation passports” handed out by the UK Medicines and Healthcare products Regulatory Agency is growing as more companies seek to take advantage of the tools and flexibilities available under the ILAP. InnoSkel is one such company.
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UK Regulator Issues 41 ‘Innovation Passports’ In First Year Of New Pathway
The UK’s ILAP, a post-Brexit scheme introduced in 2021 to accelerate the development of, and access to, new innovative medicines, proved popular in its first year of operation. A total of 71 applications were received last year from companies wanting to take advantage of the regulatory advice, tools and flexibilities on offer.
The Story So Far: The UK’s New Licensing And Access Pathway
As the UK’s new pathway for innovative drugs approaches the end of its first year of operation, representatives of the national regulatory agency and England’s HTA body assess progress so far, including the greater role assigned to patients in the system.
Rare Disease Body Wants EU Legislative Overhaul To Address Orphan Definitions & Incentives
Eurordis has welcomed some parts of the leaked proposals for overhauling the EU medicines legislation, but it has a number of concerns, including the future role of patient representatives if the European Medicines Agency’s committee structure is slimmed down as planned.