The UK’s Early Access Scheme: Breakthrough Or Mixed Blessing?
Executive Summary
The UK's Early Access to Medicines Scheme is designed to give patients with high unmet needs access to certain therapies before they are licensed for use, but it presents a number of challenges that will only be addressed in real-world testing. Part one of a two-part series on European programs for improving patient access to new therapies.
You may also be interested in...
Biopharma In 2014: Early Access Gains Offset Taxation, Pricing Woes
The year was marked by record levels of biopharma M&A activity and a strong IPO market. Measures designed to deliver early access to new medicines continued to advance on both sides of the Atlantic, while pricing came in for renewed attention as new, highly effective but extremely expensive products reached the market.
Beyond "Breakthrough": FDA, Industry See Benefits For Drugs Outside Expedited Pathway
Pharmaceutical manufacturers and FDA have enthusiastically embraced the “breakthrough therapy” program as a way to more quickly bring new drugs with substantial effects to patients in need. With two years of program experience now under their belts, agency and industry representatives talk about learnings and best practices that could be applied to the development and review of drugs outside the program.
Firms May Lose Data Exclusivity Earlier Under Planned EU Adaptive Licensing Regime
Adaptive licensing is coming to Europe and, while it will be beneficial to patients, data exclusivity considerations may render it a double-edged sword to the innovative drug industry.