The European Medicines Agency (EMA) will provide up to five selected advanced therapy medicinal products (ATMPs) with enhanced regulatory support - and in the process hopes to learn how to improve the regulatory processes for other ATMP drugs in the future.
EU systems need to become more streamlined to help bring novel technologies to market - which would in turn encourage investment and activity in healthcare biotech, says EuropaBio as it publishes key policy recommendations for the sector.
Irish regulators say it is still not clear how Brexit will affect companies that make drugs in the UK, raising issues like MA status and mutual inspection agreements between the EMA and US FDA as areas of concern.
The European Commission has urged UK Pharma firms to check how Brexit will impact their drugs, pointing out that EU law requires that authorisation holders have a base in a member state or EEA country.
Tory Prime Minister Teresa May’s decision to call a snap general election to stymie political opposition of her stewardship of the UK’s withdrawal from the European Union will see the MHRA limit communication to essential information.
Benepali has become the first biosimilar of Amgen’s Enbrel (etanercept) approved in Europe and marks the first regulatory success for Samsung Bioepis – a joint venture between Samsung Biologics and Biogen.
The European Generic and Biosimilar Medicines Association (EGA) and the Spanish Generic Medicines Association (AESEG) today revealed plans to remove market barriers to biosimilars and small molecule generics and create thousands of jobs.
A new round of €8.4m ($8.9m) in grants will help develop a scalable manufacturing process to wean vaccines off of their cold-chain dependency and help ensure they can be manufactured as stable and temperature independent.