European Union

Pic:gettyismagilov

EU approves first gene therapy for hemophilia B

By Jonathan Smith

Three months after receiving the US green light, CSL’s candidate Hemgenix has become the first gene therapy to gain EU approval for the treatment of hemophilia B.

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EMA pilot to provide regulatory support to selected ATMP developers

By Rachel Arthur

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.

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Nurturing biotech in Europe: EuropaBio sets out recommendations

By Rachel Arthur

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.

UK MHRA announces pre-election quiet period

UK MHRA announces pre-election quiet period

By Staff reporter

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.

Capping the price of reference drugs 'is detrimental' to biosimilars and generics, says the EGA

EGA: let originators charge more in Spain… to boost biosimilars

By Fiona BARRY

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.