Latest News

EMA keeps approval speedway open

© Pixabay (CC0)


After a two-year pilot period, the EMA has published its report on its adaptive pathways approach. The agency plans to “explore the concept further” and will continue to accept proposals.

The European Medicines Agency (EMA) has published a final report on the experiences with its new accelerated route to approval for innovative drugs, the adaptive pathways. 

“The pilot project, which has now ended, showed that adaptive pathways can bring multiple stakeholders together – regulators, health technology assessment (HTA) bodies, healthcare professionals and patients – to agree on a prospective plan to generate data on a medicine across its lifespan in areas of unmet medical need,” the EMA stated. “Adaptive pathways can support medicine development in therapeutic areas where evidence generation is challenging, such as infectious diseases, Alzheimer’s disease, degenerative diseases, and rare cancers.”

The project phase was launched in 2014. Since then, 62 companies applied with a product to be included. However, only 18 met the EMA’s criteria for inclusion, and no more than six progressed to receive formal parallel advice by EMA and HTA bodies. The adaptive pathways concept is still under development, the EMA pointed out. It has announced a workshop to gather the views from stakeholders, which will take place in December. 

More about adaptive pathways 

© european-biotechnology-news.com/um

BioFIT: innovation and investors

Around 1.500 people came to Lille to participate in the event. BioFIT is hitting a nerve, says Etienne Varvaecke. The general manager of Eurosanté,...

Liquid biopsy: size matters

Usually, tumour DNA in blood is outnumbered by much larger quantities of noncancerous DNA. The novel method developed...

New cheap CRS-blockers at the horizon

In mice, the team headed by Bert Vogelstein and Shibin Zhou from Johns-Hopkins University in Baltimore demonstrated that severe...

Dewpoint Therapeutics kicks off with $60m financing

It’s  always worth to start a company with a potential breakthrough approach in the Boston biotech area. At the end of January, Dewpoint...

Valneva inks $59m JE vaccine supply contract

Under the agreement, Valneva will supply its FDA-approved preventive vaccine for Japanese encephalitis (JE) from 2019 to 2020. There is a minimum...

IMI launches €80m call

The new call of the joint undertaking of the European Commission and the Big Pharma federation EFPIA puts new open access tools for drug development,...

Reprogrammed pancreatic cells cure type I diabetes

Typically, only pancreatic beta, which lack in people with type I diabetes, cells can produce insulin. Pedro Herrera and colleagues investigated...