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Protelos

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Lilly to withdraw Lartruvo, a first for accelerated approval failures

Existing patients can use access programme

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AVEO warns EU approval of Fotivda could be at risk

Concerns arose with overall survival data

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Amgen, Servier heart failure drug clears trial hurdle

Drug could be a blockbuster - if it hits key endpoints

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EMA could follow FDA’s Xeljanz blood clot warning

European agency in step with FDA after safety doubts

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Amgen, Servier start second phase 3 trial of heart failure hope

Treatment is one of few in underserved area

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Big opportunities in big data, but EMA and industry just getting started

250m genomes sequenced, but data trapped in silos

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European Medicines Agency departs London ahead of Brexit

Regulator moving to Amsterdam, as Novartis adds voice to no-deal warnings

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EMA says Lilly’s Lartruvo should not be prescribed

First time EMA has acted on accelerated approval follow-up

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EMA sees approval numbers rise in 2018

Agency faces Brexit test in 2019

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Novartis withdraws EU filing for canakinumab

Further setback for cardiovascular blockbuster potential

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CHMP delays decision on Kiadis’ GVHD immunotherapy

Medicines regulator issues out Day 180 List of Outstanding Issues

- PMLiVE

Stakeholder dialogue in Europe’s adaptive pathways pilot

Is enhanced dialogue with wide stakeholder groups crucial to being able to respond to an unmet medical need?

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