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- PMLiVE

LHON

- PMLiVE

Brexit “having impact on EU drug development”

EMA and UK regulator both affected

- PMLiVE

CHMP nod for Alexion, GSK drugs, revocation for Lartruvo

Opioid dependence therapy and Pfizer's PARP inhibitor also recommended

- PMLiVE

Lilly to withdraw Lartruvo, a first for accelerated approval failures

Existing patients can use access programme

- PMLiVE

AVEO warns EU approval of Fotivda could be at risk

Concerns arose with overall survival data

- PMLiVE

CHMP recommends new Keytruda dosing schedule

Will apply to eight indications across five tumour types

- PMLiVE

EMA could follow FDA’s Xeljanz blood clot warning

European agency in step with FDA after safety doubts

- PMLiVE

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

250m genomes sequenced, but data trapped in silos

- PMLiVE

European Medicines Agency departs London ahead of Brexit

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

- PMLiVE

EMA says Lilly’s Lartruvo should not be prescribed

First time EMA has acted on accelerated approval follow-up

- PMLiVE

EMA sees approval numbers rise in 2018

Agency faces Brexit test in 2019

- PMLiVE

Novartis withdraws EU filing for canakinumab

Further setback for cardiovascular blockbuster potential

- PMLiVE

CHMP backs Sanofi’s all-oral sleeping sickness drug

Sanofi's drug and others given green light by EMA committee

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