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CHMP recommends new Keytruda dosing schedule

Will apply to eight indications across five tumour types

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Unruffled by ‘outlier’ claims, Vertex CEO upbeat on Orkambi breakthrough

NHS England going public with price makes deal impossible, says Leiden

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EMA could follow FDA’s Xeljanz blood clot warning

European agency in step with FDA after safety doubts

- PMLiVE

‘Inflexible’ NICE blocking access to rare disease drugs

Spinraza most high profile example of access problem

- PMLiVE

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

- PMLiVE

EMA sees approval numbers rise in 2018

Agency faces Brexit test in 2019

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Afinitor and Uptravi gain funding from NHS England

Rare disease treatments navigate tricky market access route

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Chugai gains FDA breakthrough status for rare CNS treatment

Adds to company's BTD roll-call

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Roche gains EU PRIME status for Spinraza rival

Oral treatment joins Novartis' gene therapy challenger

- PMLiVE

Novartis withdraws EU filing for canakinumab

Further setback for cardiovascular blockbuster potential

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