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- PMLiVE

Kadcyla

- 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

Roche gains speedy review for Tecentriq in first-line breast cancer

Set to become the first immunotherapy for triple negative breast cancer

Roche Basel Switzerland

Roche preps new Kadcyla filings after phase 3 trial win

Says the drug significantly reduced IDFS in women with residual disease

- PMLiVE

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?

Eli Lilly HQ

Lilly gets EMA nod for Verzenio in breast cancer

And puts pressure on Pfizer’s market leading Ibrance and Novartis’ Kisqali

- PMLiVE

Daiichi-Sankyo takes rival to Roche’s Kadcyla into phase 3

Contender could offer potency without dose-limiting toxicities

- PMLiVE

New chair for Europe’s key medicines committee

Appointment comes amid Brexit-induced disruption and new era in medicines

Sanofi reception

Sanofi gets EU OK for Ablynx flagship drug Cablivi

EMA clears the drug to treat adults with aTTP

- PMLiVE

Novartis considers filings for PI3K drug in breast cancer

Those treated with alpelisib had longer PFS than those on fulvestrant alone

The European Medicines Agency: PRIME’d for access?

Leela Barham examines the impact of the EMA's PRIME fast track system after two years

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