Pharmafile Logo
T40 2022 Cover
Diversity, Equity and Inclusion
Communiqué 53 Cover Image
- PMLiVE

etesevimab

- PMLiVE

Pfizer gets CHMP backing for leukaemia drug bosutinib

Provides option for patients resistant to tyrosine kinase inhibitors

- PMLiVE

Santhera’s Raxone turned down for rare eye condition

EMA concerned about drug's ability to improve eyesight

- PMLiVE

EMA recommends suspension of Merck’s Tredaptive

Pharma company had already anticipated decision by withdrawing product worldwide

EMA launches eSubmission web tool

Will accept eCTD applications from January 15

- PMLiVE

EMA starts probe into MSD’s Tredaptive

Will investigate cholesterol drug's safety and efficacy after poor phase III results

- PMLiVE

EMA to focus on efficiency, transparency and new legislation in 2013

Regulator also plans significant staff reorganisation

Novartis building

Novartis’ Exjade gets EU approval for thalassaemia

First oral treatment for condition characterised by red blood cell problems and anaemia

- PMLiVE

EMA recommends approval for alcohol dependency drug

Lundbeck’s Selincro to be used in conjunction with psychosocial support

Sanofi reception

Blow for Sanofi as EMA turns down cholesterol drug Kynamro

Points to safety concerns related to liver toxicity and cardiovascular events

- PMLiVE

Roche’s Perjeta backed in EU for breast cancer

CHMP recommends use alongside Herceptin

- PMLiVE

EMA: move to greater clinical trial transparency ‘irreversible’

New Europe data rules could be ready by 2014

- PMLiVE

EMA publishes drug shortages plan

Globalisation of manufacturing among key issues to address

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links