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

EU marketing authorisation

- PMLiVE

EMA issues new guidance to limit use of JAK inhibitors for chronic inflammatory disorders

The guidance aim to minimise the risk of serious side effects associated with these medicines

- PMLiVE

GSK’s application for its RSV vaccine accepted by EMA under accelerated assessment

The vaccine demonstrated overall efficacy of 82.5% in adults aged 60 years and older

- PMLiVE

AbbVie submits application for lymphoma therapy epcoritamab to EMA

Phase 2 trial showed an overall response rate of 63% and a complete response rate of 39%

- PMLiVE

BeiGene’s Brukinsa receives CHMP recommendation for chronic lymphocytic leukaemia

CLL accounts for around one-quarter of new leukaemia cases

- PMLiVE

EMA accepts Santen’s application for glaucoma treatment STN1013001

The intraocular pressure lowering efficacy was demonstrated in a phase 3 trial

- PMLiVE

EMA accepts Otsuka and Astex’s marketing authorisation application for acute myeloid leukaemia treatment 

The application is supported by results from a phase 3 trial demonstrating an exposure equivalence to the current standard of care for AML

EU flag

EMA accepts Mundipharma’s application for invasive candidiasis treatment rezafungin

Despite currently available treatments, the mortality rate for patients with invasive candidiasis remains high at up to 40%

- PMLiVE

AbbVie submits migraine prevention drug to EMA for marketing authorisation

If approved, atogepant would be the first daily oral CGRP receptor antagonist migraine treatment for adults in Europe

- PMLiVE

EMA grants Bavarian Nordic access to PRIME scheme for RSV vaccine candidate

It is estimated that infections caused by this respiratory virus lead to over 175,000 hospitalisations and 14,0000 deaths in older people in the US each year

- PMLiVE

AstraZeneca’s COVID-19 vaccine receives EMA approval for use as third-dose booster

Vaxzevria is a ‘viral vector’ vaccine, a technology that is also used to create vaccines for other infectious diseases like flu, HIV and Ebola

- PMLiVE

Positive CHMP opinion issued for PTC Therapeutics’ Upstaza

The treatment for AADC will be the first marketed gene therapy to be administered directly into the brain

EU flag

EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine

The vaccine is currently the only inactivated, whole virus adjuvanted candidate in clinical trials in Europe

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links