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

Brexit

- 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

- PMLiVE

MHRA approves Infex Therapeutics’s study for treatment for non-cystic fibrosis patients

The treatment, for Pseudomonas aeruginosa, will address a chronic and debilitating respiratory condition that has no approved available treatments

- PMLiVE

Biogen retracts EMA application for Alzheimer’s drug Aduhelm

The application was pulled after the CHMP said the data provided was not enough to support a marketing authorisation

- PMLiVE

AbbVie’s Crohn’s disease drug given green light by MHRA

An estimated 217,000 people aged 16 and over live with the condition in the UK

- PMLiVE

EMA and ECDC publish advice on fourth doses of mRNA COVID-19 vaccines

The regulators have concluded that there is not enough supporting evidence for an immediate fourth dose

- PMLiVE

MHRA grants approval for AstraZeneca’s Evusheld in the UK

It is the first antibody combination treatment authorised for use before exposure to COVID-19 infection in order to prevent disease licensed in the UK

EU flag

EMA establishes DARWIN EU Coordination Centre

The new centre will give the EMA and other EU member states access to reliable, real-world evidence for EU medicine assessments

- PMLiVE

MHRA issues CMA for Novavax COVID-19 vaccine

Nuvaxovid offers up to 89% protection against COVID-19

- PMLiVE

Janssen submits marketing authorisation to EMA for teclistamab

The drug has been developed to treat patients with relapsed or refractory multiple myeloma, an incurable blood cancer

EU flag

EMA proposes EU clinical trial reforms

The ACT EU paper provides a list of regulatory network objectives, priorities and governance strategies for 2022-2023

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links