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

lower respiratory tract disease

- PMLiVE

Sanofi and NIHR enrol first patient in immunisation study for RSV in infants

RSV is the leading global cause of infant hospitalisation and affects 90% of children under the age of two

- 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

- 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

Pfizer and viral infection specialist ReViral agree on $525m deal

According to the deal, Pfizer will acquire ReViral for a total of up to $525m

- 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

Pfizer receives Breakthrough Therapy Designation from FDA for RSV vaccine candidate

There are currently no preventative, therapeutic or vaccine options for older adults diagnosed with RSV

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

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