Blog
RSS FeedPosted by Michael Wonder on 22 Jul 2022
EMA recommends restricting use of cancer medicine Rubraca
22 July 2022 - EMA’s human medicines committee, CHMP, has recommended that Rubraca (rucaparib camsylate) should no longer be used ...
Posted by Michael Wonder on 22 Jul 2022
Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making
20 July 2022 - EMA has endorsed a joint statement calling for international collaboration to enable the generation and use ...
Posted by Michael Wonder on 11 Jun 2022
FDA approves new oncology drugs quicker than EMA
10 June 2022 - The US FDA is quicker to approve new oncology drugs compared with the EMA, according to ...
Posted by Michael Wonder on 26 Apr 2022
ObsEva announces confirmation of positive CHMP opinion for linzagolix, an oral GnRH antagonist, for the treatment of uterine fibroids
25 April 2022 - ObsEva today announced that the CHMP of the EMA has confirmed its previously adopted positive opinion, ...
Posted by Michael Wonder on 12 Apr 2022
EMA and the EUnetHTA 21 consortium set priorities for their collaboration
12 April 2022 - The EMA and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a joint ...
Posted by Michael Wonder on 06 Apr 2022
ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines
6 April 2022 - The European Centre for Disease Prevention and Control and EMA’s COVID-19 task force have concluded that ...
Posted by Michael Wonder on 31 Mar 2022
EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
31 March 2022 - EMA, in collaboration with the European Organisation for Research and Treatment of Cancer, has launched the Cancer ...
Posted by Michael Wonder on 08 Mar 2022
Vaccine approval before Phase 3 trial results: a consequence of vaccine access inequity
2 March 2022 - The final Phase 3 clinical data for CanSino Biologics' adenovirus type 5 vector vaccine show that Ad5-nCoV ...
Posted by Michael Wonder on 01 Mar 2022
Regulation on EMA’s extended mandate becomes applicable
1 March 2022 - The regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices becomes ...
Posted by Michael Wonder on 22 Feb 2022
European medicines regulatory network adopts EU common standard for electronic product information
22 February 2022 - The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines ...
Posted by Michael Wonder on 20 Feb 2022
BioNTech plans to make vaccines in shipping containers
19 February 2022 - These standardised factories could be quickly scaled up to expand capacity worldwide. ...
Posted by Michael Wonder on 18 Feb 2022
Regulatory decisions diverge over aducanumab for Alzheimer’s disease
19 February 2022 - The EMA refused marketing authorisation for aducanumab (Aduhelm), a monoclonal antibody targeted at amyloid β, in December ...
Posted by Michael Wonder on 16 Feb 2022
European Commission approves Oxbryta (voxelotor) for the treatment of haemolytic anaemia in patients with sickle cell disease age 12 years and older
16 February 2022 - The first sickle haemoglobin polymerisation inhibitor approved in Europe, Oxbryta increases haemoglobin levels and reduces sickling ...
Posted by Michael Wonder on 16 Feb 2022
Merck struggles to win European approval for Covid antiviral pill
16 February 2022 - EMA said to be unlikely to grant marketing authorisation to molnupiravir this month after ‘problematic’ data. ...
Posted by Michael Wonder on 15 Feb 2022
Human medicines: highlights of 2021
15 February 2022 - In 2021, EMA recommended 92 medicines for marketing authorisation. Of these, 53 had a new active substance ...