Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 09 Feb 2022
EU ramps up collection of public health data to improve drug reviews
9 February 2022 - By 2025, centre is set to conduct over 100 studies per year. ...
Posted by Michael Wonder on 09 Feb 2022
Initiation of DARWIN EU Coordination Centre advances integration of real world evidence into assessment of medicines in the EU
9 February 2022 - EMA is initiating today the establishment of the Coordination Centre for the Data Analysis and Real ...
Posted by Michael Wonder on 31 Jan 2022
A stronger role for EMA
31 January 2022 - The regulation reinforcing EMA’s role in crisis preparedness and management for medicinal products and medical devices has ...
Posted by Michael Wonder on 25 Jan 2022
Regulatory harmonisation of clinical trials in the EU: clinical trials regulation to enter into application and new clinical trials information system to be launched
25 January 2022 - On 31 January 2022, the clinical trials regulation will come into application harmonising the submission, assessment and ...
Posted by Michael Wonder on 18 Jan 2022
COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy
18 January 2022 - Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue ...
Posted by Michael Wonder on 16 Jan 2022
Accelerating clinical trials in the EU: for better clinical trials that address patients’ need
13 January 2022 - Today, the European Commission, the Heads of Medicines Agencies and the EMA have launched an initiative to ...
Posted by Michael Wonder on 16 Jan 2022
Global regulators discuss path towards regulatory alignment on response to Omicron variant
13 January 2022 - On 12 January, regulators from around the world discussed the global regulatory response to the COVID-19 Omicron ...
Posted by Michael Wonder on 11 Jan 2022
Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant
11 January 2022 - EMA continues to monitor emerging data on the effectiveness of vaccines against COVID-19, including disease caused ...
Posted by Michael Wonder on 13 Dec 2021
International regulators recommend use of remote inspections as complementary tool beyond pandemic
13 December 2021 - Remote inspections have been useful in maintaining regulatory oversight during the COVID-19 pandemic, but cannot fully replace ...
Posted by Michael Wonder on 09 Dec 2021
Consensus lacking on ‘value’ for new anti-cancer drugs
8 December 2021 - The high price tag of new anticancer drugs has fuelled debate about the value of these treatments, ...
Posted by Michael Wonder on 07 Dec 2021
ICMRA high-level meeting on global health emergencies and regulatory approaches
6 December 2021 - On 1 - 2 December, International Coalition of Medicines Regulatory Authorities, a group of leading medicines regulatory ...