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RSS FeedPosted by Michael Wonder on 08 Nov 2023
First electronic product information published for selected human medicines
8 November 2023 - The Heads of Medicines Agencies (HMA), the European Commission and EMA have published for the first time ...
Posted by Michael Wonder on 15 Sep 2023
EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep
15 September 2023 - The CHMP has recommended not renewing the conditional marketing authorisation for Blenrep (belantamab mafodotin), a medicine ...
Posted by Michael Wonder on 30 Aug 2023
Withdrawn accelerated approvals for cancer indications in the US: what is the marketing authorisation status in the EU?
30 August 2023 - As of April, 2023, 23 accelerated approvals for cancer indications granted by the US FDA since 1992 ...
Posted by Michael Wonder on 20 Jul 2023
OPEN framework extended to a wider range of medicines
20 July 2023 - EMA has expanded the scope of the OPEN initiative from COVID-19 vaccines and treatments to a ...
Posted by Michael Wonder on 07 Jul 2023
Phasing out of extraordinary COVID-19 regulatory flexibilities
6 July 2023 - EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the ...
Posted by Michael Wonder on 06 Jul 2023
Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study
5 July 2023 - The objective was to analyse the therapeutic value of supplemental indications compared with first indications for ...
Posted by Michael Wonder on 05 Jul 2023
Global regulators confirm good safety profile of COVID-19 vaccines
5 July 2023 - EMA has just endorsed a joint statement on the safety of COVID-19 vaccines issued by the ...
Posted by Michael Wonder on 26 Jun 2023
Revise pharmaceutical legislation, or long-term access to medical breakthroughs for Europeans will be harmed
22 June 2023 - Yesterday, the newly elected Presidency team of the European Federation of Pharmaceutical Industries and Associations convened ...
Posted by Michael Wonder on 10 Jun 2023
A review of labeling based on patient reported outcome endpoints for new oncology drugs approved by the EMA (2017-2021)
9 June 2023 - A review of new oncology indications approved by the EMA for 2012-2016 showed that 33% of new ...
Posted by Michael Wonder on 30 May 2023
Global regulators agree on way forward to adapt COVID-19 vaccines to emerging variants
30 May 2023 - International regulators have published a report today highlighting the outcomes of their discussions on COVID-19 vaccines and ...
Posted by Michael Wonder on 10 May 2023
Reforming EU and national orphan drug regulations to improve outcomes for patients with rare diseases
9 May 2023 - In Europe, the number of approvals for new drugs targeting rare diseases (orphan drugs) has risen ...
Posted by Michael Wonder on 23 Apr 2023
EMA addresses considerations for single-arm trials
21 April 2023 - A new reflection paper from the EMA offers some suggestions to sponsors on how to design ...
Posted by Michael Wonder on 04 Apr 2023
New features further strengthen Priority Medicines scheme (PRIME)
4 April 2023 - The EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to ...
Posted by Michael Wonder on 28 Mar 2023
DARWIN EU has completed its first studies and is calling for new data partners
28 March 2023 - DARWIN EU, the Data Analysis and Real World Interrogation Network, has accomplished its first year of establishment. ...
Posted by Michael Wonder on 22 Mar 2023
Advancing regulatory science in the EU – mid-point report published
22 March 2023 - The EMA has published a report summarising the mid-term achievements of its regulatory science strategy to ...