Blog
RSS FeedPosted by Michael Wonder on 05 Oct 2020
EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines
5 October 2020 - The EMA has re-affirmed today that it will uphold its long-standing commitment to independence and transparency ...
Posted by Michael Wonder on 24 Sep 2020
Guideline on registry-based studies - launch of public consultation
24 September 2020 - EMA has published its draft Guideline on registry-based studies for a three-month public consultation today. ...
Posted by Michael Wonder on 17 Sep 2020
EMA close to finalising guidance for advanced therapies
16 September 2020 - The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal ...
Posted by Michael Wonder on 15 Sep 2020
European Medicines Agency approves safety label update for Novartis Beovu
14 September 2020 - Novartis worked with the EMA to update the Beovu (brolucizumab) label to guide physicians in their treatment ...
Posted by Michael Wonder on 14 Sep 2020
Making best use of big data for public health: publication of the Big Data Steering Group workplan for 2020-21
14 September 2020 - The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies has ...
Posted by Michael Wonder on 04 Sep 2020
PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids
4 September 2020 - A review by EMA’s safety committee has confirmed that 5 mg ulipristal acetate (Esmya and generic ...
Posted by Michael Wonder on 24 Aug 2020
EMA goes all-virtual for remainder of 2020
20 August 2020 - The EMA has announced that all its committee and working party meetings will be held virtually ...
Posted by Michael Wonder on 10 Aug 2020
Communication@EMA
10 August 2020 - The European Medicines Agency has launched its third communication perception survey. ...
Posted by Michael Wonder on 31 Jul 2020
Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable outcomes for clinical trials
31 July 2020 - International regulators have published a report today on the acceptability of various primary outcomes in the ...
Posted by Michael Wonder on 22 Jul 2020
First Covid-19 vaccine may be approved in 2020, EU regulator says
21 July 2020 - EMA will start rolling review of data, production after summer. ...
Posted by Michael Wonder on 21 Jul 2020
EMA sets up infrastructure for real-world monitoring of COVID-19 treatments and vaccines
21 July 2020 - EMA has now set up an infrastructure to support the monitoring of the efficacy and safety ...
Posted by Michael Wonder on 19 Jul 2020
Advanced therapy medicinal products regulations in the EU
16 July 2020 - This article explains some of the terminology relating to advanced therapy medicinal products, including gene and cell-based ...
Posted by Michael Wonder on 19 Jul 2020
Drug regulators remain united on COVID-19, says EU agency boss
18 July 2020 - The fight among governments to secure treatments has brought regulators closer together, says Guido Rasi. ...
Posted by Michael Wonder on 14 Jul 2020
Aspen offers to cut cancer drug prices, may avoid EU antitrust fine
14 July 2020 - Aspen has offered to cut prices by an average of 73% for six off-patent cancer drugs, ...
Posted by Michael Wonder on 09 Jul 2020
International regulators align positions on phase 3 COVID-19 vaccine trials
9 July 2020 - Medicines regulatory authorities from around the world have published a report today highlighting the outcomes ...