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RSS FeedPosted by Michael Wonder on 26 Jun 2023
Jardiance recommended for the treatment of adults with chronic kidney disease in the EU
23 June 2023 - The positive CHMP opinion is based on the landmark EMPA-KIDNEY trial, the largest and broadest dedicated SGLT2 ...
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 25 Jun 2023
Use of real world evidence in regulatory decision making – EMA publishes review of its studies
23 June 2023 - Real world evidence from studies led by regulators can complement evidence from other sources including clinical trials. ...
Posted by Michael Wonder on 24 Jun 2023
Amylyx Pharmaceuticals receives CHMP negative opinion on its conditional marketing authorisation application for AMX0035 for the treatment of ALS in the European Union
23 June 2023 - Amylyx will seek re-examination of its conditional marketing authorisation application. ...
Posted by Michael Wonder on 24 Jun 2023
AbbVie secures positive CHMP opinion for atogepant for the preventive treatment of adults with migraine
23 June 2023 - The positive CHMP opinion is based on results from two pivotal Phase 3 studies evaluating atogepant ...
Posted by Michael Wonder on 24 Jun 2023
Leo Pharma receives positive CHMP opinion for new Adtralza (tralokinumab) injection device
23 June 2023 - CHMP recommends approval of the Adtralza pre-filled pen. ...
Posted by Michael Wonder on 24 Jun 2023
Highlights from the 19-22 June 2023 CHMP meeting
23 June 2023 - The EMA’s CHMP recommended two medicines for approval at its June 2023 meeting. ...
Posted by Michael Wonder on 20 Jun 2023
Legacy Healthcare announces EMA validation of marketing authorisation application for coacillium for the treatment of moderate and severe alopecia areata in children and adolescents
19 June 2023 - Legacy Healthcare today announced that its marketing authorisation application to the EMA's CHMP for Coacillium for the ...
Posted by Michael Wonder on 19 Jun 2023
EMA publishes agenda for 19-22 June CHMP meeting
19 June 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 16 Jun 2023
Takeda and HUTCHMED announce marketing authorisation application of fruquintinib for previously treated metastatic colorectal cancer validated by the European Medicines Agency
15 June 2023 - Application Includes Data from Phase 3 FRESCO-2 and FRESCO Clinical Trials, which Demonstrated Superiority of Fruquintinib Plus ...
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 08 Jun 2023
European Commission authorises GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults
7 June 2023 - The authorisation is based on Phase 3 efficacy data in older adults. ...
Posted by Michael Wonder on 07 Jun 2023
UCB receives new European Commission approvals for Bimzelx (bimekizumab) for the treatment of psoriatic arthritis and axial spondyloarthritis
7 June 2023 - Bimekizumab is the first and only IL-17A and IL-17F inhibitor approved in the European Union for active ...
Posted by Michael Wonder on 06 Jun 2023
Fennec Pharmaceuticals announces European Commission marketing authorisation for Pedmarqsi (sodium thiosulphate) to reduce the risk of hearing loss in paediatric oncology patients
6 June 2023 - Pedmarqsi is the first and only approved therapy in the European Union for reducing the risk of ...
Posted by Michael Wonder on 06 Jun 2023
EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2 virus variants
6 June 2023 - The European Centre for Disease Prevention and Control and the European Medicines Agency have issued a ...