Blog
RSS FeedPosted by Michael Wonder on 25 Mar 2022
New gene therapy to treat adult patients with multiple myeloma
25 March 2022 - EMA has recommended a conditional marketing authorisation in the European Union for Carvykti (ciltacabtagene autoleucel) for the ...
Posted by Michael Wonder on 24 Mar 2022
Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis of COVID-19
24 March 2022 - Recommendation based on Phase 3 PROVENT trial showing a significant reduction in the risk of developing ...
Posted by Michael Wonder on 23 Mar 2022
Orphazyme announces withdrawal of European marketing authorisation application for arimoclomol for the treatment of Niemann-Pick disease type C
22 March 2022 - Decision to withdraw the European marketing authorisation application comes ahead of scheduled final vote on the ...
Posted by Michael Wonder on 21 Mar 2022
EMA publishes agenda for 21-24 March CHMP meeting
21 March 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 16 Mar 2022
Europe begins reviewing application for AstraZeneca COVID drug
15 March 2022 - Europe's drug regulator said on Tuesday it had begun reviewing AstraZeneca's application for antibody based COVID-19 therapy, ...
Posted by Michael Wonder on 15 Mar 2022
Drug industry says EMA’s PRIME scheme useful but could be improved
14 March 2022 - Eligibility criteria for admission to the EMA's priority medicines (PRIME) scheme are too strict to facilitate ...
Posted by Michael Wonder on 11 Mar 2022
Janssen seeks approval of a new indication for Imbruvica (ibrutinib) for use in patients with untreated mantle cell lymphoma
8 March 2022 - Application based on Phase 3 SHINE study results, which investigated the safety and efficacy of all-oral ...
Posted by Michael Wonder on 10 Mar 2022
Servier submits a marketing authorisation application to the EMA for Tibsovo (ivosidenib) for patients with IDH1 mutated acute myeloid leukaemia and cholangiocarcinoma
10 March 2022 - The submission covers countries of the European Union as well as Iceland, Liechtenstein and Norway. ...
Posted by Michael Wonder on 09 Mar 2022
Bayer submits applications in the U.S. and EU for additional indication of Nubeqa (darolutamide)
9 March 2022 - Submissions are based on data from the pivotal Phase 3 ARASENS trial recently published in The New ...
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 07 Mar 2022
Jardiance (empagliflozin) becomes the first and only approved treatment in Europe for adults with symptomatic chronic heart failure regardless of ejection fraction
7 March 2022 - The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with ...
Posted by Michael Wonder on 03 Mar 2022
PRIME enables earlier availability of life-changing medicines
3 March 2022 - EMA’s PRIority Medicines (PRIME) scheme has had a positive impact on the authorisation of new medicines that ...
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 01 Mar 2022
EMA accepts marketing authorisation application for daprodustat
1 March 2022 - Submission for the treatment of anaemia of chronic kidney disease based on the ASCEND Phase III clinical ...
Posted by Michael Wonder on 01 Mar 2022
CHMP recommends Idorsia’s dual acting treatment Quviviq for insomnia patients
28 February 2022 - Quviviq can be used on a long-term basis, addressing a key limitation of existing therapies ...