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RSS FeedPosted by Michael Wonder on 30 Nov 2021
European Commission approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) as first-line treatment for adult patients with advanced renal cell carcinoma
29 November 2021 - Approval Based on Results From CLEAR/KEYNOTE-581 Trial Demonstrating KEYTRUDA Plus LENVIMA Significantly Reduced the Risk of ...
Posted by Michael Wonder on 30 Nov 2021
AbbVie submits application for risankizumab (Skyrizi) in moderate to severe Crohn's disease to European Medicines Agency
30 November 2021 - Submission supported by three pivotal Phase 3 trials in which risankizumab demonstrated significant improvements in clinical remission ...
Posted by Michael Wonder on 30 Nov 2021
The European Medicines Agency accepts application to extend the Buvidal indication to include treatment of chronic pain
30 November 2021 - Camurus today announces that the EMA has accepted the company’s submission of a Type II variation application ...
Posted by Michael Wonder on 29 Nov 2021
Bristol Myers Squibb’s applications for deucravacitinib for the treatment of moderate to severe plaque psoriasis accepted by U.S. Food and Drug Administration and validated by European Medicines Agency
29 November 2021 - Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy ...
Posted by Michael Wonder on 26 Nov 2021
European Commission approves Byannli (6 monthly paliperidone palmitate) for the maintenance treatment of schizophrenia in adults
23 November 2021 - The approval is based on results from the Route 6 Study, which showed that 92.5 percent ...
Posted by Michael Wonder on 25 Nov 2021
Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11
25 November 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use ...
Posted by Michael Wonder on 25 Nov 2021
Bristol Myers Squibb receives European Commission approval of Zeposia (ozanimod) for use in adults with moderately to severely active ulcerative colitis
23 November 2021 - Zeposia approval is based on the Phase 3 True North trial, which demonstrated clinically meaningful improvements ...
Posted by Michael Wonder on 24 Nov 2021
Trodelvy (sacituzumab govitecan) granted European Commission marketing authorisation for treatment of metastatic triple negative breast cancer in second line
23 November 2021 - Marketing authorisation based on Phase 3 ASCENT study showing Trodelvy significantly improved overall survival versus physician’s choice ...
Posted by Michael Wonder on 24 Nov 2021
A vision for use of real world evidence in EU medicines regulation
24 November 2021 - Enabling the use of real world evidence and establishing its value for regulatory decision-making on the development, ...
Posted by Michael Wonder on 23 Nov 2021
EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID-19
23 November 2021 - EMA has started evaluating an application for marketing authorisation for the oral antiviral medicine Lagevrio (molnupiravir). ...
Posted by Michael Wonder on 23 Nov 2021
Update on regulatory review of aducanumab in the European Union
17 November 2021 - Biogen and Eisai announced today an update on the on-going review of the marketing authorisation application ...
Posted by Michael Wonder on 22 Nov 2021
Deciphera receives European Commission approval of Qinlock for the treatment of fourth-line gastro-intestinal stromal tumour
22 November 2021 - Qinlock significantly reduced the risk of disease progression or death by 85% and showed clinically meaningful overall ...
Posted by Michael Wonder on 22 Nov 2021
European Commission approves Roche’s Gavreto (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer
19 November 2021 - Gavreto is the first and only precision medicine approved in the EU for first-line treatment of people ...
Posted by Michael Wonder on 22 Nov 2021
EMA evaluating data on booster dose of COVID-19 Vaccine Janssen
22 November 2021 - EMA has started evaluating an application for the use of a booster dose of COVID-19 Vaccine ...
Posted by Michael Wonder on 20 Nov 2021
Pfizer's Xeljanz (tofacitinib) receives marketing authorisation in the European Union for the treatment of active ankylosing spondylitis
18 November 2021 - Pfizer announced today that the European Commission has approved Xeljanz (tofacitinib) 5 mg twice daily for the ...