Blog
RSS FeedPosted 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
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 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 ...
Posted by Michael Wonder on 20 Nov 2021
EMA issues advice on use of Lagevrio (molnupiravir) for the treatment of COVID-19
19 November 2021 - EMA’s CHMP has issued advice on the use of Lagevrio (molnupiravir, MK 4482) for the treatment of ...
Posted by Michael Wonder on 20 Nov 2021
EMA starts review of Paxlovid for treating patients with COVID-19
19 November 2021 - EMA is reviewing currently available data on the use of Paxlovid (PF-07321332/ritonavir), an oral treatment for COVID-19 ...
Posted by Michael Wonder on 17 Nov 2021
AbbVie expands immunology portfolio in the European Union with the European Commission approval of Skyrizi (risankizumab) for the treatment of adults with active psoriatic arthritis
17 November 2021 - Approval supported by data from two Phase 3 studies evaluating Skyrizi in psoriatic arthritis patients, KEEPsAKE-1 and ...
Posted by Michael Wonder on 17 Nov 2021
European Commission approves Nucala (mepolizumab) in three additional eosinophil-driven diseases
17 November 2021 - Approval for the first targeted treatment for eosinophilic granulomatosis with polyangiitis and the first anti-IL-5 biologic treatment ...
Posted by Michael Wonder on 16 Nov 2021
Pre-approval and post-approval availability of evidence and clinical benefit of conditionally approved cancer drugs in Europe: a comparison with standard approved cancer drugs
15 November 2021 - Cancer drugs are increasingly approved through expedited regulatory pathways including the European conditional marketing authorisation. ...
Posted by Michael Wonder on 15 Nov 2021
Horizon Therapeutics receives CHMP positive opinion for Uplinza (inebilizumab) as a monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorder
12 November 2021 - CHMP recommendation based on positive results from N-MOmentum, the largest clinical trial ever conducted in NMOSD to ...