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RSS FeedPosted by Michael Wonder on 10 Dec 2021
Intercept announces withdrawal of EMA marketing authorisation application for obeticholic acid for advanced liver fibrosis due to NASH
9 December 2021 - Intercept Pharmaceuticals today announced that it has formally notified the EMA of its decision to withdraw ...
Posted by Michael Wonder on 07 Dec 2021
EMA accepts regulatory submission for olipudase alfa, the first potential therapy for ASMD
6 December 2021 - Olipudase alfa has been granted PRIority MEdicines (PRIME) designation in Europe, breakthrough therapy designation in the United ...
Posted by Michael Wonder on 04 Dec 2021
Janssen seeks approval of Imbruvica (ibrutinib) in a fixed duration regimen for patients with untreated chronic lymphocytic leukaemia
30 November 2021 - Application based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated the safety ...
Posted by Michael Wonder on 04 Dec 2021
U.S. Food and Drug Administration accepts for priority review supplemental biologics license application for Reblozyl (luspatercept-aamt) in adults with non-transfusion dependent beta thalassaemia
3 December 2021 - Submission based on results from Phase 2 BEYOND study of Reblozyl plus best supportive care in ...
Posted by Michael Wonder on 04 Dec 2021
European Medicines Agency validates Amicus Therapeutics marketing authorisation applications for AT-GAA for the treatment of Pompe disease
3 December 2021 - Amicus Therapeutics today announced that the EMA validated the marketing authorisation applications for AT-GAA, the Company’s ...
Posted by Michael Wonder on 02 Dec 2021
EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001)
2 December 2021 - The EMA’s CHMP has started a rolling review of VLA2001, a COVID-19 vaccine being developed by ...
Posted by Michael Wonder on 01 Dec 2021
EMA validates Atara Biotherapeutics' marketing authorisation application for tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
30 November 2021 - First ever off the shelf allogeneic T-cell therapy to be reviewed by any regulatory agency in the ...
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 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 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
EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid
17 November 2021 - EMA has started evaluating an application for conditional marketing authorisation for Novavax’s COVID-19 vaccine, Nuvaxovid (also known ...
Posted by Michael Wonder on 10 Nov 2021
EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11
10 November 2021 - EMA has started evaluating an application to extend the use of Moderna’s COVID-19 vaccine, Spikevax, to ...
Posted by Michael Wonder on 03 Nov 2021
Trastuzumab deruxtecan type II variation application validated by EMA for the treatment of HER2 positive advanced gastric cancer
3 November 2021 - Application based on DESTINY-Gastric01 and DESTINY-Gastric02 phase 2 trials. ...