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RSS FeedPosted by Michael Wonder on 26 Aug 2021
Sesen Bio pulls E.U. application for FDA rejected cancer drug
26 August 2021 - Sesen Bio, a small biotech firm whose investigational cancer treatment once seemed poised for approval, said ...
Posted by Michael Wonder on 24 Aug 2021
Immunocore announces that U.S. Food and Drug Administration and European Medicines Agency accept biologics license application and marketing authorisation application for tebentafusp in metastatic uveal melanoma
24 August 2021 - FDA grants priority review to tebentafusp for the treatment of HLA-A*02:01 positive patients with metastatic uveal melanoma; ...
Posted by Michael Wonder on 19 Aug 2021
EMA validates Gilead’s marketing authorisation application for lenacapavir, an investigational, long-acting capsid inhibitor for the treatment of HIV-1 in people with limited therapy options
19 August 2021 - EMA MAA validation follows submission of NDA for Lenacapavir to the U.S. FDA. ...
Posted by Michael Wonder on 17 Aug 2021
EMA validates Bristol Myers Squibb’s applications for Opdivo (nivolumab) and Yervoy (ipilimumab) and Opdivo and chemotherapy as first-line treatments for unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma
17 August 2021 - Applications based on positive results from the Phase 3 CheckMate-648 trial, in which both Opdivo-based combinations demonstrated ...
Posted by Michael Wonder on 16 Aug 2021
EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19
16 August 2021 - EMA has started evaluating the anti-inflammatory medicine RoActemra (tocilizumab) to extend its use to include treatment ...
Posted by Michael Wonder on 24 Jul 2021
Kyowa Kirin provides update on application for marketing authorisation of istradefylline in Europe for the treatment of ‘OFF’ episodes in people living with Parkinson’s
23 July 2021 - Kyowa Kirin today announced that the EMA's CHMP issued a negative opinion for istradefylline as an add-on ...
Posted by Michael Wonder on 20 Jul 2021
EMA starts rolling review of COVID-19 vaccine Vidprevtyn
20 July 2021 - EMA’s CHMP has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur. ...
Posted by Michael Wonder on 19 Jul 2021
EMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failure
19 July 2021 - EMA has started evaluating an application to extend the use of Kineret (anakinra) to include treatment ...
Posted by Michael Wonder on 16 Jul 2021
EMA validates BioMarin's marketing authorisation application for valoctocogene roxaparvovec to treat severe haemophilia A
15 July 2021 - Potential first gene therapy in Europe for treatment of haemophilia A. ...
Posted by Michael Wonder on 16 Jul 2021
HutchMed’s marketing authorisation application for surufatinib submitted and validated by the European Medicines Agency
15 July 2021 - EMA commences review of surufatinib for the treatment of advanced neuroendocrine tumours. ...
Posted by Michael Wonder on 02 Jul 2021
Formycon and Bioeq announce submission of the marketing authorisation application for FYB201, a biosimilar candidate to Lucentis (ranibizumab) to the EMA
29 June 2021 - Formycon and its license partner Bioeq AG announce that the marketing authorisation application for FYB201, Formycon’s ...
Posted by Michael Wonder on 29 Jun 2021
Agios submits marketing authorisation application to European Medicines Agency for mitapivat for treatment of adults with pyruvate kinase deficiency
28 June 2021 - Agios Pharmaceuticals today announced that it has submitted a marketing authorisation application for mitapivat to the EMA ...
Posted by Michael Wonder on 29 Jun 2021
BioMarin resubmits marketing authorisation application to European Medicines Agency for valoctocogene roxaparvovec to treat severe haemophilia A
28 June 2021 - Valoctocogene roxaparvovec MAA granted request for accelerated assessment. ...
Posted by Michael Wonder on 29 Jun 2021
Chiasma announces submission of marketing authorisation application for Mycapssa to the European Medicines Agency
28 June 2021 - Submission supported by previously announced data from Phase 3 MPOWERED trial. ...
Posted by Michael Wonder on 28 Jun 2021
Astellas receives positive CHMP opinion for Evrenzo (roxadustat) for adult patients with symptomatic anaemia of chronic kidney disease
25 June 2021 - Astellas Pharma today announced the CHMP of the EMA has adopted a positive opinion relating to the ...