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RSS FeedPosted by Michael Wonder on 24 Feb 2020
Novartis announces FDA and EMA filing acceptance of ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis
24 February 2020 - Filings are supported by Phase III ASCLEPIOS I and II studies, where ofatumumab showed highly significant and ...
Posted by Michael Wonder on 11 Feb 2020
Fennec Pharmaceuticals completes rolling submission of new drug application to U.S. FDA for Pedmark and also submits marketing authorisation application to EMA
11 February 2020 - Pedmark is being developed for prevention of cisplatin-induced hearing loss in children. ...
Posted by Michael Wonder on 03 Feb 2020
GSK announces EMA accepted marketing authorisation application for belantamab mafodotin for the treatment of relapsed or refractory multiple myeloma
3 February 2020 - Belantamab mafodotin accepted for accelerated assessment by the EMA’s CHMP. ...
Posted by Michael Wonder on 02 Feb 2020
EMA validates Seattle Genetics’ marketing authorisation application for tucatinib for patients with locally advanced or metastatic HER2-positive breast cancer
31 January 2020 - Application Supported by Results of Pivotal HER2CLIMB Trial. ...
Posted by Michael Wonder on 31 Jan 2020
Bristol-Myers Squibb withdraws European application of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of advanced non-small cell lung cancer
31 January 2020 - Company committed to first-line lung cancer patients in Europe, U.S. and other markets with planned filing of ...
Posted by Michael Wonder on 29 Jan 2020
European Medicines Agency validates Kite’s marketing application for company’s second CAR T cell therapy
28 January 2020 - Investigational KTE-X19 to be first chimeric antigen receptor T cell therapy for mantle cell lymphoma in Europe ...
Posted by Michael Wonder on 21 Jan 2020
Janssen seeks expanded use of Imbruvica (ibrutinib) in combination with rituximab for patients with previously untreated chronic lymphocytic leukaemia
20 January 2020 - Application supported by the Phase 3 E1912 study evaluating the use of ibrutinib in combination with rituximab, ...
Posted by Michael Wonder on 16 Jan 2020
Janssen seeks expanded use of Spravato (esketamine) nasal spray in Europe as a treatment for depressive symptoms in adults with major depressive disorder who have current suicidal ideation with intent
15 January 2020 - In two pivotal Phase 3 trials, Spravato combined with comprehensive standard of care achieved statistically significant ...
Posted by Michael Wonder on 12 Jan 2020
Acerus provides update on Natesto approval process in Europe
10 January 2020 - Acerus Pharmaceuticals today announced that the dossier filed as a decentralised Procedure in 19 European countries ...
Posted by Michael Wonder on 11 Jan 2020
ViiV Healthcare submits regulatory application to the European Medicines Agency for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available
10 January 2020 - ViiV Healthcare with Pfizer and Shionogi, today announced the submission of a marketing authorisation application to ...
Posted by Michael Wonder on 08 Jan 2020
Incyte announces the validation by the European Medicines Agency of its marketing authorisation application for pemigatinib in patients with cholangiocarcinoma
7 January 2020 - Incyte today announced the validation of the Company’s marketing authorisation application for pemigatinib for the treatment of ...
Posted by Michael Wonder on 06 Jan 2020
Kyowa Kirin announces marketing authorisation application for istradefylline validated by European Medicines Agency
6 January 2020 - Kyowa Kirin today announces that its marketing authorisation application for istradefylline (KW-6002) as an adjunctive treatment ...
Posted by Michael Wonder on 03 Jan 2020
EMA accepts regulatory submission for Lumoxiti in relapsed or refractory hairy cell leukaemia
2 January 2020 - Innate Pharma today announced that the EMA has accepted the marketing authorisation application for Lumoxiti (moxetumomab ...
Posted by Michael Wonder on 03 Jan 2020
Aerie Pharmaceuticals announces acceptance for review of the Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% marketing authorisation application in Europe
2 January 2020 - Aerie Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for Roclanda ...
Posted by Michael Wonder on 24 Dec 2019
European Medicines Agency validates BioMarin's marketing authorisation application for valoctocogene roxaparvovec to treat severe haemophilia A
23 December 2019 - Potential first gene therapy in Europe directed at any type of haemophilia. ...