Blog
RSS FeedPosted by Michael Wonder on 23 Aug 2022
The EU HTA regulation: a new frontier for access to innovative technologies
23 August 2022 - A new health technology regulation is due to be applied to help EU countries determine the effectiveness ...
Posted by Michael Wonder on 23 Aug 2022
European Medicines Agency commences review of oral fixed-dose combination of decitabine and cedazuridine for the treatment of adults with acute myeloid leukaemia
22 August 2022 - Otsuka and Astex Pharmaceuticals today announce that the EMA has accepted the marketing authorisation application for the ...
Posted by Michael Wonder on 23 Aug 2022
Quizartinib marketing authorisation application validated by EMA for treatment of adult patients with newly diagnosed FLT3- ITD positive acute myeloid leukaemia
23 August 2022 - Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy ...
Posted by Michael Wonder on 23 Aug 2022
Menarini Group’s elacestrant marketing authorisation application accepted for review by the EMA for the treatment of ER+/HER2- advanced or metastatic breast cancer
19 August 2022 - Elacestrant, if approved, would be the first oral selective oestrogen receptor degrader to be available for patients ...
Posted by Michael Wonder on 22 Aug 2022
CSL Vifor and Travere Therapeutics announce EMA has accepted for review the conditional marketing authorisation application for sparsentan for the treatment of IgA nephropathy
22 August 2022 - A review decision by the EMA is expected in the second half of 2023. ...
Posted by Michael Wonder on 22 Aug 2022
European Medicines Agency accepts rezafungin marketing authorisation application for the treatment of invasive candidiasis
22 August 2022 - The EMA filing is supported by the pivotal ReSTORE Phase 3 clinical trial results, where rezafungin demonstrated ...
Posted by Michael Wonder on 22 Aug 2022
Gilead announces first global regulatory approval of Sunlenca (lenacapavir), the only twice yearly HIV treatment option
22 August 2022 - European Commission grants marketing authorisation for Sunlenca, helping to address a critical unmet clinical need for ...
Posted by Michael Wonder on 22 Aug 2022
Kyowa Kirin receives European Commission approval for use of Crysvita (burosumab) for the treatment of tumour-induced osteomalacia
19 August 2022 - Crysvita is the first approved biologic treatment in the EU for patients with tumour-induced osteomalacia who cannot ...
Posted by Michael Wonder on 20 Aug 2022
European Commission approves Celltrion Healthcare’s Vegzelma (CT-P16, biosimilar bevacizumab) for the treatment of multiple types of cancer
18 August 2022 - Vegzelma offers European patients living with certain types of breast, lung, renal, colon, rectum, ovarian and cervical ...
Posted by Michael Wonder on 20 Aug 2022
Fresenius Kabi announces acceptance of its marketing authorisation application by the European Medicines Agency for MSB11456, a tocilizumab biosimilar candidate
18 August 2022 - Fresenius Kabi announced today that its marketing authorisation application for MSB11456, the company’s tocilizumab biosimilar candidate, ...
Posted by Michael Wonder on 19 Aug 2022
European Commission approves Oncopeptides' Pepaxti for the treatment of patients with relapsed refractory multiple myeloma
18 August 2022 - Oncopeptides today announces that the European Commission has granted Pepaxti (melphalan flufenamide) marketing authorisation in combination ...
Posted by Michael Wonder on 19 Aug 2022
Aeglea BioTherapeutics announces European Medicines Agency validation of marketing authorisation application for pegzilarginase for the treatment of arginase 1 deficiency
18 August 2022 - Aeglea BioTherapeutics today announced that a marketing authorisation application for pegzilarginase for the treatment of arginase 1 ...
Posted by Michael Wonder on 16 Aug 2022
EMA publishes agenda for 16-19 August CHMP meeting
16 August 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 15 Aug 2022
argenx announces European Commission approval of Vyvgart (efgartigimod alfa-fcab) for the treatment of generalised myasthenia gravis
11 August 2022 - Vyvgart is the first neonatal Fc receptor blocker approved in Europe for the treatment of adults living ...
Posted by Michael Wonder on 11 Aug 2022
European Commission approves Imbruvica (ibrutinib) fixed duration combination for adult patients with previously untreated chronic lymphocytic leukaemia
9 August 2022 - It is the first all oral, fixed duration, once daily treatment based on a Bruton's tyrosine kinase ...