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RSS FeedPosted by Michael Wonder on 29 Aug 2022
European Commission approves Ranivisio (ranibizumab), a biosimilar to Lucentis
29 August 2022 - Formycon, Polpharma Biologics and Bioeq jointly announce that the European Commission has granted marketing authorisation for ...
Posted by Michael Wonder on 27 Aug 2022
Pfizer and BioNTech complete submission to EMA for Omicron BA.4/BA.5 adapted bivalent vaccine
26 August 2022 - Submission follows application for Omicron BA.1 adapted bivalent vaccine submitted in July. ...
Posted by Michael Wonder on 26 Aug 2022
Patient registries: EMA officials highlight opportunities in orphan drug development
25 August 2022 - Officials from the EMA tout the benefits of patient registries to support regulatory decision making for ...
Posted by Michael Wonder on 25 Aug 2022
Janssen marks first approval worldwide for Tecvayli (teclistamab) with EC authorisation of first in class bispecific antibody for the treatment of patients with multiple myeloma
24 August 2022 - Teclistamab, an off the shelf subcutaneously administered therapy, induced deep and rapid responses in triple class ...
Posted by Michael Wonder on 25 Aug 2022
First gene therapy for adults with severe haemophilia A, BioMarin's Roctavian (valoctocogene roxaparvovec), approved by European Commission
24 August 2022 - Maintains orphan drug designation in the EU providing 10 years of market exclusivity. ...
Posted by Michael Wonder on 25 Aug 2022
AB Science announces that it has filed an application for conditional marketing authorisation to EMA for masitinib in the treatment of ALS
24 August 2022 - AB Science today announced that it has filed an application for conditional marketing authorisation to the EMA ...
Posted by Michael Wonder on 23 Aug 2022
Extra-ordinary meeting of the CHMP: 1 September 2022
23 August 2022 - This extra-ordinary meeting is organised to discuss the evaluation of two applications for adapted mRNA COVID-19 ...
Posted 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
EMA’s Emergency Task Force advises on intradermal use of Imvanex/Jynneos against monkeypox
19 August 2022 - EMA’s Emergency Task Force (ETF) has reviewed data on the monkeypox vaccine Imvanex used as an ...