Blog
RSS FeedPosted by Michael Wonder on 14 Dec 2019
ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir for children living with HIV
13 December 2019 - If approved, this new formulation of DTG will be the first integrase inhibitor available as a dispersible ...
Posted by Michael Wonder on 30 Oct 2019
EMA and FDA accept marketing applications for Chugai's satralizumab in neuromyelitis optica spectrum disorder
30 October 2019 - The applications will be reviewed under accelerated assessment by EMA. ...
Posted by Michael Wonder on 09 Sep 2019
Allergan and Molecular Partners announce acceptance of U.S. FDA biologics license application and validation of EMA marketing authorisation for abicipar pegol in patients with neovascular (wet) age-related macular degeneration
9 September 2019 - Filing includes data from two Phase 3 trials which evaluated the safety and efficacy of abicipar quarterly ...
Posted by Michael Wonder on 02 Aug 2019
FDA & European Medicines Agency collaborate on drug quality and manufacturing data to improve patient access to medically necessary medications
31 July 2019 - The FDA and the EMA are publishing the discussion and main conclusions from a workshop held ...
Posted by Michael Wonder on 31 Jul 2019
Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies)
31 July 2019 - EMA and the US FDA have published today a report on their joint workshop with stakeholders ...
Posted by Michael Wonder on 15 Jul 2019
Report on the current status of the use of real‐world data and real‐world evidence in drug development and regulation
10 July 2019 - Radically expanding use of real‐world data and real‐world evidence holds the potential to substantially impact drug development, ...
Posted by Michael Wonder on 06 Jun 2019
US FDA and EMA accept applications for ozanimod for the treatment of relapsing forms of multiple sclerosis
6 June 2019 - Celgene Corporation today announced that the U.S. FDA has accepted for review the new drug application ...
Posted by Michael Wonder on 19 Mar 2019
Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
18 March 2019 - Systemic sclerosis, also known as scleroderma, is a rare chronic connective tissue disease. ...
Posted by Michael Wonder on 04 Mar 2019
Novo Nordisk files for a label update for Fiasp to the EMA and the FDA seeking approval for use in children and adolescents
1 March 2019 - Novo Nordisk today announced that it has submitted label updates to the EMA and the US FDA ...
Posted by Michael Wonder on 07 Feb 2019
Zogenix submits new drug application to U.S. FDA and marketing authorisation application to EMA for Fintepla for the treatment of Dravet syndrome
6 February 2019 - Zogenix today announced it has completed its rolling submission of a new drug application to the ...
Posted by Michael Wonder on 31 Jan 2019
A review of patient reported outcomes labelling for oncology drugs approved by the FDA and the EMA (2012-2016)
31 January 2019 - In recent years, the FDA has granted patient-reported outcome labelling to very few oncology drugs. ...
Posted by Michael Wonder on 30 Jan 2019
Statement from FDA Commissioner on the agency’s efforts to enhance the utility of the Orange Book to foster drug competition
30 January 2019 - One of our key policy priorities is encouraging the timely development and approval of generics and ...
Posted by Michael Wonder on 19 Dec 2018
Comparative assessment of clinical benefit using the ESMO Magnitude of Clinical Benefit Scale version 1.1 and the ASCO Value Framework Net Health Benefit Score
19 December 2018 - To better understand the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) ...
Posted by Michael Wonder on 20 Oct 2018
Bristol-Myers Squibb provides update on the ongoing regulatory review of Opdivo plus low dose Yervoy in first-line lung cancer patients with tumour mutational burden ≥10 mut/Mb
19 October 2018 - New analysis submitted to U.S. FDA constitutes a major amendment to the Company’s supplemental biologics license application. ...
Posted by Michael Wonder on 03 Sep 2018
Cablivi (caplacizumab) approved in Europe for adults with acquired thrombotic thrombocytopenic purpura
3 September 2018 - In addition, U.S. FDA to conduct priority review of caplacizumab with a target action date of ...