Blog
RSS FeedPosted by Michael Wonder on 13 Feb 2018
U.S., EU and Japan health authorities accept regulatory submissions for review of Pfizer's third-generation ALK inhibitor lorlatinib
12 February 2018 - U.S. new drug application granted FDA priority review. ...
Posted by Michael Wonder on 17 Jan 2018
Novartis granted US FDA priority review for Kymriah (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL
17 January 2018 - Filing acceptance marks second priority review granted to Kymriah by the FDA for two distinct indications, underscoring ...
Posted by Michael Wonder on 30 Dec 2017
GW Pharmaceuticals submits marketing authorisation application in Europe for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
29 December 2017 - GW Pharmaceuticals today announced it has submitted its marketing authorisation application to the EMA for Epidiolex (cannabidiol) ...
Posted by Michael Wonder on 17 Nov 2017
Towards a single development programme for new antibiotics in EU, Japan and US
17 November 2017 - EMA, PMDA and FDA to further align data requirements and explore options to streamline paediatric development. ...
Posted by Michael Wonder on 17 Nov 2017
Celgene and bluebird bio announce bb2121 anti-BCMA CAR-T cell therapy has been granted breakthrough therapy designation from FDA and PRIME eligibility from EMA for relapsed and refractory multiple myeloma
16 November 2017 - Designations based on preliminary clinical data from ongoing phase I study of bb2121 in heavily pre-treated multiple ...
Posted by Michael Wonder on 16 Nov 2017
Akcea and Ionis announce acceptance of marketing applications in US, EU and Canada for volanesorsen for the treatment of FCS
15 November 2017 - FDA Prescription Drug User Fee Act goal date set for 30 August 2018. ...
Posted by Michael Wonder on 31 Oct 2017
EU-FDA mutual recognition of inspections of medicines manufacturers enters operational phase
31 October 2017 - Major milestone is a testimony to mutual trust. ...
Posted by Michael Wonder on 29 Aug 2017
U.S. FDA and EMA accept regulatory submissions for Bosulif (bosutinib) for the treatment of patients with newly diagnose Ph+ chronic myeloid leukaemia
29 August 2017 - Applications seek to expand approved use of Bosulif into first- line treatment based on positive results from ...
Posted by Michael Wonder on 25 Aug 2017
Vertex announces acceptance of its applications for review of the tezacaftor/ivacaftor combination treatment in people with cystic fibrosis by the FDA and EMA
24 August 2017 - FDA grants priority review of the application and sets action date of 28 February 2018. ...
Posted by Michael Wonder on 24 Aug 2017
FDA, EMA and EC sign new confidentiality commitment
24 August 2017 - The US FDA can now share non-public and commercially confidential information, including trade secrets relating to ...
Posted by Michael Wonder on 12 Aug 2017
Gilead announces US FDA priority review designation for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for treatment of HIV
10 August 2017 - Final FDA Decision Anticipated by 12 February 2018. ...
Posted by Michael Wonder on 01 Aug 2017
Kite files the industry's first CAR-T marketing authorisation application in Europe for axicabtagene ciloleucel
31 August 2017 - Submission based on primary analysis of ZUMA-1 in patients with aggressive NHL. ...
Posted by Michael Wonder on 26 Jul 2017
UCB and Dermira announce U.S. and EU regulatory submissions for Cimzia (certolizumab pegol) for the treatment of moderate-to-severe chronic plaque psoriasis
25 July 2017 - The regulatory submissions for this new indication seek to expand the use of Cimzia for the treatment ...
Posted by Michael Wonder on 20 Jul 2017
Leo Pharma receives marketing authorisation for Kyntheum (brodalumab), a new biologic for the treatment of moderate-to-severe plaque psoriasis in the European Union
20 July 2017 - Leo Pharma today announced that the European Commission has granted marketing authorisation for Kyntheum (brodalumab), a ...
Posted by Michael Wonder on 17 Jul 2017
Amgen submits regulatory applications in US and Europe to include overall survival data in Kyprolis (carfilzomib) label
14 July 2017 - Data showed Kyprolis and dexamethasone reduced the risk of death by 21% and increased overall survival ...