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RSS FeedPosted by Michael Wonder on 11 Dec 2017
Agenda for 13 December TC meeting
11 December 2017 - HAS has posted the agenda for the next scheduled TC meeting. ...
Posted by Michael Wonder on 29 Nov 2017
Pharming submits supplemental biologics license application to FDA for Ruconest for prophylaxis of hereditary angioedema attacks
27 November 2017 - Submission based on positive results from two clinical trials. ...
Posted by Michael Wonder on 24 Nov 2017
Agenda for 22 November TC meeting
22 November 2017 - HAS has posted the agenda for the next scheduled TC meeting. ...
Posted by Michael Wonder on 01 Nov 2017
Bayer announces BAY94-9027 biologics license application accepted by U.S. Food & Drug Administration
30 October 2017 - The U.S. FDA has accepted Bayer's biologics license application filing for BAY94-9027, an extended half-life site-specifically PEGylated ...
Posted by Michael Wonder on 27 Oct 2017
Shire receives European approval for label extension of Firazyr (icatibant injection) for the symptomatic treatment of acute hereditary angioedema attacks in paediatric patients
26 October 2017 - Firazyr is the first and only subcutaneous treatment in Europe for acute HAE attacks approved for ...
Posted by Michael Wonder on 21 Oct 2017
Agenda for 25 October TC meeting
20 October 2017 - HAS has posted the agenda for the next scheduled TC meeting. ...
Posted by Michael Wonder on 14 Oct 2017
Prometic announces FDA acceptance of its biologics license application for plasminogen (Ryplazim)
13 October 2017 - Ryplazim previously granted fast track, rare paediatric disease and orphan drug designations by U.S. FDA. ...
Posted by Michael Wonder on 26 Sep 2017
FDA approves Grifols Prolastin-C liquid [alpha-1 proteinase inhibitor, liquid] for the treatment of alpha-1 anti-trypsin deficiency
22 September 2017 - Prolastin-C Liquid is the first liquid formulation of an alpha-1 anti-trypsin deficiency replacement therapy manufactured in the ...
Posted by Michael Wonder on 17 Sep 2017
CSL Behring announces FDA approval of Privigen [immune globulin intravenous (human), 10% liquid] for the treatment of chronic inflammatory demyelinating polyneuropathy in adults
14 September 2017 - Privigen shown to improve functional abilities in patients with a rare neurological condition. ...
Posted by Michael Wonder on 11 Sep 2017
Institute for Clinical and Economic Review posts draft scoping document to guide review of emicizumab for haemophilia A
11 September 2017 - Document open to public comment until 29 September 2017. ...
Posted by Michael Wonder on 03 Sep 2017
Bayer submits biologics license application in the U.S. for BAY94-9027 – a long-acting factor VIII for the treatment of haemophilia A
31 August 2017 - Pivotal studies with BAY94-9027 showed that bleed protection was achieved with extended dosing intervals. ...
Posted by Michael Wonder on 24 Aug 2017
Octapharma USA announces FDA approval of Nuwiq new product strengths, expanding haemophilia A patient treatment options
22 August 2017 - New higher vial strengths will provide added dosing flexibility & convenience. ...
Posted by Michael Wonder on 10 Aug 2017
Berinert approved by Health Canada for the treatment of hereditary angioedema in paediatric patients
9 August 2017 - CSL Behring is pleased to announce that on 31 March 2017 Berinert (C1 esterase inhibitor, human) was ...
Posted by Michael Wonder on 04 Aug 2017
Portola Pharmaceuticals announces resubmission of biologics license application for AndexXa (andexanet alfa)
3 August 2017 - Portola Pharmaceuticals today announced that on August 3, 2017 it resubmitted its Biologics License Application (BLA) ...
Posted by Michael Wonder on 10 Jul 2017
CSL to fight patent infringement claim from US based Bioverativ
10 July 2017 - Australian vaccines and blood products developer CSL says it will vigorously fight a patent infringement claim ...