Blog
RSS FeedPosted by Michael Wonder on 24 May 2018
FDA accepts supplemental biologics license application and grants priority review for prophylactic and paediatric use for Bio Products Laboratory's Coagadex (coagulation factor X, human) for treatment of hereditary factor X deficiency
23 May 2018 - FDA previously granted Coagadex orphan drug designation for the treatment of hereditary factor X deficiency. ...
Posted by Michael Wonder on 17 Apr 2018
FDA approves Vonvendi [von Willebrand factor (recombinant)] for peri-operative management of bleeding in adult patients with von Willebrand disease
17 April 2018 - Expanded use for Vonvendi – the first and only purified recombinant von Willebrand factor – builds on ...
Posted by Michael Wonder on 12 Apr 2018
ICER posts draft scoping document on therapies for prevention of hereditary angioedema attacks
12 April 2018 - Document open to public comment until 2 May 2018; report expected to review lanadelumab (Shire), and C1 ...
Posted by Michael Wonder on 26 Mar 2018
ICER to assess therapies for hereditary angioedema in upcoming assessment
23 March 2018 - Review will be subject of October CTAF meeting; open input now being accepted until 9 April. ...
Posted by Michael Wonder on 18 Mar 2018
FDA approves Hizentra (immune globulin subcutaneous [human] 20% liquid) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy
16 March 2018 - First and only subcutaneous immunoglobulin approved for the treatment of CIDP based on the largest controlled clinical ...
Posted by Michael Wonder on 28 Feb 2018
Novo Nordisk files for regulatory approval of long-acting factor VIII (N8-GP) in the US and the EU for treatment of haemophilia A
28 February 2018 - Novo Nordisk today announced the submission of a biologics license applications to the US FDA and ...
Posted by Michael Wonder on 16 Feb 2018
Shire announces FDA acceptance of application for Cinryze (C1 esterase inhibitor [human]) for paediatric hereditary angioedema use
15 February 2018 - If approved, Cinryze will be the first and only C1-INH therapy indicated to help prevent HAE attacks ...
Posted by Michael Wonder on 10 Feb 2018
Grifols HyperRAB (rabies immune globulin [human]) 300 IU/mL receives FDA approval to treat patients exposed to rabies virus infection
6 February 2018 - Reduced volume of medication offers potential for fewer injections for patients. ...
Posted by Michael Wonder on 29 Jan 2018
Agenda for 31 January TC meeting
29 January 2018 - HAS has posted the agenda for the next scheduled TC meeting. ...
Posted by Michael Wonder on 16 Jan 2018
Shire granted EU marketing authorisation for Adynovi [anti-haemophilic factor (recombinant), PEGylated] for adults and adolescents with haemophilia A
15 January 2018 - Marketing authorisation will enable patient access to Adynovi throughout Europe. ...
Posted 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 ...