Blog
RSS FeedPosted by Michael Wonder on 28 Oct 2022
Health Canada approves Rebinyn (coagulation factor IX (recombinant), pegylated) for the treatment of routine prophylaxis to prevent or reduce frequency of bleeding episodes in children with haemophilia B
27 October 2022 - Expanded indication for Rebinyn will continue to support Canadian paediatric patients living with haemophilia B. ...
Posted by Michael Wonder on 28 Sep 2022
CSL receives manufacturing and marketing authorisation in Japan for “Berinert SC injection 2000,” as a medicine for prevention of acute hereditary angioedema attacks
26 September 2022 - At home subcutaneous therapy advances treatment options for patients and marks a milestone in 40 years of ...
Posted by Michael Wonder on 08 Sep 2022
Grifols enters into agreement with Canadian Blood Services to accelerate self-sufficiency in immunoglobulins for Canada
7 September 2022 - The country, with an increasing immunoglobulin usage rate, currently imports about 85% of its immunoglobulin demand for ...
Posted by Michael Wonder on 02 Aug 2022
Novo Nordisk receives FDA approval for Rebinyn for routine prophylaxis to prevent bleeding in people living with haemophilia B
29 July 2022 - Novo Nordisk announced today that the US FDA has approved the supplemental biologics license application for Rebinyn, ...
Posted by Michael Wonder on 26 Jul 2022
LFB announces the approval of Cevenfacta (eptacog beta) in the European Union
25 July 2022 - The first new bypassing agent approved in the European Union for the treatment and control of bleeding ...
Posted by Michael Wonder on 15 Jul 2022
TGA approves Grifols' Xembify
15 July 2022 - Xembify is yet another presentation of human immunoglobulin. ...
Posted by Michael Wonder on 06 Jul 2022
Health Canada approves HyQvia, a new treatment for Canadians with immune deficiencies
6 July 2022 - New immunoglobulin treatment offers Canadian patients option of subcutaneous once-monthly (every three or four weeks) dosing. ...
Posted by Michael Wonder on 01 Jun 2022
FDA grants efanesoctocog alfa breakthrough therapy designation for haemophilia A
1 June 2022 - Designation is based on XTEND-1 Phase 3 study data demonstrating a clinically meaningful prevention of bleeds and ...
Posted by Michael Wonder on 02 Apr 2022
Novo Nordisk expands product offerings in Canada for the treatment of haemophilia A in both children and adults, with availability of Esperoct and Zonovate
1 April 2022 - Newly available treatments can help Canadians living with haemophilia A better manage their bleeding episodes ...
Posted by Michael Wonder on 28 Feb 2022
GC Pharma receives complete response letter from the U.S. FDA for Alyglo
27 February 2022 - GC Pharma today announced that it has received a complete response letter from the U.S. FDA in ...
Posted by Michael Wonder on 01 Feb 2022
FDA approves prophylactic treatment with Vonvendi [von Willebrand factor (recombinant)] for adult patients living with severe type 3 von Willebrand disease
31 January 2022 - Vonvendi [von Willebrand factor (recombinant)] is the first and only treatment approved for routine prophylaxis to reduce ...
Posted by Michael Wonder on 07 Dec 2021
FDA approves Octapharma’s Cutaquig 16.5% for paediatric PI patients, providing flexible treatment options
7 December 2021 - Families, providers can utilise flexible infusion schedule to meet patient needs. ...
Posted by Michael Wonder on 30 Aug 2021
FDA orphan drug approval: Octapharma’s Octagam 10% receives 7 years of market exclusivity for adult dermatomyositis
30 August 2021 - Octagam 10% expected to become the first treatment option for adults with rare immune-mediated inflammatory disease. ...
Posted by Michael Wonder on 13 Aug 2021
GC Pharma announces GreenGene F approval in China for the treatment of haemophilia A
12 August 2021 - GreenGene F now approved in China, provides more haemophilia A patients access to proven therapy. ...
Posted by Michael Wonder on 03 Aug 2021
FDA approves new Berinert (C1 esterase inhibitor, human (intravenous)) administration kit for increased patient convenience
3 August 2021 - CSL Behring has received U.S. FDA approval for its supplemental request for co-packaging of a convenience ...