Blog
RSS FeedPosted by Michael Wonder on 20 Feb 2019
Novo Nordisk receives US FDA approval of Esperoct (turoctocog alfa pegol, N8-GP)
19 February 2019 - Novo Nordisk today announced that the US FDA has approved the biologics license application for Esperoct ...
Posted by Michael Wonder on 29 Jan 2019
Proposal for changes to funded haemophilia treatments
29 January 2019 - PHARMAC is proposing to make changes to the funding of haemophilia treatments from 1 May 2019, ...
Posted by Michael Wonder on 07 Jan 2019
ADMA Biologics submits response and provides supplemental information to FDA for Bivigam complete response letter
7 January 2019 - ADMA Biologics announces that the Company has submitted responses to the U.S. FDA complete response letter received ...
Posted by Michael Wonder on 20 Dec 2018
ADMA Biologics provides regulatory update on Bivigam PAS submissions
19 December 2018 - FDA issues complete response letter for drug substance, approves supplement for drug product. ...
Posted by Michael Wonder on 04 Dec 2018
FDA promotes the development and adoption of innovations that can ensure the continued safety of the U.S. blood supply
4 December 2018 - Today the U.S. FDA updated a draft guidance entitled, “Bacterial Risk Control Strategies for Blood Collection Establishments ...
Posted by Michael Wonder on 30 Nov 2018
Data from patient registries to replace clinical trials in previously untreated haemophilia patients
30 November 2018 - EMA has published revised guidelines on the tests and studies needed to support marketing authorisation applications ...
Posted by Michael Wonder on 28 Nov 2018
Bayer receives EU approval for its haemophilia A treatment Jivi
27 November 2018 - The safety and efficacy profile of Jivi has been demonstrated in more than five years of clinical ...
Posted by Michael Wonder on 28 Nov 2018
Octapharma receives Swissmedic approval for fibryga to treat congenital and acquired fibrinogen deficiencies
26 November 2018 - Octapharma today announced that the Swiss Agency for Therapeutic Products, Swissmedic, granted marketing authorisation to its new ...
Posted by Michael Wonder on 28 Nov 2018
Health Canada has now authorised Adynovate [anti-haemophilic factor (recombinant), PEGylated] in paediatrics for treatment of children under 12 with haemophilia A
26 November 2018 - Canadian children now have access to Adynovate, which offers a twice-weekly prophylaxis dosing schedule and on-demand control ...
Posted by Michael Wonder on 16 Nov 2018
ICER issues final report on long-term prophylaxis for hereditary angioedema, provides policy recommendations to improve cost-effectiveness
15 November 2018 - Cost-effectiveness and coverage considerations hinge on the frequency and intensity of attacks. ...
Posted by Michael Wonder on 26 Oct 2018
Bayer receives approval for haemophilia A treatment Jivi
24 October 2018 - Extended half-life product that offers a reduction in dosing frequency and improved bleeding protection. ...
Posted by Michael Wonder on 27 Sep 2018
Draft NICE decision rejects Respreeza for incurable, genetic disorder
27 September 2018 - NICE has published draft guidelines rejecting NHS use of CSL Behring’s Respreeza for treating emphysema in ...
Posted by Michael Wonder on 27 Sep 2018
Aronora's new blood clot treatment receives FDA fast track designation
26 September 2018 - Enzyme that selectively targets blood clots has received FDA fast track designation, allowing for expedited clinical development. ...
Posted by Michael Wonder on 24 Sep 2018
Bayer receives positive CHMP opinion for its haemophilia A treatment BAY94-9027
21 September 2018 - The safety and efficacy profile of BAY94-9027 has been demonstrated in more than five years of clinical ...
Posted by Michael Wonder on 23 Sep 2018
Highlights from the 17-20 September CHMP meeting
21 September 2018 - CHMP elects new chair and recommends thirteen medicines for approval. ...