Blog
RSS FeedPosted by Michael Wonder on 28 Sep 2020
U.S. FDA approves Haegarda (C1 esterase inhibitor subcutaneous [human]) for prevention of hereditary angioedema attacks in paediatric patients
28 September 2020 - Haegarda is the first and only subcutaneous prophylactic hereditary angioedema treatment approved for children 6 years of ...
Posted by Michael Wonder on 26 Sep 2020
Medicines for haemophilia remain in the high-cost protection after TLV's reconsideration
25 September 2020 - The costs of factor IX concentrate, which is used in the treatment of haemophilia B, are reduced ...
Posted by Michael Wonder on 23 Sep 2020
Liminal BioSciences provides update on progress on BLA for Ryplazim (plasminogen)
21 September 2020 - FDA assigns PDUFA target action date of 5 March 2021. ...
Posted by Michael Wonder on 16 Sep 2020
EMA approves label update for Hyqvia (human normal immunoglobulin 10% and recombinant human hyaluronidase), expanding its use to a broader group of patients with secondary immunodeficiencies
15 September 2020 - Takeda today announced that the EMA has approved a label update for Hyqvia (human normal immunoglobulin 10% ...
Posted by Michael Wonder on 08 Sep 2020
Liminal BioSciences announces resubmission of biologics license application to U.S. FDA for Ryplazim (plasminogen)
8 September 2020 - Results from pivotal Phase 2/3 study met co-primary endpoints for improvement in trough plasminogen activity levels and ...
Posted by Michael Wonder on 29 Aug 2020
FDA ousts spokeswoman after COVID therapy misstatements
29 August 2020 - Emily Miller joined the agency as chief spokeswoman this month. ...
Posted by Michael Wonder on 26 Aug 2020
FDA chief apologises for overstating plasma effect on virus
26 August 2020 - Food and Drug Administration Commissioner Stephen Hahn is apologising for overstating the life-saving benefits of using convalescent ...
Posted by Michael Wonder on 25 Aug 2020
F.D.A. ‘grossly misrepresented’ blood plasma data, scientists say
24 August 2020 - Many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about ...
Posted by Michael Wonder on 24 Aug 2020
FDA's convalescent plasma EUA requires all donor blood units be tested only with Ortho's COVID-19 IgG antibody test
24 August 2020 - In its August 23 Emergency Use Authorisation for COVID-19 convalescent plasma for the treatment of hospitalised ...
Posted by Michael Wonder on 23 Aug 2020
FDA issues emergency use authorisation for convalescent plasma as potential promising COVID–19 treatment, another achievement in Administration’s fight against pandemic
23 August 2020 - Today, the U.S. FDA issued an emergency use authorisation for investigational convalescent plasma for the treatment ...
Posted by Michael Wonder on 30 Jul 2020
FDA nears decision authorising COVID-19 treatment with convalescent plasma
29 July 2020 - Antibody-rich blood plasma would be one of the first coronavirus treatments to receive approval, which could pave ...
Posted by Michael Wonder on 29 Jun 2020
Successful Eloctaq bid should widen access to the drug in the UK
29 June 2020 - The NHS and Sobi UK have come to an agreement that will give people living with ...
Posted by Michael Wonder on 08 May 2020
HyQvia gets a higher price
8 May 2020 - HyQvia 100 mg/mL solution for injection contains human immunoglobulin, which is an antibody used to strengthen ...
Posted by Michael Wonder on 07 May 2020
CSL Behring Australia commences development of treatment for serious cases of COVID-19
6 May 2020 - Plasma-derived therapeutic with potential to treat serious complications of COVID-19. ...
Posted by Michael Wonder on 06 May 2020
COVID-19: potentially life saving immunoglobulin treatment for seriously ill Australians
6 May 2020 - The Australian Government welcomes the announcement by CSL Behring that Australia will be one of the first ...