Blog
RSS FeedPosted by Michael Wonder on 09 Nov 2020
Liminal BioSciences announces FDA extension of review period for Ryplazim (plasminogen) BLA
9 November 2020 - PDUFA date extended by FDA from 5 March 2021 to 5 June 2021. ...
Posted by Michael Wonder on 31 Oct 2020
Extra transparency measures for COVID-19 vaccines and therapeutics
30 October 2020 - Today the EMA has implemented two further extra transparency measures for COVID-19 medicines, by publishing both ...
Posted by Michael Wonder on 28 Oct 2020
Lilly announces agreement with U.S. government to supply 300,000 vials of investigational neutralising antibody bamlanivimab (LY-CoV555) in an effort to fight COVID-19
28 October 2020 - Initial agreement for 300,000 vials with potential for purchase of an additional 650,000 vials. ...
Posted by Michael Wonder on 21 Oct 2020
Trump’s antibody ‘cure’ will be in short supply
20 October 2020 - All the weak points of American health care — testing delays, communication breakdowns, inequity — are working ...
Posted by Michael Wonder on 19 Oct 2020
Octapharma announces FDA approval of updated Nuwiq Prescribing Information to include immunogenicity data in previously untreated patients
19 October 2020 - Octapharma is pleased to announce that the U.S. FDA has approved an updated Prescribing Information for Nuwiq, ...
Posted by Michael Wonder on 08 Oct 2020
Regeneron asks FDA for emergency approval for drug that Trump claimed cured him
7 October 2020 - The company said that doses of the unproven treatment would be available for 50,000 patients. It’s impossible ...
Posted 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 ...