Blog
RSS FeedPosted by Michael Wonder on 28 Apr 2021
FDA begins review of GC Pharma’s blood product for marketing authorisation
27 April 2021 - The U.S. FDA has entered a full review of GC Pharma’s intravenous immunoglobulin therapy GC5107 for ...
Posted by Michael Wonder on 05 Apr 2021
FDA approvals strengthen Octapharma USA paediatric critical care product portfolio
30 March 2021 - Octaplas and fibryga receive new product labeling following FDA’s approval of BLA supplements to update therapy ...
Posted by Michael Wonder on 02 Mar 2021
GC Pharma submits biologics license application to US FDA for immune globulin 'GC5107'
25 February 2021 - Submission for entering the world’s largest US marketplace. ...
Posted by Michael Wonder on 01 Mar 2021
LFB announces that the EMA has accepted for filing the marketing authorisation application for eptacog beta (activated), a recombinant coagulation factor VIIa
1 March 2021 - In addition, LFB announces the online publication of the exploratory in vitro study results on eptacog beta ...
Posted by Michael Wonder on 25 Feb 2021
Teleflex announces submission of biologics license application for its investigational freeze dried plasma
24 February 2021 - Submission is eligible for priority review and accelerated approval. ...
Posted by Michael Wonder on 19 Feb 2021
Efanesoctocog alfa granted FDA fast track designation for treatment of haemophilia A
18 February 2021 - Efanesoctocog alfa, previously known as BIVV001, is an investigational factor VIII replacement therapy that has the potential ...
Posted by Michael Wonder on 15 Feb 2021
Pay for plasma collection coming to Alberta by end of the year
14 February 2021 - Repeal of NDP bill last fall clears way for Canadian Plasma Resources to set up shop. ...
Posted by Michael Wonder on 14 Feb 2021
U.S. FDA approves Panzyga for the treatment of adults with chronic inflammatory demyelinating polyneuropathy
12 February 2021 - The first and only FDA approved intravenous immunoglobulin with two maintenance dosing options for chronic inflammatory ...
Posted by Michael Wonder on 03 Dec 2020
Catalyst Biosciences receives FDA fast track designation for subcutaneous MarzAA for the treatment of episodic bleeding in haemophilia A or B with inhibitors
2 December 2020 - Catalyst Biosciences today announced the U.S. FDA has granted fast track designation for marzeptacog alfa (activated) – ...
Posted 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 ...