Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 06 Oct 2021
Aetion and NICE announce collaboration to explore use of real world evidence for comparative effectiveness studies to inform clinical guidance
6 October 2021 - Collaboration will leverage the Aetion Evidence Platform to study when and how real world evidence can support ...
Posted by Michael Wonder on 06 Oct 2021
Acer Therapeutics and Relief Therapeutics announce FDA acceptance for filing of new drug application for ACER-001 to treat urea cycle disorders
6 October 2021 - FDA sets PDUFA target action date of June 5, 2022. ...
Posted by Michael Wonder on 06 Oct 2021
Complete response letter received from FDA
6 October 2021 - Requirement to address approvability issues identified by FDA ahead of NDA resubmission ...
Posted by Michael Wonder on 06 Oct 2021
Where has PHARMAC gone?
7 October 2021 - As debate has intensified over the last year or so about the procurement of New Zealand’s ...
Posted by Michael Wonder on 06 Oct 2021
Moderna announces European Medicines Agency authorises third dose of COVID-19 vaccine for immunocompromised individuals aged 12 years and older
5 October 2021 - Moderna today announced that the EMA has authorised a third dose of the Moderna COVID-19 vaccine (Spikevax) ...
Posted by Michael Wonder on 06 Oct 2021
NICE terminates another appraisal for a Roche medicine
6 October 2021 - The sixth termination of the appraisal of a Roche medicine. ...
Posted by Michael Wonder on 06 Oct 2021
EMA to consider rolling review for Merck's molnupiravir in coming days
5 October 2021 - The EMA will consider in the coming days whether to launch a rolling review of Merck's ...
Posted by Michael Wonder on 06 Oct 2021
Johnson & Johnson announces submission of emergency use authorisation amendment to the U.S. FDA to support booster of its single shot COVID-19 vaccine
5 October 2021 - Submission includes data showing a booster increased protection to 94% against moderate to severe/critical COVID-19 in the ...
Posted by Michael Wonder on 06 Oct 2021
Australian Government buys 300,000 doses of Merck COVID-19 treatment drug molnupiravir that has not yet been approved
5 October 2021 - While Australia is still trying to reach its COVID-19 vaccination targets, treatment options for the virus ...
Posted by Michael Wonder on 06 Oct 2021
Australia secures additional supplies of sotrovimab
4 October 2021 - The Australian Government has increased supplies of the promising COVID-19 treatment sotrovimab with over 15,000 additional doses ...
Posted by Michael Wonder on 06 Oct 2021
Amber Implants VCFix spinal system receives US FDA breakthrough designation
5 October 2021 - Set to vastly improve treatment of vertebral fractures. ...
Posted by Michael Wonder on 06 Oct 2021
US FDA grants fast track designation for JR-171 for the treatment of mucopolysaccaridosis type I
5 October 2021 - JCR Pharmaceuticals announced today that the US FDA has granted fast track designation for the investigational drug ...
Posted by Michael Wonder on 05 Oct 2021
AZD7442 request for emergency use authorisation for COVID-19 prophylaxis filed in US
5 October 2021 - Filing includes data from PROVENT Phase 3 trial showing 77% reduction in risk of developing symptomatic COVID-19 ...
Posted by Michael Wonder on 05 Oct 2021
The Product Monograph for Protopic has been updated
4 October 2021 - LEO Pharma Inc. today announced that Health Canada has approved an update to the Product Monograph of ...
Posted by Michael Wonder on 05 Oct 2021
Nivolumab and ipilimumab: added benefit in pleural mesothelioma with non-epithelioid tumour histology
1 October 2021 - For the first time, a pure antibody combination has been approved as a first-line therapy for ...