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 07 Oct 2021
Ban on negotiating Medicare drug prices under pressure
7 October 2021 - Negotiating Medicare drug prices is a linchpin of President Joe Biden's ambitious health care agenda. ...
Posted by Michael Wonder on 07 Oct 2021
Mayne Pharma provides FDA update on generic Nuvaring
7 October 2021 - Mayne Pharma has received a complete response letter from the US FDA in relation to its ...
Posted by Michael Wonder on 07 Oct 2021
Joint statement: supply allocations of intravenous tocilizumab (Actemra) during serious shortage
7 October 2021 - Roche, the sponsor of tocilizumab (Actemra), notified the TGA of shortages of multiple presentations of tocilizumab ...
Posted by Michael Wonder on 07 Oct 2021
COVID-19 vaccine weekly safety report (7 October 2021)
7 October 2021 - To 3 October 2021, approximately 28.8 million vaccine doses have been given in Australia 17 million first ...
Posted by Michael Wonder on 07 Oct 2021
Moderna asks Health Canada to approve COVID-19 vaccine booster shot
5 October 2021 - Moderna has applied for Canadian approval of a third dose of its COVID-19 vaccine, the company ...
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 ...