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 09 Aug 2021
Forxiga approved in the EU for the treatment of chronic kidney disease in patients with and without type 2 diabetes mellitus
9 August 2021 - Approval based on unprecedented DAPA-CKD Phase 3 data is the most significant advancement in chronic kidney ...
Posted by Michael Wonder on 09 Aug 2021
Barriers to US biosimilar market growth: lessons from biosimilar patent litigation
6 August 2021 - High biologic drug prices have placed substantial strain on the US health care system. ...
Posted by Michael Wonder on 09 Aug 2021
Japan drug maker Shionogi to seek approval for oral COVID-19 drug
6 August 2021 - Pharmaceutical firm Shionogi plans to seek state approval for its oral coronavirus drug by the end ...
Posted by Michael Wonder on 09 Aug 2021
Competition from biosimilars drives price reductions for biologics in the French single payer health system
6 August 2021 - France has a single payer health insurance system that has the authority to impose pharmaceutical price reductions ...
Posted by Michael Wonder on 09 Aug 2021
Version 4 and counting
9 August 2021 - The Department of Health has published yet another revised agenda for the November 2021 PBAC meeting. ...
Posted by Michael Wonder on 09 Aug 2021
Quality assurance requirements of the G-BA also apply to new CAR-T cell therapy
5 August 2021 - The Federal Joint Committee (G-BA) today evaluated the new cancer drug with the trade name Tecartus and ...
Posted by Michael Wonder on 09 Aug 2021
COVID-19 vaccine: international collaboration
6 August 2021 - The Therapeutic Goods Administration has strong working relationships with a wide range of international agencies and ...
Posted by Michael Wonder on 08 Aug 2021
Biden yet to nominate new FDA chief even as delta surges
8 August 2021 - President Biden has yet to nominate a permanent head of the FDA at a time when ...
Posted by Michael Wonder on 08 Aug 2021
US tropical disease priority review vouchers: lessons in promoting drug development and access
6 August 2021 - The COVID-19 global pandemic has devastated lives and economies. It has served as a reminder of how ...
Posted by Michael Wonder on 08 Aug 2021
New contraceptive pill: ‘safer’ Slinda pill with no blood clot risk, no periods available in Australia
8 August 2021 - A new generation contraceptive pill with no blood clot risks, that can be used by almost all ...
Posted by Michael Wonder on 08 Aug 2021
Additional COVID-19 treatment for Australia
8 August 2021 - The Australian Government has secured an initial shipment of over 7,700 doses of the novel monoclonal ...
Posted by Michael Wonder on 08 Aug 2021
Moderna vaccine set to be available in Australia by September
8 August 2021 - Australians will have a third vaccine option within weeks, with the country’s drug regulator set to ...
Posted by Michael Wonder on 08 Aug 2021
Novavax booster doses to soon join stockpile
6 August 2021 - Novavax will apply for approval for its COVID-19 vaccine in Australia “within weeks” of making a ...
Posted by Michael Wonder on 06 Aug 2021
Actuate Therapeutics announces FDA fast track designation for 9-ING-41 for treatment of pancreatic cancer
5 August 2021 - Actuate Therapeutics today announced that the U.S. FDA has granted fast track designation for 9-ING-41 for treatment ...
Posted by Michael Wonder on 06 Aug 2021
FDA approves new treatment for Pompe disease
6 August 2021 - Today, the U.S. FDA approved Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year of ...