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 08 Jun 2021
Moderna files for conditional marketing approval for its COVID-19 vaccine in adolescents in the European Union
7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...
Posted by Michael Wonder on 08 Jun 2021
Health Canada approves AbbVie's Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis
7 June 2021 - Approval supported by efficacy and safety data of two pivotal Phase 3 trials in which Rinvoq demonstrated ...
Posted by Michael Wonder on 07 Jun 2021
America’s wary approval of an Alzheimer’s drug offers hope to millions
7 June 2021 - But its makers still have work to do to prove it can slow the advance of dementia. ...
Posted by Michael Wonder on 07 Jun 2021
Alexion announces FDA approval of Ultomiris (ravulizumab-cwvz) for children and adolescents with paroxysmal nocturnal haemoglobinuria
7 June 2021 - Approval based on interim results from Phase 3 study showing Ultomiris demonstrated complete terminal complement inhibition through ...
Posted by Michael Wonder on 07 Jun 2021
Medicare rebate changes for surgeries kick in next month, but doctors say more time is needed
7 June 2021 - One of the biggest overhauls of the Medicare rebate system in decades is set to kick ...
Posted by Michael Wonder on 07 Jun 2021
Limiting coverage based on efficacy and safety: a path forward for Medicare regarding the Alzheimer’s treatment aducanumab
7 June 2021 - Today, the FDA will announce a decision on whether to approve the biologic aducanumab, intended to alleviate ...
Posted by Michael Wonder on 07 Jun 2021
Proposed refinements to the regulation of personalised medical devices
7 June 2021 - Regulatory changes introducing a new framework for the regulation of personalised medical devices commenced on 25 ...
Posted by Michael Wonder on 07 Jun 2021
SMC - June 2021 decisions
7 June 2021 - Advice on five new medicines for use in conditions including advanced gastric cancer and chronic lymphocytic leukaemia ...
Posted by Michael Wonder on 07 Jun 2021
Queensland pharmacies join rollout, 1 million regional vaccines delivered
7 June 2021 - More rural and remote Queenslanders will be rolling up their sleeves as local pharmacies join the national ...
Posted by Michael Wonder on 07 Jun 2021
Safer and more effective shingles vaccine will be available to Aussies - but it won’t come cheap
8 June 2021 - A new shingles vaccine almost twice as effective as the one currently available to Australians will ...
Posted by Michael Wonder on 07 Jun 2021
ICER issues statement on the FDA’s approval of aducanumab for Alzheimer’s disease
7 June 2021 - The ICER believes that the FDA, in approving aducanumab (Aduhelm, Biogen) for the treatment of Alzheimer’s ...
Posted by Michael Wonder on 07 Jun 2021
FDA grants accelerated approval for Alzheimer’s drug
7 June 2021 - Today, the U.S. FDA approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 ...
Posted by Michael Wonder on 07 Jun 2021
Innovative regenerative medicine therapies – patient safety comes first
3 June 2021 - The U.S. FDA continues to facilitate the development and availability of innovative medical products, such as regenerative ...
Posted by Michael Wonder on 07 Jun 2021
MHRA authorises Pfizer/BioNTech’s COVID-19 vaccine for 12 to 15 year-olds
7 June 2021 - The UK MHRA has extended the authorisation of Pfizer/BioNTech’s COVID-19 vaccine for use in children aged ...
Posted by Michael Wonder on 07 Jun 2021
GSK’s PD-1 inhibitor Jemperli approved in the UK
7 June 2021 - GSK's PD-1 inhibitor Jemperli has been authorised by the UK MHRA for the treatment of recurrent ...