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 10 Feb 2022
Bayer receives U.S. FDA fast track designation for asundexian stroke program
10 February 2022 - Bayer today announced that the U.S. FDA has granted fast track designation for its investigational drug ...
Posted by Michael Wonder on 10 Feb 2022
ATAGI update following weekly COVID-19 meeting – 9 February 2022
10 February 2022 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their weekly meeting on 9 ...
Posted by Michael Wonder on 10 Feb 2022
FDA accepts Dupixent (dupilumab) for priority review in children aged 6 months to 5 years with moderate to severe atopic dermatitis
10 February 2022 - If approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled ...
Posted by Michael Wonder on 10 Feb 2022
New life-extending drug for advanced womb cancer to be rolled out on the NHS
8 February 2022 - A 30 minute treatment, the first of its kind for advanced womb cancer, is being rolled ...
Posted by Michael Wonder on 10 Feb 2022
COVID-19 vaccine weekly safety report (10 February 2022)
10 February 2022 - To 6 February 2022, the TGA has received 446 reports which have been assessed as likely to ...
Posted by Michael Wonder on 10 Feb 2022
Gamida Cell initiates rolling submission of biologics license application for omidubicel
9 February 2022 - Gamida Cell today announced that it has initiated the biologics license application rolling submission process with the ...
Posted by Michael Wonder on 10 Feb 2022
BioMarin sells priority review voucher for $110 million
9 February 2022 - BioMarin Pharmaceutical today announced that it has entered into a definitive agreement with an undisclosed purchaser to ...
Posted by Michael Wonder on 10 Feb 2022
A new way to contain unaffordable medication costs - exercising the Government’s existing rights
9 February 2022 - Existing laws could be used to help make many drugs more affordable. ...
Posted by Michael Wonder on 10 Feb 2022
National Medicines Policy too important to be rushed before Federal Election
10 February 2022 - Following consultation with members – and heeding the concerns of the Consumers Health Forum and patient ...
Posted by Michael Wonder on 09 Feb 2022
Novavax underdelivers on COVID vaccine promises
9 February 2022 - Novavax has delivered just a small fraction of the 2 billion COVID-19 shots it plans to ...
Posted by Michael Wonder on 09 Feb 2022
Topic selection process in health technology assessment agencies around the world: a systematic review
7 February 2022 - The purpose of this study was to systematically review the process for topic selection by health technology ...
Posted by Michael Wonder on 09 Feb 2022
Nova Scotia becomes fifth Canadian province to implement a biosimilar switching program
5 February 2022 - The province is the latest jurisdiction to adopt a program that will require patients to switch ...
Posted by Michael Wonder on 09 Feb 2022
FDA awards QIDP designation for prevention of chlamydia to Evofem Biosciences
9 February 2022 - Adds five years of market exclusivity on approval. ...
Posted by Michael Wonder on 09 Feb 2022
EU ramps up collection of public health data to improve drug reviews
9 February 2022 - By 2025, centre is set to conduct over 100 studies per year. ...
Posted by Michael Wonder on 09 Feb 2022
FDA raises concerns about China developed drugs
9 February 2022 - Agency could slow the plans of big Western drugmakers to sell Chinese tested medicines in U.S. ...