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 03 Dec 2020
Australia 'ahead of schedule' on COVID-19 vaccine plan
3 December 2020 - Australia could approve a COVID-19 vaccine almost two months ahead of schedule, the head of the ...
Posted by Michael Wonder on 03 Dec 2020
Janssen seeks Health Canada approval for its COVID-19 vaccine
1 December 2020 - Regulator currently evaluating data from 4 vaccine makers. ...
Posted by Michael Wonder on 03 Dec 2020
Pushed to rush, FDA head says feds will get vaccine 'right'
2 December 2020 - The head of the agency responsible for authorising COVID-19 vaccines says it will take the time needed ...
Posted by Michael Wonder on 03 Dec 2020
Incomplete data stalls Swiss authorisation of COVID-19 vaccines
3 December 2020 - Switzerland’s medical regulator Swissmedic says it lacks the necessary information to sign off on three different coronavirus ...
Posted by Michael Wonder on 02 Dec 2020
IQWiG publishes 1,000th report
2 December 2020 - In the 16th year of its existence, IQWiG has published its 1,000th report: a dossier assessment ...
Posted by Michael Wonder on 02 Dec 2020
Trump to meet next week with industry, government officials on COVID vaccine
2 December 2020 - President Donald Trump will gather leaders from industry and government next week for a summit on the ...
Posted by Michael Wonder on 02 Dec 2020
BridgeBio Pharma and Affiliate QED Therapeutics announce FDA acceptance of new drug application for infigratinib for the treatment of cholangiocarcinoma
1 December 2020 - Application will also be submitted for review in Australia and Canada under Project Orbis. ...
Posted by Michael Wonder on 02 Dec 2020
Amicus Therapeutics initiates rolling biologic license application to the U.S. FDA for AT-GAA in late-onset Pompe disease
1 December 2020 - On track for completing the BLA submission in 1H2021. ...
Posted by Michael Wonder on 02 Dec 2020
What the UK's COVID-19 vaccine means for Australia
2 December 2020 - The race for a COVID-19 vaccine appears to have hit the final stretch, with the UK ...
Posted by Michael Wonder on 02 Dec 2020
International reference pricing: a lazy, misguided, bi-partisan plan to lower US drug prices
2 December 2020 - Pharmaceutical pricing is a perpetually contentious policy issue. Branded drug list prices grew annually by 9.1% over ...
Posted by Michael Wonder on 02 Dec 2020
COVID-19: Australia on track for Pfizer vaccine in March
2 December 2020 - Health Minister Greg Hunt says the UK’s approval of the Pfizer vaccine, to be rolled out from ...
Posted by Michael Wonder on 02 Dec 2020
TGA statement on UK government emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer and BioNTech
2 December 2020 - The TGA notes the emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer ...
Posted by Michael Wonder on 02 Dec 2020
PHARMAC boss to talk with Crohn’s sufferers protesting for drug funding
2 December 2020 - The head of the government's drug-buying agency says they would like to have the budget to fund ...
Posted by Michael Wonder on 02 Dec 2020
Health Canada licenses Xeomin (incobotulinumtoxinA) for adult patients with sialorrhea
1 December 2020 - Merz Therapeutics today announced Health Canada’s notice of compliance for Xeomin (incobotulinumtoxinA) for the treatment of chronic ...
Posted by Michael Wonder on 02 Dec 2020
FDA approves Hetlioz (tasimelteon) for the treatment of nighttime sleep disturbances in Smith-Magenis syndrome
1 December 2020 - Vanda Pharmaceuticals today announced that the U.S. FDA has approved Hetlioz (tasimelteon) capsule and liquid formulations for ...