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 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 ...
Posted by Michael Wonder on 02 Dec 2020
TG Therapeutics initiates rolling submission of biologics license application to U.S. FDA for ublituximab in combination with umbralisib as a treatment for patients with chronic lymphocytic leukaemia
1 December 2020 - Completion of rolling submission for the BLA expected in 1H21. ...
Posted by Michael Wonder on 02 Dec 2020
Britain becomes the first country to license a fully tested COVID-19 vaccine
1 December 2020 - Inoculations with the Pfizer-BioNTech jab could start in less than a week. ...
Posted by Michael Wonder on 02 Dec 2020
UK approves Pfizer/BioNTech’s COVID-19 vaccine
2 November 2020 - The UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) has authorised Pfizer/BioNTech’s COVID-19 vaccine BNT162b2 for ...
Posted by Michael Wonder on 01 Dec 2020
Ipsen receives FDA fast track designation for investigational irinotecan liposome injection (Onivyde) as a second-line monotherapy treatment for small cell lung cancer
30 November 2020 - Ipsen today announced the United States FDA has granted the company fast track designation for irinotecan liposome ...
Posted by Michael Wonder on 01 Dec 2020
VBI Vaccines announces submission of biologics license application to FDA for 3 antigen prophylactic hepatitis B vaccine
1 December 2020 - VBI Vaccines today announced the submission of a biologics license application to the U.S. FDA seeking approval ...
Posted by Michael Wonder on 01 Dec 2020
EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S
1 December 2020 - EMA’s CHMP has started a rolling review of Ad26.COV2.S, a COVID-19 vaccine from Janssen-Cilag. ...
Posted by Michael Wonder on 01 Dec 2020
Genentech announces FDA approval of Xolair (omalizumab) for adults with nasal polyps
1 December 2020 - Xolair is the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E, ...