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 21 Oct 2022
Pfizer COVID vaccine price hike to boost revenue for years, rivals may follow
21 October 2022 - Pfizer's plan to as much as quadruple US prices for its COVID-19 vaccine next year is ...
Posted by Michael Wonder on 21 Oct 2022
Silverback Therapeutics announces the FDA’s acceptance of ARS Pharmaceuticals’ NDA for neffy (epinephrine nasal spray) for the treatment of allergic reactions (type I) including anaphylaxis
21 October 2022 - neffy has potential to be the first non-injectable medicine indicated to treat allergic reactions (type I) including ...
Posted by Michael Wonder on 21 Oct 2022
US FDA accepts supplemental new drug application for Camzyos (mavacamten) in symptomatic obstructive hypertrophic cardiomyopathy to reduce the need for septal reduction therapy
21 October 2022 - Application based on results from the Phase 3 VALOR-HCM study. ...
Posted by Michael Wonder on 21 Oct 2022
Akeso's ivonescimab granted breakthrough therapy designation by China NMPA for the treatment of advanced NSCLC
20 October 2022 - Akeso announced that the Center for Drug Evaluation of China NMPA has granted breakthrough therapy designation ...
Posted by Michael Wonder on 21 Oct 2022
PBS minimum stockholding requirements
21 October 2022 - Amendments made by the National Health Amendment Act 2021 give effect to the commitments in the new ...
Posted by Michael Wonder on 21 Oct 2022
Leo Pharma announces European Commission approval of Adtralza (tralokinumab) for the treatment of moderate to severe atopic dermatitis in adolescents
20 October 2022 - Adtralza, a biologic that targets and neutralises the interleukin-13 cytokine, is now approved in Europe for adolescents ...
Posted by Michael Wonder on 21 Oct 2022
FDA finalises multiple endpoints guidance
20 October 2022 - The US FDA on Thursday finalised guidance to sponsors on managing multiple outcomes in clinical trials ...
Posted by Michael Wonder on 21 Oct 2022
Revance submits supplemental biologics license application for Daxxify (daxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia
20 October 2022 - Supplemental biologics license application filing based on the pivotal ASPEN Phase 3 program demonstrating Daxxify's median ...
Posted by Michael Wonder on 20 Oct 2022
Drug makers look to limit Medicare’s new power to negotiate lower drug prices
20 October 2022 - Industry tries to ease impact of Inflation Reduction Act, as regulators start to implement the law. ...
Posted by Michael Wonder on 20 Oct 2022
Drugs should be priced based on one factor – value
20 October 2022 - For a number of years, the price of drugs has drawn extraordinary attention. ...
Posted by Michael Wonder on 20 Oct 2022
AbbVie's Skyrizi (risankizumab) receives Health Canada approval as the first and only specific interleukin-23 to treat moderately to severely active Crohn's disease in adults
20 October 2022 - Third approved indication for Skyrizi (rizankizumab) is supported by safety and efficacy data from two induction and ...
Posted by Michael Wonder on 20 Oct 2022
MSAC recommends targeted carrier testing of certain ethic people for severe monogenic conditions
20 October 2022 - An 'eventful' week for Jewish people in Australia. ...
Posted by Michael Wonder on 20 Oct 2022
ICER publishes final evidence report and policy recommendations on treatments for obesity management
20 October 2022 - Independent appraisal committee voted that evidence is adequate to demonstrate that semaglutide provides a net health benefit ...
Posted by Michael Wonder on 20 Oct 2022
Consultation on the revised PBS post-market review framework
20 October 2022 - The Department of Health and Aged Care is inviting stakeholders to provide feedback on a revised ...
Posted by Michael Wonder on 20 Oct 2022
ICER evaluates drug price increases in California
20 October 2022 - Unsupported Price Increase” final report based on drugs identified through SB-17, the California drug price transparency law. ...