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 20 Aug 2022
Fresenius Kabi announces acceptance of its marketing authorisation application by the European Medicines Agency for MSB11456, a tocilizumab biosimilar candidate
18 August 2022 - Fresenius Kabi announced today that its marketing authorisation application for MSB11456, the company’s tocilizumab biosimilar candidate, ...
Posted by Michael Wonder on 19 Aug 2022
European Commission approves Oncopeptides' Pepaxti for the treatment of patients with relapsed refractory multiple myeloma
18 August 2022 - Oncopeptides today announces that the European Commission has granted Pepaxti (melphalan flufenamide) marketing authorisation in combination ...
Posted by Michael Wonder on 19 Aug 2022
Recommendations made by the PBAC - July 2022
19 August 2022 - The recommendations from the July 2022 PBAC meeting are now available. ...
Posted by Michael Wonder on 19 Aug 2022
FDA accepts Krystal Biotech’s biologics license application for dystrophic epidermolysis bullosa
18 August 2022 - FDA granted priority review designation. ...
Posted by Michael Wonder on 19 Aug 2022
1 September 2022 updates as part of the digital transformation of authority required (written) PBS listings
19 August 2022 - From 1 September 2022, the PBS listings for certain cancer medicines will be updated as part of ...
Posted by Michael Wonder on 19 Aug 2022
Aeglea BioTherapeutics announces European Medicines Agency validation of marketing authorisation application for pegzilarginase for the treatment of arginase 1 deficiency
18 August 2022 - Aeglea BioTherapeutics today announced that a marketing authorisation application for pegzilarginase for the treatment of arginase 1 ...
Posted by Michael Wonder on 18 Aug 2022
Stability of changes in health status: next step in comprehensively assessing patient reported outcomes
18 August 2022 - Chronic diseases can impair patients’ health status due to symptoms, functional limitations, and impaired quality of life. ...
Posted by Michael Wonder on 18 Aug 2022
Canadians seek diabetes medication as replacement for weight loss drug during arrival delays
18 August 2022 - High demand in the United States for a new weight-loss medication has indefinitely delayed its arrival ...
Posted by Michael Wonder on 18 Aug 2022
AARP Pennsylvania convenes discussion on lower prescription drug costs after Inflation Reduction Act signed into law
18 August 2022 - Senator Bob Casey joins AARP Discussion. ...
Posted by Michael Wonder on 18 Aug 2022
Caps on prescription drug price hikes most popular aspect of Inflation Reduction Act: poll
18 August 2022 - A cap on prescription drug price increases is the most popular part of the Inflation Reduction ...
Posted by Michael Wonder on 18 Aug 2022
CSL Vifor plans UK launch after NICE backs rare disease drug Tavneos
18 August 2022 - UK cost-effectiveness organisation NICE has recommended routine NHS use of a recently approved therapy for two ...
Posted by Michael Wonder on 18 Aug 2022
Chiesi’s Trimbow recommended for use within NHS Scotland
18 August 2022 - The SMC approval brings much needed boost to asthma sufferers across Scotland. ...
Posted by Michael Wonder on 18 Aug 2022
EMA starts review of conditional marketing authorisation application for Skycovion COVID-19 vaccine
18 August 2022 - The EMA’s CHMP has started a review of a conditional marketing authorisation application for Skycovion, a ...
Posted by Michael Wonder on 18 Aug 2022
Restart of National Medicines Policy Review is welcome, but assurances needed over further consultation and feedback processes
18 August 2022 - Medicines Australia welcomes the restart of the National Medicines Policy Review, which was put on hold ...
Posted by Michael Wonder on 18 Aug 2022
Valneva initiates rolling submission of FDA biologics license application for its single shot Chikungunya vaccine candidate
18 August 2022 - Valneva today announces that it has initiated rolling submission of the biologics license application to the ...