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 Aug 2021
National Medicines Policy Review Committee and Terms of Reference
3 August 2021 - The National Medicines Policy has influenced a number of important strategies, frameworks and programs developed since ...
Posted by Michael Wonder on 02 Aug 2021
FDA’s Pazdur challenges attack on accelerated approval program
2 August 2021 - In response to continued criticism of FDA’s initiative to make promising new therapies available to seriously ill ...
Posted by Michael Wonder on 02 Aug 2021
Novartis’ psoriatic arthritis drug to get expanded reimbursement
2 August 2021 - Novartis Korea said Monday its interleukin-17a inhibitor Cosentyx (secukinumab) began receiving reimbursement as a first-line biologics ...
Posted by Michael Wonder on 02 Aug 2021
Pfizer, Moderna raise prices of COVID-19 coronavirus vaccines for European Union
1 August 2021 - What’s the best way to get more people vaccinated against COVID-19 to try to end the ...
Posted by Michael Wonder on 02 Aug 2021
NICE approves first treatment in pilot of new approach to cost comparison fast track appraisals
2 August 2021 - As part of the recovery from the COVID-19 pandemic, NICE has been working hard to find new ...
Posted by Michael Wonder on 02 Aug 2021
UCB’s bimekizumab issued NICE recommendation for severe plaque psoriasis
2 August 2021 - NICE has issued a Final Appraisal Determination recommending UCB’s bimekizumab as an option for the treatment ...
Posted by Michael Wonder on 02 Aug 2021
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) as adjuvant treatment for oesophageal or gastro-oesophageal junction cancer patients with residual pathologic disease following chemoradiotherapy
30 July 2021 - Approval is based on Phase 3 results from the CheckMate-577 trial. ...
Posted by Michael Wonder on 02 Aug 2021
Alkermes receives FDA fast track designation for nemvaleukin alfa for the treatment of mucosal melanoma
2 August 2021 - Alkermes today announced that the U.S. FDA has granted fast track designation to nemvaleukin alfa, the ...
Posted by Michael Wonder on 02 Aug 2021
Working towards harmonised access to clinical trial data across European drug regulatory agencies
31 July 2021 - On 31 May 2021, a group of researchers and NGOs submitted an open letter to the ...
Posted by Michael Wonder on 02 Aug 2021
GSK receives authorization under Health Canada's Interim Order for sotrovimab for Injection to treat COVID-19 in high-risk adults and adolescents
30 July 2021 - GSK announced today that Health Canada has granted an Interim Order Authorisation for sotrovimab for Injection (sotrovimab, ...
Posted by Michael Wonder on 02 Aug 2021
Benlysta now approved in Canada in addition to standard therapy for treatment of active lupus nephritis in adult patients
30 July 2021 - Benlysta (belimumab) has been approved in Canada for the treatment of active lupus nephritis in adult ...
Posted by Michael Wonder on 02 Aug 2021
Six month countdown to go live for the Clinical Trials Information System
2 August 2021 - The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and ...
Posted by Michael Wonder on 02 Aug 2021
Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus
2 August 2021 - Saphnelo is a first in class type I interferon receptor antibody and the only new medicine ...
Posted by Michael Wonder on 02 Aug 2021
ATAGI statement regarding vaccination of adolescents aged 12–15 years
2 August 2021 - Following the recent approval by the TGA for the provisional registration of the Comirnaty (Pfizer) COVID-19 vaccine ...
Posted by Michael Wonder on 02 Aug 2021
Government subsidises medicine to combat high cholesterol in ‘high-risk’ Australians
1 August 2021 - Experts are welcoming the PBS listing of a medicine that helps reduce unacceptably high ‘bad cholesterol’ ...