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 25 Feb 2023
Review of National Hospital Funding Agreement
24 February 2023 - The five-year agreement on public hospital funding between the Australian Government and all states and territories is ...
Posted by Michael Wonder on 25 Feb 2023
AI developers battle with FDA, what’s next with Amazon and One Medical, & protecting wearables data
23 February 2023 - Health tech companies are in a tizzy. After years of letting companies roll out software tools to ...
Posted by Michael Wonder on 24 Feb 2023
Highlights from the 20-23 February 2023 CHMP meeting
24 February 2023 - Eight new medicines recommended for approval ...
Posted by Michael Wonder on 24 Feb 2023
Merck and Ridgeback provide update on EU marketing authorisation application for Lagevrio (molnupiravir)
24 February 2023 - Merck and Ridgeback Biotherapeutics today announced that the CHMP of the EMA has recommended the refusal ...
Posted by Michael Wonder on 24 Feb 2023
Enhertu approved in China for patients with HER2 positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens
24 February 2023 - First approval for AstraZeneca and Daiichi Sankyo’s Enhertu in China. ...
Posted by Michael Wonder on 24 Feb 2023
Member of Canada’s drug pricing regulator quits over ‘lack of support’ for medicine cost reforms
23 February 2023 - A member of the Patented Medicine Prices Review Board, Canada’s drug pricing regulator, has resigned over ...
Posted by Michael Wonder on 24 Feb 2023
Libtayo (cemiplimab) in combination with chemotherapy receives positive CHMP opinion for the treatment of advanced PD-L1 positive non-small cell lung cancer
24 February 2023 - Recommendation based on a Phase 3 trial demonstrating superior survival outcomes for Libtayo plus chemotherapy compared to ...
Posted by Michael Wonder on 24 Feb 2023
Chiesi Global Rare Diseases and Protalix BioTherapeutics receive positive CHMP opinion for pegunigalsidase alfa for treatment of Fabry disease
24 February 2023 - European Commission decision anticipated in beginning of May 2023. ...
Posted by Michael Wonder on 24 Feb 2023
Janssen receives positive CHMP opinion for Akeega (niraparib and abiraterone acetate dual action tablet) plus prednisone or prednisolone for the treatment of adult patients with BRCA1/2 gene mutated metastatic castration resistant prostate cancer
24 February 2023 - The positive CHMP opinion is based on results from the Phase 3 MAGNITUDE study where the ...
Posted by Michael Wonder on 24 Feb 2023
Akebia receives positive CHMP opinion in Europe for Vafseo (vadadustat) for the treatment of symptomatic anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis
23 February 2023 - Akebia Therapeutics today announced that the CHMP of the EMA has adopted a positive opinion recommending ...
Posted by Michael Wonder on 24 Feb 2023
Recommendations made out of session by the PBAC November 2022 and March 2023 meetings
24 February 2023 - Recommendations made out of session by the PBAC between its November 2022 and March 2023 meetings are ...
Posted by Michael Wonder on 24 Feb 2023
FDA approves once weekly Altuviiio, a new class of factor VIII therapy for haemophilia A that offers significant bleed protection
23 February 2023 - FDA approves once weekly Altuviiio, a new class of factor VIII therapy for haemophilia A that ...
Posted by Michael Wonder on 24 Feb 2023
ViiV Healthcare receives EU marketing authorisation for Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once daily treatment for Children living with HIV in Europe
23 February 2023 - The authorisation is an important step to meet ViiV Healthcare’s commitment to bring paediatric formulations to children ...
Posted by Michael Wonder on 23 Feb 2023
US FDA approves Sanofi's bleeding disorder therapy
24 February 2023 - The US FDA has approved French drug maker Sanofi's therapy to treat a type of inherited ...
Posted by Michael Wonder on 23 Feb 2023
Arcutis submits roflumilast 0.3% topical foam new drug application to the FDA for the treatment of seborrheic dermatitis in adults and adolescents
21 February 2023 - In a pivotal Phase 3 trial, 80% of individuals treated with roflumilast foam achieved IGA success at ...