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RSS FeedPosted by Michael Wonder on 28 Feb 2023
“Killing time” one year on, still no final response from PHARMAC to the independent review
28 February 2023 - Today marks one year since the PHARMAC Review was delivered to then Health Minister Andrew Little. ...
Posted by Michael Wonder on 28 Feb 2023
Axicabtagene ciloleucel for the treatment of adults with diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma after two or more systemic therapies
28 February 2023 - This appraisal reviews the additional evidence collected as part of the Cancer Drugs Fund managed access ...
Posted by Michael Wonder on 27 Feb 2023
Incyte announces positive CHMP opinion for ruxolitinib cream (Opzelura) for the treatment of non-segmental vitiligo in adults and adolescents
24 February 2023 - The positive CHMP opinion is based on Phase 3 data showing treatment with ruxolitinib cream resulted in ...
Posted by Michael Wonder on 27 Feb 2023
AbbVie receives positive CHMP opinion for upadacitinib (Rinvoq) for the treatment of adults with moderate to severe Crohn's disease
27 February 2023 - The positive CHMP opinion for upadacitinib is based on results from two induction studies and one maintenance ...
Posted by Michael Wonder on 26 Feb 2023
Servier receives a positive CHMP opinion for Tibsovo in IDH1 mutated acute myeloid leukaemia and cholangiocarcinoma patients
24 February 2023 - The positive CHMP opinion is based on clinical data from the AGILE (in AML) and ClarIDHy (in ...
Posted by Michael Wonder on 25 Feb 2023
Health technology assessment 2025 and beyond: lifecycle approaches to promote engagement and efficiency in health technology assessment
23 February 2023 - Lifecycle considerations have always been part of health technology assessment. However, the concept of taking a fuller, ...
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
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 23 Feb 2023
Vir Biotechnology announces positive final draft guidance on sotrovimab from the UK’s NICE
22 February 2023 - Final draft guidance based on cost effectiveness evaluation of sotrovimab. ...
Posted by Michael Wonder on 23 Feb 2023
Daratumumab in combination with lenalidomide and dexamethasone for the first-line treatment of patients with multiple myeloma when stem cell transplantation is unsuitable
22 February 2023 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...