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RSS FeedPosted by Michael Wonder on 18 Sep 2023
BioMarin receives positive CHMP opinion in Europe to expand use of Voxzogo (vosoritide) to treat children aged 4 months and older with achondroplasia
15 September 2023 - BioMarin today announced that the EMA's CHMP has adopted a positive opinion recommending marketing authorisation to expand ...
Posted by Michael Wonder on 18 Sep 2023
Ascendis Pharma receives positive CHMP opinion for TransCon PTH (palopegteriparatide) for adults with chronic hypoparathyroidism
14 September 2023 - Final European Commission decision expected within 67 days after positive opinion; if approved, first European Union ...
Posted by Michael Wonder on 18 Sep 2023
Sandoz receives positive CHMP opinion for breast and gastric cancer biosimilar trastuzumab
18 September 2023 - Positive CHMP opinion based on comprehensive package of analytical, pre-clinical and clinical data. ...
Posted by Michael Wonder on 17 Sep 2023
Highlights from the 11-14 September 2023 CHMP meeting
15 September 2023 - The EMA’s CHMP recommended nine medicines for approval at its September 2023 meeting. ...
Posted by Michael Wonder on 16 Sep 2023
argenx announces positive CHMP opinion for subcutaneous efgartigimod for generalised myasthenia gravis
15 September 2023 - Positive opinion based on Phase 3 ADAPT-SC study demonstrating non-inferior total IgG reduction at day 29 with ...
Posted by Michael Wonder on 16 Sep 2023
Quizartinib recommended for approval in EU by CHMP for patients with newly diagnosed FLT3-ITD positive AML
15 September 2023 - Positive opinion based on QuANTUM-First results demonstrating quizartinib combined with standard chemotherapy improved overall survival. ...
Posted by Michael Wonder on 16 Sep 2023
EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
15 September 2023 - EMA’s human medicines committee (CHMP) has recommended not renewing the marketing authorisation for Translarna (ataluren), a ...
Posted by Michael Wonder on 16 Sep 2023
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) as adjuvant treatment for adults with non-small cell lung cancer at high risk of recurrence following complete resection and platinum-based chemotherapy
15 September 2023 - Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial. ...
Posted by Michael Wonder on 16 Sep 2023
Vertex receives CHMP positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor for children with cystic fibrosis ages 2 through 5
15 September 2023 - If approved, more than 1,200 children would be newly eligible for a medicine that could treat ...
Posted by Michael Wonder on 15 Sep 2023
Enhertu recommended for approval in the EU by CHMP for patients with HER2 mutant advanced non-small cell lung cancer
15 September 2023 - Recommendation based on DESTINY-Lung02 trial results which showed AstraZeneca and Daiichi Sankyo’s Enhertu achieved strong and durable ...
Posted by Michael Wonder on 15 Sep 2023
UCB receives CHMP positive opinion of zilucoplan for the treatment of adults with generalized myasthenia gravis in Europe
15 September 2023 - The CHMP positive opinion is based on the pivotal Phase 3 RAISE study in generalised myasthenia gravis ...
Posted by Michael Wonder on 15 Sep 2023
EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep
15 September 2023 - The CHMP has recommended not renewing the conditional marketing authorisation for Blenrep (belantamab mafodotin), a medicine ...
Posted by Michael Wonder on 13 Sep 2023
European Medicines Agency validates type II variation for Astellas' Xtandi (enzalutamide) for treatment of non-metastatic hormone sensitive prostate cancer with high risk biochemical recurrence
13 September 2023 - Application based on results from Phase 3 EMBARK trial, which showed Xtandi plus leuprolide reduced risk ...
Posted by Michael Wonder on 11 Sep 2023
EMA publishes agenda for 11-14 September 2023 CHMP meeting
11 September 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 09 Sep 2023
Janssen submits marketing authorisation application to the EMA seeking approval of erdafitinib for the treatment of patients with locally advanced or metastatic urothelial cancer with susceptible FGFR alterations
8 September 2023 - The submission is based on results from the Phase 3 THOR study, which were featured in ...