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RSS FeedPosted 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 14 Sep 2023
Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
14 September 2023 - EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax vaccine targeting the Omicron XBB.1.5 ...
Posted by Michael Wonder on 10 Sep 2023
European Commission expands Merck’s Ervebo [Ebola Zaire vaccine, live] indication to include children 1 year of age and older
7 September 2023 - Milestone signifies on-going effort to help prepare for outbreaks of Zaire ebolavirus. ...
Posted by Michael Wonder on 05 Sep 2023
SK Bioscience withdraws conditional marketing authorisation for COVID-19 vaccine in EU
4 September 2023 - SK Bioscience said it has voluntarily withdrawn its application for a conditional marketing authorisation license to ...
Posted by Michael Wonder on 30 Aug 2023
EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
30 August 2023 - The EMA’s CHMP has recommended authorising an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant. ...
Posted by Michael Wonder on 30 Aug 2023
European Commission approves Roche’s Evrysdi for babies under two months old with spinal muscular atrophy
29 August 2023 - Approval is based on interim data from ongoing RAINBOWFISH trial showing majority of Evrysdi-treated babies were able ...