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RSS FeedPosted by Michael Wonder on 21 Sep 2022
Tezspire approved in the EU for the treatment of severe asthma
21 September 2022 - First and only biologic approved in the EU in patients with severe asthma with no phenotype ...
Posted by Michael Wonder on 20 Sep 2022
CHMP adopts positive opinion for Mycapssa for the treatment of acromegaly
16 September 2022 - Positive opinion based on MPOWERED Phase 3 trial. ...
Posted by Michael Wonder on 20 Sep 2022
EMA accepts MediWound’s application for extended indication for NexoBrid to treat paediatric patients with severe thermal burns
20 September 2022 - Upon approval, NexoBrid will serve as a safe and effective non-surgical treatment option in the EU for ...
Posted by Michael Wonder on 20 Sep 2022
Aurinia announces European Commission approval of Lupkynis (voclosporin) for the treatment of lupus nephritis
19 September 2022 - Lupkynis is the first oral medicine approved in both the US and Europe for the treatment of ...
Posted by Michael Wonder on 20 Sep 2022
Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19
20 September 2022 - Evusheld significantly reduced risk of severe COVID-19 or death in TACKLE Phase 3 treatment trial. ...
Posted by Michael Wonder on 20 Sep 2022
European Medicine Agency accepts marketing authorisation applications for bimekizumab in psoriatic arthritis and axial spondyloarthritis
20 September 2022 - First regulatory submissions for bimekizumab in psoriatic arthritis and axial spondyloarthritis worldwide. ...
Posted by Michael Wonder on 19 Sep 2022
European Commission approves Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
19 September 2022 - Phase 3 data that showed people with neovascular or ‘wet’ age-related macular degeneration and diabetic macular oedema treated with ...
Posted by Michael Wonder on 19 Sep 2022
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with marginal zone lymphoma
19 September 2022 - If approved, Brukinsa will be the first and only approved Bruton’s tyrosine kinase inhibitor for marginal zone ...
Posted by Michael Wonder on 19 Sep 2022
Bristol Myers Squibb receives European Commission approval for LAG-3 blocking antibody combination, Opdualag (nivolumab and relatlimab), for the treatment of unresectable or metastatic melanoma with tumour cell PD-L1 expression < 1%
16 September 2022 - In RELATIVITY-047, Opdualag more than doubled median progression-free survival compared to nivolumab monotherapy. ...
Posted by Michael Wonder on 19 Sep 2022
Biosimilar medicines can be interchanged
19 September 2022 - EMA and the Heads of Medicines Agencies have issued a joint statement confirming that biosimilar medicines ...
Posted by Michael Wonder on 19 Sep 2022
AbbVie secures positive CHMP opinion for risankizumab (Skyrizi) for the treatment of adults with moderate to severe Crohn's disease
19 September 2022 - CHMP positive opinion is based on results from three Phase 3 studies: two for induction and one ...
Posted by Michael Wonder on 18 Sep 2022
Agios receives positive CHMP opinion for Pyrukynd (mitapivat) for the treatment of pyruvate kinase deficiency in adult patients
16 September 2022 - Agios expects a decision on the marketing authorisation application by the European Commission within 67 days of ...
Posted by Michael Wonder on 17 Sep 2022
Highlights from the 12-15 September 2022 CHMP meeting
16 September 2022 - 12 new medicines recommended for approval. ...
Posted by Michael Wonder on 17 Sep 2022
ADC Therapeutics and Sobi announce Zylonta (loncastuximab tesirine) receives positive CHMP opinion in Europe for the treatment of relapsed or refractory diffuse large B-cell lymphoma
16 September 2022 - Approval decision expected in 4Q 2022. ...
Posted by Michael Wonder on 17 Sep 2022
Leo Pharma receives positive CHMP opinion of Adtralza (tralokinumab) for the treatment of adolescents with moderate to severe atopic dermatitis
16 September 2022 - Recommendation supported by data from the Phase 3 ECZTRA 6 trial. ...