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RSS FeedPosted by Michael Wonder on 24 Dec 2024
Datopotamab deruxtecan application in the EU for patients with advanced non-squamous non-small sell lung cancer voluntarily withdrawn
24 December 2024 - Daiichi Sankyo and AstraZeneca have voluntarily withdrawn the marketing authorisation application in the EU for datopotamab ...
Posted by Michael Wonder on 24 Dec 2024
Blarcamesine receives EMA filing acceptance for treatment of Alzheimer’s disease
23 December 2024 - Submission based on favourable ANAVEX 2-73-AD-004 trial results in patients with early Alzheimer’s disease. ...
Posted by Michael Wonder on 24 Dec 2024
Cytokinetics announces EMA validation of marketing authorisation application for aficamten for the treatment of obstructive hypertrophic cardiomyopathy
23 December 2024 - Cytokinetics today announced that the EMA has validated the marketing authorisation application for aficamten, a next in ...
Posted by Michael Wonder on 23 Dec 2024
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer
23 December 2024 - Approval based on results of the Phase 3 CheckMate-8HW trial, in which the dual immunotherapy combination ...
Posted by Michael Wonder on 23 Dec 2024
Tagrisso approved in the EU for patients with unresectable EGFR mutated lung cancer
23 December 2024 - Approval based on LAURA Phase 3 trial results which showed Tagrisso extended median progression-free survival to ...
Posted by Michael Wonder on 22 Dec 2024
Dong-A ST secures European approval for Stelara biosimilar Imuldosa
19 December 2024 - Global market expansion accelerates with back to back FDA and EC authorisations. ...
Posted by Michael Wonder on 19 Dec 2024
Gilead’s seladelpar receives positive CHMP opinion for primary biliary cholangitis
13 December 2024 - Recommendation based on the RESPONSE study which demonstrated ALP normalisation in 25% of participants at 12 months ...
Posted by Michael Wonder on 18 Dec 2024
Johnson & Johnson submits application to the EMA seeking approval of a new indication for Imbruvica (ibrutinib) in adult patients with previously untreated mantle cell lymphoma who are eligible for autologous stem cell transplant
18 December 2024 - The European MCL Network Phase 3 TRIANGLE study, evaluated ibrutinib in combination with induction immunochemotherapy, both with ...
Posted by Michael Wonder on 18 Dec 2024
GSK’s B7-H3 targeted antibody drug conjugate, GSK’227, receives EMA Priority Medicines (PRIME) designation in relapsed extensive-stage small-cell lung cancer
16 December 2024 - Regulatory designation based on promising preliminary clinical data. ...
Posted by Michael Wonder on 18 Dec 2024
ViiV Healthcare announces CHMP positive opinion for Vocabria + Rekambys, the first and only complete long-acting HIV treatment, for adolescents in Europe
16 December 2024 - Vocabria + Rekambys (cabotegravir + rilpivirine) is the first and only complete long-acting regimen for the treatment ...
Posted by Michael Wonder on 18 Dec 2024
Geron announces positive CHMP opinion for Rytelo (imetelstat) for the treatment of adults with transfusion-dependent anaemia due to lower-risk MDS
13 December 2024 - Geron Corporation today announced that the CHMP of the EMA has adopted a positive opinion recommending the ...
Posted by Michael Wonder on 16 Dec 2024
CHMP recommends approval of Galderma’s nemolizumab for moderate to severe atopic dermatitis and prurigo nodularis in the European Union
13 December 2024 - Nemolizumab is a first in class monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling ...
Posted by Michael Wonder on 16 Dec 2024
CSL receives positive CHMP opinion for garadacimab in hereditary angioedema
13 December 2024 - If approved, garadacimab will be the first and only once monthly treatment inhibiting factor XIIa to ...
Posted by Michael Wonder on 16 Dec 2024
Celltrion receives positive CHMP opinion for three biosimilars in the European Union
15 December 2024 - The CHMP adopts positive opinions for Celltrion’s three biosimilar candidates – Eydenzelt (aflibercept), Stoboclo and Osenvelt (denosumab), ...
Posted by Michael Wonder on 16 Dec 2024
EMA’s CHMP recommends approval of Biocon Biologics’ Yesintek, biosimilar to J&J’s Stelara
15 December 2024 - Biocon Biologics today announced that the EMA’s CHMP has issued a positive opinion recommending approval of Yesintek, ...