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RSS FeedPosted by Michael Wonder on 19 Sep 2021
GSK receives CHMP positive opinions recommending approval of Nucala (mepolizumab) in three additional eosinophil driven diseases
17 September 2021 - If approved in Europe, mepolizumab would be the only treatment indicated for use in four eosinophil-driven diseases. ...
Posted by Michael Wonder on 19 Sep 2021
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy for certain patients with locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥10)
17 September 2021 - Recommendation based on data from Phase 3 KEYNOTE-355 trial. ...
Posted by Michael Wonder on 19 Sep 2021
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with Waldenström’s macroglobulinaemia
17 September 2021 - The CHMP recommendation is based on results from the Phase 3 ASPEN trial, in which BRUKINSA ...
Posted by Michael Wonder on 18 Sep 2021
Roche receives positive CHMP opinion for Gavreto (pralsetinib) for the treatment of adults with RET fusion positive advanced non-small-cell lung cancer
17 September 2021 - If approved, Gavreto will be the first and only targeted treatment approved by the EMA that ...
Posted by Michael Wonder on 18 Sep 2021
Alvotech welcomes positive CHMP opinion for AVT02, a proposed biosimilar to Humira
17 September 2021 - Alvotech today welcomed the positive opinion of the EMA's CHMP recommending the approval of Alvotech‘s high-concentration AVT02 ...
Posted by Michael Wonder on 04 Sep 2021
GSK’s shingles vaccine Shingrix gains UK license
2 September 2021 - GlaxoSmithKline's Shingrix has been licensed in the UK for the prevention of shingles in adults aged ...
Posted by Michael Wonder on 03 Sep 2021
Ultomiris approved in the EU for children and adolescents with paroxysmal nocturnal haemoglobinuria
3 September 2021 - Approval based on interim results from Phase 3 trial demonstrating complete terminal complement inhibition with reduced ...
Posted by Michael Wonder on 28 Aug 2021
Incyte and MorphoSys announce the European Commission approval of Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma
26 August 2021 - In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL. ...
Posted by Michael Wonder on 24 Aug 2021
European Commission approves Rinvoq (upadacitinib) as first JAK inhibitor in the European Union for the treatment of both adults and adolescents with moderate to severe atopic dermatitis
24 August 2021 - Approval supported by data from one of the largest registrational Phase 3 programs in atopic dermatitis evaluating ...
Posted by Michael Wonder on 24 Aug 2021
UCB announces European Commission approval of Bimzelx (bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis
24 August 2021 - The approval in the European Union represents the first marketing authorisation for UCB’s new psoriasis treatment worldwide. ...
Posted by Michael Wonder on 23 Aug 2021
Europe has its first Lucentis biosimilar, Samsung Bioepis’ Byooviz
23 August 2021 - Novartis and Roche’s big-selling eye drug Lucentis has its first biosimilar competitor in Europe, after the ...
Posted by Michael Wonder on 23 Aug 2021
Xeljanz (tofacitinib citrate) receives marketing authorisation in the European Union for the treatment of active polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis
20 August 2021 - Pfizer announced today that the European Commission has approved Xeljanz (tofacitinib) for the treatment of active polyarticular ...
Posted by Michael Wonder on 20 Aug 2021
Bristol Myers Squibb receives European Commission approval for Abecma (idecabtagene vicleucel), the first anti-BCMA CAR T cell therapy for relapsed and refractory multiple myeloma
19 August 2021 - Abecma represents the only cell therapy approved for multiple myeloma. ...
Posted by Michael Wonder on 20 Aug 2021
Astellas receives European Commission approval for first in class Evrenzo (roxadustat) for adult patients with symptomatic anaemia of chronic kidney disease
20 August 2021 - Roxadustat is the first orally administered hypoxia-inducible factor prolyl hydroxylase inhibitor available for adult patients with anaemia ...
Posted by Michael Wonder on 09 Aug 2021
Forxiga approved in the EU for the treatment of chronic kidney disease in patients with and without type 2 diabetes mellitus
9 August 2021 - Approval based on unprecedented DAPA-CKD Phase 3 data is the most significant advancement in chronic kidney ...