Blog
RSS FeedPosted by Michael Wonder on 04 Aug 2022
Lynparza approved in the EU as adjuvant treatment for patients with germline BRCA mutated HER2 negative high-risk early breast cancer
4 August 2022 - First and only approved medicine targeting BRCA mutations in early breast cancer ...
Posted by Michael Wonder on 01 Aug 2022
Pharming receives accelerated assessment in Europe for leniolisib for the treatment of rare immunodeficiency, APDS
1 August 2022 - Pharming is on track to submit its marketing authorisation application for leniolisib in H2 2022. ...
Posted by Michael Wonder on 29 Jul 2022
Rinvoq (upadacitinib) approved by European Commission as an oral treatment for adults with active non-radiographic axial spondyloarthritis
29 July 2022 - Approval is supported by data from the Phase 3 SELECT-AXIS 2 pivotal clinical trial in which ...
Posted by Michael Wonder on 27 Jul 2022
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in Crohn's disease
27 July 2022 - Submissions are supported by three Phase 3 clinical trials demonstrating upadacitinib achieved the co-primary endpoints of clinical ...
Posted by Michael Wonder on 26 Jul 2022
European Commission approves Rinvoq (upadacitinib) for the treatment of adults with moderate to severe ulcerative colitis
26 July 2022 - The approval is based on the results of three Phase 3 studies: two for induction and one ...
Posted by Michael Wonder on 25 Jul 2022
BridgeBio Pharma and Sentynl Therapeutics receive positive CHMP opinion for Nulibry (fosdenopterin) for the treatment of MoCD type A
25 July 2022 - CHMP recommendation for approval of Nulibry in the European Union for the treatment of patients with molybdenum ...
Posted by Michael Wonder on 25 Jul 2022
Tezspire recommended for approval in the EU by CHMP for the treatment of severe asthma
25 July 2022 - First and only biologic recommended for EU approval in patients with severe asthma with no phenotype ...
Posted by Michael Wonder on 25 Jul 2022
Ultomiris recommended for approval in the EU by CHMP for the treatment of adults with generalised myasthenia gravis
25 July 2022 - First and only long-acting C5 complement inhibitor showed early effect and demonstrated clinical improvement in activities ...
Posted by Michael Wonder on 25 Jul 2022
Applications for proposed first of a kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA
25 July 2022 - Submission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple ...
Posted by Michael Wonder on 25 Jul 2022
Aurinia announces positive CHMP opinion for Lupkynis (voclosporin) for the treatment of adults with active lupus nephritis in Europe
22 July 2022 - Positive CHMP opinion is based on a comprehensive submission including data from the pivotal AURORA efficacy study ...
Posted by Michael Wonder on 24 Jul 2022
Rhythm Pharmaceuticals receives positive CHMP opinion for Imcivree (setmelanotide) for the treatment of obesity and control of hunger in patients with Bardet-Biedl syndrome
European Commission decision anticipated in fourth quarter of 2022. ...
Posted by Michael Wonder on 24 Jul 2022
CHMP recommends EU approval of Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
22 July 2022 - The CHMP recommendation is based on results across four Phase 3 studies: TENAYA and LUCERNE in neovascular age-related ...
Posted by Michael Wonder on 23 Jul 2022
CHMP adopts positive opinion recommending Veklury (remdesivir) receive full marketing authorisation for the treatment of patients with COVID-19
22 July 2022 - If Granted by the European Commission, Veklury will become the only direct-acting antiviral with full marketing authorisation ...
Posted by Michael Wonder on 23 Jul 2022
Bristol Myers Squibb receives positive CHMP opinion recommending approval for LAG-3-blocking antibody combination Opdualag (nivolumab and relatlimab) for treatment of patients with unresectable or metastatic melanoma
22 July 2022 - Recommendation based on results from the Phase 2/3 RELATIVITY-047 trial, in which the fixed-dose combination of the ...
Posted by Michael Wonder on 23 Jul 2022
New medicine for multiple myeloma patients with limited treatment options
22 July 2022 - The EMA has recommended a conditional marketing authorisation in the European Union for Tecvayli (teclistamab) for ...