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RSS FeedPosted by Michael Wonder on 24 Feb 2023
Janssen receives positive CHMP opinion for Akeega (niraparib and abiraterone acetate dual action tablet) plus prednisone or prednisolone for the treatment of adult patients with BRCA1/2 gene mutated metastatic castration resistant prostate cancer
24 February 2023 - The positive CHMP opinion is based on results from the Phase 3 MAGNITUDE study where the ...
Posted by Michael Wonder on 24 Feb 2023
Akebia receives positive CHMP opinion in Europe for Vafseo (vadadustat) for the treatment of symptomatic anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis
23 February 2023 - Akebia Therapeutics today announced that the CHMP of the EMA has adopted a positive opinion recommending ...
Posted by Michael Wonder on 22 Feb 2023
Calquence tablet formulation approved in the EU for patients with chronic lymphocytic leukaemia
22 February 2023 - Approval based on ELEVATE-PLUS trials which showed bioequivalence and consistent dosing versus current capsule. ...
Posted by Michael Wonder on 21 Feb 2023
First gene therapy for haemophilia B, CSL's Hemgenix, approved by the European Commission
20 February 2023 - Hemgenix underscores CSL's promise to deliver life-changing innovations that have the potential to help patients lead ...
Posted by Michael Wonder on 08 Feb 2023
Fintepla (fenfluramine) oral solution approved in the EU for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome
8 February 2023 - UCB’s Fintepla (fenfluramine) oral solution has been approved in the European Union for the treatment of ...
Posted by Michael Wonder on 07 Feb 2023
Forxiga approved in the EU for the treatment of symptomatic chronic heart failure
7 February 2023 - First and only heart failure therapy with proven mortality benefit across the full ejection fraction range ...
Posted by Michael Wonder on 04 Feb 2023
European Commission approves label expansion of Roche’s Hemlibra to include people with moderate haemophilia A in the EU
1 February 2023 - The approval is based on the HAVEN 6 results, where Hemlibra demonstrated effective bleed control and ...
Posted by Michael Wonder on 30 Jan 2023
Sandoz receives positive CHMP opinion for citrate free high concentration formulation of adalimumab biosimilar
30 January 2023 - Sandoz is seeking approval of high concentration formulation adalimumab for use in all indications of reference medicine. ...
Posted by Michael Wonder on 30 Jan 2023
Dupixent (dupilumab) approved by European Commission as the first and only targeted medicine indicated for eosinophilic oesophagitis
30 January 2023 - Approximately 60% of patients aged 12 years and older treated with Dupixent 300 mg weekly in the ...
Posted by Michael Wonder on 29 Jan 2023
Pfizer receives positive CHMP opinion for conversion of Paxlovid conditional marketing authorisation to full marketing authorisation in the European Union
27 January 2023 - Pfizer today announced that the CHMP of the EMA has recommended converting the conditional marketing authorisation ...
Posted by Michael Wonder on 28 Jan 2023
Ipsen receives CHMP negative opinion for palovarotene as a treatment for fibrodysplasia ossificans progressiva in EU
27 January 2023 - Ipsen to request re-examination of CHMP opinion on palovarotene as a potential treatment for fibrodysplasia ossificans progressiva ...
Posted by Michael Wonder on 28 Jan 2023
Bristol Myers Squibb receives positive CHMP opinion for Reblozyl (luspatercept) for adult patients with anaemia-associated, non-transfusion-dependent beta thalassaemia
27 January 2023 - In the pivotal BEYOND study, Reblozyl significantly increased haemoglobin levels, which were sustained over longer time ...
Posted by Michael Wonder on 27 Jan 2023
CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone sensitive prostate cancer
27 January 2023 - CHMP recommendation is based on Phase 3 data, which demonstrated that darolutamide plus androgen deprivation therapy in ...
Posted by Michael Wonder on 27 Jan 2023
Bristol Myers Squibb announces positive CHMP opinion for once daily Sotyktu (deucravacitinib) as a treatment for adults with moderate to severe plaque psoriasis
27 January 2023 - CHMP recommendation based on positive results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials and ...
Posted by Michael Wonder on 27 Jan 2023
Highlights from the CHMP 23-26 January 2023 meeting
27 January 2023 - Four new medicines recommended for approval. ...