Blog
RSS FeedPosted 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 06 Feb 2023
Actions to support the development of medicines for children
6 February 2023 - Regulators in the European Union have taken several initiatives in the past four years to increase the ...
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 01 Feb 2023
Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU
31 January 2023 - From 31 January 2023, all initial clinical trial applications in the European Union must be submitted via ...
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. ...
Posted by Michael Wonder on 27 Jan 2023
Dupixent (dupilumab) recommended for expanded EU approval by the CHMP to treat children as young as six months old with severe atopic dermatitis
27 January 2023 - Recommendation based on a Phase 3 trial in children 6 months to 5 years old showing Dupixent ...
Posted by Michael Wonder on 27 Jan 2023
Marketing authorisation application for lecanemab as treatment for early Alzheimer's disease accepted by EMA
27 January 2023 - Eisai and Biogen announced today that the EMA has accepted a marketing authorisation application for lecanemab, an ...
Posted by Michael Wonder on 26 Jan 2023
Enhertu approved in the EU as the first HER2 directed therapy for patients with HER2 low metastatic breast cancer
26 January 2023 - Approval based on DESTINY-Breast04 results where AstraZeneca and Daiichi Sankyo’s Enhertu reduced the risk of disease ...