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RSS FeedPosted 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 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 ...
Posted by Michael Wonder on 14 Jan 2023
Roche announces the European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above
12 January 2023 - Xofluza is now approved in the EU for the treatment of uncomplicated influenza and for post-exposure prophylaxis ...
Posted by Michael Wonder on 13 Jan 2023
Tezspire approved for self-administration in the EU in a new pre-filled pen
13 January 2023 - New administration option for first and only severe asthma biologic approved in the EU with no ...
Posted by Michael Wonder on 21 Dec 2022
European Commission approves Eladynos (abaloparatide) for the treatment of osteoporosis in post-menopausal women at increased risk of fracture
19 December 2022 - Radius Health announced that the European Commission has granted marketing authorisation for abaloparatide under the trade name ...
Posted by Michael Wonder on 21 Dec 2022
Lynparza in combination with abiraterone approved in the EU as first-line treatment for patients with metastatic castration-resistant prostate cancer
21 December 2022 - First approved PARP inhibitor to demonstrate clinically meaningful benefits in combination with a new hormonal agent. ...
Posted by Michael Wonder on 21 Dec 2022
Imfinzi plus chemotherapy approved in the EU as first immunotherapy regimen for patients with advanced biliary tract cancer
21 December 2022 - Approval based on TOPAZ-1 updated survival results showing Imfinzi combination reduced risk of death by 24% ...
Posted by Michael Wonder on 20 Dec 2022
Atara Biotherapeutics’ Ebvallo (tabelecleucel) receives European Commission approval as first ever therapy for adults and children with EBV+ PTLD
19 December 2022 - Pierre Fabre to lead commercialisation and distribution activities in Europe. ...