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RSS FeedPosted by Michael Wonder on 24 Feb 2023
Merck and Ridgeback provide update on EU marketing authorisation application for Lagevrio (molnupiravir)
24 February 2023 - Merck and Ridgeback Biotherapeutics today announced that the CHMP of the EMA has recommended the refusal ...
Posted by Michael Wonder on 24 Feb 2023
Libtayo (cemiplimab) in combination with chemotherapy receives positive CHMP opinion for the treatment of advanced PD-L1 positive non-small cell lung cancer
24 February 2023 - Recommendation based on a Phase 3 trial demonstrating superior survival outcomes for Libtayo plus chemotherapy compared to ...
Posted by Michael Wonder on 24 Feb 2023
Chiesi Global Rare Diseases and Protalix BioTherapeutics receive positive CHMP opinion for pegunigalsidase alfa for treatment of Fabry disease
24 February 2023 - European Commission decision anticipated in beginning of May 2023. ...
Posted 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 20 Feb 2023
EMA publishes agenda for 20-23 February 2023 CHMP meeting
20 February 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
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 23 Jan 2023
EMA publishes agenda for 23-26 January 2023 CHMP meeting
23 January 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 19 Dec 2022
Forxiga recommended for approval in the EU by CHMP for symptomatic chronic heart failure
19 December 2022 - f approved, Forxiga will be the first heart failure therapy indicated across the full ejection fraction ...
Posted by Michael Wonder on 19 Dec 2022
Enhertu recommended for approval in the EU by CHMP for patients with HER2 low metastatic breast cancer
19 December 2022 - AstraZeneca and Daiichi Sankyo’s Enhertu is the first HER2 directed therapy to demonstrate a significant survival ...
Posted by Michael Wonder on 19 Dec 2022
Enhertu approved in the EU for patients with previously treated HER2 positive advanced gastric cancer
19 December 2022 - Based on DESTINY-Gastric02 and DESTINY-Gastric01 where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated clinically meaningful efficacy. ...
Posted by Michael Wonder on 19 Dec 2022
Imfinzi plus Imjudo recommended for approval in the EU by CHMP for the treatment of advanced liver and lung cancers
19 December 2022 - Positive opinions based on significant survival benefit in HIMALAYA and POSEIDON Phase 3 trials. ...
Posted by Michael Wonder on 19 Dec 2022
Fintepla (fenfluramine) oral solution recommended for approval in the EU for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome
19 December 2022 - Recommendation based on Phase 3 trial data demonstrating safety and efficacy in the most difficult to treat ...
Posted by Michael Wonder on 18 Dec 2022
Amicus Therapeutics receives positive CHMP opinion for Pombiliti (cipaglucosidase alfa) for late-onset Pompe disease
16 December 2022 - CHMP adopts positive opinion based upon complete review of all pre-clinical, clinical studies and CMC data. ...