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RSS FeedPosted by Michael Wonder on 27 Apr 2023
CHMP recommends EU approval of Roche’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
26 April 2023 - The recommendation is based on results from the Phase I/II NP30179 study, where Columvi given as a ...
Posted by Michael Wonder on 27 Apr 2023
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy
26 April 2023 - Recommendation based on positive Phase 3 EXPLORER-HCM and VALOR-HCM trials demonstrating benefit in patients receiving Camzyos ...
Posted by Michael Wonder on 27 Apr 2023
First vaccine to protect older adults from respiratory syncytial virus (RSV) infection
26 April 2023 - EMA has recommended a marketing authorisation in the European Union for Arexvy (recombinant, adjuvanted), the first vaccine ...
Posted by Michael Wonder on 26 Apr 2023
Highlights from the 24-26 April 2023 CHMP meeting
26 April 2023 - The EMA’s CHMP recommended seven medicines for approval at its April 2023 meeting. ...
Posted by Michael Wonder on 24 Apr 2023
EMA publishes agenda for 24-26 April 2023 CHMP meeting
24 April 2023 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 03 Apr 2023
Ultomiris recommended for approval in the EU by CHMP for the treatment of adults with neuromyelitis optica spectrum disorder
3 April 2023 - No relapses observed in pivotal trial of first and only long-acting C5 inhibitor, indicating potential to ...
Posted by Michael Wonder on 02 Apr 2023
Samsung Bioepis receives positive CHMP opinion for eculizumab biosimilar, Epysqli
31 March 2023 - Epysqli, a biosimilar referencing Soliris (eculizumab), is Samsung Bioepis’ first biosimilar in haematology to be recommended for ...
Posted by Michael Wonder on 02 Apr 2023
TG Therapeutics announces positive CHMP opinion for Briumvi (ublituximab-xiiy) for the treatment of relapsing forms of multiple sclerosis in adults
31 March 2023 - TG Therapeutics today announced that the CHMP of the EMA has issued a positive opinion recommending ...
Posted by Michael Wonder on 02 Apr 2023
Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory large B-cell lymphoma after one prior therapy
31 March 2023 - Recommendation for approval based on Phase 3 TRANSFORM study, supporting the potential of Breyanzi in earlier ...
Posted by Michael Wonder on 02 Apr 2023
Novartis Entresto receives positive CHMP opinion for a heart failure
31 March 2023 - The positive opinion is based on final data from the 52 week Phase 3 PANORAMA-HF trial, the ...
Posted by Michael Wonder on 01 Apr 2023
Highlights from the 27 - 30 March 2023 CHMP meeting
31 March 2023 - The EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its March 2023 meeting. ...
Posted by Michael Wonder on 27 Feb 2023
Incyte announces positive CHMP opinion for ruxolitinib cream (Opzelura) for the treatment of non-segmental vitiligo in adults and adolescents
24 February 2023 - The positive CHMP opinion is based on Phase 3 data showing treatment with ruxolitinib cream resulted in ...
Posted by Michael Wonder on 27 Feb 2023
AbbVie receives positive CHMP opinion for upadacitinib (Rinvoq) for the treatment of adults with moderate to severe Crohn's disease
27 February 2023 - The positive CHMP opinion for upadacitinib is based on results from two induction studies and one maintenance ...
Posted by Michael Wonder on 26 Feb 2023
Servier receives a positive CHMP opinion for Tibsovo in IDH1 mutated acute myeloid leukaemia and cholangiocarcinoma patients
24 February 2023 - The positive CHMP opinion is based on clinical data from the AGILE (in AML) and ClarIDHy (in ...
Posted by Michael Wonder on 24 Feb 2023
Highlights from the 20-23 February 2023 CHMP meeting
24 February 2023 - Eight new medicines recommended for approval ...