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Celltrion's Omlyclo gets EU nod as first Xolair biosimilar

Korean biosimilar giant Celltrion announced Thursday that its anti-IgE antibody biosimilar Omlyclo has been approved in Europe, after a series of clinical trials with the reference product Novartis Xolair. Omlyclo, also called by project name CT-P39, received formal product approval from the European Commission on Tuesday, approximately two months after receiving the initial approval recommendation from the C. ....

United States , Novarti Xolair , Drug Administration , European Commission On , European Medicines Agency , Committee For Medicinal Products Human , European Commission , Medicinal Products , Human Use , European Medicines ,

Pearce IP BioBlast w/e 22 March 2024

On 22 March 2024, the first case management hearing was held before Justice Nicholas in the Federal Court of Australia, Sydney, in proceedings… ....

South Korea , United States , United Kingdom , New South Wales , Samsung Bioepis , Genentech Avastin , Novo Nordisk Awiqli , Novarti Xolair , Celltrion Omalizumab Biosimilars , Celltrion Omlyclo , Ustekinumab Biosimilar , Justice Nicholas , Fresenius Kabi , Sandoz Denosumab , Janssen Stelara , Australian Court , Novo Holdings Nordisk , China Daily , European Union , European Medicines Agency , Committee For Medicinal Products Human Use , Bio Thera Solutions Partners , European Commission , Novo Nordisk , Bio Thera Solutions , Samsung Bioepis Seeks ,

Rx Rundown: Emergent BioSolutions, Bayer, United Therapeutics and more

Check out this week’s medical marketing news, people on the move and industry chatter. ....

United States , Iovance Biotherapeutics , Marcia Goddard , Ross Taylor , Aline Santos , Jason Valdez , Joseph Papa , Clotilde Delbos , Julie Inouye , Cynthia Spitalny , Astellas Pharma , Novarti Xolair , Wendy Williams , Julie Brown , John Sundy , Tentarix Biotherapeutics , Daiichi Sankyo , Hydeia Broadbent , Arun Divakaruni , Digital Health Networks , We Communications , Bausch Health , American Medical Association , Ionis Pharmaceuticals , Exp Health , M Agency ,

After FDA says no on Dupixent for hives disorder, Japan says yes

After FDA says no on Dupixent for hives disorder, Japan says yes
fiercepharma.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from fiercepharma.com Daily Mail and Mail on Sunday newspapers.

Regeneron Dupixent , Novarti Xolair , Len Schleiffer , Japan Ministry Of Health ,

FDA approves Roche, Novartis' Xolair for common food allergies

FDA approves Roche, Novartis' Xolair for common food allergies
fiercepharma.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from fiercepharma.com Daily Mail and Mail on Sunday newspapers.

Novarti Xolair , Reshema Kemps Polanco , Stallergenes Greer , Us National Institutes Of Health , Evaluate Pharma ,