(IN BRIEF) Fresenius Kabi, an operating company of Fresenius, has announced that the U.S. FDA has approved a rituximab biosimilar developed by Dr. Reddy’s Laboratories for the U.S. market. Under an exclusive commercialisation agreement, Fresenius Kabi holds the U.S. commercialisation … Read the full press release
Posted in Business, Germany, Government, Healthcare, Pharma & Biotech, Science
Tagged #FutureFresenius, affordable biologic therapies, analytical data, autoimmune diseases, B cells, B lymphocytes, B-cell malignancies, Bad Homburg v. d. Höhe, biologic medicines, biopharma, biopharmaceuticals, Biosimilar, biosimilars portfolio, CD20 antigen, chronic lymphocytic leukemia, clinical data, clinical nutrition, Dr. Eduard Fresenius, Dr. Reddy’s, Dr. Reddy’s Laboratories, Dr. Sang-Jin Pak, Else Kröner, Else Kröner Fresenius Foundation, exclusive commercialisation agreement, FDA, FDA approval, FDA Approves Dr. Reddy’s Rituximab Biosimilar for U.S. Commercialisation by Fresenius Kabi, Fresenius, Fresenius Helios, Fresenius Kabi, Fresenius Kabi Announces FDA Approval of Rituximab Biosimilar for U.S. Market, Fresenius Kabi Strengthens U.S. Biosimilars Portfolio With Rituximab Approval, Fresenius Medical Care, Fresenius SE & Co KGaA, Genentech, Germany, GPA, granulomatosis with polyangiitis, hematologic malignancies, immunology, intravenous generic drugs, medical technology, microscopic polyangiitis, monoclonal antibody, MPA, Nicole Meier, non-clinical data, Non-Hodgkin lymphoma, oncology, patient access, pharmacokinetic studies, rheumatoid arthritis, Rituxan, rituximab, rituximab biosimilar, totality of the evidence, U.S. Food and Drug Administration, U.S. market
(IN BRIEF) Roche has announced that the US FDA has accepted its supplemental Biologics License Application for Lunsumio VELO, a subcutaneous formulation of mosunetuzumab, in combination with Polivy for adults with relapsed or refractory large B-cell lymphoma, including diffuse large … Read the full press release
Posted in Business, European Union, Healthcare, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged antibody-drug conjugate, ASCO Annual Meeting, Basel, CD20xCD3 bispecific antibody, CD79b, CELESTIMO, chemotherapy-free regimen, community oncology, crs, cytokine release syndrome, diffuse large B-cell lymphoma, DLBCL, European Hematology Association Congress, FDA, FDA Filing Acceptance Brings Roche’s Chemotherapy-Free Lymphoma Combination Closer to Potential Approval, follicular lymphoma, gemcitabine, haematology, LBCL, Levi Garraway, Lunsumio, Lunsumio VELO, Lunsumio VELO and Polivy Combination Shows 59 Percent Risk Reduction in Roche’s FDA Filing for LBCL, lymphoma care, Lymphoma Research Foundation, MabThera®, Meghan Gutierrez, Mission Cancer and Blood, MorningLyte, mosunetuzumab, Non-Hodgkin lymphoma, outpatient-ready treatment, oxaliplatin, PFS, Phase III Trial, polatuzumab vedotin, Polivy, progression-free survival, R-GemOx, relapsed or refractory large B-cell lymphoma, Rituxan, rituximab, Roche, Roche Reports FDA Acceptance of sBLA Based on SUNMO Study Results in Relapsed or Refractory Large B-Cell Lymphoma, sBLA, SUNMO study, supplemental Biologics License Application, Switzerland, T-cell engaging bispecific antibody, Tara M Graff
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