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830,771 Results for "bio thera solutions ltd".
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Bio-Thera Solutions Receives Positive CHMP Opinion for Avzivi® (bevacizumab), a Biosimilar Referencing Avastin®
Bio-Thera Solutions Inc., a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for Avzivi®, a biosimilar monoclonal antibody referencing AVASTIN®.
June 3, 2024
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5 min read
Business
Bio-Thera Solutions Partners with SteinCares to Market Two Biosimilars in LATAM
Bio-Thera Solutions announced today a new licensing agreement for two biosimilars under which SteinCares will have exclusive rights to distribute and market Bio-Thera’s pharmaceuticals in Brazil and the rest of the region.
March 18, 2024
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5 min read
Business
Bio-Thera and STADA Reach Exclusive Agreement for BAT2506, a Proposed Golimumab Biosimilar, in the EU and UK
Bio-Thera Solutions (688177:SH) and global specialty, generic and consumer healthcare medicines company STADA Arzneimittel AG have reached an exclusive commercialization and license agreement for BAT2506, a biosimilar candidate to Simponi® (golimumab).
May 28, 2024
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5 min read
Bio-Thera Solutions Presents Clinical Data for BAT8006 (Folate Receptor-alpha-ADC) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
Bio-Thera Solutions Inc. will present a poster at the 2024 ASCO Annual Meeting entitled “Phase 1 study of BAT8006, a folate receptor α antibody drug conjugate with strong bystander effect, in subjects with advanced solid tumors,” that highlights clinical data for the potential best-in-class efficacy and safety of BAT8006 as a potential treatment for ovarian cancer patients and other patients with tumors that express Folate Receptor-alpha.
June 2, 2024
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5 min read
FDA
FDA Approves Bio-Thera Solutions’ Avzivi® (bevacizumab-tnjn), a biosimilar referencing Avastin®
Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, today announced that the United States Food and Drug Administration (FDA) has approved Avzivi® (bevacizumab-tnjn), a biosimilar referencing Avastin®.
December 7, 2023
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6 min read
Drug Development
Bio-Thera Solutions Receives IND Clearance From US FDA to Initiate a Phase II Study for BAT8006, an Innovative Antibody Drug Conjugate Targeting Folate Receptor α
Bio-Thera Solutions today announced receiving IND clearance from the US FDA for a phase II Study for BAT8006, an innovative Antibody Drug Conjugate (ADC) targeting Folate Receptor α (FRα).
March 25, 2024
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4 min read
Press Releases
Bio-Thera Solutions Announces Regulatory Filing Acceptance for BAT2206, a Proposed Biosimilar to Stelara® in the US and EU
July 24, 2024
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5 min read
Drug Development
Bio-Thera Solutions Announces Positive Results from Phase 3 Study of BAT2206, a Proposed Biosimilar Referencing Stelara®
Bio-Thera Solutions, Ltd., a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, announced results from the Phase 3 study of BAT2206, a proposed biosimilar referencing Stelara®.
November 29, 2023
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5 min read
Press Releases
European Medicines Agency (EMA) Approves Bio-Thera Solutions’ BAT1706 (Avzivi®, bevacizumab), a biosimilar referencing Avastin®
July 30, 2024
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6 min read
Policy
FDA Approves TOFIDENCE™ (tocilizumab-bavi) a Biosimilar of ACTEMRA® developed by Bio-Thera Solutions
Bio-Thera Solutions, Ltd announced that its partner Biogen recently received notification from the United States Food and Drug Administration on the approval of TOFIDENCE intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA.
October 8, 2023
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7 min read
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