[{"orgOrder":0,"company":"Organon","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Forendo Pharma Successfully Completes Phase 1 Studies of FOR-6219 in Endometriosis, Aiming to Advance Program into Phase 2 Clinical Studies","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase I"},{"orgOrder":0,"company":"Organon","sponsor":"Organon","pharmaFlowCategory":"D","amount":"$945.0 million","upfrontCash":"$75.0 million","newsHeadline":"Organon to Acquire Forendo Pharma","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 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(Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Organon","sponsor":"Perrigo Company plc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Perrigo Announces U.S. Fda Approval For Otc Use Of Nasonex\u00ae 24hr Allergy","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved"},{"orgOrder":0,"company":"Organon","sponsor":"Shanghai Henlius Biotech","pharmaFlowCategory":"D","amount":"$103.0 million","upfrontCash":"$73.0 million","newsHeadline":"Organon Enters into Global License Agreement to Commercialize Henlius\u2019 Investigational Perjeta\u00ae (Pertuzumab) and Prolia\u00ae\/Xgeva\u00ae (Denosumab) Biosimilar Candidates","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Organon","sponsor":"Dar\u00e9 Bioscience","pharmaFlowCategory":"D","amount":"$192.5 million","upfrontCash":"$10.0 million","newsHeadline":"Dare Bioscience Announces Closing of Global License Agreement with Organon to Commercialize XACIATO (clindamycin phosphate vaginal gel, 2%), FDA-Approved Treatment for Females 12 and Older with Bacterial Vaginosis","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Infections and Infectious 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(adalimumab-bwwd)","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"August 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Organon","sponsor":"Samsung Bioepis","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Organon & Samsung Bioepis Announce US Launch of HUMIRA Biosimilar HADLIMA (adalimumab-bwwd) in Multiple Presentations Consistent with Originator","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Organon","sponsor":"Merck & Co","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Merck Announces Completion of Organon & Co. Spinoff","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Organon","sponsor":"Samsung Bioepis","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis & Organon Announce Topline Results from Interchangeability Study of SB5 Humira Biosimilar","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"August 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Phase IV"},{"orgOrder":0,"company":"Organon","sponsor":"Dar\u00e9 Bioscience","pharmaFlowCategory":"D","amount":"$192.8 million","upfrontCash":"$10.0 million","newsHeadline":"Dar\u00e9 Bioscience Announces Achievement of First Commercial Milestone Under License Agreement for XACIATO\u2122 (Clindamycin Phosphate) Vaginal Gel, 2%, FDA-Approved Treatment for Bacterial Vaginosis in Females 12 Years or Older","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Organon","sponsor":"Samsung Bioepis","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA\u201e\u00a2 (adalimumab-bwwd), a Biosimilar to Humira\u00ae","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Organon","sponsor":"Eli Lilly","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Organon & Lilly Enter Commercialization Agreement in Europe for Two Migraine Medicines","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Organon","sponsor":"Dar\u00e9 Bioscience","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Organon\u2019s XACIATO (clindamycin phosphate) Vaginal Gel 2% Available Nationwide to Treat Bacterial Vaginosis (BV) in Females Aged 12 and Older","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals by Organon
Xaciato (clindamycin phosphate) vaginal gel 2% is a USFDA approved medication for the treatment of bacterial vaginosis (BV) in females 12 years of age and older.
Under the agreement, Organon becomes the sole distributor and promoter of Emgality (galcanezumab), a humanized monoclonal antibody calcitonin gene-related peptide (CGRP) antagonist, and RAYVOW™ (lasmiditan), a first-in-class serotonin 5-HT1F receptor agonist, in Europe.
Hadlima (adalimumab-bwwd), a biosimilar of Humira (adalimumab), is a TNF blocker indicated to treat Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. Yusimry will be the first biologic product offered by the Cost Plus Drugs.
Under the agreement, Daré has the global rights to Xaciato (clindamycin phosphate vaginal gel), an FDA-approved medication for the treatment of bacterial vaginosis (BV) in females 12 years of age and older.
HADLIMA (Adalimumab-bwwd) is a biosimilar product of HUMIRA®, formulated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritisetc. The drug bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface.
HADLIMA (adalimumab-bwwd) is a biosimilar product of HUMIRA®, formulated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritisetc. The drug bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface.
Approval of citrate-free, high-concentration HADLIMA™ (adalimumab-bwwd), TNF blocker indicator was based on clinical data from study that compare PK, safety, tolerability, and immunogenicity of two formulations of HADLIMA (100 mg/mL vs 50 mg/mL) in healthy volunteers.
Under the terms of the agreement, Cirqle will be responsible for conducting preclinical studies according to the mutually agreed research plan. Organon will obtain exclusive worldwide rights to develop and commercialize the asset OUI (mushroom-derived biopolymer).
Under the agreement, Organon licensed global rights to XACIATO (clindamycin phosphate vaginal gel, 2%), an FDA-approved medication for the treatment of bacterial vaginosis in females 12 years of age and older.
The agreement includes an option to negotiate an exclusive license for global commercialization rights for a biosimilar candidate referencing Yervoy ® (ipilimumab, HLX13), Perjeta® (pertuzumab, HLX11) and Prolia®/Xgeva® (denosumab, HLX14).
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