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[{"orgOrder":0,"company":"OPKO Health","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"OPKO Health to Present Somatrogon Phase 3 Pediatric Trial Results at ENDO Online 2020","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"OPKO Health","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Authorizes OPKO Health Clinical Trial Evaluating RAYALDEE in COVID-19 Patients","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"OPKO Health","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"OPKO Health Announces Top-Line Results of Phase 3 Efficacy and Safety Study of Somatrogon for the Treatment of Growth Hormone Deficiency","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"OPKO Health","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"OPKO Health Initiates Clinical Trial of RAYALDEE in COVID-19 Patients","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small 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Outpatients","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"OPKO Health","sponsor":"Leader Medical","pharmaFlowCategory":"D","amount":"$12.0 million","upfrontCash":"$1.0 million","newsHeadline":"LeaderMed Group and OPKO Health Form Joint Venture to Develop and Commercialize Oxyntomodulin and Factor VIIa-CTP in China","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase II"},{"orgOrder":0,"company":"OPKO Health","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"OPKO Health 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Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"EMA Adopts a Positive CHMP Opinion for Pfizer\u2019s and OPKO\u2019s Somatrogon, a Long-Acting Treatment for Pediatric Growth Hormone Deficiency","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"OPKO Health","sponsor":"Pfizer Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pfizer and OPKO Provide Update on the Biologics License Application for Somatrogon for Pediatric Growth Hormone Deficiency","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Peptide","productStatus":"Approved","date":"January 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molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"OPKO Health","sponsor":"Pfizer Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pfizer and OPKO\u2019s Once-Weekly NGENLA\u2122 (somatrogon) Injection Receives Marketing Authorization in European Union for Treatment of Pediatric Growth Hormone Deficiency","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Peptide","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"OPKO Health","sponsor":"OPKO Health","pharmaFlowCategory":"D","amount":"$300.0 million","upfrontCash":"Undisclosed","newsHeadline":"OPKO Health Acquires ModeX Therapeutics, Gains Proprietary Immunotherapy Technology with a Focus on Oncology and Infectious Diseases","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"OPKO Health","sponsor":"Merck & Co","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"OPKO Health's ModeX Therapeutics Enters into Exclusive Worldwide License and Collaboration Agreement with Merck to Develop Epstein-Barr Virus Vaccine Candidate","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Vaccine","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"IND Enabling"},{"orgOrder":0,"company":"OPKO Health","sponsor":"Pfizer Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Pfizer\u2019s NGENLA, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"ModeX Therapeutics","sponsor":"BARDA","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ModeX Therapeutics Secures BARDA Contract to Develop Novel Multispecific Antibodies Against Viral Infectious Disease Threats","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Discovery","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Discovery"},{"orgOrder":0,"company":"OPKO Health","sponsor":"EnteraBio Ltd","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Entera Bio Announces Robust Pharmacokinetic Data for First-in-Class Oral GLP-2 Peptide Tablet Treatment for Patients with Short Bowel Syndrome","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Preclinical"}]

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            Entera Bio & Opko Health is developing the first and only GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption.

            Lead Product(s): Undisclosed

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: Preclinical Product Type: Peptide

            Recipient: EnteraBio Ltd

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 20, 2024

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            The agreement aims to advance a platform and specific candidates addressing a range of viral infectious diseases and will enable research, development and clinical evaluation of potent multispecific antibodies, based on ModeX proprietary MSTAR technology.

            Lead Product(s): Undisclosed

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Discovery Product Type: Large molecule

            Partner/Sponsor/Collaborator: BARDA

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement September 28, 2023

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            NGENLA (somatrogon-ghla), a once-weekly, HGH analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone. it's expected to become available for U.S. prescribing in August 2023.

            Lead Product(s): Somatrogon-ghla

            Therapeutic Area: Endocrinology Product Name: Ngenla

            Highest Development Status: Approved Product Type: Large molecule

            Recipient: Pfizer Inc

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 28, 2023

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            ModeX and Merck will jointly advance MDX-2201 to an IND application filing, after which Merck will be responsible for clinical and regulatory activities and product commercialization. MDX-2201 leverages ModeX’s innovative biologics platform to target multiple EBV proteins.

            Lead Product(s): MDX-2201

            Therapeutic Area: Infections and Infectious Diseases Product Name: MDX-2201

            Highest Development Status: IND Enabling Product Type: Vaccine

            Partner/Sponsor/Collaborator: Merck & Co

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration March 08, 2023

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            ModeX Therapeutics has developed highly flexible multi-specific antibody technology platforms with broad targeting and functional capabilities, simpler manufacturing and potentially better specificity and safety, providing significant differentiation from competing platforms.

            Lead Product(s): Antibody

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Preclinical Product Type: Large molecule

            Partner/Sponsor/Collaborator: OPKO Health

            Deal Size: $300.0 million Upfront Cash: Undisclosed

            Deal Type: Acquisition May 09, 2022

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            The European Union marketing authorization of Ngenla (somatrogon) was supported by results from Phase 3 study which evaluated the safety and efficacy of once-weekly NGENLA compared to once-daily GENOTROPIN® (somatropin).

            Lead Product(s): Somatrogon

            Therapeutic Area: Endocrinology Product Name: Ngenla

            Highest Development Status: Approved Product Type: Peptide

            Recipient: Pfizer Inc

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 15, 2022

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            RAYALDEE extended-release capsules are indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

            Lead Product(s): Calcifediol

            Therapeutic Area: Endocrinology Product Name: Rayaldee

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Vifor Fresenius Medical Care Renal Pharma

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 03, 2022

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            Somatrogon is an investigational once-weekly long-acting recombinant human growth hormone for the treatment of growth hormone deficiency in pediatric patients. Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward.

            Lead Product(s): Somatrogon

            Therapeutic Area: Endocrinology Product Name: PF-06836922

            Highest Development Status: Approved Product Type: Peptide

            Recipient: Pfizer Inc

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 21, 2022

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            This approval is based on the results of a Phase 3 study conducted in Japanese subjects and a global clinical study, both of which were conducted in subjects with pediatric GHD, and compared the efficacy and safety of once-weekly NGENLA® with GENOTROPIN® (somatropin).

            Lead Product(s): Somatrogon

            Therapeutic Area: Endocrinology Product Name: PF-06836922

            Highest Development Status: Approved Product Type: Peptide

            Recipient: Pfizer Inc

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 20, 2022

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            CHMP’s positive opinion of PF-06836922 (somatrogon) is based on the results from Phase 3, the study demonstrated that treatment improved the mean overall life interference total score after 12 weeks.

            Lead Product(s): Somatrogon

            Therapeutic Area: Endocrinology Product Name: PF-06836922

            Highest Development Status: Phase III Product Type: Peptide

            Recipient: Pfizer Inc

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 17, 2021

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