CSBio CSBio

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[{"orgOrder":0,"company":"Pluri","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pluristem Completes Enrollment of Its Multinational Phase III Study of Muscle Regeneration Following Hip Fracture Surgery","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Pluri"},{"orgOrder":0,"company":"Pluri","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pluristem Reports Topline Results from its Phase III Study of Muscle Regeneration Following Hip Fracture Surgery","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Pluri"},{"orgOrder":0,"company":"EnteraBio Ltd","sponsor":"U.S. Food and Drug Administration","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Entera Bio Announces FDA Agreement for a Single Phase 3 Clinical Trial to Support an NDA for EB613 for the Treatment of Osteoporosis","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Peptide","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Peptide","graph2":"EnteraBio Ltd"},{"orgOrder":0,"company":"Assia Chemical Industries Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Teva Announces Results from 3-Year Study Assessing the Safety and Tolerability of AUSTEDO\u00ae (deutetrabenazine) Tablets for the Treatment of Chorea Associated with Huntington\u2019s Disease","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Assia Chemical Industries Ltd"},{"orgOrder":0,"company":"EnteraBio Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Entera Bio Announces FDA\u2019s Acceptance of a Type D Meeting Review to Affirm Design of the Pivotal, Phase 3 Protocol for EB613 PTH Mini Tablets, as the First Oral Osteoanabolic Treatment of Post-Menopausal Osteoporosis","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Peptide","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Peptide","graph2":"EnteraBio Ltd"},{"orgOrder":0,"company":"EnteraBio Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Entera Bio Provides Guidance from FDA Type D Meeting Related to EB613 Pivotal Program","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Peptide","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Peptide","graph2":"EnteraBio Ltd"},{"orgOrder":0,"company":"EnteraBio Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Entera Bio Reports Key Milestone Relating to Oral PTH (1-34) Peptide (EB613) Phase 3 Program: ASBMR-SABRE Has Submitted to FDA the Full Qualification Plan to Approve BMD as a Surrogate Endpoint for Osteoporosis","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Peptide","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Peptide","graph2":"EnteraBio Ltd"}]

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            EB613 (oral PTH (1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for osteoporosis.

            Lead Product(s): Teriparatide

            Therapeutic Area: Musculoskeletal Product Name: EB613

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 09, 2023

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            EB613 is the first oral, once daily mini tablet presentation of synthetic hPTH (1-34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo®, which requires daily SC injections.

            Lead Product(s): Teriparatide

            Therapeutic Area: Musculoskeletal Product Name: EB613

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 03, 2023

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            EB613 (teriparatide) is an oral, daily tablet which stimulates new bone formation on trabecular and cortical bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity. It is being investigated for post-menopausal osteoporosis.

            Lead Product(s): Teriparatide

            Therapeutic Area: Musculoskeletal Product Name: EB613

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 15, 2023

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            AUSTEDO (deutetrabenazine) is the first and only vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of tardive dyskinesia (TD) in adults and for the treatment of chorea associated with Huntington’s disease.

            Lead Product(s): Deutetrabenazine

            Therapeutic Area: Musculoskeletal Product Name: Austedo

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 18, 2022

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            EB613 is the first oral, daily tablet formulation of synthetic hPTH (1-34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo® which has been the leading anabolic treatment of osteoporosis.

            Lead Product(s): Teriparatide

            Therapeutic Area: Musculoskeletal Product Name: EB613

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: U.S. Food and Drug Administration

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 06, 2022

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            Patients treated with PLX-PAD (allogeneic PLX-PAD Cell) showed an increase of 2.3kg from reference (week 6) to week 26 compared to 0.51kg in the placebo group, a 1.8kg difference (p=0.073).

            Lead Product(s): Allogeneic PLX-PAD Cell

            Therapeutic Area: Musculoskeletal Product Name: PLX-PAD

            Highest Development Status: Phase III Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 13, 2022

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            PLX-PAD cells demonstrated statistically significant superiority, in ability to increase muscle strength and volume for patients who have undergone total hip replacement surgery due to osteoarthritis.

            Lead Product(s): PLX-PAD

            Therapeutic Area: Musculoskeletal Product Name: PLX-PAD

            Highest Development Status: Phase III Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 15, 2021

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