[{"orgOrder":0,"company":"Specialised Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Small Cell Lung Cancer Drug Accepted for TGA Evaluation Under Project Orbis","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Specialised Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Early Breast Cancer Drug Now Approved in Malaysia","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Specialised 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2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Specialised Therapeutics","sponsor":"PharmaMar","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Therapy to Treat Advanced Small Cell Lung Cancer Approved for Australian Patients","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Specialised Therapeutics","sponsor":"PharmaMar","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Therapy to Treat Advanced Small Cell Lung Cancer ZEPZELCA\u00ae (lurbinectedin) Approved in Singapore","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Specialised Therapeutics","sponsor":"Incyte Corporation","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Specialised Therapeutics Enters into a New Supply and Distribution Agreement with Incyte to Launch Two New Cancer Therapies, Tafasitamab and Pemigatinib, in Australia, New Zealand and Singapore","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Large molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Specialised Therapeutics","sponsor":"Incyte Corporation","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Treatment for Rare Cancer Cholangiocarcinoma Approved in Australia","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Specialised Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Therapy to Treat Rare Gastrointestinal Stromal Tumour Approved for New Zealand Patients","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Specialised Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Global Sarcoma Therapy Now Approved for New Zealand Patients","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Specialised Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lymphoma Therapy Now Approved for Australian Patients with Diffuse Large B-Cell Lymphoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Large molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Specialised Therapeutics","sponsor":"Treeway","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Treeway Licensing Deal with Specialised Therapeutics","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Specialised Therapeutics","sponsor":"CanariaBio","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Specialised Therapeutics Signs Exclusive License Agreement with CanariaBio For New Ovarian Cancer Therapy","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Specialised Therapeutics","sponsor":"Ascendis Pharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Specialised Therapeutics Signs Exclusive Agreement with Ascendis Pharma A\/s for Distribution and Commercialisation of Three Endocrinology Therapies in Australia and Select South-East Asia Countries","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Large molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals by Specialised Therapeutics
Under the terms of the arrangement, ST will be responsible for all commercial, medical, regulatory and distribution activities for oregovomab in its key territories of Australia, New Zealand, Singapore, Thailand, Vietnam, Brunei and Malaysia.
Under the licensing agreement, ST will be responsible for all marketing, regulatory and distribution activities of TW001, a unique oral formulation of edaravone which works by reducing the oxidative damage associated with neuron death in ALS, in Australia and New Zealand.
Monjuvi® and Minjuvi® (tafasitamab) is a humanized Fc-modified CD19 targeting immunotherapy used in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
Yondelis (trabectedin) binds guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix triggering a cascade of events like DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death.
Qinlock (ripretinib) is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRA mutated kinases, involved in GIST, by using a dual mechanism of action that regulates the kinase switch pocket and activation loop.
PEMAZYRE (pemigatinib) a FGFR inhibitor, is used for the treatment of adult patients with metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy.
Under the terms of the agreement, Incyte will be responsible for the development, manufacture and supply of both products tafasitamab (sold as Monjuvi) and pemigatinib (Pemazyre) and ST will be responsible for regulatory, distribution and local marketing related activities.
ZEPZELCA® (lurbinectedin) is an alkylating drug that binds guanine residues within DNA. This triggers cascade of events that can affect activity of DNA binding proteins, including some transcription factors to treat 2L metastatic small cell lung cancer.
ZEPZELCA® (lurbinectedin) is the first new therapy approved to treat second-line metastatic SCLC in Australia in more than 20 years. ZEPZELCA approval granted under a provisional regulatory pathway.
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