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[{"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Glaxosmithkline's Nucala as the First and Only Biologic Treatment for Hypereosinophilic Syndrome (HES)","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"GSK"},{"company":"AstraZeneca","sponsor":"FibroGen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Update on US Regulatory Review of Roxadustat in Anaemia of Chronic Kidney Disease","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"AstraZeneca"},{"company":"Shield Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Australia\u2019s Therapeutic Goods Administration (TGA) Approves Feraccru\u00ae to Treat Iron Deficiency With or Without Anaemia in Adults","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Shield Therapeutics"},{"company":"AstraZeneca","sponsor":"FibroGen","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"US FDA\u2019s CRDA Committee Votes Against Approval Of AstraZeneca\u2019s Roxadustat to Treat Anaemia in Chronic Kidney Disease","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"AstraZeneca"},{"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Seeks More Trial Data on Astrazeneca\u2019s NDA for Roxadustat for CKD","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"August 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"AstraZeneca"},{"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AstraZeneca\u2019s Ultomiris Approved for Use on Children in EU","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"AstraZeneca"},{"company":"GSK","sponsor":"","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GSK Announces Positive Phase III Efficacy and Safety Data for Daprodustat in Patients with Anaemia Due to Chronic Kidney Disease","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"GSK"},{"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Medicines Agency (EMA) Accepts Marketing Authorisation Application for Daprodustat","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"GSK"},{"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ondexxya Approved in Japan for Reversal of Acute Major Bleeds in Patients on Factor Xa Inhibitors","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"AstraZeneca"},{"company":"Bio Products Laboratory","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BPL Receives Orphan Drug Marketing Authorization for Coagadex\u00ae in Mexico","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Bio Products Laboratory"},{"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GSK Announces Update on US FDA Regulatory Review of Daprodustat in Anaemia of Chronic Kidney Disease","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"GSK"}]

GSK

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GSK Announces Update on US FDA Regulatory Review of Daprodustat in Anaemia of Chronic Kidney Disease

Details:

Studies demonstrated that Duvroq (daprodustat) improved or maintained Hb within target level, and primary safety analysis of populations showed that daprodustat achieved non-inferiority of MACE compared to standard of care, both non-dialysis and dialysis patient settings.

Lead Product(s): Daprodustat

Therapeutic Area: Hematology Product Name: Duvroq

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 06, 2022

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Bio Products Laboratory

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BPL Receives Orphan Drug Marketing Authorization for Coagadex® in Mexico

Details:

Coagadex® is the first and only treatment specifically for Hereditary Factor X Deficiency, a very rare inherited clotting disorder that causes problems with blood clotting due to not having enough Factor X in the blood.

Lead Product(s): Coagulation Factor X (Human)

Therapeutic Area: Hematology Product Name: Coagadex

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 04, 2022

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AstraZeneca

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Ondexxya Approved in Japan for Reversal of Acute Major Bleeds in Patients on Factor Xa Inhibitors

Details:

Ondexxya is the first approved medicine in Japan to specifically reverse the anticoagulant effect of FXa inhibitors apixaban, rivaroxaban or edoxaban in patients experiencing a life-threatening or uncontrolled bleed.

Lead Product(s): Andexanet Alfa

Therapeutic Area: Hematology Product Name: Ondexxya

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 29, 2022

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GSK

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European Medicines Agency (EMA) Accepts Marketing Authorisation Application for Daprodustat

Details:

The MAA based on positive data from ASCEND Phase III clinical trial programme for GSK1278863 (daprodustat), a HIF-PHI met co-primary efficacy and safety endpoints also, approved in Japan as Duvroq for patients with renal anaemia.

Lead Product(s): Daprodustat

Therapeutic Area: Hematology Product Name: GSK1278863

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 01, 2022

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GSK

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GSK Announces Positive Phase III Efficacy and Safety Data for Daprodustat in Patients with Anaemia Due to Chronic Kidney Disease

Details:

GSK1278863 (Daprodustat) is first oral HIF-PHI to clearly show positive efficacy, along with no increased cardiovascular risk as assessed in primary analysis. Daprodustat is currently approved in Japan as Duvroq for patients with renal anaemia.

Lead Product(s): Daprodustat

Therapeutic Area: Hematology Product Name: GSK1278863

Highest Development Status: Approved Product Type: Small molecule

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Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 05, 2021

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AstraZeneca

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AstraZeneca’s Ultomiris Approved for Use on Children in EU

Details:

Approval of Ultomiris is based on interim results from Phase III trial demonstrating complete terminal complement inhibition with reduced dosing frequency compared to Soliris.

Lead Product(s): Ravulizumab

Therapeutic Area: Hematology Product Name: Ultomiris

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 03, 2021

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AstraZeneca

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FDA Seeks More Trial Data on Astrazeneca’s NDA for Roxadustat for CKD

Details:

The safety and efficacy of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, have been demonstrated in the Phase III programme including more than 8,000 patients and published in five peer-reviewed journal articles.

Lead Product(s): Roxadustat

Therapeutic Area: Hematology Product Name: Evrenzo

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 11, 2021

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US FDA’s CRDA Committee Votes Against Approval Of AstraZeneca’s Roxadustat to Treat Anaemia in Chronic Kidney Disease

Details:

The safety and efficacy of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, have been demonstrated in the Phase III programme including more than 8,000 patients and published in five peer-reviewed journal articles.

Lead Product(s): Roxadustat

Therapeutic Area: Hematology Product Name: Evrenzo

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: FibroGen

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 16, 2021

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Shield Therapeutics

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Australia’s Therapeutic Goods Administration (TGA) Approves Feraccru® to Treat Iron Deficiency With or Without Anaemia in Adults

Details:

The commercial stage pharmaceutical company focused on addressing iron deficiency with its lead product Feraccru®/Accrufer® (ferric maltol) confirmed to investors that the TGA has registered Feraccru® as a treatment in the Australian Register of Therapeutic Goods.

Lead Product(s): Ferric Maltol

Therapeutic Area: Hematology Product Name: Feraccru

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 09, 2021

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Update on US Regulatory Review of Roxadustat in Anaemia of Chronic Kidney Disease

Details:

US FDA has requested further clarifying analyses of clinical data, to complete its review of the New Drug Application (NDA) for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for patients with anaemia of chronic kidney disease (CKD).

Lead Product(s): Roxadustat

Therapeutic Area: Hematology Product Name: Evrenzo

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: FibroGen

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 18, 2020

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