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[{"company":"Italfarmaco S.p.A","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Italfarmaco Provides Update on Advanced-Stage Clinical Development Program with Givinostat in Duchenne Muscular Dystrophy","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Italfarmaco S.p.A"},{"company":"Italfarmaco S.p.A","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Italfarmaco Provides Update on Ongoing Clinical Programs with Givinostat in Oral Presentation at XVIII International Conference","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Italfarmaco S.p.A"},{"company":"Chiesi Group","sponsor":"Protalix BioTherapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chiesi Global Rare Diseases Announces Presentations on Lysosomal Storage Diseases at the Society for the Study of Inborn Errors of Metabolism Annual Symposium","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Chiesi Group"},{"company":"MolMed","sponsor":"Orchard Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Orchard Therapeutics and MolMed Announce Extension of Gene Therapy Manufacturing Collaboration","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"MolMed"},{"company":"The Italfarmaco Group","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Italfarmaco Gets FDA Rare Pediatric Disease Designation for Givinostat in Duchenne Muscular Dystrophy","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"The Italfarmaco Group"},{"company":"The Italfarmaco Group","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Italfarmaco Group Announces Positive Topline Data from Phase 3 Trial Showing Beneficial Effect of Givinostat in Patients with Duchenne Muscular Dystrophy","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"The Italfarmaco Group"},{"company":"Palladio Zannini Industrie","sponsor":"Samsara BioCapital","pharmaFlowCategory":"D","amount":"$20.0 million","upfrontCash":"Undisclosed","newsHeadline":"Palladio Completes $20 Million Series B Financing","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Palladio Zannini Industrie"}]

Chiesi Group

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Chiesi Global Rare Diseases Announces Presentations on Lysosomal Storage Diseases at the Society for the Study of Inborn Errors of Metabolism Annual Symposium

Details:

Results from the clinical development programme developed with Protalix BioTherapeutics evaluating pegunigalsidase alfa (PRX-102) an investigational enzyme replacement therapy (ERT), support its potential as a treatment option for adult patients with Fabry disease.

Lead Product(s): Pegunigalsidase alfa

Therapeutic Area: Genetic Disease Product Name: PRX-102

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Protalix BioTherapeutics

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 02, 2022

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The Italfarmaco Group

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Italfarmaco Group Announces Positive Topline Data from Phase 3 Trial Showing Beneficial Effect of Givinostat in Patients with Duchenne Muscular Dystrophy

Details:

The study compared ITF2357 (givinostat) to placebo and met the primary endpoint (change from baseline in the time to climb 4 stairs) following 18 months of treatment in the target population1 with key secondary endpoints consistent with the functional primary endpoint.

Lead Product(s): Givinostat

Therapeutic Area: Genetic Disease Product Name: ITF2357

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 June 25, 2022

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Italfarmaco S.p.A

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Italfarmaco Provides Update on Ongoing Clinical Programs with Givinostat in Oral Presentation at XVIII International Conference

Details:

Italfarmaco provided evidence which continues to show a delay in disease progression in DMD boys aged 7-11 years at treatment start, supported by data on the 7-year follow-up period from the long-term study with Givinostat in addition to steroid treatment.

Lead Product(s): Givinostat

Therapeutic Area: Genetic Disease Product Name: ITF2357

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 February 22, 2021

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The Italfarmaco Group

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Italfarmaco Gets FDA Rare Pediatric Disease Designation for Givinostat in Duchenne Muscular Dystrophy

Details:

Third regulatory designation Italfarmaco has received from the FDA for Givinostat after the Orphan Drug designation and Fast Track designation and reflects the agency’s recognition of Givinostat’s potential to treat DMD, a devastating genetic disease.

Lead Product(s): Givinostat

Therapeutic Area: Genetic Disease Product Name: ITF2357

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 09, 2020

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Palladio Zannini Industrie

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Palladio Completes $20 Million Series B Financing

Details:

Proceeds from the financing will fund Palladio’s Phase 3 ALERT Study and advance operations.

Lead Product(s): Lixivaptan

Therapeutic Area: Genetic Disease Product Name: VPA-985

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Samsara BioCapital

Deal Size: $20.0 million Upfront Cash: Undisclosed

Deal Type: Series B Financing September 25, 2020

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MolMed

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Orchard Therapeutics and MolMed Announce Extension of Gene Therapy Manufacturing Collaboration

Details:

With the extension of the collaboration, MolMed will continue to support activities related to the development and manufacturing of vectors and drug products for several of Orchard’s investigational ex vivo hematopoietic stem cell (HSC) gene therapies in the upcoming years.

Lead Product(s): OTL-200

Therapeutic Area: Genetic Disease Product Name: OTL-200

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

Partner/Sponsor/Collaborator: Orchard Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration July 09, 2020

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Italfarmaco S.p.A

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Italfarmaco Provides Update on Advanced-Stage Clinical Development Program with Givinostat in Duchenne Muscular Dystrophy

Details:

The Interim data from EPYDIS Phase 3 trial shows that the trial is NOT FUTILE and the Independent Data Monitoring Committee recommends trial continuation.

Lead Product(s): Givinostat

Therapeutic Area: Genetic Disease Product Name: Undisclosed

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 April 27, 2020

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