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[{"orgOrder":0,"company":"Formycon","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Formycon Announce current Status of BLA Review of FYB201","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"February 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Formycon"},{"orgOrder":0,"company":"STADA Arzneimittel","sponsor":"Bausch & Lomb Incorporated","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Bausch + Lomb Licenses Exclusive Rights from STADA and Xbrane to a Biosimilar Candidate for Lucentis in the United States and Canada","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"STADA Arzneimittel"},{"orgOrder":0,"company":"Formycon","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Formycon Announces Update On Biosimilar Programs","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Formycon"},{"orgOrder":0,"company":"Novaliq","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novaliq Completes Enrollment of Second Phase 3 Study for CyclASol\u00ae for the Treatment of Dry Eye Disease","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Peptide","productStatus":"Approved","date":"August 2021","url1":"","url2":"","graph1":"Peptide","graph2":"Novaliq"},{"orgOrder":0,"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bayer Submits Aflibercept For Regulatory Approval in the EU and Japan for Retinopathy of Prematurity in Premature Babies","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Bayer AG"},{"orgOrder":0,"company":"Novaliq","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Phase 3 Trial of SHR8058 Eye Drops (Perfluorohexyloctane) Conducted by Jiangsu Hengrui Pharmaceuticals in The People\u2019s Republic of China Shows Statistically Significant Topline Results","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Novaliq"},{"orgOrder":0,"company":"Novaliq","sponsor":"Bausch & Lomb Incorporated","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bausch + Lomb Presents Data from First Pivotal Phase 3 Trial of Investigational Treatment NOV03 (Perfluorohexyloctane) at the American Society of Cataract and Refractive Surgery Annual Meeting","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Novaliq"},{"orgOrder":0,"company":"Midas Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"EMA CHMP Recommends Grant of Marketing Authorization of Ranibizumab Biosimilar","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"June 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Midas Pharma"},{"orgOrder":0,"company":"Novaliq","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novaliq Announces FDA Acceptance of the New Drug Application for CyclASol\u00ae for the Treatment of Dry Eye Disease","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Peptide","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Peptide","graph2":"Novaliq"},{"orgOrder":0,"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Detailed Data From Pivotal Studies With Aflibercept 8 Mg Demonstrate Sustained Improvements In Visual Acuity And Anatomic Measures With Large Majority Of Patients Maintaining Treatment Intervals Of 16","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Bayer AG"},{"orgOrder":0,"company":"Klinge Pharma","sponsor":"Coherus Biosciences","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"$32.5 million","newsHeadline":"Coherus Agrees to Acquire Exclusive U.S. Commercial Rights to Eylea\u00ae Biosimilar FYB203 from Klinge Biopharma","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"January 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Klinge Pharma"},{"orgOrder":0,"company":"Novaliq","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novaliq Plans to File a Markting Authorisation Application for CyclASol\u00ae in the E.U. for the Treatment of Dry Eye Disease in July 2023","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Peptide","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Peptide","graph2":"Novaliq"}]

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            Details:

            The active substance of Ranivisio is ranibizumab, a monoclonal antibody fragment (ATC code: S01LA04) which modulates angiogenesis by inhibiting vascular endothelial growth factor A. Ranivisio is a biosimilar medicinal product.

            Lead Product(s): Ranibizumab

            Therapeutic Area: Ophthalmology Product Name: Ranivisio

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 23, 2022

            Details:

            CyclASol® consists of cyclosporine solubilized in a novel water-free excipient, perfluorobutylpentane , it is specifically developed as a potent and comfortable anti-inflammatory dry eye drug therapy with rapid onset of effect for dry eye patients.

            Lead Product(s): Cyclosporine

            Therapeutic Area: Ophthalmology Product Name: CyclASol

            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 08, 2023

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            Details:

            FYB203, a biosimilar candidate to Eylea (aflibercept), which Klinge Biopharma has in-licensed from the German biosimilar developer Formycon AG, is being evaluated in a Phase 3 clinical trial in patients with Neovascular (wet) Age-Related Macular Degeneration (nAMD).

            Lead Product(s): Aflibercept

            Therapeutic Area: Ophthalmology Product Name: FYB203

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Coherus Biosciences

            Deal Size: Undisclosed Upfront Cash: $32.5 million

            Deal Type: Acquisition January 09, 2023

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            Details:

            Phase III PULSAR trial in nAMD and phase II/III PHOTON trial in DME respectively met primary endpoint of non-inferiority of Eylea (aflibercept) 8 mg extended dosing regimens for best visual acuity at week 48, compared to Eylea dosed every 8 weeks.

            Lead Product(s): Aflibercept

            Therapeutic Area: Ophthalmology Product Name: Eylea

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 05, 2022

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            Details:

            CyclASol® (cyclosporine ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment for the signs and symptoms of dry eye disease (DED).

            Lead Product(s): Cyclosporine

            Therapeutic Area: Ophthalmology Product Name: CyclASol

            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 October 24, 2022

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            Details:

            The data show that NOV03, (perfluorohexyloctane) met both primary endpoints of total Corneal Fluorescein Staining, a measure that assesses damage to the eye, and visual analogue scale dryness score at day 57.

            Lead Product(s): Perfluorohexyloctane

            Therapeutic Area: Ophthalmology Product Name: NOV03

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Bausch & Lomb Incorporated

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 25, 2022

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            Details:

            Company provided update on phase 3 trial of SHR8058 eye drops (perfluorohexyloctane) for the treatment of dry eye disease associated with Meibomian gland dysfunction and the trial met its prespecified primary sign endpoint improvement of total corneal fluorescein staining.

            Lead Product(s): Perfluorohexyloctane

            Therapeutic Area: Ophthalmology Product Name: SHR8058

            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 December 16, 2021

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            Details:

            Aflibercept showed a positive benefit-risk profile in patients with ROP treated in 27 countries worldwide in the FIREFLEYE study, the first randomized prospective clinical trial comparing aflibercept to laser in premature babies with ROP requiring treatment.

            Lead Product(s): Aflibercept

            Therapeutic Area: Ophthalmology Product Name: Eylea

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 10, 2021

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            Details:

            CyclASol® is a topical, anti-inflammatory and immunomodulating ophthalmic solution, containing 0.1% cyclosporine A in EyeSol®, developed for the treatment of DED.

            Lead Product(s): Cyclosporine

            Therapeutic Area: Ophthalmology Product Name: CyclASol

            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 August 10, 2021

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            Details:

            Formycon continues to work with license partner Bioeq AG and its manufacturing partner on the resubmission of the Biologics License Application (BLA) for the FYB201 project, a biosimilar candidate for Lucentis(R)* (Ranibizumab), despite the situation regarding COVID-19.

            Lead Product(s): Ranibizumab

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 15, 2020

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