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Details:
Tascenso (fingolimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.
Lead Product(s): Fingolimod Hydrochloride
Therapeutic Area: Neurology Product Name: Tascenso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 13, 2023
Details:
Tascenso (fingolimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.
Lead Product(s): Fingolimod Hydrochloride
Therapeutic Area: Neurology Product Name: Tascenso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 17, 2023
Details:
Fingolimod, an orally available immunomodulatory drug, is a sphingosine 1-phosphate receptor modulator used to treat patients with the relapsing-remitting form of multiple sclerosis (MS).
Lead Product(s): Fingolimod Hydrochloride
Therapeutic Area: Neurology Product Name: Fingolimod-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 31, 2022
Details:
GILENYA (fingolimod) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and children 10 years of age and older.
Lead Product(s): Fingolimod Hydrochloride
Therapeutic Area: Neurology Product Name: Gilenya
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2022
Details:
Mean reduction in ADSI score from baseline was -4.05 (-60.62% mean reduction) for FMX114 (tofacitinib) treated lesions compared to -3.48 (-51.32% mean reduction) for vehicle treated lesions at week 4 (p=0.228, OC, ITT).
Lead Product(s): Tofacitinib Citrate,Fingolimod Hydrochloride
Therapeutic Area: Dermatology Product Name: FMX114
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 10, 2022
Details:
Gilenya® (fingolimod), an oral, once-daily at 0.5mg and 0.25mg versus once-daily subcutaneous injections of glatiramer acetate 20mg in reducing disease activity over 12 months in patients with relapsing remitting multiple sclerosis (RRMS).
Lead Product(s): Fingolimod Hydrochloride
Therapeutic Area: Neurology Product Name: Gilenya
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2022
Details:
FMX114 (tofacitinib), is VYNE’s proprietary investigational combination gel formulation of tofacitinib and fingolimod, which has been designed to address both the source and cause of inflammation in AD.
Lead Product(s): Tofacitinib Citrate,Fingolimod Hydrochloride
Therapeutic Area: Dermatology Product Name: FMX114
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2022
Details:
FMX114, an investigational combination gel formulation of tofacitinib and fingolimod, demonstrated a statistically significant reduction in both absolute and percent change in ADSI score compared to vehicle at week 2.
Lead Product(s): Tofacitinib Citrate,Fingolimod Hydrochloride
Therapeutic Area: Dermatology Product Name: FMX114
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2022
Details:
HEC Pharma filed the ANDA to get generic version of Novartis' Gilenya® (fingolimod), in response to that Novartis filed litigation against ANDA filers for US Patent No. 9,187,405 and extend the validity of Gilenya till 2027.
Lead Product(s): Fingolimod Hydrochloride
Therapeutic Area: Neurology Product Name: Gilenya
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2022
Details:
FMX114 is VYNE’s proprietary investigational combination gel formulation of tofacitinib and fingolimod for the treatment of mild-to-moderate atopic dermatitis (AD).
Lead Product(s): Tofacitinib Citrate,Fingolimod Hydrochloride
Therapeutic Area: Dermatology Product Name: FMX114
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2021
Details:
Fingolimod is an immunomodulating drug. It is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS).
Lead Product(s): Fingolimod Hydrochloride
Therapeutic Area: Neurology Product Name: Fingolimod-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 2020
Details:
United States Food & Drug Administration (U.S. FDA) for Fingolimod Capsules, 0.5 mg, the generic versionof Gilenya®1Capsules, 0.5 mg, of Novartis Pharmaceuticals Corporation.
Lead Product(s): Fingolimod Hydrochloride
Therapeutic Area: Neurology Product Name: Fingolimod HCl-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 19, 2020
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