Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Deflazacort
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Cranbury Receives FDA Approval for First Generic Emflaza Oral Suspension
Details : Emflaza-Generic (deflazacort) is a corticosteroid prodrug, which acts through the glucocorticoid receptor as an agonist. It is approved for the treatment of duchenne muscular dystrophy.
Brand Name : Emflaza-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 12, 2024
Lead Product(s) : Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Deflazacort
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Aurobindo Pharma Receives USFDA Approval for Deflazacort Tablets in Multiple Strengths
Details : Emflaza (deflazacort), a corticosteroid prodrug whose active metabolite acts as a glucocorticoid receptor agonist. It is approved for treating duchenne muscular dystrophy in patients 5 years & older.
Brand Name : Emflaza
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 12, 2024
Lead Product(s) : Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : FG-3019 (pamrevlumab) is a potential first-in-class antibody being developed to inhibit the activity of CTGF, a common factor in fibrotic and proliferative disorders, which is investigated for the treatment of ambulatory patients with Duchenne muscular d...
Brand Name : FG-3019
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 29, 2023
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : FG-3019 (pamrevlumab) is a potential first-in-class antibody being developed to inhibit the activity of CTGF, a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction an...
Brand Name : FG-3019
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 07, 2023
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Pamrevlumab (FG-3019), is a potential antibody, have potential to inhibit the activity of connective tissue growth factor, a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ d...
Brand Name : FG-3019
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 08, 2022
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Deflazacort
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Results Add to Body of Evidence Confirming EMFLAZA®'s Benefit Over Prednisone
Details : The results of this analysis adds to the body of evidence and clearly demonstrates the clinical benefit of EMFLAZA over prednisone. These results also reflect the benefit that patients experience in the real-world setting.
Brand Name : Emflaza
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 24, 2021
Lead Product(s) : Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : This designation follows review of the Phase 2 clinical data from a single-arm trial in non-ambulatory patients with DMD, and represents recognition by the FDA that pamrevlumab has the potential to address an unmet medical need for this disease.
Brand Name : FG-3019
Molecule Type : Large molecule
Upfront Cash : Not Applicable
April 12, 2021
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : FibroGen has initiated LELANTOS, a Phase 3, randomized, double-blind, placebo-controlled trial of pamrevlumab or placebo in combination with systemic corticosteroids in patients with non-ambulatory Duchenne muscular dystrophy (DMD).
Brand Name : FG-3019
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 11, 2020
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
LOOKING FOR A SUPPLIER?