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 FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Zydus Lifesciences Receives USFDA Approval for DMD Treatment Drug
Details : Jaythari (deflazacort) is a corticosteroid, acts as glucocorticoid receptor agonist. It is approved for the treatment of duchenne muscular dystrophy in patients 5 years of age and older.
Product Name : Jaythari
Product Type : Steroid
Upfront Cash : Inapplicable
April 14, 2025
Lead Product(s) : Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Deflazacort
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Emflaza-Generic
Product Type : Steroid
Upfront Cash : Inapplicable
December 06, 2024
Lead Product(s) : Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Deflazacort
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Emflaza
Product Type : Steroid
Upfront Cash : Inapplicable
December 02, 2024
Lead Product(s) : Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : FG-3019
Product Type : Antibody
Upfront Cash : Inapplicable
August 29, 2023
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : FG-3019
Product Type : Antibody
Upfront Cash : Inapplicable
July 06, 2023
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : FG-3019
Product Type : Antibody
Upfront Cash : Inapplicable
August 06, 2022
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : FG-3019
Product Type : Antibody
Upfront Cash : Inapplicable
December 04, 2021
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Deflazacort
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Emflaza
Product Type : Steroid
Upfront Cash : Inapplicable
June 24, 2021
Lead Product(s) : Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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).
Product Name : FG-3019
Product Type : Antibody
Upfront Cash : Inapplicable
November 08, 2020
Lead Product(s) : Pamrevlumab,Deflazacort
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable