Lead Product(s) : Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Receives USFDA Approval for Ursodiol Capsules
Details : Strides Pharma, has received approval for Ursodiol Capsules USP, 300 mg from the USFDA. The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Actigall® Capsules, 300 mg, of Allergan Sales, LLC.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 25, 2021
Lead Product(s) : Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Receives USFDA Approval for Ursodiol Tablets
Details : USFDA approved generic version of Ursodiol Tablet, which is indicated for the treatment of patients with Primary Biliary Cirrhosis. It inhibits the absorption of cholesterol in the intestine and the secretion of cholesterol into bile, decreasing biliary ...
Brand Name : Urso Forte-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 21, 2020
Lead Product(s) : Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Seladelpar Lysine,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
With FDA Approval of Livdelzi, Gilead Launches an Inflammatory Drug for The First Time
Details : Livdelzi (seladelpar) is a novel selective, first-in-class, PPAR delta agonist, indicated to treat adults with primary biliary cholangitis (PBC).
Brand Name : Livdelzi
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 15, 2024
Lead Product(s) : Seladelpar Lysine,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Seladelpar Lysine,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Approved
Sponsor : Gilead
Deal Size : $320.0 million
Deal Type : Licensing Agreement
Gilead shells out $320M to J&J to buy out rare liver disease drug royalties
Details : Gilead will buy out Johnson & Johnson’s global royalties for primary biliary cholangitis drug Livdelzi (seladelpar lysine), a peroxisome proliferator-activated receptor (PPAR)-delta agonist.
Brand Name : Livdelzi
Molecule Type : Small molecule
Upfront Cash : Undisclosed
August 08, 2024
Lead Product(s) : Seladelpar Lysine,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved
Sponsor : Gilead
Deal Size : $320.0 million
Deal Type : Licensing Agreement
Lead Product(s) : Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Approved
Sponsor : Alfasigma
Deal Size : $794.0 million
Deal Type : Acquisition
Details : Through the acquisition, Alfasigma adds Ocaliva (obeticholic acid), a farnesoid X receptor agonist approved in the United States for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults with an inadequate respon...
Brand Name : Ocaliva
Molecule Type : Small molecule
Upfront Cash : $794.0 million
September 26, 2023
Lead Product(s) : Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved
Sponsor : Alfasigma
Deal Size : $794.0 million
Deal Type : Acquisition
Lead Product(s) : Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Approved
Sponsor : Advanz Pharma
Deal Size : $450.0 million
Deal Type : Acquisition
Details : Agreement includes rights for Advanz to commercialize orphan drug Ocaliva® (Obeticholic Acid) for PBC outside the U.S., as well as the transition to Advanz of the international commercial and medical infrastructure of Intercept.
Brand Name : Ocaliva
Molecule Type : Small molecule
Upfront Cash : $405.0 million
May 05, 2022
Lead Product(s) : Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved
Sponsor : Advanz Pharma
Deal Size : $450.0 million
Deal Type : Acquisition
Lead Product(s) : Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Approved
Sponsor : Duquesne University School of Pharmacy
Deal Size : Not Applicable
Deal Type : Not Applicable
AllianceRx Walgreens Prime Studies Use of Ocaliva® in the Treatment of Primary Biliary Cholangitis
Details : A recent study evaluating Ocaliva® (obeticholic acid) in patients diagnosed with primary biliary cholangitis (PBC) revealed similar patient-reported adverse effects as in clinical trials while also exploring patient out-of-pocket cost and utilization.
Brand Name : Ocaliva
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 30, 2022
Lead Product(s) : Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved
Sponsor : Duquesne University School of Pharmacy
Deal Size : Not Applicable
Deal Type : Not Applicable
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Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
