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NEWS #PharmaBuzz
11 Sep 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/09/11/3148535/23024/en/Intercept-Announces-Voluntary-Withdrawal-of-OCALIVA-for-Primary-Biliary-Cholangitis-PBC-from-the-US-Market-US-Clinical-Trials-Involving-Obeticholic-Acid-Placed-on-Clinical-Hold.html
30 Jul 2025
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/alfasigma-touts-results-phase-3-trial-former-galapagos-jak-inhibitor-jyseleca
28 Jul 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20250728902063/en/Filgotinib-Shows-Positive-Topline-Results-Across-Full-Spectrum-of-Axial-Spondyloarthritis-in-OLINGUITO-Phase-3-Study
19 Nov 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/forging-new-paths-alfasigma-group-and-fangzhou-inc-chart-a-course-for-internet-healthcare-302310791.html
12 Sep 2024
// ENDPTS
https://endpts.com/fda-is-poised-to-pull-ocaliva-as-adcomm-documents-question-post-approval-study-results/
06 Sep 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/09/06/2942227/23024/en/Findings-From-COBALT-Trial-Including-External-Control-Arm-Published-in-The-American-Journal-of-Gastroenterology.html
Drugs in Development
Details:
Filgotinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Colitis, Ulcerative.
Lead Product(s): Filgotinib
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 07, 2025
Lead Product(s) : Filgotinib
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis
Details : Filgotinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Colitis, Ulcerative.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 07, 2025
Details:
Filgotinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Behcet Syndrome.
Lead Product(s): Filgotinib
Therapeutic Area: Rare Diseases and Disorders Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: UMC Utrecht
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 29, 2024
Lead Product(s) : Filgotinib
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : UMC Utrecht
Deal Size : Inapplicable
Deal Type : Inapplicable
Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases
Details : Filgotinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Behcet Syndrome.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 29, 2024
Details:
Alfasigma completed acquisition of Jyseleca (filgotinib), which provides European and UK Marketing Authorizations. It is used for the treatment of moderate to severe rheumatoid arthritis.
Lead Product(s): Filgotinib
Therapeutic Area: Immunology Brand Name: Jyseleca
Study Phase: Approved FDFProduct Type: Miscellaneous
Recipient: Galapagos
Deal Size: $184.9 million Upfront Cash: $54.3 million
Deal Type: Acquisition January 31, 2024
Lead Product(s) : Filgotinib
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Recipient : Galapagos
Deal Size : $184.9 million
Deal Type : Acquisition
Galapagos Completes Transaction to Transfer Jyseleca® Business to Alfasigma
Details : Alfasigma completed acquisition of Jyseleca (filgotinib), which provides European and UK Marketing Authorizations. It is used for the treatment of moderate to severe rheumatoid arthritis.
Product Name : Jyseleca
Product Type : Miscellaneous
Upfront Cash : $54.3 million
January 31, 2024
Details:
Filgotinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Arthritis, Juvenile.
Lead Product(s): Filgotinib
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 24, 2024
Lead Product(s) : Filgotinib
Therapeutic Area : Immunology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Filgotinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Arthritis, Juvenile.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 24, 2024
Details:
Galapagos transfers Jyseleca (filgotinib) to Alfasigma as part of its transformation into a biotech company focused on immunology and oncology, marking a significant milestone for the company.
Lead Product(s): Filgotinib
Therapeutic Area: Immunology Brand Name: Jyseleca
Study Phase: Approved FDFProduct Type: Miscellaneous
Recipient: Galapagos
Deal Size: $229.7 million Upfront Cash: $54.7 million
Deal Type: Agreement January 02, 2024
Lead Product(s) : Filgotinib
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Recipient : Galapagos
Deal Size : $229.7 million
Deal Type : Agreement
Galapagos Signs Agreement to Transfer Jyseleca® Business to Alfasigma
Details : Galapagos transfers Jyseleca (filgotinib) to Alfasigma as part of its transformation into a biotech company focused on immunology and oncology, marking a significant milestone for the company.
Product Name : Jyseleca
Product Type : Miscellaneous
Upfront Cash : $54.7 million
January 02, 2024
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 response to UDCA.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Ocaliva
Study Phase: Approved FDFProduct Type: Miscellaneous
Recipient: Intercept Pharmaceuticals
Deal Size: $794.0 million Upfront Cash: $794.0 million
Deal Type: Acquisition November 08, 2023
Lead Product(s) : Obeticholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved FDF
Recipient : Intercept Pharmaceuticals
Deal Size : $794.0 million
Deal Type : Acquisition
Alfasigma Completes Acquisition of Intercept Pharmaceuticals, Inc.
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...
Product Name : Ocaliva
Product Type : Miscellaneous
Upfront Cash : $794.0 million
November 08, 2023
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 response to UDCA.
Lead Product(s): Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Ocaliva
Study Phase: Approved FDFProduct Type: Miscellaneous
Recipient: Intercept Pharmaceuticals
Deal Size: $794.0 million Upfront Cash: $794.0 million
Deal Type: Acquisition September 26, 2023
Lead Product(s) : Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved FDF
Recipient : Intercept Pharmaceuticals
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...
Product Name : Ocaliva
Product Type : Miscellaneous
Upfront Cash : $794.0 million
September 26, 2023
Details:
Filgotinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Axial Spondyloarthritis.
Lead Product(s): Filgotinib
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 27, 2023
Lead Product(s) : Filgotinib
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis
Details : Filgotinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Axial Spondyloarthritis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 27, 2023
Details:
Velusetrag is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Intestinal Pseudo-Obstruction.
Lead Product(s): Velusetrag
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 13, 2023
Lead Product(s) : Velusetrag
Therapeutic Area : Gastroenterology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction (CIPO).
Details : Velusetrag is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Intestinal Pseudo-Obstruction.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 13, 2023
Details:
Sulodexide is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of COVID-19.
Lead Product(s): Sulodexide
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Recipient: Centro Medico del Noroeste
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 12, 2022
Lead Product(s) : Sulodexide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Recipient : Centro Medico del Noroeste
Deal Size : Inapplicable
Deal Type : Inapplicable
Endothelial Protection in Post COVID-19 Patients With Sulodexide
Details : Sulodexide is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of COVID-19.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 12, 2022
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
Dosage Form : TABLET; ORAL
Proprietary Name : MAOLATE
Dosage Strength : 400MG
Approval Date : 1982-01-01
Application Number : 14217
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ZELNORM
Dosage Strength : EQ 2MG BASE
Approval Date : 2002-07-24
Application Number : 21200
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ZELNORM
Dosage Strength : EQ 6MG BASE
Approval Date : 2002-07-24
Application Number : 21200
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
Europe
Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Brand Name : Jyseleca
Approval Date : 24/09/2020
Application Number : 20190725000011
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Dosage Strength : 200mg
Packaging :
Brand Name : Jyseleca
Approval Date : 24/09/2020
Application Number : 20190725000028
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Dosage Form : Tablets
Dosage Strength : 800 mg
Packaging : 35 UNITS 800 MG - ...
Brand Name : CYCLOVIRAN
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Tablets
Dosage Strength : 200 mg
Packaging : 20 UNITS 200 MG - ...
Brand Name : AMIODAR
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Approved
Registration Country : Sweden
Artenimol; Piperaquine Tetraphosphate
Dosage Form : Film Coated Tablet
Dosage Strength : 160mg;20mg
Packaging :
Brand Name : Eurartesim
Approval Date : 27/10/2011
Application Number : 20090813000025
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Artenimol; Piperaquine Tetraphosphate
Dosage Form : Film Coated Tablet
Dosage Strength : 320mg;40mg
Packaging :
Brand Name : Eurartesim
Approval Date : 27/10/2011
Application Number : 20090813000018
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Artenimol; Piperaquine Tetraphosphate Tetrahydrate
Dosage Form : Film Coated Tablet
Dosage Strength : 320MG; 40 MG
Packaging :
Brand Name : Eurartesim
Approval Date : 2011-12-16
Application Number : 11716004
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info :
Registration Country : Italy
Dosage Form : Film-Coated Tablets
Dosage Strength : 50 mg
Packaging : 50 UNITS 50 MG - O...
Brand Name : AZAFOR
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Film-Coated Tablets
Dosage Strength : 500 mg
Packaging : 3 UNITS 500 MG - O...
Brand Name : BITCH
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Powder For Oral Suspension
Dosage Strength : 200 mg/5ml
Packaging : 37.5 ML 4% - ORAL ...
Brand Name : BITCH
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Inspections and registrations
THIRD-PARTY AUDIT
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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