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[{"company":"Allergan Plc","sponsor":"Teva Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Allergan keeps Linzess generics out until 2029 with Teva settlement","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Peptide","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Peptide","graph2":"Allergan Plc"},{"company":"Cosmo Pharmaceuticals","sponsor":"RedHill Biopharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"RedHill Biopharma Strengthens Partnership with Cosmo Pharmaceuticals with Manufacturing Agreements for Movantik and RHB-204","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Cosmo Pharmaceuticals"},{"company":"AbbVie Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HUMIRA\u00ae (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"AbbVie Inc"},{"company":"AbbVie Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AbbVie's Humira Gets Approval In Canada for Treatment of Pediatric Patients With Ulcerative Colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"AbbVie Inc"},{"company":"AbbVie Inc","sponsor":"Eisai","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fully Human Anti-TNF\u03b1 Monoclonal Antibody HUMIRA\u00ae Obtains Additional Approval for High-Dose Regimen of Ulcerative Colitis in Adult Patients and for New Regimen in Pediatric Patients","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"September 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"AbbVie Inc"},{"company":"Mallinckrodt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mallinckrodt Presents Results on Real World Treatment Patterns and Outcomes in Hospitalized Patients with Esophageal Variceal Hemorrhage and Liver Cirrhosis Treated with Terlipressin at the American College of Gastroenterology Annual Scientific Meeting","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Mallinckrodt Pharmaceuticals"},{"company":"AbbVie Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RINVOQ\u00ae (upadacitinib) Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"AbbVie Inc"},{"company":"AbbVie Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AbbVie to Showcase Depth of Gastroenterology Portfolio and Pipeline at Digestive Disease Week\u00ae","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Peptide","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Peptide","graph2":"AbbVie Inc"},{"company":"Perrigo Company plc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Perrigo Announces U.S. FDA Approval For Omeprazole Magnesium Delayed-Release Mini Capsules","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Perrigo Company plc"},{"company":"AbbVie Inc","sponsor":"Boehringer Ingelheim GmbH","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"SKYRIZI\u00ae (risankizumab-rzaa) Receives FDA Approval as the First and Only Specific Interleukin-23 (IL-23) to Treat Moderately to Severely Active Crohn's Disease in Adults","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"AbbVie Inc"},{"company":"AbbVie Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Commission Approves RINVOQ\u00ae (upadacitinib) for the Treatment of Adults With Moderate to Severe Ulcerative Colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"AbbVie Inc"}]

AbbVie Inc

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European Commission Approves RINVOQ® (upadacitinib) for the Treatment of Adults With Moderate to Severe Ulcerative Colitis

Details:

In human cellular assays, RINVOQ (upadacitinib 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) preferentially inhibits signalling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.

Lead Product(s): Upadacitinib

Therapeutic Area: Gastroenterology Product Name: Rinvoq

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 26, 2022

Abbvie Company Banner

BioProcess International 2022

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AbbVie Inc

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SKYRIZI® (risankizumab-rzaa) Receives FDA Approval as the First and Only Specific Interleukin-23 (IL-23) to Treat Moderately to Severely Active Crohn's Disease in Adults

Details:

SKYRIZI (risankizumab) is an interleukin-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including Crohn's disease.

Lead Product(s): Risankizumab

Therapeutic Area: Gastroenterology Product Name: Skyrizi

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Boehringer Ingelheim GmbH

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 17, 2022

Abbvie Company Banner

BioProcess International 2022

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AbbVie Inc

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AbbVie to Showcase Depth of Gastroenterology Portfolio and Pipeline at Digestive Disease Week®

Details:

Total of 27 abstracts AbbVie leadership in advancing research and standard of care across multiple gastroenterological condition, also presentations include analyses of Phase 3 study programs for RINVOQ (upadacitinib) in ulcerative colitis and risankizumab in Crohn's disease.

Lead Product(s): Linaclotide

Therapeutic Area: Gastroenterology Product Name: Linzess

Highest Development Status: Approved Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 16, 2022

Abbvie Company Banner

BioProcess International 2022

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AbbVie Inc

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RINVOQ® (upadacitinib) Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

Details:

RINVOQ (upadacitinib), achieved clinical remission at weeks 8 and 52, the primary endpoint based on the mMS: stool frequency subscore ≤ 1 and not greater than Baseline, rectal bleeding subscore = 0, endoscopy subscore of ≤ 1 without friability, compared to placebo.

Lead Product(s): Upadacitinib

Therapeutic Area: Gastroenterology Product Name: Rinvoq

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 16, 2022

Abbvie Company Banner

BioProcess International 2022

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AbbVie Inc

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Fully Human Anti-TNFα Monoclonal Antibody HUMIRA® Obtains Additional Approval for High-Dose Regimen of Ulcerative Colitis in Adult Patients and for New Regimen in Pediatr...

Details:

HUMIRA® is a fully human anti-TNF-α monoclonal antibody, got additional approval for a highdose regimen in adult patients with ulcerative colitis and for a new regimen in pediatric patients.

Lead Product(s): Adalimumab

Therapeutic Area: Gastroenterology Product Name: Humira

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Eisai

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 27, 2021

Abbvie Company Banner

BioProcess International 2022

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AbbVie Inc

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AbbVie's Humira Gets Approval In Canada for Treatment of Pediatric Patients With Ulcerative Colitis

Details:

HUMIRA (adalimumab) is the first and only subcutaneous biologic treatment option for pediatric patients from 5 years of age with moderately to severely active ulcerative colitis.

Lead Product(s): Adalimumab

Therapeutic Area: Gastroenterology Product Name: Humira

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 24, 2021

Abbvie Company Banner

BioProcess International 2022

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AbbVie Inc

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HUMIRA® (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis

Details:

Approval for adalimumab based on results from the pivotal Phase 3 ENVISION I study showing the higher dosage of HUMIRA induced clinical remission in 60 percent of patients at Week 8 and 45 percent of patients, who responded at Week 8, were in remission at Week 52.

Lead Product(s): Adalimumab

Therapeutic Area: Gastroenterology Product Name: Humira

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 24, 2021

Abbvie Company Banner

BioProcess International 2022

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Perrigo Company plc

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Perrigo Announces U.S. FDA Approval For Omeprazole Magnesium Delayed-Release Mini Capsules

Details:

Omeprazole Magnesium Delayed-Release Mini Capsules, 20 mg over-the-counter (OTC),represents a first-to-market mini capsule form of omeprazole, which is indicated for treatment of frequent heartburn.

Lead Product(s): Omeprazole Magnesium

Therapeutic Area: Gastroenterology Product Name: Omeprazole Magnesium-Generic

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 26, 2022

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Mallinckrodt Pharmaceuticals

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Mallinckrodt Presents Results on Real World Treatment Patterns and Outcomes in Hospitalized Patients with Esophageal Variceal Hemorrhage and Liver Cirrhosis Treated with Te...

Details:

Terlipressin is one of the accepted vasoactive therapies recommended by the European Association for the Study of the Liver guidelines, which recommends that vasoconstrictive therapy should be initiated as soon as acute variceal bleeding is suspected and before endoscopy.

Lead Product(s): Terlipressin Acetate

Therapeutic Area: Gastroenterology Product Name: Teripress

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 25, 2021

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Cosmo Pharmaceuticals

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RedHill Biopharma Strengthens Partnership with Cosmo Pharmaceuticals with Manufacturing Agreements for Movantik and RHB-204

Details:

The agreements secure high-quality manufacturing capacity of Movantik® for opioid-induced constipation and RHB-204, currently in a Phase 3 study for pulmonary NTM disease.

Lead Product(s): Naloxegol Oxalate

Therapeutic Area: Gastroenterology Product Name: Movantik

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: RedHill Biopharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership February 18, 2021

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