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Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AbbVie Submits Supplemental New Drug Application to U.S. FDA to Support New Indication of LINZESS\u00ae (linaclotide) for Functional Constipation in Children and Adolescents 6 to 17 Years of Age","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Peptide","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Peptide","graph2":"AbbVie Inc"},{"orgOrder":0,"company":"Abivax","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Abivax Receives FDA Agreement on Pediatric Development Plan with Obefazimod in IBD","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Abivax"},{"orgOrder":0,"company":"Pfizer Inc","sponsor":"Everest Medicines","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Everest Medicines' Licensing Partner Pfizer Announces FDA and EMA Acceptance of Etrasimod Regulatory Submissions for Ulcerative Colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Pfizer Inc"},{"orgOrder":0,"company":"Celltrion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celltrion USA Announces Submission of the Biologics License Application (BLA) of Novel Subcutaneous Formulation of CT-P13 to U.S. Food and Drug Administration","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Biosimilar","date":"December 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Celltrion"},{"orgOrder":0,"company":"Phathom Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Phathom Pharmaceuticals Provides Update on New Drug Application Review of Vonoprazan for Erosive Esophagitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phathom Pharmaceuticals"},{"orgOrder":0,"company":"Abivax","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Abivax Publishes Novel Data with Respect to Obefazimod\u2019s Anti-Inflammatory Mechanism of Action","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Abivax"},{"orgOrder":0,"company":"Phathom Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Phathom Pharmaceuticals Announces Positive Topline Results from Phase 3 PHALCON-NERD-301 Trial Evaluating Daily Dosing of Vonoprazan for Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phathom Pharmaceuticals"},{"orgOrder":0,"company":"Infant Bacterial Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Infant Bacterial Therapeutics\u2019 (IBT) Publishes Clinical Findings in The British Journal of Gastroenterology on The Convincing Association of Clinical Events to The Feeding Primary Endpoint of The \u2018Connection Study\u2019","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Infant Bacterial Therapeutics"},{"orgOrder":0,"company":"Jaguar Health","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Jaguar Health Announces Completion of Key Milestone in Process of Establishing Indena S.p.A. as a Reliable Approved Crofelemer Manufacturer","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Jaguar Health"},{"orgOrder":0,"company":"InDex Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"InDex Pharmaceuticals Updates the Timeline of The Phase Iii Study CONCLUDE With Cobitolimod","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"InDex Pharmaceuticals"}]

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AbbVie Inc

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AbbVie Submits Supplemental New Drug Application to U.S. FDA to Support New Indication of LINZESS® (linaclotide) for Functional Constipation in Children and Adolescents 6 ...

Details:

Linaclotide is a guanylate cyclase-C (GC-C) agonist that is thought to work in two ways based on nonclinical studies. Linaclotide binds to the GC-C receptor locally within the intestinal epithelium.

Lead Product(s): Linaclotide

Therapeutic Area: Gastroenterology Product Name: Linzess

Highest Development Status: Phase III Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 16, 2022

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AbbVie Inc

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AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) in Crohn's Disease

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Based on enzymatic and cellular assays, RINVOQ (upadacitinib) demonstrated greater inhibitory potency for JAK-1 vs. JAK-2, JAK-3 and TYK-2. The safety results of upadacitinib were generally consistent with the known safety profile, and no new safety risks observed.

Lead Product(s): Upadacitinib

Therapeutic Area: Gastroenterology Product Name: Rinvoq

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 29, 2022

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Sanofi

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Pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Dupixent® (Dupilumab) Phase 3 Trial Shows Positive Results in Children 1 to 11 Years of Age With Eosinophilic Esophagitis

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First and only investigational Phase 3 trial to show positive results in these young children; results follow recent approval of Dupixent (Dupilumab) in people with eosinophilic esophagitis aged 12 years and older who weigh at least 40 kilograms.

Lead Product(s): Dupilumab

Therapeutic Area: Gastroenterology Product Name: Dupixent

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 14, 2022

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AbbVie Inc

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The Lancet Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Risankizumab (SKYRIZI®) in Crohn's Disease

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SKYRIZI (Risankizumab) is an interleukin-23 (IL-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: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 27, 2022

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AbbVie Inc

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Upadacitinib (RINVOQ) Achieved Clinical Remission and Endoscopic Response at One Year in Phase 3 Maintenance Study in Patients with Crohn's Disease

Details:

In patients with Crohn's disease who achieved clinical response showed, a significantly greater proportion treated with either upadacitinib achieved clinical remission, a,b endoscopic response, and endoscopic remission at week 52 compared to placebo.

Lead Product(s): Upadacitinib

Therapeutic Area: Gastroenterology Product Name: Rinvoq

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 11, 2022

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Sanofi

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Pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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FDA Accepts Dupixent® (Dupilumab) for Priority Review in Patients Aged 12 Years and Older With Eosinophilic Esophagitis

Details:

Dupixent 300 mg weekly, a fully human mAB that inhibits signaling of interleukin-4 and interleukin-13 pathways, significantly improved signs and symptoms of EoE at 24 weeks compared to placebo, including ability to swallow and reduction in eosinophil count in esophagus.

Lead Product(s): Dupilumab

Therapeutic Area: Gastroenterology Product Name: Dupixent

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 04, 2022

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AbbVie Inc

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AbbVie Provides Update Regarding SKYRIZI® (risankizumab-rzaa) for the Treatment of Moderate to Severe Crohn's Disease in the U.S.

Details:

The FDA has extended PDUFA action date by three months to review additional data submitted by AbbVie for SKYRIZI (risankizumab-rzaa) for the treatment of moderate to severe Crohn's disease in patients 16 years and older.

Lead Product(s): Risankizumab-rzaa

Therapeutic Area: Gastroenterology Product Name: Skyrizi

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 28, 2022

Abbvie Company Banner

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AbbVie Inc

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Second Phase 3 Induction Study Confirms Upadacitinib (RINVOQ®) Improved Clinical and Endoscopic Outcomes in Patients with Crohn's Disease

Details:

Consistent with results from the U-EXCEED induction study, higher proportion of patients receiving upadacitinib 45 mg also achieved steroid-free clinical remissiond per CDAI and per SF/AP compared to placebo at week 12 among patients taking corticosteroids at baseline.

Lead Product(s): Upadacitinib

Therapeutic Area: Gastroenterology Product Name: Rinvoq

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 24, 2022

Abbvie Company Banner

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AbbVie Inc

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Upadacitinib (RINVOQ®) Achieved Primary and Key Secondary Endpoints in First Phase 3 Induction Study in Patients with Crohn's Disease

Details:

Rinvoq (Upadacitinib), selective and reversible JAK inhibitor achieved both primary endpoints of clinical remission and endoscopic response at week 12 in adults with moderate to severe Crohn's disease.

Lead Product(s): Upadacitinib

Therapeutic Area: Gastroenterology Product Name: Rinvoq

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 06, 2021

Abbvie Company Banner

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Sanofi

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Pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Second Dupixent® (Dupilumab) Phase 3 Eosinophilic Esophagitis Trial to Demonstrate Significant Disease Improvements, Underscoring Role of Type 2 Inflammation in This Compl...

Details:

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 and interleukin-13. IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis.

Lead Product(s): Dupilumab

Therapeutic Area: Gastroenterology Product Name: Dupixent

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 25, 2021

Sanofi Company Banner

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