RedHill Biopharma Ltd. announced that the U.S. FDA has accepted for review the New Drug Application (NDA) for Talicia (RHB-105)1 for H. pylori infection. The NDA for Talicia has also been granted Priority Review designation and was assigned a target Prescription Drug User Act (PDUFA) action date by the FDA of November 2, 2019.
Commercial launch of Talicia with RedHill’s existing U.S. sales force is planned shortly following potential FDA approval. If approved, Talicia would be eligible for a total of eight years of U.S. market exclusivity.
“The efficacy of current standard-of-care therapies for H. pylori bacterial infection continues to decline due to the high and steadily increasing prevalence of antibiotic-resistant strains. This public health concern is widely recognized by the U.S. government and other leading health agencies, including the World Health Organization, which classified H. pylori as a Group I carcinogen and highlighted the urgent need for new treatments for H. pylori eradication,” said Dror Ben-Asher, Chief Executive Officer of RedHill Biopharma. “The acceptance for review of the NDA for Talicia and the Priority Review designation are encouraging steps as we continue our intensive preparations for a potential U.S. commercial launch of Talicia as a new first-line, standard-of-care therapy for H. pylori. We continue to work closely with the FDA, with the aim of bringing this important new therapy to patients.”
Breaking News
FDA Accepts RedHill Biopharma’s NDA for Talicia
Commercial launch of H. pylori treatment is planned shortly following potential FDA approval
07.16.19
Related Breaking News
-
Breaking News
Jones Healthcare Group Earns Silver-Medal Ranking from EcoVadis
Puts Jones in the top 20% best companies rated by EcoVadis in 2021.10.19.21
-
Breaking News | Drug Development | Promotions & Moves
Boyds Adds Two Product Development Experts to Its Team
Welcomes Diane Shattock Ph.D., as director of product development & Ian Hollingsworth M.Sc. as associate director of product development.10.19.21
-
Financial Reports
J&J Pharmaceutical Sales up 14% in the Quarter
COVID-19 Vaccine contributes $502 million in sales.10.19.21
-
Breaking News | Industry News
Aptar CSP Awarded $19M U.S. Govt. Contract for Activ-Film Technology
To support expanded domestic production capacity for Activ-Film technology used to protect and ensure COVID-19 test kit integrity and accuracy.10.19.21
-
Breaking News | Industry News | Injectables
West to Unveil DeltaCube and New NovaGuard SA at INTERPHEX
DeltaCube Platform aims to aid decisions for container closure systems and NovaGuard SA Pro safety system expanded for ISO standard 0.5mL glass syringes.10.19.21
-
Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Logistics | Supply Chain
Autolomous, Vineti Form Cell and Gene Therapy Supply Chain Pact
To integrate Autolomous’ critical manufacturing management systems with Vineti’s Personalized Therapy Management platform to create a seamless delivery pathway.10.19.21
-
Breaking News | Industry News
Phillips-Medisize Increases Global Mfg. Capacity
Expands production facilities and R&D centers in Poland, China and the U.S.10.19.21
-
Collaborations & Alliances
Antios Therapeutics, Assembly Biosciences Enter Clinical Collaboration
Will evaluate a triple combination treatment in patients with chronic hepatitis B virus (HBV) infection.10.19.21
-
Fill/Finish | Reader Showcase
Syntegon Introduces Solutions for Lab-Scale and Small Batch Filling
The new GKF 60 capsule filling machine and the Versynta Flexible Filling Platform (FFP) make their first live appearance at INTERPHEX.10.19.21
-
Reader Showcase | Serialization
WIPOTEC-OCS to Demonstrate Serialization & Aggregation Units at INTERPHEX
TQS-SP Serialization Unit for applying track & trace data and TQS-CP Aggregation Unit provides semi-automatic aggregation of manually repacked folding boxes.10.19.21
-
Breaking News | Drug Development
Landmark Bio Appoints Two New Leaders to Executive Team
Welcomes Gregg Nyberg as chief technology officer and Michael Covington as chief quality and regulatory officer.10.19.21
-
Fill/Finish | Reader Showcase
TurboFil to Showcase Latest Syringe Fillers at INTERPHEX
To showcase the SimpliFil Syringe Filling & Assembly System and new benchtop syringe filling machine TipFil Syringe Filler.10.19.21
-
Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Trials & Filings
Valneva COVID Vax Meets Co-primary Endpoints in Phase III Trial
Inactivated, adjuvanted VLA2001 demonstrates superiority against AZD1222 in terms of neutralization antibodies.10.18.21
-
Breaking News | Chemistry | Formulation Development | Industry News
Saniona Submits CMC Program for Tesomet Capsules
Expects to initiate its Phase 2b clinical trials for Tesomet before the end of 2021.10.18.21
-
Breaking News | cGMP Manufacture | Industry News
WuXi ATU Opens Fourth Manufacturing Facility
Shanghai facility offers integrated development, manufacturing, and testing services for viral vectors and cell therapies.10.18.21
