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May 10, 2019

RedHill Biopharma Submits NDA for for H. Pylori Infection Drug May 10, 2019

RedHill Biopharma Ltd. recently announced that, following a positive pre-NDA meeting held recently with the US FDA, it has submitted a New Drug Application (NDA) to the FDA for Talicia (RHB-105) for the treatment of H. pylori infection.

October 4, 2016

COMBINATION PRODUCTS - Device Development for Pharmaceutical & Biologic Combination Products October 4, 2016

Bill Welch says when developing a combination product, there are many things to be considered – relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding user needs, determining product requirements, as well as device manufacturing variation.

September 30, 2014

Daiichi Sankyo to Acquire Ambit Biosciences September 30, 2014

Daiichi Sankyo Company, Ltd. and Ambit Biosciences jointly announced they have entered into a definitive merger agreement under which Daiichi...