Having regained full rights to the first-in-class NHE3 inhibitor from AstraZeneca, Ardelyx plans a Phase III study in IBS-C and a Phase IIb study in hyperphosphatasia related to kidney dialysis before year’s end.
Roughly six weeks after regaining rights to first-in-class NHE3 inhibitor tenapanor from AstraZeneca PLC, Ardelyx Inc. is planning a Phase IIb study in hyperphosphatasia where it hopes to show lower doses can sufficiently reduce serum phosphate levels while minimizing adverse events that led to treatment discontinuations in a prior Phase IIb trial.
During its investor day presentation July 14, the Fremont, Calif.-based company outlined plans for that program as well for Phase...
Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.
US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.
Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.
Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
