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Once suspended due to safety issues, bardoxolone now has completed a Phase II study that showed kidney function benefit in four rare types of CKD. A pivotal study is underway, with another planned and more possible.
In its latest TANGO trial for chronic lower back pain, Eli Lilly and Pfizer’s tanezumab has shown efficacy at 10 mg, but its 5 mg dose missed the statistically significant mark. Vitally, analysts are encouraged by safety data.
The drug demonstrates improvements in overall survival and progression-free survival, but not enough for success in KEYNOTE-240.
Updated data from PIVOT-02 at the ASCO GU meeting suggest a path for accelerated approval of the NKTR-214/Opdivo combination as first-line treatment of patients with PD-L1-negative urothelial cancers.
A week after Gilead missed its primary endpoint in the first Phase III NASH trial, Intercept shows a statistically significant fibrosis benefit in Phase III with OCA. It plans to file for approval later this year.
Gyroscope Therapeutics, which aims to develop genetically defined therapies for a range of eye diseases, has begun dosing in a Phase I/II clinical trial in dry age-related macular degeneration using its lead candidate.
IQVIA has impressed industry observers with its Q4 results, which show the potential of the freshly merged company, especially in its technology division. With biotech money and strategic outsourcing as prevalent as it has been in recent memory, could the rest of the CRO industry follow suit?
In another globally pioneering move, Japan approves a trial with its flagship iPS cell technology in spinal cord injury, following a controversial earlier marketing approval in the same indication.
ASCO GU: Darolutamide is important for the company's oncology portfolio, but does it have enough to compete against J&J's Erleada and Pfizer/Astellas' Xtandi?
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