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Latest From Janssen Inc.
US FDA advisory committee recommendation to combine interstitial cystitis and bladder pain syndrome patients in clinical trials is an interesting example of encouraging drug development by broadening the patient population. That runs counter to the personalized medicine mantra of narrowing patient populations based on mechanism of action.
The latest drug development news and highlights from our US FDA Performance Tracker.
Amid turmoil at Bayer's R&D unit, the company revealed that a Phase III trial of Xofigo had thrown up a safety issue for the product. Bayer insists peaks sales will be unaffected, but what had been a large potential new patient population now looks unlikely.
More Phase III data for Janssen's first once-daily single tablet containing four drugs for use against HIV Symtuza support its use in treatment-naïve patients; the product awaits US approval.
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