Duchenne Delay, Forum’s Fate, Califf, Ionis & More
Summary
In Boston, one company’s controversial quest to potentially get the first drug for Duchenne muscular dystrophy approved drags on, while the fate of another seems to hang by a thread.And on the West Coast, the first implantable device for opioid addiction was approved—just as the FDA’s commissioner made some pointed remarks at a Stanford University chat about the future rate of drug approvals.—At a Stanford University conference, new FDA commissioner Robert Califf predicted that the high rate of drug approvals in recent years would continue, thanks to better understanding of biology and adoption of “big data” and other sophisticated technology.—The agency rejected, meanwhile, a drug from AstraZeneca (NYSE: AZN) called ZS-9 for the kidney disease hyperkalemia, citing manufacturing issues.That’s positive news for Redwood City, CA-based Relypsa (NASDAQ: RLYP), which has a rival hyperkalemia drug on the market—Relypsa shares soared 37 percent Friday morning—and a setback for the British drugmaker, which acquired ZS-9 when it paid $2.7 billion for Coppell, TX-based ZS Pharma in November.