Regulatory setbacks for a new migraine treatment have led Zosano Pharma to restructure, laying off about 31% of its staff. Zosano is one of several biotechs that announced cost-saving measures this week.
Ardelyx drug tenapanor was rejected by the FDA as a treatment for a complication experienced by chronic kidney disease patients. The regulatory decision came two weeks after the company received an FDA letter citing deficiencies in the drug application.
Across the nation, state-based health insurance exchanges are searching for ways to better serve their communities while making enrollment easier, more personal, and more accessible for everyone.
The company plans a Phase II study next year in a subset of non-small cell lung cancer patients who usually don't respond to existing therapies.
Shockwave Medical is harnessing sound waves to break up calcium in blocked arteries and using them with the familiar angioplasty balloon catheter to treat patients with peripheral artery disease.