As FDA Turns Watchful Eye On Silicon Valley, Health-Related Tech Companies Adjust Mindset On Agency
Those in the highly competitive industry have begun to think of the Food and Drug Administration as an ally instead of a powerful brake on progress.
The Washington Post:
There’s A New Sheriff In Town In Silicon Valley — The FDA
Helmy Eltoukhy’s company is on a roll. The start-up is a leading contender in the crowded field of firms working on “liquid biopsy” tests that aim to be able to tell in a single blood draw whether a person has cancer. Venture investors are backing Guardant Health to the tune of nearly $200 million. Leading medical centers are testing its technology. And earlier this month, it presented promising data on how well its screening tool, which works by scanning for tiny DNA fragments shed by dying tumor cells, worked on an initial group of 10,000 patients with late-stage cancers. Just one thing is holding the company back: Guardant Health has yet to get approval from the Food and Drug Administration. (Cha, 4/28)
In other FDA news —
The Wall Street Journal:
Acadia Gets FDA OK For Drug Treating Parkinson’s-Related Psychosis
Acadia Pharmaceuticals Inc. has received U.S. Food and Drug Administration approval for Nuplazid, which the FDA said is the first drug it has approved to treat psychosis associated with Parkinson’s disease. Acadia said it plans to launch the drug in June. The biotech company’s shares surged in March after an advisory panel voted 12-2 in favor of approval. In after-hours trading Friday, the stock rose 10 cents to $32.40. (Beckerman, 4/29)
The Associated Press:
First Drug For Delusions In Parkinson’s Patients Approved
Federal health officials have approved an experimental drug to treat psychotic delusions and behaviors that often afflict patients with Parkinson’s disease, the debilitating movement disorder. The drug from Acadia Pharmaceuticals Inc. is the first drug for the condition, which affects approximately half of Parkinson’s patients. An estimated 50,000 Americans are diagnosed with Parkinson’s each year, making it the second-most common neurodegenerative disease in the U.S. (4/29)