FDA Staff Voice Concern Over Eagerly Awaited Blood-Based Colon Cancer Test
The remarks about the Shield test, made by Guardant Health, came ahead of Thursday's meeting with outside advisers. Other pharmaceutical news is on alcohol-associated liver disease, weight loss drugs, the Biotechnology Innovation Organization, and more.
Reuters:
US FDA Staff Says Guardant's Test May Fail To Detect Some Pre-Cancerous Tumors
The U.S. Food and Drug Administration's staff reviewers on Tuesday raised concerns that Guardant Health's blood test for a cancer of colon or rectum may fail to detect some types of tumors that can later become cancerous. The comments come ahead of the FDA's meeting with outside advisers on Thursday. (5/21)
Stat:
Liver Decline Slowed By Off-Label Use Of Nerve Pain Drug
There are three FDA-approved drugs for treating alcohol use disorder. But a different medication, one frequently used off-label for the condition, could provide greater benefit to patients with alcohol-associated liver disease, a new study suggests. (Cueto, 5/22)
Reuters:
Medical Device Company To Pay $42 Million To Resolve US Lead-Testing Defect Charges
A medical device company has agreed to pay $42 million and plead guilty to resolve U.S. charges that it concealed a malfunction in its lead-testing devices that resulted in thousands of children and other patients receiving inaccurate, low test results. Federal prosecutors in Boston in court filings on Tuesday said Magellan Diagnostics, now owned by Ohio-based Meridian Bioscience, had entered into a deferred prosecution agreement to resolve felony fraud conspiracy charges and agreed to plead guilty to two misdemeanors. (Raymond, 5/21)
Stat:
BIO To Announce Reorganization, Senior Leaders Expected To Depart
The Biotechnology Innovation Organization on Monday announced 30 layoffs that are part of a restructuring of the organization, according to an email announcement obtained by STAT. In the email, BIO CEO John Crowley said the changes are intended to “better align our operations with our mission and the strategic priorities.” (Wilkerson and Zhang, 5/20)
On weight loss drugs —
Bloomberg:
Many Quit Weight-Loss Drugs Too Early For Benefits, Insurer Says
Nearly 60% of Americans who started taking weight-loss drugs between 2014 and 2023 didn’t continue long enough to see meaningful health benefits, according to a study of people covered by members of the Blue Cross Blue Shield Association insurance trade group. About 30% of people who were prescribed the drugs stopped in the first month, according to data published in a report from the association. (Tozzi, 5/21)
CBS News:
Nestle To Launch Food Products That Cater To Wegovy And Ozempic Users
Nestle is launching a new line of high-fiber, protein-packed foods directed at the growing number of Americans on Wegovy or Ozempic, and others trying to lose weight. Called Vital Pursuit foods, the products are "well-suited to support a balanced diet for anyone on a weight management journey" the Swiss food and beverage maker said Tuesday, but "are portion-aligned" for consumers taking GLP-1 medications, also known as semaglutides. (Brooks, 5/21)
