Archive for November 2022

The FDA has approved Ferring Pharmaceuticals’ fecal transplant therapy Rebyota for the prevention of recurrence of C. difficile infection (CDI) in individuals that have completed antibiotic treatment for recurrent CDI. Source: Drug Industry Daily

Eisai’s antiamyloid antibody lecanemab nearly eliminated amyloid brain plaques in 68 percent of Alzheimer’s (AD) patients, while modestly slowing decline on all four cognitive and functional measures in the CLARITY AD study, company executives and clinicians involved in the study said at the Clinical Trials on Alzheimer’s Disease annual meeting in San Francisco. Source: Drug…

In FDA’s ongoing efforts to clean up the accelerated approval (AA) program, the agency has withdrawn approval for an antibiotic cream that’s been on the market for 24 years without its required confirmatory trial to show that the product works. Source: Drug Industry Daily

The FDA has issued a warning letter to a clinical trial site in Illinois for failing to submit an investigational new drug application (IND) before launching a clinical investigation of a combination drug-device product. Source: Drug Industry Daily

FDA leaders’ efforts to enact meaningful accelerated approval reform — minus any Congressional support — are beginning to show dividends. Source: Drug Industry Daily

Biosimilars with “skinny labeling” saved Medicare $1.5 billion over 5 years, equivalent to almost 5 percent of what the federal system spent on five pricey biologics, according to a new report in JAMA Network. Source: Drug Industry Daily

The FDA is investigating reports that the osteoporosis medicine Prolia (denosumab) may cause dangerously low calcium levels in the blood of patients with advanced kidney disease, particularly those on dialysis. Source: Drug Industry Daily

A comprehensive readiness plan for an FDA inspection includes thorough knowledge of your document archiving and transfer procedures, according to an FDA inspections expert speaking at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Source: Drug Industry Daily

The FDA is not extending its enforcement discretion policy for Investigational New Drug (IND) requirements governing the use of fecal microbiota for transplantation (FMT) obtained from stool banks for treatment of C. difficile infection that is not responding to standard therapy, the agency said in a final guidance released yesterday. Source: Drug Industry Daily

Spectrum Pharmaceuticals, receiving yet another blow from the FDA on its cancer therapy candidate, poziotinib, has announced that it will drop its poziotinib program and is laying off 75 percent of its research and development staff. Source: Drug Industry Daily