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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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
Axsome Therapeutics’ proprietary combination of dextromethorphan and bupropion — already approved for major depressive disorder as AXS-05 — also reduced the risk of agitation related to Alzheimer’s disease (AD), the company reported. Read More
Included in — then stripped out of — user fee legislation in September were requirements that the FDA and drug manufacturers agree on post-approval study conditions prior to a drug’s accelerated approval (AA) and require more regular study progress updates from manufacturers. The proposals also sought to permit the FDA to require studies to be underway at the time the drug is approved, or prior to that time, and to allow use of real-world evidence to support the studies. Read More