The FDA continues to break records in approving generics to ramp up competition in the U.S. drug market. In fiscal 2019, the agency approved 1,171 generic drug approvals – 935 full approvals and 236 tentative approvals. That breaks fiscal 2018's record of 971 approvals, Acting FDA Commissioner Ned Sharpless said. The 2019 approvals included 125 applications for first generics of drugs that had no generic competition.
The FDA's Antimicrobial Drugs Advisory Committee backed by a large margin cefiderocol for treatment of complicated urinary tract infections (cUTIs), despite the mortality disparity found by Shionogi & Co. Ltd. among critically ill drug-treated patients in the descriptive phase III trial in severe infections called Credible-CR.
The U.S. Department of Justice (DoJ) has taken action to tamp down on False Claims Act (FCA) lawsuits. However, according to attorneys with the law firm of Gibson, Dunn & Crutcher LLP, the courts have come to different conclusions as to whether federal attorneys have appropriately dismissed FCA cases, a development that opens a new area of concern for drug and device makers.
Briefing documents released ahead of Wednesday’s meeting of the FDA’s Antimicrobial Drugs Advisory Committee, slated to review Shionogi & Co. Ltd.’s cefiderocol for treatment of complicated urinary tract infections (cUTIs), spotlighted a finding of increased mortality among critically ill cefiderocol-treated patients in the company’s Credible-CR study.
Even as the U.S. House of Representatives fast tracks H.R. 3, the Lower Drug Costs Now Act, as its solution to making prescription drugs more affordable, other bills aimed at drug pricing continue to roll in.
The U.S. FDA has posted its guidance agenda for this still-young fiscal year (FY), a list that covers topics such as Clinical Laboratory Improvements Amendments (CLIA) waivers. However, the agency appears to be concerned about a lack of compliance with Section 522 postmarket surveillance studies, as indicated by the inclusion of the related guidance in the high priority list for do-overs in fiscal 2020.
PERTH, Australia – Following stunning interim clinical results for its Celgro nerve regeneration treatment in quadriplegic patients, regenerative medicine company Orthocell Ltd. will focus all its efforts on gaining quick U.S. FDA approval based on the early results.
Briefing documents released ahead of Wednesday's meeting of the FDA's Antimicrobial Drugs Advisory Committee, slated to review Shionogi & Co. Ltd.'s cefiderocol for treatment of complicated urinary tract infections (cUTIs), spotlighted a finding of increased mortality among critically ill cefiderocol-treated patients in the company's Credible-CR study. Unclear whether it was "a chance finding or truly reflects a deficit in the activity of cefiderocol," FDA reviewers asked committee members to discuss the point.