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.

After proposing an undisclosed alternative price, Clovis Oncology Inc., of Boulder, Colo., got the approval of the U.K.'s National Institute for Health and Care Excellence (NICE) for coverage of its ovarian cancer drug Rubraca (rucaparib) under the Cancer Drugs Fund (CDF) while the company continues to collect long-term overall survival data.

A lot of U.S. lawmakers are seeing dollar signs – 345 billion of them, to be exact. That's how much the Congressional Budget Office (CBO) is estimating could be saved in direct federal spending on Medicare Part D prescription drugs from 2023 through 2029 if H.R. 3, the Lower Drug Costs Now Act, was passed.

Incremental budget increases and continuing resolutions that hold FDA spending of both tax dollars and user fees to the previous year's level aren't going to cut it as the agency faces the growing challenge of reviewing more and more innovative technologies on the condensed timeframe of priority review.

The Institute for Clinical and Economic Review (ICER), of Boston, said it released an updated draft evidence report assessing the comparative clinical effectiveness and value of treatments for rheumatoid arthritis.

Think Surgical Inc., of Fremont, Calif., won good news from the U.S. FDA, which cleared the company's Tsolution One total knee application for use in total knee arthroplasty (TKA). The Tsolution One total knee application includes computed tomography-based 3D presurgical planning software, providing surgeons the ability to design and prepare the patient's knee joint replacement plan. During surgery, the physician puts the patient's pre-planned procedure using the robot into effect, with the goal of precisely placing the knee implants.

The FDA’s Office of Pediatric Therapeutics will hold a public workshop at the agency’s Silver Springs, Md., campus Nov. 12 to discuss pediatric patient-specific engagement in the development of clinical trial endpoints for rare diseases.