Regulatory decisions affecting biopharma products in development, including approvals, recommendations, rejections and the granting of regulatory pathways, in September 2019.

WASHINGTON – The U.S. FDA's 2018 final guidance for payer communications widely was seen as long overdue upon delivery. For his part, Paul Savidge, U.S. general counsel at Philadelphia-based Spark Therapeutics Inc., said his company's development of the required information for such communication was "a massive undertaking" that proved useful a second time when it came to promoting its product after FDA approval.

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.

While other industries have completely modernized the way they manufacture their products, the biopharma industry, in large part, is stuck in the "this is how we've always done it" mode.

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. 

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.