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BioWorld - Monday, June 16, 2025
Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
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BioWorld, Regulatory
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Regulatory front

Oct. 16, 2019
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. 
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FDA adcom to review Shionogi's cefiderocol for cUTIs

Oct. 15, 2019
By Michael Fitzhugh
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.
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Regulatory front

Oct. 15, 2019
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.
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CBO: Yes, H.R. 3 would deliver Rx savings, but at what cost?

Oct. 15, 2019
By Mari Serebrov
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.
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Pipeline of innovative technologies could pressurize FDA resources

Oct. 14, 2019
By Mari Serebrov
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.
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Regulatory front

Oct. 14, 2019
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.
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Regulatory front

Oct. 11, 2019
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.
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Regulatory actions for Oct. 9, 2019

Oct. 10, 2019

ICER's search for evidence to support U.S. price increases comes up mostly empty

Oct. 9, 2019
By Mari Serebrov
Unexplained price increases are a recurring theme whenever a congressional committee discusses U.S. prescription drug prices, and both state and federal lawmakers have proposed measures to force drug manufacturers to justify those increases.
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Gilead's Biktarvy included in Taiwan's National Health Insurance scheme

Oct. 9, 2019
By David Ho
HONG KONG – Taiwan's National Health Insurance Administration has added Gilead Sciences Inc.'s Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide), a once-daily single tablet for the treatment of adults with HIV-1, to its list of reimbursed medicines.
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