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BioWorld - Saturday, July 18, 2026
Home » Topics » Regulatory

Regulatory
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Map of Europe highlighting Germany with its flag

Industry hits back as rebate on drugs more than doubles in Germany

July 16, 2026
By Nuala Moran
No Comments
Rebates on sales of patented drugs in Germany are to increase from 7% to 15.5%, following passage of an act to reduce healthcare spending across the board. There also will be a 9% rebate on patented vaccines, whilst at the same time prices will be frozen until 2030 and price-volume controls will be introduced to restrict the amount spent overall.
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CLIA regs may be in for an update

July 16, 2026
By Mari Serebrov
No Comments
Citing the significant advancements made in lab testing technologies since the Clinical Laboratory Improvement Amendments (CLIA) were enacted nearly 40 years ago, the U.S. CDC and Center for Medicare and Medicaid Services are considering updating the regulations to reflect today’s technology.
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Labcorp, Tactile Systems resolve FCA allegations

July 16, 2026
By Mari Serebrov
No Comments
Two med-tech companies agreed to settlements with the U.S. government to resolve False Claims Act (FCA) allegations that they submitted Medicare claims for medically unnecessary testing and devices.
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Illustration of lipids in the bloodstream
Endocrine/metabolic

Fosun cleared to conduct clinical trials with FXR-0906

July 16, 2026
No Comments
Fosun Pharma subsidiary Fosun Pharmaceutical Industrial Development (Shenzhen) Co. Ltd. has received approval from China’s National Medical Products Administration (NMPA) to commence clinical trials for FXR-0906 for the treatment of hypertriglyceridemia.
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Senator calls for investigation of Kennedy’s ‘election interference’

July 15, 2026
By Mari Serebrov
No Comments
There have been plenty of complaints about U.S. Health and Human Services Secretary Robert Kennedy interfering with science. Now he’s facing allegations of a different kind of interference. Sen. Ron Wyden, D-Ore., the ranking member of the Senate Finance Committee, asked the U.S. Office of Special Counsel to immediately open an investigation into election interference claims against the secretary.
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FTC settling case against CVS’ PBM

July 15, 2026
No Comments
In an effort to drive down out-of-pocket costs for Americans, the U.S. FTC is resolving an antitrust case through a proposed second settlement with a large pharmacy benefit manager (PBM) and its affiliates.
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Erica Schwartz, CDC director nominee

CDC nominee’s qualifications shadowed by Kennedy agenda

July 15, 2026
By Mari Serebrov
No Comments
U.S. Health and Human Services Secretary Robert Kennedy was the 800-pound gorilla that couldn’t be ignored as the Senate Health, Education, Labor and Pensions Committee held a joint confirmation hearing July 15 for President Donald Trump’s nominees for CDC director and the head of the Administration for Strategic Preparedness and Response.
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Illustration of heart analysis for DNA and drug impacts
Cardiovascular

Atrium’s ATR-1072 gains IND clearance for PRKAG2 syndrome

July 15, 2026
No Comments
Atrium Therapeutics Inc. has obtained IND clearance from the FDA for ATR-1072 for the treatment of protein kinase AMP-activated non-catalytic subunit γ2 (PRKAG2) syndrome.
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Generic drugs and bottle

Korea targets generics, innovation in drug pricing overhaul

July 14, 2026
By Marian (YoonJee) Chu
No Comments
South Korea is moving ahead with its biggest reform of drug review and pricing in more than a decade, reflecting a wider shift across Asian markets to reward innovation and tighten controls on generics.
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Liver tumor treatment conceptual illustration

HLB, Hengrui receive third US FDA rejection on liver cancer combo

July 14, 2026
By Marian (YoonJee) Chu
No Comments
The U.S. FDA declined to approve, for a third time, an investigational liver cancer drug regimen comprising HLB Co. Ltd.’s rivoceranib and Jiangsu Hengrui Pharmaceutical Co. Ltd.’s camrelizumab, reportedly citing issues from a drug manufacturing facility inspection.
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