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BioWorld - Friday, July 17, 2026
Home » Topics » Regulatory, BioWorld

Regulatory, BioWorld
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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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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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Teva’s beef with Lilly over Forteo settlement lives again

July 14, 2026
By Mari Serebrov
No Comments
The U.S. Court of Appeals for the Seventh Circuit revived Teva Pharmaceuticals USA Inc.’s breach-of-contract suit against Eli Lilly and Co. July 13, as it chided the lower court for dismissing the complaint at the pleadings stage.
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Speech bubbles

OMB flooded with comments on proposed rule impacting grants

July 14, 2026
By Mari Serebrov
No Comments
More than 52,000 individuals, lawmakers, institutions and other organizations have submitted comments on the White House Office of Management and Budget’s (OMB) proposal to revise its Guidance for Federal Financial Assistance, which serves as a government-wide framework for administering grants, cooperative agreements and other forms of assistance.
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Newronika aDBS system

Newronika gains CE mark for adaptive DBS system with Webbiobank

July 14, 2026
By Shani Alexander
No Comments
Newronika SpA received CE mark certification for its latest adaptive deep brain stimulation (aDBS) system, which includes the integration of Webbiobank, its proprietary cloud-based neural data platform.
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Med-tech companies slapped with historic FTC penalty

July 14, 2026
By Mari Serebrov
No Comments
Edwards Lifesciences Corp. and Genesis Medtech Group Ltd. will pay a total of $12 million in penalties as part of a U.S. FTC settlement resolving allegations that they intentionally structured a deal in which Edwards acquired Genesis’ JC Medical to avoid complying with the notification and waiting period requirements of the Hart-Scott-Rodino Act.
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