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Home » Topics » Regulatory

Regulatory
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Critics of Super Bowl Rx ad call for new playbook

Feb. 10, 2025
By Mari Serebrov
Amid a strengthening offensive against direct-to-consumer drug ads, two senators flagged a Super Bowl ad promoting compounded drugs as part of the company’s attack on the U.S. weight-loss industry that it said was built to keep Americans “sick and stuck.”
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Efforts revived to stem flow of US funding for China R&D

Feb. 10, 2025
By Mari Serebrov
The Biosecure Act may have died with the 118th U.S. Congress, but efforts to stop U.S. government funding of R&D in China are alive and well. Rep. Claudia Tenney, R-N.Y., introduced the Stop Funding our Adversaries Act in the House Feb. 7 to prohibit direct and indirect federal funding of research in China or entities owned by China.
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Female scientist looking through microscope

Scientists warn NIH cost-cutting will impair research

Feb. 10, 2025
By Nuala Moran
From Feb. 10, the U.S. NIH is to cut the amount of its grants that go to indirect costs, in a move it says will save $4 billion per annum, but which scientists say will hit breakthrough biomedical research. The NIH announced the cut on Friday, Feb. 7, saying there would be a flat rate of 15% for indirect costs, such as running laboratories, buying and maintaining equipment, data processing and storage, across all of its grants. That compares to an average rate historically of between 27% and 28%, the NIH said.
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Squamous cell carcinoma.

Skin Analytics DERM gets CE mark for autonomous cancer detection

Feb. 10, 2025
By Shani Alexander
Skin Analytics Ltd. received CE mark for its AI-based tool Deep Ensemble for the Recognition of Malignancy (DERM), which can assess images of lesions and detect skin cancer autonomously. The technology has an accuracy rate of 99.8% compared to 98.9% for dermatologists.
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Heart scientific overlay

MDMA calls for TTVR coverage to include expanded indications

Feb. 10, 2025
By Mark McCarty
The U.S. national coverage analysis for transcatheter tricuspid valve replacement drew support from cardiologists and device makers alike, but the Medical Device Manufacturers Association is urging CMS to plan ahead in its final coverage memo and consider the coverage needs outside the confines of the existing U.S. FDA-approved device.
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U.S. intellectual property illustration

Inari fends off Imperative’s quest for IPR over infringement lawsuit

Feb. 10, 2025
By Mark McCarty
The med tech patent wars conscripted another two companies via a patent infringement lawsuit between Inari Medical Inc. and Imperative Care Inc. — a struggle that is playing out in a California district court.
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Vaccine vial and syringe
Immune

CSPC’s herpes zoster vaccine gains clinical trial clearance in China

Feb. 10, 2025
CSPC Pharmaceutical Group Ltd. has gained clinical trial clearance from China’s National Medical Products Administration (NMPA) for SYS-6017, an mRNA vaccine to prevent herpes zoster infections.
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3D illustration of tumor
Immuno-oncology

Bioray’s BR-111 cleared to enter clinic in China for ROR1-positive cancers

Feb. 10, 2025
Bioray Pharmaceutical Co. Ltd. has announced clinical trial clearance in China by the National Medical Products Administration (NMPA) for BR-111 for injection for the treatment of ROR1-positive hematological malignancies and solid tumors.
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Microscope with slide
Analysis

Admin's actions toward science agencies 'not a measured reappraisal'

Feb. 7, 2025
By Anette Breindl

In the early days of the second Trump administration, what will happen to various government science agencies is not yet clear. Given the communications blackout imposed on agencies including the NIH and the CDC, most of what is known comes from anonymous sources and secondhand reports. Executive orders affecting the agencies are also still in the process of being interpreted, as well as subject to multiple legal challenges.


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Globe showing Asia-Pacific region

Mixed reactions from Asia on biotech implications of Trump 2.0

Feb. 7, 2025
By Tamra Sami
“This current administration is like nothing that we've seen before,” said a managing partner of a global venture capital firm who spoke to BioWorld on the condition of anonymity. “President Trump’s first term was bad,” he said, “but nobody knows what’s coming.” “This is truly nationalism at its worst, because he won on the campaign [largely] to protect American jobs, claiming that Americans have been unfairly treated.” And it's not just China, he said, but India and other countries will also likely be affected.
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