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Regulatory
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Efforts revived to stem flow of US funding for China R&D

Feb. 11, 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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Henlius lands European approval of PD-1 lung cancer drug

Feb. 11, 2025
By Marian (YoonJee) Chu
The European Commission on Feb. 5 cleared Shanghai Henlius Biotech Inc.’s serplulimab (HLX-02) under the brand name of Hetronifly as a first-line combination therapy with carboplatin and etoposide to treat extensive-stage small-cell lung cancer.
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Globe showing Asia-Pacific region

Mixed reactions from Asia on biotech implications of Trump 2.0

Feb. 11, 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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Indirect costs of NIH grants

Feb. 11, 2025
In fiscal 2023, the NIH spent more than $35 billion on nearly 50,000 competitive grants to more than 300,000 researchers at more than 2,500 universities, medical schools and other research institutions across the nation. Of this funding, the NIH said about $26 billion was spent on direct research costs, while $9 billion was allocated to help cover “facilities and administration” through the agency’s indirect cost rate.
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Woman holding display of business, regulatory icons

BIO CEO 2025: Navigating from policy to innovation to patients

Feb. 11, 2025
By Karen Carey
The fast pace in which the Trump administration has rolled out changes to how government and businesses operate – a disruptive effort that appears to be creating a new world order – has caught the attention of biopharma industry leaders who spoke Tuesday at the Biotechnology Innovation Organization’s CEO and Investor Conference in New York.
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Dollar sign dropper and test tube

Court orders full stop to US NIH slashing of indirect rates

Feb. 11, 2025
By Mari Serebrov
The immediate implementation of the U.S. NIH’s guidance to cut indirect costs included in its grants to 15% was quickly halted late Feb. 10 when a federal district judge granted a nationwide temporary restraining order in two separate challenges to the cuts that were to go into effect that day on all existing and new NIH grants.
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DBS for stroke

Newronika gets IDE from the FDA for adaptive DBS trial

Feb. 11, 2025
By Shani Alexander
Newronika SpA's AlphaDBS recently secured an investigational device exemption from the U.S. FDA allowing it to begin a pivotal trial to evaluate the safety and efficacy of its adaptive deep brain stimulation system in patients with movement disorders, including Parkinson's disease.
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Artificial intelligence and digital health icons

European Commission provides guidance for AI Act

Feb. 11, 2025
By Mark McCarty
The European Commission issued a set of guidelines for the use of AI as a supplement to the EU’s Artificial Intelligence Act, a document of which chatbot developers will want to take note.
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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.
Read More
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