The U.K. Medicines and Health Care Products Regulatory Agency reported a pilot program for the use of RWE in regulatory decision making, which is largely directed toward drug products.
The European Commission’s proposal for an AI-specific liability law seemed destined to pile onto existing EU liability law, but the commission reported it will pull the legislative proposal dubbed the AI Liability Directive.
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.
“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.
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.
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.
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.
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.
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.
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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