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2 days ago | 
bioworld.com | Mari Serebrov
Home » US lawmakers call for action in addressing PBM practices BioWorld briefs for May 13, 2025. BioWorld MedTech briefs for May 13, 2025. After a week of hype, the most-favored nation (MFN) drug pricing executive order (EO) U.S. President Donald Trump signed May 12 has a lot of bark but little bite,... Targeted protein degradation has yet to notch its first approval. But with more than two dozen agents now in clinical trials, the strategy’s ultimate clinical...
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2 days ago | 
bioworld.com | Mari Serebrov
HHS asks for input on which regs to kill As the U.S. Department of Health and Human Services (HHS) and its agencies begin weeding out old regulations, the department is requesting public input to help identify and eliminate outdated or unnecessary regulations. BioWorld BioWorld MedTech Regulatory U.S. FDA Policy
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3 days ago | 
bioworld.com | Mari Serebrov
Home » Most-favored nation Rx pricing voluntary, for now BioWorld briefs for May 9, 2025. BioWorld MedTech briefs for May 9, 2025. Targeted protein degradation has yet to notch its first approval. But with more than two dozen agents now in clinical trials, the strategy’s ultimate clinical... BioWorld Asia briefs for May 6, 2025 As biopharma companies continue to roll out their first-quarter earnings, Trump administration tariffs remain at the top of investors’ minds. While executives...
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3 days ago | 
bioworld.com | Mari Serebrov
After a week of hype, the most-favored nation (MFN) drug pricing executive order (EO) U.S. President Donald Trump signed May 12 has a lot of bark but little bite, as one analyst put it. Brian Abrahams, head of global healthcare research at RBC Capital Markets LLC, said the EO is unlikely to rattle the biopharma sector, even though it lacked the certainty to completely remove the MFN overhang.
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6 days ago | 
bioworld.com | Mari Serebrov
Home » Sun shines on Leqselvi at Federal Circuit BioWorld briefs for May 8, 2025. BioWorld MedTech briefs for May 8, 2025. The first 100 days of the Trump administration have been nothing short of chaotic, both in the U.S. and throughout the world. Shining a light through the... Targeted protein degradation has yet to notch its first approval. But with more than two dozen agents now in clinical trials, the strategy’s ultimate clinical...
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1 week ago | 
bioworld.com | Mari Serebrov
Home » Sun shines on Leqselvi at Federal Circuit BioWorld briefs for May 8, 2025. BioWorld MedTech briefs for May 7, 2025. The first 100 days of the Trump administration have been nothing short of chaotic, both in the U.S. and throughout the world. Shining a light through the... A metabolic vulnerability of pancreatic ductal adenocarcinoma (PDAC) could be used to address this type of cancer that often resists treatments. Scientists at the... BioWorld Asia briefs for May 6, 2025
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1 week ago | 
bioworld.com | Mari Serebrov
US-funded gain-of-function research paused for stiffer oversightIn a throwback to the Obama administration, U.S. President Donald Trump signed an executive order pausing federally funded research using infectious pathogens and toxins that may pose a danger until a safer, more enforceable and transparent policy governing such research can be developed and implemented. BioWorld BioWorld MedTech Regulatory U.S. NIH Policy
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1 week ago | 
bioworld.com | Mari Serebrov
Home » EO offers US onshoring relief, FDA steps up foreign inspections BioWorld briefs for May 6, 2025. BioWorld MedTech briefs for May 6, 2025. The U.S. FDA has accepted the NDA for an oral formulation of Novo Nordisk A/S’s Wegovy (semaglutide) in treating obesity. If approved, the daily pill will be the... The first 100 days of the Trump administration have been nothing short of chaotic, both in the U.S. and throughout the world. Shining a light through the...
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1 week ago | 
bioworld.com | Mari Serebrov
Annual US 301 trade report has louder bark Echoing President Donald Trump’s justification for reciprocal tariffs, the U.S. Trade Representative’s annual Special 301 Report is a bit more aggressive in tone this year as it calls out trading partners that don't adequately enforce intellectual property rights or that otherwise discriminate against products from foreign companies. BioWorld MedTech BioWorld Asia Regulatory Asia-Pacific Australia China Japan U.S. Policy Trade
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1 week ago | 
bioworld.com | Mari Serebrov
More stringency expected under new CBER head U.S. FDA Commissioner Marty Makary is starting to fill the vacancies at the agency that’s seen its senior leadership ravaged by retirements and terminations. Makary’s first pick is Vinay Prasad as the new head of the FDA’s Center for Biologics Evaluation & Research (CBER), the center that oversees vaccines, blood products, allergenics and cellular, tissue and gene therapies. BioWorld Regulatory Cell therapy Gene therapy Vaccine U.S. FDA
