President Biden’s first budget is likely to include a call to create a new health research agency modeled on the Defense Advanced Research Projects Agency.
Biden Administration Will Back New Health Research Contracting Agency
Upcoming budget proposal likely to include a proposal for funding of a DARPA-like contracting entity. Any focus on innovations and breakthroughs is likely welcome news for industry – though perhaps not the message that government is taking on work that drug companies can’t or won’t do.
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US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth
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Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.
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The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.
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Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.
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The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.
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Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.
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Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.