Billing it as a necessary reform to protect tax dollars from frivolous government spending, redundancy and waste, U.S. President Donald Trump issued a new executive order (EO) requiring his political appointees to sign off on grants and awards from agencies such as the NIH and to monitor those awards over time to ensure they’re being used properly.
With half-year industry financings down 59% from last year, and a U.S. administration supportive of cryptocurrencies, biopharma companies are building treasuries of digital assets to secure future R&D efforts and operational runways. Companies such as Artelo Biosciences Inc., MEI Pharma Inc., Windtree Therapeutics Inc. and 180 Life Sciences Corp. and have entered crypto deals in recent weeks, with the latter noting the potential to “unlock value outside traditional biotech milestones.”
The U.S. Department of Health and Human Services has tapped Sean Keveney for the job of FDA chief counsel, but the recent history of the position muddies the waters when it comes to HHS oversight of FDA legal affairs.
Precision medicine is becoming a reality in Asia Pacific as more targeted therapies are being developed that are tailored to individual patients, offering a potential cure for disease. But is Asia Pacific ready to harness this transformation, and if not, what are the hurdles that need to be cleared? A new report by LEK Consulting examines Asia Pacific’s readiness for what it calls the “Precision Era,” and examines four key biopharma markets in Australia, China, Japan and South Korea.
While inflation in the U.S. is hovering below 3%, increases in some FDA user fees for fiscal 2026 are tripling that rate. PDUFA fees for branded prescription drugs and biological products will see a 9% hike come Oct. 1, and the increase in MDUFA fees will more than double the inflation rate with a 7% hike across the board.
While U.S. President Donald Trump’s country-by-country reciprocal and newly negotiated tariffs go into effect today, a separate, global biopharma sector tariff of, possibly, 200% continues to loom over the sector. For many stakeholders, a biopharma sector tariff of even 25%, as first proposed by Trump, would be a disaster in the making, especially when combined with the pressures of Medicare price negotiations and the president’s escalation of most-favored-nation pricing.
The Senate Appropriations Committee met July 31 to markup legislation that would fund the Department of Health and Human Services – including an additional $400 million for the National Institutes of Health. The increase in NIH funding repudiates the Trump administration’s efforts to drastically cut those appropriations, which is an outcome marking a clear win for companies in the life sciences.
Alterity Therapeutics Ltd. helped develop a new neuroimaging biomarker called the multiple system atrophy index (MSA-AI), which looks to be a more reliable biomarker for tracking disease progression of MSA. Developed using deep learning methods, the MSA-AI offers a superior, objective and quantifiable measure of brain atrophy in MSA patients.
Radiopharma Clarity Pharmaceuticals Ltd. raised AU$203 million (US$132.22 million) in an institutional placement on Australia’s Securities Exchange to advance its late-stage pipeline of copper-based radiopharmaceuticals.
While U.S. government cost-cutting seems to be the Trump administration’s priority that consumes all others, some Republican senators are pushing back – at least when it comes to the NIH. Fourteen senators wrote to Russell Vought, head of the White House Office of Management and Budget, to voice their concerns about the administration’s slow disbursement rate of the NIH’s fiscal 2025 funds.