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Home » Topics » Regulatory

Regulatory
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Illustration of cancer tumor
Cancer

UTR Therapeutics files IND application for UTRxM1-18 for c-MYC-driven cancers

May 9, 2025
No Comments
UTR Therapeutics Inc. has submitted an IND application to the FDA for UTRxM1-18, a novel therapeutic approach for targeting c-MYC-driven cancers. Pending approval, a first-in-human phase I trial is slated to begin next year.
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Precision Neuro eletrode array

Precision Neuro leads BCI race following FDA clearance

May 8, 2025
By Shani Alexander
The recent 510(k) clearance by the U.S. FDA for a core part of Precision Neuroscience Corp. brain-computer interface technology is certainly a boon for the company, and others developing the devices. For the millions of people suffering from health disorders, such as motor neuron disease, spinal cord injury or severe stroke, its sign that a solution which could transform their lives could be just a few years away.
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Approved label with medical icons, professional

FDA posts regulation for 2018 test for hematological malignancies

May 8, 2025
By Mark McCarty
The U.S. FDA in 2018 granted the de novo petition by Seattle-based Adaptive Biotechnologies Corp. for the company’s DNA test for evaluation of residual hematological malignancies, but waited until March 8, 2025, to post notice of the attendant regulation.
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Sun shines on Leqselvi at Federal Circuit

May 8, 2025
By Mari Serebrov
No Comments
Planting seed money and “wishing” is not enough to claim “irreparable harm” to secure a preliminary injunction or to establish the standing required to appeal a patent board decision, the U.S. Court of Appeals for the Federal Circuit ruled May 7 in two decisions involving Incyte Corp. and Sun Pharmaceutical Industries Ltd.
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Jorge A. Goldstein at Bio Korea 2025

US legal issues to track in pharma, biotech: Bio Korea 2025

May 8, 2025
By Marian (YoonJee) Chu
No Comments
Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.
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U.S. Capitol building, Washington D.C.

Congress poised to revisit two legislative proposals for patents

May 7, 2025
By Mark McCarty
Legislators in Washington again are considering a pair of bills that would affect how patents are obtained and sustained including the Patent Eligibility Restoration Act of 2025. This would constitute a big win for companies in the life sciences thanks to provisions that clarify just what is and is not eligible for patent protection.
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Microscope and coronavirus illustration

US-funded gain-of-function research paused for stiffer oversight

May 7, 2025
By Mari Serebrov
No Comments
In 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.
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Trump tariff EO signing

South Korea urges US to exempt pharma, allies from tariffs

May 7, 2025
By Marian (YoonJee) Chu
No Comments
South Korean government and biopharmaceutical industry representatives urged American policymakers May 7 to refrain from imposing tariffs on pharmaceutical imports, and to spare allies if pharma tariffs are deemed necessary. Both Korea’s Ministry of Health and Welfare on May 4 and the Korea Biotechnology Industry Organization on May 6 submitted comments to the U.S. Department of Commerce in response to its ongoing investigation of pharmaceutical imports.
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Red arrow pointing downward on a stock market ticker

Some unshod by Prasad nod as CBER change socks stocks

May 7, 2025
By Randy Osborne
No Comments
The appointment May 6 of Vinay Prasad as the head of the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) “bodes poorly” for Sarepta Therapeutics Inc.’s development-stage pipeline, said Wainwright analyst Mitchell Kapoor – and Wall Street reflected as much, as the stock (NASDAQ:SRPT) ended that day down 26.6% vs. an XBI drop of 6.6% – this ahead of the after-hours earnings disclosure that pushed the Cambridge, Mass.-based firm down even farther by more than another 20%, with the XBI unchanged.
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Illustration of stent angioplasty balloon in artery

UK’s NICE seeks to apply price pressures on drug-eluting stents

May 6, 2025
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) opened a late-stage assessment for drug-eluting stents (DES) with an eye toward costs, advising clinicians that they should implant the least expensive DES unit that is clinically appropriate for that patient while the assessment is underway.
Read More
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