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Home » Topics » Regulatory

Regulatory
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Koreabio Humanase KOH Sungho
Bio Korea 2025

FDA shift from animal testing fuels organoid, organ-on-chip demand

May 9, 2025
By Marian (YoonJee) Chu
The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 said.
Read More
Judge's gavel with US flag

Sun shines on Leqselvi at Federal Circuit

May 9, 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.
Read More
Avmapki-Fakzynja packaging

High-graded low-grade ovarian duo wins for Verastem at FDA

May 9, 2025
By Randy Osborne
No Comments
Verastem Oncology Inc. CEO Dan Paterson said he is “not expecting a huge bolus [of ovarian cancer patients] at the beginning” of Avmapki/Fakzynja’s launch, but momentum will build over time. “Based on our market research, this [drug] is the most likely thing for them to go on next,” he added, noting that patients tend to be on the drug for an average of 18 months.
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US court reversed in safe harbor overreach

May 9, 2025
By Mari Serebrov
No Comments
Finding that a lower court went too far with an injunction that ignores the Hatch-Waxman safe harbor protections for drug development, the U.S. Court of Appeals for the Federal Circuit handed Avadel CNS Pharmaceuticals LLC a win of sorts.
Read More
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.
Read More
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.
Read More
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.
Read More

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.
Read More
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.
Read More
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.
Read More
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