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BioWorld - Saturday, May 2, 2026
Home » Topics » U.S., BioWorld

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Silhouette of child and brain

Australia launches world-first pediatric mRNA brain cancer trial

Feb. 13, 2026
By Tamra Sami
No Comments
A world-first pediatric mRNA cancer vaccine trial is launching in Australia that could open new possibilities for children with aggressive brain tumors. The Paedneo-Vax trial, funded by Canada’s Providence Therapeutics Holdings Inc., in combination with the Australian Government and philanthropic donors, is the first multisite pediatric study to evaluate individualized mRNA vaccines designed specifically for each child's cancer.
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Abbvie claims CMS’ selection of Botox violates the IRA

Feb. 12, 2026
By Mari Serebrov
No Comments
Undeterred by all the unsuccessful biopharma suits challenging the U.S. Medicare price negotiations, Abbvie Inc. filed its own complaint Feb. 11 in the U.S. District Court for the District of Columbia, seeking to undo CMS’ selection of Botox in the third round of the negotiations.
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Lab mouse

Human-relevant models lining up to replace animal tests

Feb. 12, 2026
By Nuala Moran
No Comments
The pressure to replace animal testing with human-relevant assays that are more predictive of human-drug responses has now reached a tipping point, and there is a movement toward greater acceptance of these potentially more translatable tests.
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Interleukin 17 (IL-17)
Newco news

Quantx raises $85M to advance oral immunology drugs

Feb. 12, 2026
By Tamra Sami
No Comments
After closing an oversubscribed $85 million series B round, Quantx Biosciences Inc. is gearing up to begin clinical trials of its two lead immunology compounds, a STAT6 oral small-molecule inhibitor and an IL-17 oral small-molecule inhibitor.
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Pills and bottle

Viking to push oral GLP-1/GIP drug into phase III obesity trial

Feb. 12, 2026
By Marian (YoonJee) Chu
No Comments
Viking Therapeutics Inc. said after-market hours Feb. 11 that it plans to advance its oral dual GLP-1/GIP receptor, VK-2735, into a phase III trial for obesity in the third quarter of 2026. VK-2735 is a novel dual glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide (GLP-1/GIP) receptor agonist.
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Toddler walking with adult

Dwarfism golden gate? Bridgebio’s infigratinib phase III hits

Feb. 12, 2026
By Randy Osborne
No Comments
Bridgebio Pharma Inc. kept the phase III wins coming, this time with positive top-line results from Propel 3, the global phase III pivotal study of oral infigratinib, designed to inhibit FGFR3 signaling in children with achondroplasia.
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NIH ends Xarelto arm of stroke trial due to safety, futility

Feb. 11, 2026
No Comments
Citing an increase in safety events and evidence of futility, the U.S. NIH stopped an investigational low-dose rivaroxaban arm of its Comparison of Anticoagulation and Antiplatelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) trial.
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Madrigal adds siRNA approach to MASH pipeline in $4.4B Ribo deal

Feb. 11, 2026
No Comments
Continuing to build on the successful launch of Rezdiffra (resmetirom), Madrigal Pharmaceuticals Inc. is adding six preclinical-stage siRNA therapies to its metabolic dysfunction-associated steatohepatitis (MASH) pipeline in a deal with Ribo Life Science Co. Ltd. and its subsidiary, Ribocure Pharmaceuticals AB, that could be worth $4.4 billion if all milestones are achieved.
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Takeda’s oral narcolepsy drug steps closer to FDA approval

Feb. 11, 2026
By Marian (YoonJee) Chu
No Comments

The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.


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Boston Scientific Farapulse PFS system

Boston Sci’s Farapulse better than thermal ablation at 4 years

Feb. 11, 2026
By Shani Alexander
No Comments
Boston Scientific Corp. recently reported new four-year data on its Farapulse pulsed field ablation platform, which demonstrated that patients with paroxysmal atrial fibrillation achieved better long-term success than those treated with thermal ablation. The data come as sales of the Farapulse system in the U.S. have begun to slow amid rising competition from other PFA technologies, particularly Medtronic plc’s Affera platform.
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