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BioWorld - Saturday, May 16, 2026
Home » Topics » North America » U.S.

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Australia flag with microscope, test tubes

Australia looks to Asia as Trump administration threatens funding

April 1, 2025
By Tamra Sami
Australia’s top universities are looking more to Asia for research collaborations following threats from the Trump administration to stop funding research at institutions that don’t comply with U.S. narratives.
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4-9-Abbott-Triclip.png
AAC25

Hospitalizations decline shows clearer benefit in Triclip study

April 1, 2025
By Annette Boyle
The two-year results of TRILUMINATE trial showed the first objective benefit to use of Abbott Laboratories’ Triclip transcatheter tricuspid edge-to-edge repair device in a presentation at ACC.25, the American College of Cardiology’s annual scientific session held March 29-31 in Chicago and simultaneously published in Circulation.
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Edwards-SAPIEN3-12-6.png

Edwards’ Early TAVR refutes surveillance recs for aortic stenosis

April 1, 2025
By Annette Boyle
Don’t wait. Edwards Lifesciences Corp.’s additional insights from the Early TAVR trial showed a clear benefit for transcatheter aortic valve replacement (TAVR) in patients with asymptomatic aortic stenosis.
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U.S. flag on columned building

FDA’s loss in lawsuit opens door to LDT promotion

April 1, 2025
By Mark McCarty
The U.S. FDA famously lost a lawsuit over its final rule for regulation of lab-developed tests (LDTs), but Jeff Shapiro of King & Spalding told BioWorld that the implications of this decision go beyond FDA regulation of clinical lab operations.
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Single strand RNA

Airna’s $155M series B advances RNA editing drug AIR-001 for AATD

April 1, 2025
By Karen Carey
As it prepares to advance its lead RNA editing candidate, AIR-001, into a phase I/II trial for alpha-1 antitrypsin deficiency, Airna Corp. Inc. closed an oversubscribed $155 million series B financing less than a year after completing its series A round. The company, based in Cambridge, Mass., with research operations in Tübingen, Germany, focuses not only on repairing harmful genetic variants found in rare genetic disorders, but also on introducing beneficial variants that improve health in common conditions.
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HHS Secretary Robert Kennedy

Where’s the ‘radical transparency’ Kennedy promised?

April 1, 2025
By Mari Serebrov
As the U.S. Department of Health and Human Services begins implementing its reorganization and reduction-in-force plan by sending out termination notices this week to 10,000 more employees across its agencies, top Democrats in Congress are demanding details about the plan.
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Phase III primary endpoint data disappoint Axsome but subgroup beckons

April 1, 2025
By Lee Landenberger

Despite missing the primary endpoint in a phase III study of solriamfetol in major depressive disorder, Axsome Therapeutics Inc. still sees a path to another phase III study. It’s a path some analysts and investors are concerned about, though its precision-medicine approach got plenty of nods of approval.


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Lungs

Street can a-GRI on phase IIb safety win in IPF with tazarotene

April 1, 2025
By Randy Osborne
GRI Bio Inc.’s oral version of tazarotene is showing phase IIa promise in idiopathic pulmonary fibrosis (IPF). The peek at interim safety with the compound, a RAR-βɣ dual agonist designed to inhibit the activity of human type 1 invariant natural killer T cells, consisted of a preplanned analysis of two-week results in the biomarker study. GRI-0621 at 4.5 mg once daily proved safe and well-tolerated in the first 12 patients.
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Evolut device image
ACC.25

At 5 years, TAVR as good as SAVR in low-risk patients

March 31, 2025
By Annette Boyle
Medtronic plc’s Evolut Low-Risk trial continued to show non-inferiority of transcatheter aortic valve replacement to surgical aortic valve replacement in terms of death or disabling stroke at five years in a late-breaking presentation at the American College of Cardiology’s Annual Scientific Session in Chicago on March 30.
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Blood pressure gauge, ECG and medication
ACC.25

AI-enhanced ECG readings beat clinicians and labs in identifying MI

March 31, 2025
By Annette Boyle
When every minute matters, quickly determining which patients in the emergency department need urgent care for myocardial infarction can save lives. Researchers at the University Hospital Münster in Münster, Germany, developed a deep learning model that can detect features on electrocardiograms that more accurately identifies which patients require urgent revascularization than clinicians and provides results faster than high-sensitivity troponin lab tests.
Read More
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