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BioWorld - Thursday, January 8, 2026
Home » Topics » North America » U.S.

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PhRMA takes aim at most of world for unfair trade practices

March 25, 2025
By Tamra Sami
In a move that echoes tariff threats from U.S. President Donald Trump, the Pharmaceutical Research and Manufacturers of America (PhRMA) lobby is taking aim at most of the world for unfair trade practices in its special 2025 Special 301 Report to the U.S. Trade Representative.
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Report shows increased pharma innovation despite rising R&D costs

March 25, 2025
By Nuala Moran
The obesity market is driving pharma’s return on investment (ROI) upward, with the projected return rising to 5.9% overall in 2024, but only reaching 3.8% if GLP-1 assets are excluded. At the same time, the average cost of developing a drug continues to rise and now stands at $2.23 billion, compared to $2.12 billion in 2023, according to Deloitte’s 15th annual analysis of the ROI from pharmaceutical innovation.
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Fallopian tubes, ovaries and uterus

Mural Oncology sinks on nemvaleukin miss in ovarian cancer

March 25, 2025
By Karen Carey
Losing nearly 60% of its value, Mural Oncology plc backed away from its lead interleukin-2 (IL-2) drug, nemvaleukin alfa, in platinum-resistant ovarian cancer based on interim results showing it failed to reach significance in the overall survival primary endpoint.
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Newco news

Hillstar launches with $67M series A to target TRBV9+ T cells

March 25, 2025
By Brian Orelli
Hillstar Bio came out of stealth mode, announcing a $67 million series A financing round with investors including Droia Ventures, Frazier Life Sciences, Novo Holdings A/S and Lifearc Ventures.
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OP5_INSU_POD_PDM_NoADH_RIGHT_RGB.jpg

Insulet glows with RADIANT results, CGMs becoming T2D standard

March 25, 2025
By Annette Boyle
For people with type 1 or type 2 diabetes and the companies developing technologies to help them, the International Conference on Advanced Technologies & Treatments for Diabetes delivered an abundance of good news. On the type 1 diabetes front, Insulet Corp.’s RADIANT study demonstrated massive improvement in time in range as well as lower glycemic levels for patients switching from multiple injections to the Omnipod 5 automated insulin delivery system.
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Art concept for antimicrobial research

FDA clears Biomérieux’s Vitek Compact antimicrobial resistance system

March 25, 2025
By Shani Alexander
Biomérieux SA recently received U.S. FDA 510(k) clearance for its Vitek Compact Pro, a system for microorganism identification and Antibiotic Susceptibility Testing. The company hopes that the system will help clinical laboratories combat antimicrobial resistance and diagnose infectious diseases as well as support industrial laboratories in identifying contaminants to ensure consumer safety.
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CMS logo and website

Oz hits Wyden’s wall of skepticism in Senate CMS post hearing

March 25, 2025
By Mark McCarty
Mehmet Oz, the Trump administration’s pick to lead the U.S. Centers for Medicare & Medicaid Services (CMS), appeared for a second time in the Senate for the CMS administrator’s job.
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Product recall concept image

Smith’s Medical removes endotracheal tubes due to small diameter

March 25, 2025
By Mark McCarty
The FDA reported March 25 that Smiths Medical Inc., is recalling a series of oral and nasal endotracheal tubes because the diameters of the tubes may present with “a smaller diameter than expected.”
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CDC’s ACIP meeting rescheduled

March 24, 2025
By Karen Carey
A meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP) was rescheduled for April 15-16, according to the Federal Register.
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Unity eyes path forward for UBX-1325 despite missed DME endpoint

March 24, 2025
By Jennifer Boggs
Shares of Unity Biotechnology Inc. (NASDAQ:UBX) sank 28.8% to close at $1.30 March 24 as a top-line readout of its phase IIb Aspire study testing UBX-1325 head-to-head against aflibercept in diabetic macular edema (DME) fell short of statistical noninferiority on the primary analysis endpoint. But that’s not the full story, according to company executives, who have plans for moving the senolytic Bcl-xL inhibitor into late-stage studies.
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