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BioWorld - Saturday, January 17, 2026
Home » Topics » North America » U.S.

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Digital representation of U.S.-U.K. flags

With trade agreement secured, US and UK await section 232 outcome

May 12, 2025
By Nuala Moran
No Comments
The U.K. became the first country to reach agreement with the U.S. over threatened tariffs in an “economic prosperity deal” that leaves the pharma industry hanging on for the outcome of the U.S. section 232 probe into the implications of pharmaceutical imports for America’s national security.
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Digital globe illustrating pharma trade, tariffs

Investors unfazed by uncertainties around tariffs in med tech

May 9, 2025
By Shani Alexander
Despite the uncertain macro environment created by the threat of reciprocal tariffs on goods into the U.S., some investors are still upbeat about the med tech sector. Even with changes at the HHS and disruption to product approvals throughout the FDA, venture capital investors remain cautiously optimistic.
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Astrazeneca production and manufacture facility

FDA to conduct unannounced inspections at OUS sites

May 9, 2025
By Mark McCarty
The U.S. FDA typically announces its inspections at facilities located outside the U.S. – a courtesy not extended to domestic manufacturing sites. This is about to change per an agency press release quoting commissioner Marty Makary as describing the disparate treatment as a double standard.
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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.
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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.
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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.
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Digital globe illustrating pharma trade, tariffs

Navigating the Trump tariffs, part two: Amgen, Biogen, others

May 9, 2025
By BioWorld staff
No Comments
As biopharma companies continue to roll out their first-quarter  earnings, Trump administration tariffs remain at the top of investors’ minds. While executives offer their various strategies to appease concerns, the uncertainty prevails, making it difficult to clearly satisfy all of the questions.
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Dollar sign between hands

Sounds of relief as Masimo unloads audio division

May 8, 2025
By Annette Boyle
News of the sale of Masimo Corp.’s consumer audio unit may be music to the ears of investors, even at the steep discount from its original purchase price. Samsung Electronics Co. Ltd.’s Harman International Industries Inc. unit snapped up the Sound United business for about $350 million – roughly one-third of the $1.025 billion Masimo paid for the company in 2022.
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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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