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BioWorld - Saturday, July 11, 2026
Home » Topics » North America » U.S.

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Modius Spero wearable neuromodulation device

Neurovalens granted FDA approval for PTSD therapy for US veterans

July 6, 2026
By Shani Alexander
No Comments
Veterans in the U.S. suffering from post-traumatic stress disorder (PTSD) now have access to Neurovalens Ltd.’s Modius Spero, a wearable neuromodulation device, which can reduce their symptoms in as little as four weeks. The treatment, designed for at-home use of 30-minute daily sessions, was approved for use within the Department of Veterans Affairs after the company secured FDA de novo approval.
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Legal scales and clipboard

Wuxi Apptec seeks immediate relief from US listing

July 2, 2026
By Mari Serebrov
No Comments
Despite the Biosecure Act’s five-year wind-down period that isn’t expected to start until mid-2028, Wuxi Apptec is already feeling the repercussions of being added last month to the U.S. Department of War’s Section 1260H list. Instead of just waiting for its June 11 challenge to its listing as a “Chinese military company” to play out in court, the Shanghai-based contract research, development and manufacturing organization (CRDMO) is now seeking a preliminary injunction to suspend the designation during the court proceedings.
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Stem cells and DNA

Cell and gene therapy access is up, but capacity constraints may be looming

July 2, 2026
By Nuala Moran
No Comments
With more and more approved products, cell and gene therapies (CGTs) are moving from the initial stronghold in academic medical centers, and these complex biologics are now available across a wider network of treatment centers.
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Illustration of lungs with cancer inset

Genentech’s KRAS G12C inhibitor divarasib shines in NSCLC phase III

July 2, 2026
By Karen Carey
No Comments
Roche Holding AG’s Genentech unit achieved superior phase III results with its KRAS G12C inhibitor divarasib over approved therapies in previously treated non-small-cell lung (NSCLC) cancer patients.
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U.S. Capitol building

US primaries continue to rattle congressional health leadership

July 1, 2026
By Mari Serebrov
No Comments
Regardless of whether the Republicans or Democrats come out on top in November’s midterm congressional elections, some of the state primaries in the U.S. have already guaranteed major shuffles in key House and Senate committees overseeing national health issues.
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Handshake icon engraved on metal hexagonal background

‘Cool move’ by Zimmer part of med-tech’s tuck-in deals trend

July 1, 2026
By Shani Alexander
No Comments
Zimmer Biomet Holdings Inc.’s deal to buy Pacira Biosciences Inc.’s Iovera system for up to $140 million and Eurobio Scientific SA’s acquisition of Caredx Inc.’s lab products business for $171.2 million are symptomatic of a broader trend among med-tech and diagnostics companies using targeted acquisitions to strengthen specific areas of their portfolio.
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China and U.S. flags

Some clinical trials in China under US congressional scrutiny

July 1, 2026
By Mari Serebrov
No Comments
The House Select Committee on China launched an investigation into clinical trials involving U.S. companies that are conducted at Chinese military hospitals and in Xinjiang, China.
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FDA approval seal on blue glittering background

Orca’s T-cell therapy approach to HSCT wins FDA nod as Tregzi

July 1, 2026
By Jennifer Boggs
No Comments
Orca Bio Inc. is bringing to market a precision-engineered cell therapy approach designed to improve outcomes in patients with hematologic malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT) following U.S. FDA approval of Tregzi, a first-of-its-kind, personalized cell therapy.
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Illustration of woman with anxiety, ADHD

Otsuka’s centanafadine scores in ADHD, comorbid anxiety trial

June 30, 2026
By Marian (YoonJee) Chu
No Comments
Otsuka Pharmaceutical Co. Ltd. reported another clinical study win with once-daily centanafadine, a non-stimulant compound targeting attention deficit hyperactivity disorder (ADHD). Top-line results of a dedicated phase IIIb study in patients with ADHD and comorbid anxiety found that centanafadine met the primary endpoint, defined as score improvements on the Adult Investigator Symptom Rating Scale, compared with placebo at week 8.
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Close-up of a human eye featuring a dollar sign in the iris

Ollin’s $330M series B underscores rise of China-origin newco model

June 30, 2026
By Tamra Sami
No Comments
The oversubscribed $330 million series B round secured by Ollin Biosciences Inc. marks more than another large venture round in ophthalmology. It also highlights an emerging biotech financing model in which Chinese pharma companies discover and clinically validate promising drugs before handing global development to well-capitalized U.S. startups backed by blue-chip venture investors.
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