Roche Holding AG’s Genentech unit achieved superior phase III results with KRAS G12C inhibitor divarasib over approved therapies in previously treated non-small-cell lung cancer (NSCLC) patients. In the head-to-head Krascendo 1 trial at the interim analysis, divarasib showed clinically meaningful and statistically significant improvements in overall survival and progression-free survival over Lumakras (sotorasib, Amgen Inc.) and Krazati (adagrasib, Bristol Myers Squibb Co.), with no new safety signals, demonstrating best-in-class potential in previously treated patients with non-small-cell lung cancer. Genentech expects to submit the data to regulators and to present details at an upcoming medical meeting. Due to acquired resistance to first-generation therapies, the FDA granted breakthrough therapy designation in 2022 and orphan drug designation in 2026 for divarasib for KRAS G12C NSCLC.

Neurovalens brings FDA-cleared PTSD therapy to US veterans

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 clearance. “PTSD is a very high-risk condition, and there has never been a previous approval or previous clearance for this type of technology,” Jason McKeown, CEO of Neurovalens, told BioWorld.

Neuracle eyes Shanghai IPO as global BCI funding surges

Neuracle Medical Technology Co. Ltd. is seeking a Shanghai IPO that could make it China’s first publicly listed invasive brain-computer interface (BCI) company, months after winning approval for the country’s first invasive BCI system. The company’s filing for a potential ¥2.5 billion (US$370 million) IPO on the Shanghai Stock Exchange (SSE) STAR Market, if approved, would set the first valuation benchmark for China’s invasive BCI sector, which has historically relied on a mix of government and private funding.

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

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. An analysis of U.S. claims data for 15 approved CGTs shows there was a 740% increase of the volume of CGT-related claims from 2018 to 2025, with new sites beyond major metropolitan areas starting to administer these therapies.

Behind China’s retractions, a paper-mill economy built on incentives

To Ivan Oransky, China’s paper-mill problem is best understood as an incentives story. “This is literally organized crime,” the Retraction Watch co-founder told BioWorld. “Follow the money. When there’s an opportunity to make money, they will find it, and if your whole career is based on how often you publish and what journals you publish in and how often you’re cited, it’s not surprising that leads to bad behavior.” Oransky said the Retraction Watch database contains about 65,000 retractions, more than half of them from China. Globally, he said, retractions now run at about 6,000 a year, or roughly 15 a day.

Bellaseno speeds breast scaffold trial as J&J deal clears path to market

Regenerative medicine company Bellaseno GmbH is accelerating development of its absorbable breast scaffold, with a pivotal Australian trial recruiting faster than expected and a newly announced licensing deal with Johnson & Johnson subsidiary Mentor Worldwide LLC positioning the technology for global commercialization. The trial was designed to enroll 53 patients over about a year, but Bellaseno has already implanted 30 patients and is now fully recruited after just three months, Mohit Chhaya, CEO, said. Surgeries are expected to be completed by September, followed by one year of patient monitoring to assess safety and complications.

With GPNMB, CAR T makes further inroads in solid tumors

Two papers published in the July 1, 2026, issues of Nature and Nature Cancer have reported on preclinical and early clinical data with glycoprotein nonmetastatic melanoma protein B (GPNMB)-targeting CAR T cells in two separate solid tumor types. Investigators at the University of Calgary reported on preclinical work and one human case of treating a patient with alveolar soft part sarcoma with a GPNMB-targeting CAR T, while a British/Canadian team showed that GPNMB was overexpressed in multiple glioblastoma cell lines, and treatment with a GPNMB-targeting CAR T extended survival in mice.

Wuxi Apptec seeks immediate relief from US listing

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 Defense’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, China-based contract research, development and manufacturing organization is now seeking a preliminary injunction to suspend the designation during the court proceedings. This week’s injunction filing in the U.S. District Court for the District of Columbia “provides the first concrete evidence that Wuxi Apptec's 1260H designation is translating into customer losses,” RBC Capital Markets analyst Charles Weston noted.

H1 2026 biopharma financings double last year's, approach pandemic highs

Biopharma financings across all categories totaled $59.8 billion on 567 deals in the first half (H1) of 2026, more than double H1 2025's $29.5 billion and the strongest first-half showing since 2021's record $71.6 billion. Much was driven by a rebound in follow-on offerings, which reached $29.7 billion in six months.

Holiday notice

BioWorld's offices will be closed in observance of Independence Day in the U.S. No issue will be published Friday, July 3.

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