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STAT+: Biosecure didn’t stop China’s rise in biotech. Some lawmakers want to do more

WASHINGTON — Last year, Congress passed a bill restricting how U.S. pharmaceutical and biotechnology companies can do business with Chinese firms. Many political leaders don’t seem to be satisfied. 

Already, they’re laying the groundwork for additional legislative and regulatory measures to counter the rise of Chinese biopharma companies. And federal health officials are working to make it easier for companies to operate in the U.S.

“The itch has not been entirely scratched,” said Bobby McMillin, partner at Arnold Porter.

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WASHINGTON — Last year, Congress passed a bill restricting how U.S. pharmaceutical and biotechnology companies can do business with Chinese firms. Many political leaders don’t seem to be satisfied. 

Already, they’re laying the groundwork for additional legislative and regulatory measures to counter the rise of Chinese biopharma companies. And federal health officials are working to make it easier for companies to operate in the U.S.

“The itch has not been entirely scratched,” said Bobby McMillin, partner at Arnold Porter.

Continue to STAT+ to read the full story…

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InduPro Licenses Lonza’s Linker Payload Technologies and Bioconjugation Platforms

InduPro Licenses Lonza’s Linker Payload Technologies and Bioconjugation Platforms

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Lonza and InduPro signed a licensing agreement to support the advancement of innovative antibody–drug conjugate (ADC) therapies. According to Lonza officials, the company, through one of its affiliated companies, will grant InduPro a non-exclusive, worldwide license to its proprietary GlycoConnect®, HydraSpace® and linker-payload technologies. The technologies, which will be applied to the development of ADCs targeting up to two oncology antigens, are intended to support the advancement of highly targeted cancer therapies.

InduPro will combine its proprietary bispecific antibody capabilities with Lonza’s ADC platform. By leveraging these complementary technologies, the companies aim to develop differentiated therapeutic approaches designed to address complex diseases such as cancer, where precision targeting and efficacy remain critically important, notes Jan Vertommen, vice president of commercial development, advanced synthesis, Lonza.

“By combining our expertise in bioconjugation technologies and manufacturing with InduPro’s innovative proximity guided antibody platform, we reinforce our commitment to enabling our licensing partners and supporting the advancement of next-generation ADC programs,” says Vertommen.

“This agreement represents an important step in advancing our pipeline of proximity-driven bispecific ADCs,” adds Prakash Raman, CEO, InduPro. “By combining InduPro’s ability to identify novel, disease-specific co-target pairs with Lonza’s industry-leading ADC technologies, we aim to develop differentiated, first-in-class therapeutics that improve selectivity, expand therapeutic windows, and ultimately deliver better outcomes for patients with hard-to-treat tumors.”

The post InduPro Licenses Lonza’s Linker Payload Technologies and Bioconjugation Platforms appeared first on GEN – Genetic Engineering and Biotechnology News.

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STAT+: FDA gives generative AI in radiology two breakthrough designation nods

The Food and Drug Administration has granted breakthrough designation to two devices that use generative AI to interpret chest X-rays and draft the radiology reports typically written by human radiologists.

Machine learning systems have long analyzed images like X-rays and CT scans. But more recently, large vision language models have ushered in a new capability. Instead of highlighting a spot for a radiologist to review and write up, generative AI can process the entire image and draft many of its findings for a radiologist to review — a technological advancement that is challenging traditional validation and regulatory frameworks. 

In March, one breakthrough designation went to Cognita, a Stanford researcher-founded startup acquired late last year by the large radiology practice Radiology Partners. Radiology AI company Aidoc announced its own breakthrough designation Thursday for a tool called First Read, specifically when it is used to detect and describe four life-threatening findings. 

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The Food and Drug Administration has granted breakthrough designation to two devices that use generative AI to interpret chest X-rays and draft the radiology reports typically written by human radiologists.

Machine learning systems have long analyzed images like X-rays and CT scans. But more recently, large vision language models have ushered in a new capability. Instead of highlighting a spot for a radiologist to review and write up, generative AI can process the entire image and draft many of its findings for a radiologist to review — a technological advancement that is challenging traditional validation and regulatory frameworks. 

In March, one breakthrough designation went to Cognita, a Stanford researcher-founded startup acquired late last year by the large radiology practice Radiology Partners. Radiology AI company Aidoc announced its own breakthrough designation Thursday for a tool called First Read, specifically when it is used to detect and describe four life-threatening findings. 

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Labs see rising demand for nitrosamine, topical performance and microbiome testing

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Recent BioSpace industry conference conversations point to sponsors pushing earlier on safety, quality and performance data, leading to demand for nitrosamine analysis, IVRT/IVPT and microbiome database capabilities.

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