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BioWorld - Wednesday, March 18, 2026
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Regulatory actions for Oct. 14, 2025

Oct. 14, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biolytical Labs, Centinel Spine, Medtronic, Relu.ai, Simergent.
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Abbott sign

Abbott makes cancer screening play with $21B Exact Sciences buy

Oct. 14, 2025
By Holland Johnson
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Abbott Laboratories made plans to enter the cancer screening market with its reported acquisition of Exact Sciences Corp. The deal will pay Exact Sciences shareholders $105 per share in cash, a nearly 50% premium to Exact’s unaffected share price on Nov. 19. That represents a total equity value of approximately $21 billion and an estimated enterprise value of $23 billion.
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Johnson & Johnson signage

Johnson & Johnson plans orthopedics break up

Oct. 14, 2025
By Annette Boyle
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Breaking up isn’t so hard to do, after all. Just two years after spinning off its consumer products as Kenvue Inc., Johnson & Johnson aims to part ways with its orthopedics unit, which will take with it the Depuy Synthes name first created when Synthes Inc. married into the J&J Depuy ortho unit in 2012 for a tidy sum of $19.7 billion. Depuy was itself acquired in 1998.
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Dollar sign and Euro symbol in cogwheels

Kneu secures $5.6M for neurological disorders platform

Oct. 13, 2025
By Shani Alexander
Who knew? In addition to adopting a new name, Kneu Health Ltd. recently raised $5.6 million in a seed funding round for its smart-phone-based platform which helps to monitor neurological disorders to enable timely intervention. The funds secured will be used to expand commercial operations in the U.S., scale deployments for Parkinson's disease and advance the monitoring capabilities of the platform for dementia.
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U.S. Capitol building, Washington D.C.

US federal shutdown bites FDA

Oct. 13, 2025
By Mark McCarty
The budget impasse between Democrats and Republicans on Capitol Hill has implications for a wide range of federal government operations, including at the U.S. FDA, which is absorbing another round of layoffs and cannot accept new premarket filings that require user fee submissions.
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Digital 3-D illustration of Japan's flag, light effects

Japan reimagines mental health care through AI

Oct. 13, 2025
By Tamra Sami
Japan is reimagining how mental health care can be delivered digitally and proactively, with local governments investing in digital technology to create data-driven safety nets that aim to detect distress and deliver help, presenters said during the Bio Japan 2025 conference in Yokohama, Oct. 8 to 10.
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AI-generated digital horse illustration

PTO director strikes a blow for ML patent subject matter eligibility

Oct. 13, 2025
By Mark McCarty
John Squires, the recently anointed director of the U.S. Patent and Trademark Office, has determined that a machine learning (ML) patent application met the standard for patent subject matter eligibility, an outcome that seems to bode well for ML-based patent applications going forward.
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Financings for Oct. 13, 2025

Oct. 13, 2025
Med-tech firms raising money in public or private financings, including: Bluejay.
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In the clinic for Oct. 13, 2025

Oct. 13, 2025
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adagio Medical, Billiontoone.
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Other news to note for Oct. 13, 2025

Oct. 13, 2025
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 1Cell.AI, Accugenomics, Cardiofocus, Dario, Genedx, Hyperfine, Nextbiomedical, Pacbio, Stereotaxis, Upcare Europe.
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