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BioWorld - Tuesday, December 16, 2025
Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
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Free access to BioWorld coronavirus articles

Dec. 15, 2025
The articles in this collection are from BioWorld’s ongoing coverage of the COVID-19 coronavirus pandemic. They are available for free with registration. Note that we have added five critical tables, which are continuously updated:

Biopharma vaccines and therapeutics in development
Diagnostics with U.S. FDA emergency use authorization
Clinical trials of biopharma products affected by COVID-19

Therapeutics and vaccines
Med-tech diagnostics


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CT scan of brain showing subdural hematoma

FDA greenlights Medtronic Onyx subdural hematoma treatment

Dec. 12, 2025
By Annette Boyle
Sometimes the darkest products (names) bring a bright spot of news to their developers, as the U.S. FDA clearance for Galway, Ireland-based Medtronic plc's Onyx liquid embolic system demonstrates. Onyx gained the indication for embolization of the middle meningeal artery as an adjunct to surgery for the treatment of symptomatic subacute or chronic subdural hematoma based on the EMBOLISE trial results. The approval represents a significant advancement in treating this common neurosurgical condition.
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Ebenbuild technology lung with ARDS

Ebenbuild aims to transform lung care with digital twin tech

Dec. 12, 2025
By Shani Alexander
Ebenbuild GmbH is hoping that its digital twin technology platform that combines AI and physics-based computational models tailored to individual patients will transform respiratory care. From drug development to optimizing mechanical ventilation in critical care, the company’s software-based solutions aim to reveal what is happening in the ‘black box’ of the lungs, helping clinicians to improve outcomes and reduce mortality.
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Line graph arrow trending upward

November reignites med-tech momentum with $4.7B raised

Dec. 12, 2025
By Amanda Lanier
Med-tech financing activity from January through November 2025 reached $31.32 billion, marking a strong rebound from the sector’s lows in 2023 to 2024, which saw $16.61 billion and $23.64 billion in the same period, respectively. While still far below the capital inflows seen in 2020 and 2021, when the first 11 months of the year exceeded $48 billion, the steady upward progression over recent years suggests renewed investor engagement and improving capital availability. In November, $4.73 billion was collected through 36 transactions, up from $3.25 billion in October.
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Appointments and advancements for Dec. 12, 2025

Dec. 12, 2025
New hires and promotions in the med-tech industry, including: Advamed.
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In the clinic for Dec. 12, 2025

Dec. 12, 2025
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Exact Sciences, Roivios.
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Other news to note for Dec. 12, 2025

Dec. 12, 2025
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cadwell Industries, Datasea, Essilorluxottica Mainstay Medical, Sentante.
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Regulatory actions for Dec. 12, 2025

Dec. 12, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Peijia Medical, Ruthless Spine, Zenflow.
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Gastrointestinal

Optimized organoid model gives insights into celiac disease

Dec. 12, 2025
By Anette Breindl
No Comments
Investigators at the Netherlands Hubrecht Institute have developed a novel gut organoid model, and used it to gain insight into the functions on human microfold (M) cells. Their experiments, which were published in the Dec. 10, 2025, issue of Nature, showed that M cells present gluten-derived antigens to T cells, which suggests a role for this cell type in the onset of celiac disease.
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COVID-19 vaccine vials on conveyor belt

Petition claims FDA oops! means COVID-19 vaccines misbranded

Dec. 11, 2025
By Mari Serebrov
No Comments
Restricting the recommended use of COVID-19 vaccines in the U.S. wasn’t enough. Now the Children’s Health Defense (CHD) is trying to get the FDA to revoke the BLAs for all versions of the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 vaccines.
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