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BioWorld - Tuesday, December 16, 2025
Home » Topics » Regulatory

Regulatory
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World globe, DNA sequencing illustration.

Advamed goes 21st Century digital with its code of ethics

Oct. 23, 2025
By Mark McCarty
The Advanced Medical Technology Association has updated its code of ethics for interactions with health care professionals, which includes some much-needed updates that address both the burgeoning reliance on data and the increasing emphasis on the part of U.S. regulators on data security.
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Europe map, white on blue

Medtech Europe says EU Innovation Act no substitute for regulatory fix

Oct. 22, 2025
By Mark McCarty
The European Commission has proposed legislation that would ease some of the EU’s barriers to innovation, but MedTech Europe said that while the European Innovation Act would be helpful, it is no substitute for fixing what’s already ailing the EU med-tech industry.
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3D rendering showing osteoporosis in the femur

NICE nods to AI in detection of osteoporosis-driven vertebral fracture

Oct. 22, 2025
By Mark McCarty
Vertebral compression fractures are one of the more obvious signs of osteoporosis but can be difficult to diagnose, one of several reasons the U.K. National Institute for Health and Care Excellence has given the nod to five AI products that can improve rapid detection of these fractures.
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Drug R&D concept image.
Cancer

IND open for Dewpoint’s condensate modulator DPTX-3186

Oct. 22, 2025
No Comments
Dewpoint Therapeutics Inc. has announced an IND in the U.S. for DPTX-3186, a first-in-class oral condensate modulator designed to selectively disrupt oncogenic Wnt/β-catenin signaling in tumors. Dosing is set to begin before year-end in a phase I/II trial conducted in partnership with cancer centers and opinion leaders in gastric and other Wnt-driven cancers.
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US flag, gavel, book

Dexcom faces class action lawsuit following FDA warning

Oct. 21, 2025
By Mark McCarty
San Diego-based Dexcom Inc., is the target of a class action lawsuit in U.S. district court over the company’s G7 continuous glucose monitors, an action which follows a U.S. FDA warning letter by a mere seven months and a recall announced in July, suggesting that litigation often follows other sources of bad news for firms in the med-tech business.
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World with digital overlay

BIX 2025: What ‘radical’ changes in US, China mean for bio sector

Oct. 21, 2025
By Marian (YoonJee) Chu
No Comments
Sweeping “radical” changes in both the U.S. FDA and China’s drug development landscape are keeping the global life science industry on its toes in assessing what’s temporary and what’s not, speakers said at the Bioplus Interphex (BIX) Korea 2025 conference in Seoul, South Korea, on Oct. 15.
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Test tube, dropper
Gastrointestinal

Proqr’s AX-0810 gains European clinical trial clearance

Oct. 21, 2025
No Comments
Proqr Therapeutics NV has received clinical trial application (CTA) authorization under the EMA’s new centralized review process for a phase I study of AX-0810, which is being developed for the treatment of cholestatic diseases such as primary sclerosing cholangitis and biliary atresia.
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United Kingdom flag, map

UK CMA’s merger remedies draft seeks level competitive field

Oct. 20, 2025
By Mark McCarty
The U.K. Competition and Markets Authority (CMA) has issued draft guidelines for remedies for mergers and acquisitions, which the agency insists incorporates some regulatory flexibility. However, CMA said its approach is premised on the notion that any regulated transaction should have zero effect on competition in the affected industry, a premise that would seem to quash any transaction that leads to fewer companies in that industry.
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Interconnected nodes representing a digital supply chain network

MHRA announces winners in AI Airlock challenge

Oct. 20, 2025
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency reported the winners of the second phase of the AI Airlock challenge, which includes the Tortus AI, a medical scribe system developed by physicians in the U.K. National Health Service.
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Palsonify
Biopharma regulatory actions and approvals September 2025

US FDA drug approvals reach 160 in 2025, second-highest year on record

Oct. 20, 2025
By Amanda Lanier
No Comments
The U.S. FDA approved 17 drugs in September 2025, following 18 approvals in August and 17 in July. That brings the year-to-date total to 160 approvals for the first three quarters, making it the second-highest total on record for this period, behind 183 approvals logged during the same timeframe in 2024.
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