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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

May 9, 2025

View Archived Issues
Digital globe illustrating pharma trade, tariffs

Investors unfazed by uncertainties around tariffs in med tech

Despite the uncertain macro environment created by the threat of reciprocal tariffs on goods into the U.S., some investors are still upbeat about the med tech sector. Even with changes at the HHS and disruption to product approvals throughout the FDA, venture capital investors remain cautiously optimistic. Read More
Astrazeneca production and manufacture facility

FDA to conduct unannounced inspections at OUS sites

The U.S. FDA typically announces its inspections at facilities located outside the U.S. – a courtesy not extended to domestic manufacturing sites. This is about to change per an agency press release quoting commissioner Marty Makary as describing the disparate treatment as a double standard. Read More
Koreabio Humanase KOH Sungho

FDA shift from animal testing fuels organoid, organ-on-chip demand

The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 said. Read More
Judge's gavel with US flag

Sun shines on Leqselvi at Federal Circuit

Planting seed money and “wishing” is not enough to claim “irreparable harm” to secure a preliminary injunction or to establish the standing required to appeal a patent board decision, the U.S. Court of Appeals for the Federal Circuit ruled May 7 in two decisions involving Incyte Corp. and Sun Pharmaceutical Industries Ltd. Read More
3D illustration of mesenchymal stem Cells

Cynata’s MSC cells show positive results across variety of delivery systems

The promise of mesenchymal stem cells (MSCs) to heal heart disease could be around the corner thanks to a new delivery method tested by regenerative medicine company Cynata Therapeutics Ltd. Read More

Financings for May 9, 2025

Med-tech firms raising money in public or private financings, including: Path Ex. Read More

Other news to note for May 9, 2025

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cytel, Dignitana, DNV, Icotec, Mediso, Nested Knowledge, Osteotec, Paxman, Superconducting Systems. Read More

Regulatory actions for May 9, 2025

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb. Read More

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