Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ainnova, Avant, Histosonics, Icotec, Osteotec, Zynex.
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.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb.
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.
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.
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