Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bridge to Life, Qvella.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cook Medical, Coopercompanies, Curebase, Direct Biologics, Irp Health, Pathway Health, Portal Innovations, Thermo Fisher Scientific, Vicore Pharma, Wellbeing Digital Sciences.
New hires and promotions in the med-tech industry, including: Avita Medical, Enveda Biosciences, Globus Medical, Merit Medical Systems, Stella Diagnostics.
China’s Amoy Diagnostics Co. Ltd. (Amoydx) signed a development and commercialization agreement under which Amoy will develop multiple companion diagnostics for Astrazeneca plc across China, the E.U. and Japan.
The U.S. FDA has been scrutinizing surgical meshes for safety considerations for longer than a decade, but litigation continues to dot the legal landscape. An appeals court in the state of California decreed recently that Johnson & Johnson of Franklin Lakes, N.J. must pay more than $300 million over allegations that its Ethicon subsidiary had downplayed to patients the risks associated with its pelvic meshes, but J&J said its next step is to appeal the outcome in the state’s highest court.
Pacific Biosciences of California Inc.’s technology could rapidly increase the number of rare diseases—and their causes—identified by sequencing. Researchers at Children’s Mercy Research Institute in Kansas City found four times as many rare coding structural variants using Pacbio’s highly accurate long reads (Hifi) sequencing than standard sequencing detected. Results of the study were published in Genetics in Medicine.
Satellite Biosciences Inc. has become the latest biotech to emerge from stealth, backed with more than $110 million in VC financing to develop bioengineered tissues that fix damaged tissues or organs. With former Novartis executive Dave Lennon leading as CEO, the Cambridge, Mass.-based company is hoping to find therapies for hard-to-treat diseases.
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