TORONTO – Spino Modulation Inc., a subsidiary of Montreal-based med-tech company Spinologics Inc., has received breakthrough device designation for a vertebral body tethering (VBT) device to treat adolescent idiopathic scoliosis, one of three types of scoliosis that cause the spine to develop an abnormal curve.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: East End Medical, Stryker, Xenios.
Safety will be the focus July 15 when the FDA’s Cardiovascular and Renal Drugs Advisory Committee dives into the data for Fibrogen Inc.’s roxadustat as a treatment for anemia due to chronic kidney disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Antengene, Bayer, Chemocentryx, Coya, Diurnal, Enochian, Gensight, Inotrem, Iveric, Janssen, Kintor, Prilenia, Provention, Seagen, Sigilon, Sirnaomics, Soleno, Tetra, Tevogen, Valneva.
The M&As that are the current business model of the drug and device world are in for increased scrutiny under the executive order U.S. President Joe Biden signed July 9. Answering the administration’s call for a whole-of-government-approach to increasing competition in the U.S., the Department of Justice “will closely examine its antitrust guidelines and policy statements to better educate the public on its enforcement priorities, and it will heighten its efforts to prevent mergers that would result in excessive consolidations of purchasing power,” U.S. Attorney General Merrick Garland said.
The FDA’s draft guidance for the form and content of unique device identifiers (UDIs) may have lacked the controversy of some other policies, but the 2016 draft languished for five years even though only 10 comments appear in the docket. While the agency made some concessions regarding substantial edits of the draft, the final retains a need for data delimiters in the definition of “easily readable” plain text in UDIs, despite industry’s argument that this was not required in the agency’s UDI rulemaking.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carrot, Quidel, Ortho Clinical Diagnostics, Uvision360.
LONDON – The World Health Organization (WHO) is to set up a channel for confidential reporting of illegal, unregistered, unethical or unsafe human genome editing research, as part of a new governance framework it is proposing to develop.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Bluebird, Humanigen, Innovent, Lysogene.
The FDA granted breakthrough device designation for the Hyalex Cartilage System, a biomimetic materials platform designed to restore function and repair cartilage defects in the knee. The system, developed by Hyalex Orthopaedics Inc., combines two polymers that improve adhesion on one side and create a low-friction surface that protects the cartilage counterface on the other.