Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerie, Agios, Amgen, Bayer, Biomarin, Boehringer Ingelheim, Chiesi, Heron, Innate, Menari, Moderna, Roche, Samsung, Shionogi, Sobi, UCB, Viiv.
The competitive din in the vocal sound diagnostic space rose to new levels as Sonde Health Inc. launched a developer portal to enable other companies to incorporate its vocal biomarker-based health check technology into their apps. Sonde joins a growing number of companies and academic labs around the world talking up the ability of voice recordings to detect a surprising range of diseases.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA eyes grant of license for spectrometer for SARS; HQO eyes TAVI/TAVR for low-risk patients; ACLA says testing capacity beginning to strain.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioelectronics, Perkinelmer, Spiderwort, Wren Laboratories.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied DNA Sciences, Avicenna.AI, Becton Dickinson, Canon Medical Systems, Cb Scientific, Cubex, Decision Diagnostics, Djo, Fedoc, Isohelix, Mindray North America, Perspectum, Precision Genetics, Stryker, Tidepool, Virusight Diagnostic, Vizient, Zoll Medical.
Mymd Pharmaceuticals Inc., the privately held developer of a synthetic derivative of tobacco alkaloids for the potential treatment of autoimmune diseases and age-related disorders, will soon list on Nasdaq via its acquisition of former point-of-care testing company Akers Biosciences Inc., shares of which (NASDAQ:AKER) climbed 29.1% to $2.22 on Nov. 12. The combined company, to be headquartered in Baltimore, will retain Mymd's name and adopt the trading symbol MYMD. Concurrent with the merger, Akers is raising $18 million in a private placement priced at-the-market.
Researchers at Yale University have described what they have called a “data sanitization tool,” enabling them to strip personal identifiers out of functional genomics data while preserving their usefulness for research.
BOGOTA, Colombia and VANCOUVER, Canada – Anvisa, Brazil’s health care surveillance agency, re-started phase III trials for Coronavac, the COVID-19 vaccine candidate developed by China-based Sinovac Biotech Ltd., after a suspension of just two days. “Anvisa understands that it has sufficient subsidies to allow the resumption of vaccination,” the regulator said on Nov. 11. Anvisa said it plans to continue monitoring “the possible relationship of causality” between an unexpected serious adverse event and the vaccine.
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