Clinical updates, including trial initiations, enrollment status and data readouts and publications: Addex, Enlivex, Graybug, Ideaya, Iveric, Sellas, Vivoryon.
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic kits to battle the pandemic in the country, which is home to one of the largest outbreaks in the world outside of China.
Chronic disease patients are facing serious risks both from keeping away from necessary care settings, as well as from potential COVID-19 infection. One in five chronic disease patients was already starting to avoid seeking care in physician’s offices and hospitals, according to a survey that started early last week of a panel of 1,300 chronic disease patients across several indications.
The importance of artificial intelligence and machine learning (AI/ML) has not been lost on drug development companies. Recently, to help accelerate the discovery of therapies to treat COVID-19, several deals have been established to help deploy those tools.
As companies scramble to develop diagnostic tests and vaccines for COVID-19, there is a need for effective treatments for patients suffering severe respiratory effects from the novel coronavirus. To that end, Beyond Air Inc., of Garden City, N.Y., and Rehovot, Israel, has applied to the U.S. FDA to conduct an IDE trial of its inhaled nitric oxide (NO) system, Lungfit Bro, in COVID-19 patients.
BEIJING – Biotech companies in China were among the first to experience disruptions in their operations and development plans from the COVID-19 outbreak, with employees unable to report to work and difficulties continuing trials.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Ariosa Diagnostics, Illumina, Transmedics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hologic, Neural Fiber Optic Systems, Medx Health.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied Extracts, Arima Genomics, Asuragen, Aytu Bioscience, Becton, Dickinson and Co., Biogx, Blue Earth Diagnostics, Bracco Imaging, Caredx, Cefaly, Co-Diagnostics, Datos, Geacom, Haselmeier, Healthcall, Heiq Materials, IDbyDNA, Illumina, Impulse Dynamics, Invo Bioscience, Nobio, Pharmajet, Qiagen, Roche, Supergum, Tandem Diabetes Care, Twist, West China Hospital, XCR Diagnostics.
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