Following the temporary lapse in FDA inspections of manufacturing sites amid the COVID-19 pandemic, this year has already seen more class I medical device recalls issued than in all of 2020. The agency is now working to remediate the interruptions resulting from the pandemic among certain manufacturers of high-risk medical devices in reporting these recalls to the FDA.
SD Biosensor Inc. made a splash in its KOSPI board debut on July 16, raising a total ₩776.4 billion (US$679.26 million). The company will now use the funds to mass-produce and promote the company’s diagnostic machines for various indications, including COVID-19.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dexcom, Foundation Medicine, NG Biotech.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Azova, Canon Medical, Cleerly, Core One Labs, Polarityte, SQI Diagnostics.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomarin, Canbridge, Direct, Emmaus, Navidea, NLS, Ocugen, RDIF, Theratechnologies.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Checkmate, Constellation, Exevir, Generate, Gentibio, Forge, Halucenex, J&J, Kuros, Lexaria, Mithra, Morphosys, Pharmenable, Puma, Red Light Holland, Rubius, Sana, Xoma.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Advaxis, Aeglea, Bio-Thera, Compugen, Galapagos, Incyte, Mirror, Synlogic, Transcenta, Vir.
LONDON – The message that COVID-19 is a disease of the elderly needs to change, according to U.K. researchers who have analyzed complications suffered by 73,197 patients admitted to 302 hospitals in the first wave of the pandemic last year.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkeus, Antengene, Immunitybio, Kintor, Qualigen, Ryvu, Sesen.
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