Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Vela Diagnostics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied Biocode, Assure Holdings, Cylera, Doctor On Demand, Evanston Technology Partners, Micron Solutions, Nexstim, Readcube, Royal Philips, Tauriga Sciences, Thermo Fisher Scientific, Vizient.
PERTH, Australia – Australian stem cell company Mesoblast Ltd.’s shares were up nearly 39% on the news that its allogeneic cell therapy showed an 83% survival rate in ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) treated at New York’s Mount Sinai Hospital.
LONDON – The World Health Organization (WHO) launched a global collaboration to accelerate development and production of COVID-19 vaccines, therapeutics and diagnostics, with leaders of countries around the world appearing live to pledge their support.
The U.S. Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) said that they will offer enforcement discretion for their respective final rules for electronic health records (EHRs), a nod to the COVID-19 pandemic.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch, Biosig, Innovent, Janssen, Lilly, Oryzon, Sanofi, Viralclear.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptvac, AGC, Agastiya, Axovant, Emergent, Johnson & Johnson, Epimab, Hoth, Voltron, Nexstim, Sanofi, Scancell, Sumitomo Dainippon, Takeda, Orifarm, Tracon.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Amidebio, Caladrius, CNS Pharma, Cstone, Immuneoncia, Immunomedics, Merck and Co., Rafael, Revive, Samsung Biologics, Vitalis.
The U.S. Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) said that they will offer enforcement discretion for their respective final rules for electronic health records (EHRs), a nod to the COVID-19 pandemic. The term of the delays of compliance for several of these rules is not uniform, ranging from “late 2020” to “spring 2021,” and vendors thus will have to be vigilant to ensure they do not cross any compliance tripwires.
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