Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neocis, Nowdiagnostics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aegea Biotechnologies, Aminoverse, Bioivt, Ciox Health, Cytosorbents, Datos Health, Edifecs, Exagen, Guided Therapeutics, Heart Health Intelligence, Hims & Hers, Ireceptor Plus, Medal, Midwest Institute for Minimally Invasive Therapies, Neuroone Medical Technologies, Orbis Diagnostics, Osi Systems, Saykara, Tauriga Sciences, Truework, Tscan, Twist Bioscience, Vaica Medical.
As Pfizer Inc. and Biontech SE start their massive phase II/III safety and efficacy trial evaluating a single nucleoside-modified messenger RNA candidate from their BNT-162-based vaccine program against SARS-CoV-2, smaller, privately held Codagenix Inc. plans a different approach.
HONG KONG – Mumbai, India-headquartered Glenmark Pharmaceuticals Ltd. have released statistically significant top-line results from a phase III trial showing that Fabiflu (favipiravir), an antiviral pyrazine RNA polymerase inhibitor, can treat cases of mild to moderate COVID-19 in four days.
LONDON - The combined force of Belgian life sciences has been brought together in the launch of Exevir Bio BV, which arrives on the scene with a €23 million (US$27 million) series A and ready for a phase I study of its novel antiviral therapy in hospitalized COVID-19 patients.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apogenix, Black Diamond, Chi-Med, Foresee, Hemoshear, Larimar, Momenta, Nabriva, Protara, Realta.
The U.S. FDA has rewritten the emergency use authorization (EUA) for the Laboratory Corp. of America Holdings Inc. (Labcorp) COVID-19 polymerase chain reaction (PCR) test to allow for diagnostic testing of those who are asymptomatic and those who have no reason to suspect they are infected with the SARS-CoV-2 virus.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Fortress Diagnostics, Lemaitre Vascular, MedPAC.
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