Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Emmaus, Inovio, Melt, Merck, Novartis, Regulus, Relief, Ridgeback, Roche, Scynexis, Teva.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Auris, Constant, Denali, Dimerix, Genentech, Krystal, Repare, Samus, Sanofi.
Thermo Fisher Scientific expanded its Globalaccess Sequencing Program to include oncology laboratories in addition to research labs working on COVID-19 studies. The company will subsidize a limited number of Genexus systems to help pathology laboratories around the world.
Diagnostics testing company Laboratory Corp. of America Holdings Inc. (Labcorp) saw its second-quarter revenue decline by 4% to $2.8 billion, but that still beat the Street consensus of $2.5 billion. Diagnostics revenue fell 3.9% year over year to $1.7 billion, but that was offset by solid demand for the company’s COVID-19 tests.
The U.S. Senate Finance Committee held the first of its two hearings on the supply chains for a variety of products vital to the response to the COVID-19 pandemic. While electoral politics were on full display during the hearing, a recurrent theme was the need to bring supply chains back to the Western Hemisphere as a solution to the fraudulent products shipped to the U.S. from Hong Kong and China.
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.
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