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FDA Warns of Potential False Results with Roche Molecular Systems for COVID, Flu Test americanpharmaceuticalreview
March 22, 2021
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff, point-of-care (POC) facility staff, and health care providers that false positive results can occur with the Roche Molecular Systems, Inc. (Roche) cobas SARS-CoV-2 & ...
Vaccine development software shows promise in influenza effort, could help defeat coronavirus worldpharmanews
March 04, 2021
A novel computer algorithm that could create a broadly reactive influenza vaccine for swine flu also offers a path toward a pan-influenza vaccine and possibly a pan-coronavirus vaccine as well, according to a new paper published in Nature Communications.
GSK, Vir expand collaboration for influenza, respiratory virus therapies pharmaceutical-technology
February 18, 2021
GlaxoSmithKline (GSK) has signed a binding agreement with Vir Biotechnology to expand its existing partnership to research and develop novel therapies for influenza and other respiratory viruses.
EU OK for Roche’s oral flu treatment Xofluza pharmatimes
January 12, 2021
The European Commission (EC) has approved Roche’s oral treatment Xofluza (baloxavir marboxil) for the treatment of influenza.
Roche’s Xofluza gets FDA approval for influenza prevention pharmaceutical-technology
November 26, 2020
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Roche’s Xofluza (baloxavir marboxil) as a treatment to prevent influenza in people aged 12 years and above following post-exposure prophylaxis.
Open Orphan announces £2.5m influenza challenge study contract pharmatimes
November 09, 2020
Open Orphan has announced the signing of a £2.5m contract by its subsidiary hVIVO to conduct an influenza human challenge study with a US biotechnology company.
OPKO Health's BioReference Laboratories Launches Multiplex COVID-19 and Influenza A/B Test prnewswire
October 22, 2020
BioReference Laboratories, Inc., an OPKO Health company, is now accepting specimens for a new multiplex COVID-19 and influenza test for use by healthcare providers, clinics and health systems throughout the United States, to aid in the diagnosis of ...
Seattle AVM Announces Second IND for AVM0703 for COVID-19, Influenza ARDS americanpharmaceuticalreview
September 23, 2020
AVM Biotechnology has received U.S. Food and Drug Administration (FDA) permission to proceed with clinical trials to evaluate its proprietary drug AVM0703 in the treatment of Acute Respiratory Distress Syndrome (ARDS) mediated by COVID-19 or Influenza ...
Janssen's lead coronavirus vaccine shows preclinical promise pharmatimes
September 07, 2020
Janssen’s lead SARS-CoV-2 investigational vaccine candidate, Ad26.COV2.S, prevented severe clinical disease in Syrian golden hamsters when challenged with SARS-CoV-2, the virus that causes COVID-19 in people.
GSK Shipping Influenza Vaccine Doses for 2020-21 Season for US Market americanpharmaceuticalreview
August 05, 2020
GSK has started shipping its quadrivalent influenza vaccines to US healthcare providers and pharmacies for the 2020-21 flu season. This immediately follows a licensing and lot-release approval from the US Food and Drug Administration's (FDA) Center for...

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