NIH launched study of third COVID-19 vaccine dose in kidney transplant recipients
On Aug. 10, 2021, the National Institutes of Health (NIH) announced that a pilot study had begun to…
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Moderna and Canada announced collaboration to bring mRNA manufacturing to Canada
On Aug. 10, 2021, the government of Canada The Government of Canada announced it had established a memorandum…
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Cardinal Health partnered with Abbott and Quidel to offer rapid OTC COVID-19 tests
On Aug. 10, 2021, Cardinal Health announced its efforts to commercialize and broaden access to over-the-counter rapid COVID-19…
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West Africa’s first-ever case of Marburg virus disease confirmed in Guinea
On Aug. 9, 2021, health authorities in Guinea confirmed a case of Marburg virus disease in the southern…
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Australian Therapeutic Goods Administration granted provisional registration for Moderna’s COVID-19 vaccine
On Aug. 9, 2021, the Therapeutic Goods Administration (TGA), part of the Department of Health, granted provisional approval…
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INOVIO and Advaccine receive regulatory allowance for prime-boost clinical trials in China using INO-4800, COVID-19 DNA vaccine candidate
On Aug. 9, 2021, Inovio Pharma announced that it had received regulatory allowance for two clinical trials investigating…
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FDA approved new treatment for Pompe Disease
On Aug. 6, 2021, the U.S. Food and Drug Administration (FDA) approved Sanofi’s Nexviazyme® (avalglucosidase alfa-ngpt) for the…
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BD and CerTest Biotec announced CE Mark for molecular test to detect, identify certain SARS-CoV-2 variants
On Aug. 6, 2021, BD (Becton, Dickinson) and CerTest Biotec announced the CE mark for a molecular test…
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CDC reported vaccination offers higher protection than previous COVID-19 infection
On Aug. 6, 2021, the Centers for Disease Control and Prevention (CDC) announced in MMWR that a study…
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NIH-funded study discovered gene involved in male infertility
On Aug. 5, 2021, an international team of researchers announced that a mutation in a single gene appeared…
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Novavax announced COVID-19 vaccine booster data demonstrating four-fold Increase in neutralizing antibody
On Aug. 5, 2021, Novavax announced preliminary data demonstrating that a single booster dose of its recombinant nanoparticle…
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Novavax and EC finalized advance purchase agreement for up to 200 million doses of COVID-19 vaccine
On Aug. 4, 2021, Novavax announced that it had reached an agreement with the European Commission (EC) for…
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Bio-Techne’s RNAscope aids in tissue diagnosis of COVID-19 in cases with no previous SARS-CoV-2 testing
On Aug. 4, 2021, Bio-Techne announced that scientists at the U.S. Centers for Disease Control and Prevention (CDC)…
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NEJM published positive phase 3 trial results for REGEN-COV to prevent SARS-CoV-2 infection
On Aug. 4, 2021, Regeneron announced that the New England Journal of Medicine (NEJM) had published positive detailed…
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INOVIO dosed first participant in phase 2 trial for its DNA vaccine against MERS, a Coronavirus Disease
On Aug. 4, 2021, Inovio Pharma announced that the company had dosed the first Phase 2 trial subject…
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Vanda closed enrollment in ODYSSEY study comparing tradipitant and placebo In COVID-19 pneumonia patients
On Aug. 3, 2021, Vanda Pharmaceuticals announced that enrollment had closed in the ODYSSEY study comparing tradipitant and…
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Illumina donated US $1 Million in sequencing capabilities for COVID-19 genomic surveillance in India
On Aug. 3, 2021, Illumina announced it had donated US $1 million in sequencing capabilities to the Molecular…
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CytoDyn received clearance from Brazil’s FDA (ANVISA) to commence pivotal phase 3 trial in critically ill COVID-19 patients
On Aug. 3, 2021, CytoDyn announced that Brazil’s regulatory authority ANVISA (Agência Nacional de Vigilância Sanitária) has approved…
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Lilly and Incyte’s baricitinib reduced deaths among patients with COVID-19 receiving invasive mechanical ventilation
On Aug. 3, 2021, Eli Lilly and Incyte announced results from an additional cohort of 101 adult patients…
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FDA cleared Vaxart’s IND application for S-only oral tablet COVID-19 vaccine candidate
On Aug. 2, 2021, Vaxart announced that the U.S. Food and Drug Administration has cleared Vaxart’s Investigational New…
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MPP, WHO, AFRIGEN, BIOVAC, SAMRC and Africa CDC announced LOI for tech transfer hub in South Africa
On Jul. 30, 2021, the Medicines Patent Pool and the World Health Organization, Afrigen Biologics, the Biologicals and…
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FDA expanded authorized use of REGEN-CO (casirivimab and imdevimab)
On Jul. 30, 2021, Regeneron announced that the U.S. Food and Drug Administration (FDA) had updated the Emergency…
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FDA broadened existing EUA of Lilly and Incyte’s baricitinib in patients hospitalized with COVID-19
On Jul. 29, 2021, Incyte announced the U.S. Food and Drug Administration (FDA) had broadened the Emergency Use…
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Biotechnology | FDA | Imaging | Therapeutics
FDA Approved Expanded BOTOX® Label to Include Eight New Muscles to Treat Adults with Upper Limb Spasticity
On Jul. 29, 2021, BOTOX(R) Allergan, an AbbVie company, announced that the U.S. Food and Drug Administration (FDA)…
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National Science Foundation partnerships expand National AI Research Institutes to 40 states
On Jul. 29, 2021, the National Science Foundation announced the establishment of 11 new NSF National Artificial Intelligence…
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Clinical Research | Disease | Neurology | NIH | Therapeutics
NIH unveiled new online tool to improve Alzheimer’s clinical trials recruitment
On Jul. 29, 2021, the National Institutes of Health (NIH) announced it had launched a new online research…
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Emergent BioSolutions resumed manufacturing COVID-19 vaccine at Bayview facility
On Jul. 29, 2021, Emergent BioSolutions announced that the U.S. Food and Drug Administration (FDA) had begun allowing…
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Vaxart reported boosting immune responses in subjects previously vaccinated by a Vaxart vaccine
On Jul. 29, 2021, Vaxart announced that it has shown for the first time in clinical trials that…
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SIGA announced collaboration with Oxford University to expanded Access Protocol for Use of TPOXX in Central African Republic
On Jul. 29, 2021, SIGA Technologies announced that it had entered into a collaboration with Oxford University in…
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Cocrystal’s SARS-CoV-2 3CL protease lead CDI-45205 demonstrated broad-spectrum activity against SARS-CoV-2 Delta and Gamma variants
On Jul. 29, 2021, Cocrystal Pharma announced that its SARS-CoV-2 3CL protease lead CDI-45205 and several analogs showed…
