Moderna announced MOU to supply up to 110 million doses of Its COVID-19 vaccine to the African Union
On Oct. 26, 2021, Moderna announced a new Memorandum of Understanding (MoU) to make up to 110 million…
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Axcella Therapeutics launched clinical program to develop treatment for patients with long COVID
On Oct. 26, 2021, Axcella Therapeutics announced a new clinical program to investigate AXA1125 as a potential treatment…
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Moderna announced Swissmedic authorized booster dose of Moderna’s COVID-19 vaccine
On Oct. 26, 2021, Moderna announced that Swissmedic had authorized a booster dose of Spikevax, the Company’s vaccine…
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FDA Advisory Committee votes in favor of granting EUA for Pfizer-BioNTech Covid-19 vaccine in children 5 to <12 years
On Oct. 26, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administrationﾒs (FDA) Vaccines and…
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Merck and Ridgeback initiated rolling review by EMA for Molnupiravir, investigational oral antiviral medicine, for treatment of COVID-19
On Oct. 25, 2021, Merck and Ridgeback Biotherapeutics announced the European Medicines Agency (EMA) had initiated a rolling…
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Moderna announced EMA’s CHMP recommended booster dose of Moderna’s COVID-19 vaccine in the European Union
On Oct. 25, 2021, Moderna announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human…
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COVID-19 infection presents greater risk of causing very rare neurological events than vaccines
On Oct. 25, 2021, scientists at Oxford University reported that Infection with COVID-19 carried a much higher risk…
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Moderna announced positive top line data from phase 2/3 study of COVID-19 vaccine in children 6 to 11 years of age
On Oct. 25, 2021, Moderna announced positive interim data from the Phase 2/3 study, called the KidCOVE study,…
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European Commission selected Humanigenﾒs lenzilumab as one of the 10 most promising treatments for COVID-19
On Oct. 25, 2021, Humanigen announced the European Commission had identified lenzilumab as one of the ﾓ10 most…
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The Department of Veterans Affairs expanded mandate for COVID-19 vaccines among VHA employees
On Oct. 22, 2021, the U.S. Department of Veterans Affairs (VA) announced that it had begun offering Moderna…
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The U.S. CDC reported two new variant Influenza (Flu) virus infections
On Oct. 22, 2021, the U.S. Centers for Disease Control and Prevention (CDC) reported two new U.S. human…
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HHS invested over $560 million to bolster product manufacturing to increase supply, availability of COVID-19 tests
On Oct. 22, 2021, the Department of Health and Human Services (HHS), announced that it had invested more…
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U.S. CDC Advisory Committee unanimously recommended Johnson & Johnson COVID-19 vaccine as booster for all eligible individuals
On Oct. 21, 2021, Johnson & Johnson announced that the U.S. Centers for Disease Control and Prevention (CDC)…
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Ligand and CR Double-Crane entered agreement to develop oral COVID-19 therapeutic
On Oct. 21, 2021, Ligand Pharmaceuticals announced the signing of a collaboration agreement granting China Resources Double-Crane Pharmaceutical…
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COVID-19 booster increased antibody responses, was protective in rhesus macaques
On Oct. 21, 2021, the National Institutes of Health announced that a booster dose of the mRNA-1273 COVID-19…
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INOVIO announced MOU with Colombia for protecting against COVID-19 and broader health initiatives
On Oct. 21, 2021, Inovio Pharma announced the signing of a non-binding memorandum of understanding with Colombia’s Ministry…
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Pfizer and BioNTech announced phase 3 trial data showing high efficacy of booster dose of COVID-19 vaccine
On Oct. 21, 2021, Pfizer and BioNTech announced topline results from a Phase 3 randomized, controlled trial evaluating…
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Johnson & Johnson COVID-19 vaccine booster shot authorized for Emergency Use by U.S. FDA
On Oct. 20, 2021, Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) had issued Emergency…
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Moderna announced FDA authorization of booster dose of COVID-19 vaccine in the U.S.
On Oct. 20, 2021, Moderna announced that the U.S. Food and Drug Administration (FDA) had authorized for emergency…
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Quest Diagnostics provided K-12 School COVID-19 testing with Ginkgo Bioworks to support safer classrooms in Texas
On Oct. 20, 2021, Quest Diagnostics announced it had formed an agreement with the Texas Department of State…
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NIH launched program to map a rare type of non-dividing cells implicated in human health and disease
On Oct. 18, 2021, the National Institutes of Health launched a program to study a rare type of…
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Study found that for the unvaccinated, reinfection by COVID-19 was likely
On Oct. 19, 2021, National Science Foundation funded scientists at the Yale School of Public Health and the…
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NYU Langone Health’s Groundbreaking Transplant Offers Hope amid Organ Shortages
On Oct. 19, 2021, the first investigational transplant of a genetically engineered, nonhuman kidney to a human body…
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Largest ever global study of tuberculosis identified genetic causes of drug resistance
On Oct. 19 , 2021, researchers at the University of Oxford, using cutting-edge genomic sequencing techniques, announced they…
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COVID-19 vaccine developed by Valneva using Dynavax’s CpG 1018 adjuvant met co-primary endpoints in phase 3 trial
On Oct. 18, 2021, Dynavax Technologies announced that Valneva reported positive topline results from the Phase 3 pivotal…
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Subcutaneous Interferon does not improve outcomes for hospitalized adults with COVID-19
On Oct. 18, 2021, a NIAID sponsored clinical trial found that treatment with the immunomodulator interferon beta-1a plus…
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Biotechnology | FDA | HIV | Therapeutics
U.S. FDA approved expanded indication of Gilead’s Biktarvy for Treatment of HIV-1 in pediatric populations
On Oct. 18, 2021, Gilead Sciences announced that the Food and Drug Administration had approved a new low-dose…
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Pfizer and BioNTech submitted data to EMA for vaccination of children 5 to <12 years of age with COMIRNATY
On Oct. 18, 2021, Pfizer and BioNTech announced that the European Medicines Agency’s Committee for Human Medicinal Products…
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FDA approved naloxone injection to counteract opioid overdoses
On Oct. 18, 2021, the Food and Drug Administration approved ZIMHI (naloxone hydrochloride) injection as an additional option…
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Athenex and Center for Cell and Gene Therapy announced allowance of first U.S. patent around CAR-NKT cell therapy
On Oct. 18, 2021, Athenex and the Center for Cell and Gene Therapy at Baylor College of Medicine,…
