FDA authorized first COVID-19 test for self-testing at home
On Nov. 17, 2020, the FDA issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test…
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CureVac established European-based network for manufacturing of COVID-19 vaccine candidate, CVnCoV
On Nov. 17, 2020, CureVac announced that it had accelerated the expansion of its manufacturing network to deliver…
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Mayo Clinic reported 900 employees contracted COVID-19 from local community
On Nov. 17, 2020, the Mayo Clinic reported that more than 900 employees had contracted COVID-19 in the…
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RedHill completed enrollment for COVID-19 US phase 2 study with opaganib
On Nov. 16, 2020, RedHill Biopharma announced that the U.S. Phase 2 study with opaganib (Yeliva, ABC294640)1 in…
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Bausch Health announced investigational in vitro data indicating inactivation of SARS-CoV-2 with eye drops
On Nov. 16, 2020, Bausch Health announced the results of new investigational in vitro data showing that two…
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bioMerieux announced CE marking of ARGENE SARS-CoV-2 diagnostic test to include saliva specimens
On Nov. 16, 2020, bioMerieux announced the expansion of its ARGENE range for the detection of SARS-CoV-2. As…
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Aegis Sciences launched combined test for SARS-CoV-2 and influenza A/B virus
On Nov. 16, 2020, Aegis Sciences announced that it had launched a combined test for SARS-CoV-2 and influenza…
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European Medicines Agency began rolling review of Moderna’s mRNA vaccine candidate against COVID-19
On Nov. 16, 2020, Moderna announced that the European Medicines Agency (EMA) human medicines committee (CHMP) had started…
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Biological E Limited started phase I/II clinical trial of its COVID-19 vaccine candidate
On Nov. 16, 2020, Biological E. Limited (BE), a Hyderabad-based vaccines and pharmaceutical company, Dynavax Technologies, and Baylor…
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Innovation Pharma announced overseas regulatory filing submitted for COVID-19 clinical study
On Nov. 16, 2020, Innovation Pharmaceuticals announced that an overseas Clinical Trial Application (CTA) has been submitted to…
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Tonix Pharmaceuticals reported positive immune response results from COVID-19 Vaccine candidate
On Nov. 16, 2020, Tonix Pharmaceuticals announced preliminary results following vaccination of non-human primates with TNX-1800 (modified horsepox…
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BioNTech and Fosun Pharma approved to commence COVID-19 vaccine candidate BNT162b2 trial in China
On Nov. 16, 2020, BioNTech and Shanghai Fosun Pharmaceutica announced that the China National Medical Products Administration had…
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Wellcome Sanger Institute and COG-UK received £122M UK investment for COVID-19 genomic surveillance
On Nov. 16, 2020, the UK Department for Health and Social Care Testing Innovation Fund announced £12.2M funding…
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Moderna announced longer shelf life for its COVID-19 vaccine candidate at refrigerated temperatures
On Nov. 16, 2020, Moderna announced new data showing that mRNA-1273, its COVID-19 vaccine candidate, remained stable at…
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INOVIO announced initiation of phase 2/3 clinical trial for COVID-19 DNA vaccine candidate, INO-4800
On Nov. 16, 2020, INOVIO announced that it had received clearance from the the U.S. Food & Drug…
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Moderna’s COVID-19 vaccine candidate met primary endpoint in first interim analysis of phase 3 COVE study
On Nov. 15, 2020, an independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of…
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Johnson & Johnson Initiated second global phase 3 clinical trial of Janssen COVID-19 vaccine candidate
On Nov. 15, 2020, Johnson & Johnson announced that it continued to enroll and vaccinate study participants for…
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COVID-19 patients treated with fluvoxamine had lower likelihood of clinical deterioration over 15 days
On Nov. 14, 2020, JAMA reported that in a preliminary study, adult outpatients with symptomatic COVID-19 treated with…
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Biotechnology | FDA | Oncology | Therapeutics
Agilent received expanded FDA approval for PD-L1 IHC 22C3 pharmDx in triple-negative breast cancer
On Nov. 13, 2020, Agilent Technologies announced it had received U.S. Food and Drug Administration (FDA) approval for…
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FDA approved Merck’s KEYTRUDA (pembrolizumab) in combination with chemo for patients with TNBC
On Nov. 13, 2020, Merck announced that the U.S. Food and Drug Administration (FDA) had approved KEYTRUDA, Merck’s…
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Cardiac arrest treatment that uses life support machine boosted survival
On Nov. 13, 2020, the NIIH announced that using a life support machine to replicate the functions of…
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CHMP recommended EU approval of Roche’s Xofluza (baloxavir marboxil) for the treatment of influenza
On Nov. 13, 2020, Roche announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human…
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Swissmedic began rolling review of Moderna’s mRNA vaccine against COVID-19
On Nov. 13, 2020, Moderna announced that Swissmedic had started a rolling review of mRNA-1273, the Company’s vaccine…
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Biotechnology | COVID-19 | FDA | Therapeutics
NeuroRx and Relief Therapeutics announce enrollment of 150 patients in phase 2b/3 trial of RLF-100™ for Critical COVID-19 with Respiratory Failure
On Nov. 13, 2020, NeuroRx and Relief Therapeutics announced that to-date, 150 patients (out of a targeted enrollment…
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Respiratory failure in COVID-19 usually not driven by cytokine storm
On Nov. 13, 2020, a study from Washington University School of Medicine in St. Louis and St. Jude…
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Albert Einstein College of Medicine received $5 million NIH grant to study HIV and HPV cancers in Africa
On Nov. 13, 2020, Albert Einstein College of Medicine announced that it had received a five-year, $4.9 million…
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Vaxart announced additional data from Hamster Challenge Study of its oral COVID-19 vaccine
On Nov. 12, 2020 Vaxart announced additional results from its Hamster Challenge Study. The study evaluated Vaxartﾒs recombinant…
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Early mutation in SARS-CoV-2 virus in Europe led to its domination world wide
On Nov. 12, 2020, a study published in Science by a team of researchers in the U.S. and…
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Biotechnology | COVID-19 | Diagnostics | FDA
Wren Laboratories launched saliva-based PCR COVID-19 test
On Nov. 12, 2020, Wren Laboratories announced that it had been granted an emergency use authorization by the…
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Gates Foundation announced funds to develop COVID-19 vaccines and increase access in low-income countries
On Nov. 12, 2020, the Bill & Melinda Gates Foundation announced new commitments totaling $70 million to global…
