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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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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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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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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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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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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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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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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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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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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CALAVI did not meet the primary endpoint in patients hospitalised with respiratory symptoms of COVID-19
On Nov. 12, 2020, AstraZeneca announced that the CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised…
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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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Sorrento announced IND filing for COVI-DROPS against SARS-CoV-2
On Nov. 11, 2020, Sorrento Therapeutics announced that it was filing an investigational new drug application (IND) for…
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DSMB analysis recommended continuance of P3 COVID-19 ARDS trial
On Nov. 11, 2020, Mesoblast announced that the randomized controlled Phase 3 trial of remestemcel-L in patients with…
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COVISHIELD completed enrollment of phase III clinical trials under partnership of ICMR and Serum Institute
On Nov. 11, 2020, the Serum Institute of India (SII) and Indian Council of Medical Research (ICMR) announced…
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Mateon and Windlas Biotech announced agreement to commercialize ARTIVEDA against COVID-19
On Nov. 11, 2020, Mateon Therapeutics announced an agreement with Windlas Biotech of India to commercialize ARTIVeda. ARTIVeda…
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Moderna completed case accrual for first planned interim analysis of mRNA vaccine against COVID-19
On Nov. 11, 2020, Moderna announced that it had completed case accrual for the first interim analysis of…
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Medigen Vaccines and BlueWillow Biologics partnered to Develop intranasal vaccine for SARS-COV-2
On Nov. 19, 2020, Medigen Vaccine Biologics and BlueWillow Biologics announced a partnership to develop S-2P-NE-01, a nasal…
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Ultragenyx announced plans to build large-scale gene therapy manufacturing facility for rare diseases
On Nov. 9, 2020, Ultragenyx announced that it planned to build a new large-scale gene therapy manufacturing facility…
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Pfizer and BioNTech announced vaccine candidate against COVID-19 achieved success in interim analysis from phase 3 study
On Nov. 9, 2020, Pfizer and BioNTech announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 had demonstrated evidence…
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Biotechnology | HIV | NIH | Therapeutics
Long-acting injectable drug prevented HIV in cisgender women
On Nov. 9, 2020, the NIH reported that a pre-exposure prophylaxis (PrEP) regimen containing an investigational long-acting form…
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Hydroxychloroquine does not benefit adults hospitalized with COVID-19
On Nov. 9, 2020, a National Institutes of Health (NIH) clinical trial evaluating the safety and effectiveness of…
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Effect of hydroxychloroquine on clinical status at 14 days in hospitalized patients with COVID-19
On Nov. 9, 2020, a study published in JAMA reported the effect of hydroxychloroquine on clinical status at…
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White-tailed deer found to be huge reservoir of SARS-CoV-2 infection
On Nov. 8, 2020, research from the U.S. had shown that white-tailed deer were being infected with SARS-CoV-2,…
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Mesa Biotech received additional $13 million from HHS to develop 30 minute SARS-CoV-2 & Flu A/Flu B test
On Nov. 6, 2020, Mesa Biotech announced it had been awarded a contract up to $13 million from…
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Humanigen announced CRADA agreement with U.S. government to develop lenzilumab for COVID-19
On Nov. 6, 2020, Humanigen announced that it had entered into a Cooperative Research and Development Agreement (CRADA)…
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Thermo Fisher Scientific and Innoforce established biologics and steriles drug manufacturing facility in China
On Nov. 6, 2020, Thermo Fisher Scientific and Innoforce announced a joint venture agreement to establish a new…
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Single-cell study of Ebola highlighted virus’s lethal maneuvers
On Nov. 6, 2020, in a study published in Cell, the researchers identified antiviral defense genes that the…
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Denmark tightened lockdown in north, mink cull devastates industry
On Nov. 5, 2020, Denmark announced strict lockdown rules in the north of the country after authorities discovered…
