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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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…
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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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CIRM Board approved four new clinical trials
On Nov.12, 2020, the governing Board of the California Institute for Regenerative Medicine (CIRM) approved four new clinical…
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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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COVID-19 immunity may last six months or more
On Nov. 11, 2020, Howard Hughes Medical Institute Investigator Michel Nussenzweig and his team reported that people who…
