ApiJect approved for $590 million loan from US International DFC to build drug manufacturing facility in North Carolina
On Nov. 19, 2020, ApiJect Systems, a public benefit corporatio, announced that it had been approved by the…
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XBiotech data showed effective anti-virus activity for antibodies in candidate influenza-COVID-19 therapeutic
On Nov. 19, 2020, XBiotech announced data for its breakthrough candidate therapy for treating infections of influenza and…
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Biotechnology | COVID-19 | FDA | Therapeutics
Baricitinib received Emergency Use Authorization from FDA for treatment of hospitalized patients with COVID-19
On Nov. 19, 2020, Eli Lilly and Incyte announced that the FDA had issued an Emergency Use Authorization…
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Todos Medical announced positive initial clinical proof-of-concept data for rapid SARS-CoV-2 3CL protease detection assay
On Nov. 18, 2020, Todos Medical announced positive clinical proof of concept data from its lab-based rapid SARS-CoV-2…
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11th Ebola outbreak in the Democratic Republic of the Congo declared over
On Nov. 18, 2020, marked the end of the 11th Ebola outbreak in the Democratic Republic of the…
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BioVersys announced first subjects dosed in phase 1 clinical trial of BV100
On Nov. 18, 2020, BioVersys announced a milestone by entering clinical development with the start of Phase 1…
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Pfizer and BioNTech announced phase 3 study of COVID-19 vaccine candidate met all efficacy endpoints
On Nov. 18, 2020, Pfizer and BioNTech announced that, after conducting the final efficacy analysis in their ongoing…
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Gilead announced long-acting HIV-1 capsid inhibitor, lenacapavir, achieved primary endpoint in phase 2/3 study
On Nov. 18, 2020, Gilead Sciences announced topline results from the Phase 2/3 CAPELLA trial evaluating the company’s…
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OHSU study screened wastewater, test volunteers for coronavirus
On Nov. 18, 2020, Oregon Health & Science University (OHSU) announced an initiative that will attempt to discern…
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Relief Therapeutics selected CRO and CDMO for RLF-100TM in Europe
On Nov. 18, 2020, RELIEF THERAPEUTICS announced the appointment of Syneos Healthﾮ, a leading global clinical research organization…
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Moderna announced supply agreement with UK Government to supply mRNA vaccine against COVID-19
On Nov. 17, 2020, Moderna announced a supply agreement with the government of the United Kingdom (UK) to…
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Bankruptcy judge approved federal settlement with Purdue Pharma
On Nov. 17, 2020, the proposed settlements between the federal government and OxyContin maker Purdue Pharma and its…
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Celdara Medical secured SBIR funding to develop an adjuvanted universal flu vaccine
On Nov. 17, 2020, Celdara Medical announced that the National Institute of Allergy and Infectious Disease (NIAID) of…
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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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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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Overweight and obese younger people at greater risk for severe COVID-19
On Nov. 17, 2020, UT Southwestern researchers reported that being younger doesnﾒt protect against the dangers of COVID-19…
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The US Dept of Veterans Affairs, federal partners plan for COVID-19 vaccination distribution
On Nov. 17, 2020, the U.S. Dept. of Veterans Affairs (VA) announced it was working with the Centers…
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NIH to fund research of racial disparities in pregnancy-related complications and deaths
On Nov. 17, 2020, the NIH announced funding of new research examining racial and ethnic disparities in pregnancy-related…
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Biotechnology | COVID-19 | FDA | Therapeutics
RedHill’s second COVID-19 candidate cleared by FDA for phase 2/3 Study in symptomatic COVID-19 disease
On Nov. 17, 2020, RedHill Biopharma announced that the U.S. Food and Drug Administration (FDA) had cleared the…
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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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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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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 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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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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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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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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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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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…
