Rising protocol design complexity reported driving rapid growth in clinical trial data volume
On Jan. 12, 2021, the Tufts Center for the Study of Drug Development (Tufts CSDD) reported that ever…
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Swissmedic authorized COVID-19 vaccine Moderna for Use in Switzerland
On Jan. 12, 2021, Moderna announced that Swissmedic, the Swiss Agency for Therapeutic Products, had authorized the COVID-19…
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Regeneron announced US Government sgreement to purchase additional COVID-19 antibody cocktail doses
On Jan. 12, 2021, Regeneron announced that the U.S. Department of Health and Human Services (HHS) and the…
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Biotechnology | Disease | Genomics | Oncology
UTSW researchers identified new gene involved in breast cancer growth
On Jan. 12, 2021, a team researchers from the University of Texas Southwestern (UTSW) announced they had identified…
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Roche’s Xofluza approved by the EC for treatment of influenza, first new influenza antiviral in almost 20 years
On Jan. 11, 2021, Roche announced that the European Commission (EC) had approved Xofluza (baloxavir marboxil) for the…
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Abbott received CE Mark for its COVID-19 IgG quantitative antibody blood test
On Jan. 11, 2021, Abbott announced it had received FDA 510(k) clearance for the first rapid handheld traumatic…
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FDA conditionally approved first oral tablet to treat lymphoma in dogs
On Jan. 11, 2021, the FDA conditionally approved Anivive Lifesciences’ Laverdia-CA1 (verdinexor tablets) to treat dogs with lymphoma,…
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Biotechnology | CRISPR | FDA | Therapeutics
FDA cleared initiation of the Editas Medicine’s EDIT-301 clinical trial using CRISPR/Cas12a gene editing
On Jan. 11, 2021, Editas Medicine announced the U.S. Food and Drug Administration (FDA) had cleared the initiation…
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Baxter Biopharma Solutions announced sterile manufacturing agreement for Novavax COVID-19 vaccine
On Jan. 11, 2021, Baxter announced an agreement to provide sterile manufacturing services for NVX-CoV2373, Novavax COVID-19 recombinant…
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T2 Biosystems T2SARS-CoV-2 panel proved effective with global rise in variants of the SARS-CoV-2 virus
On Jan. 11, 2021, T2 Biosystems announced that its T2SARS-CoV-2 Panel – a molecular diagnostic test that detects…
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Biotechnology | COVID-19 | HIV | Influenza | Vaccine
Moderna announced three new development programs in infectious disease vaccines
On Jan. 11, 2021, Moderna announced that it was expanding its pipeline of innovative vaccines with three new…
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AXIM released manuscript describing rapid point-of-care test that measures COVID-19 neutralizing antibodies
On Jan. 11, 2021, AXIM Biotechnologies announced that it had released a preprint of its manuscript describing the…
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Humanigen announced CRADA agreement with US government to develop lenzilumab for COVID-19
On Jan. 10, 2021, Humanigen announced that they were partnering to make lenzilumab available to hospitalized and hypoxic…
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Biotechnology | Diagnostics | Disease | Oncology | Radiology | Therapeutics
American Cancer Society reported largest one-year drop in cancer mortality from 1991-2017
On Jan. 8, 2021, the American Cancer Society reported that the death rate from cancer in the U.S….
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FDA issued alert regarding SARS-CoV-2 viral mutation to health care providers and clinical laboratory staff
On Jan. 8, 2021, the FDA alerted clinical laboratory staff and health care providers that it was monitoring…
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UK medicines regulator approved Moderna vaccine as third COVID-19 vaccine
On Jan. 8, 2021, the COVID-19 vaccine developed by Moderna has today been given regulatory approval for supply…
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UK Medicines and Healthcare products regulatory agency authorized use of COVID-19 Vaccine Moderna
On Jan. 8, 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) announced it had accepted the recommendation…
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In vitro study showed Pfizer-BioNTech COVID-19 vaccine elicited antibodies that neutralize SARS-CoV-2 with mutation
On Jan. 8, 2021, Pfizer and BioNTech announced results from an in vitro study conducted by Pfizer and…
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BioNTech confirmed EC’s proposal to purchase additional doses of vaccine
On Jan. 8, 2021, BioNTech announced that it was in talks with the European Commission (EC) about an…
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PerkinElmer announced the acquisition of Oxford Immunotec for $591 million in cash
On Jan. 7, 2021, PerkinElmer and Oxford Immunotec announce an agreement under which PerkinElmer acquired Oxford Immunotec for…
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Twist Bioscience supplied Centers for Disease Control and Prevention with custom SARS-CoV-2 synthetic RNA controls
On Jan. 7, 2021, Twist Bioscience announced it would supply the U.S. Centers for Disease Control and Prevention…
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Oragenics entered into material transfer agreement with adjuvance technologies for COVID-19 vaccine adjuvant
On Jan. 7, 2021, Oragenics announced entering into a material transfer agreement with Adjuvance Technologies for use of…
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Novavax finalized agreement with Commonwealth of Australia for 51 million doses of COVID-19 vaccine
On Jan. 7, 2021, Novavax announced that it had executed an Advance Purchase Agreement with the Commonwealth of…
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Labcorp awarded CDC contract to study variants of COVID-19 virus and improve public health response
On Jan. 7, 2021, LabCorp announced that it had been awarded a contract from the Centers for Disease…
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BioNTech published data on novel mRNA vaccine approach to treat autoimmune diseases in Science
On Jan. 7, 2021, BioNTech announced publication of preclinical data on its novel mRNA vaccine approach against autoimmune…
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HHS announced $22 billion in funding to support expanded testing, vaccination distribution
On Jan. 6, 2021, the U.S. Department of Health and Human Services (HHS) announced the Centers for Disease…
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Protective immunity against SARS-CoV-2 could last eight months or more
On Jan. 6, 2021, the La Jolla Institute for Immunology announced data that suggest nearly all COVID-19 survivors…
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European Commission authorized COVID-19 vaccine Moderna in Europe
On Jan. 6, 2021, Moderna announced that the European Commission had granted a conditional marketing authorization for COVID-19…
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Large clinical trial tested combination monoclonal antibody therapy for mild/moderate COVID-19
On Jan. 5, 2021, the National Institute of Allergy and Infectious Diseases (NIAID) announed that a phase 2/3…
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Biotechnology | CDC | COVID-19 | Diagnostics
Illumina and Helix collaborated to assess prevalence of New SARS-CoV-2 UK variant (B117) in the U.S.
On Jan. 5, 2021, Illumina and Helix announced a collaboration to augment national surveillance infrastructure in the U.S….
