CDC Advisory Committee recommended single-shot COVID-19 vaccine for adults 18 and older in US
On Feb. 28, 2021, Johnson & Johnson announced that the U.S. Centers for Disease Control and Preventionﾒs (CDC)…
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Johnson & Johnson single-shot COVID-19 vaccine authorized by US FDA for Emergency Use
On Feb. 27, 2021, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) had issued…
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EMA accepted Pfizerﾒs MAA for investigational 20-valent pneumococcal conjugate vaccine
On Feb. 26, 2021, Pfizer announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization…
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Johnson & Johnson COVID-19 vaccine candidate recommended for EUA by FDA advisory committee
On Feb. 26, 2021, Johnson & Johnson announced that the FDA Vaccines and Related Biological Products Advisory Committee…
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Novavax and Takeda finalized license agreement for Novavax COVID-19 vaccine candidate in Japan
On Feb. 26, 2021, Novavax and Takeda Pharmaceutical announced an exclusive license agreement for Takeda’s development, manufacturing and…
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EMA issued advice on Regeneron’s antibody cocktail (casirivimab with imdevimab) for COVID-19 patients
On Feb. 26, 2021, Regeneron announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use…
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Roche SARS-CoV-2 rapid rntigen test received special approval for at-home patient self-testing in Germany
On Feb. 26, 2021, Roche announced it had been granted special approval by the German Federal Institute for…
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Innovation Pharma provided study details for phase 2 clinical trial of Brilacidin in hospitalized COVID-19 patients
On Feb. 26, 2021, Innovation Pharmaceuticals announced that after an interim review, by an independent Data Monitoring Committee…
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Biotechnology | Disease | FDA | Genomics | Therapeutics
FDA approved targeted treatment for rare Duchenne muscular dystrophy mutation
On Feb. 25, 2021, the U.S. Food and Drug Administration (FDA) granted approval to Sarepta Therapeutics for Amondys…
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FDA allowed more flexible storage, transportation conditions for Pfizer-BioNTech COVID-19 vaccine
On Feb. 25, 2021, the U.S. Food and Drug Administration announced that it was allowing undiluted frozen vials…
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Altimmune commenced enrollment in phase 1 trial of AdCOVID needle-free, single-dose Intranasal COVID-19 vaccine candidate
On Feb. 25, 2021, Altimmune announced that it had commenced enrollment in a Phase 1 clinical trial of…
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Chimerix reported promising topline results from first cohort of a randomized COVID-19 trial with DSTAT
On Feb. 25, 2021, Chimerix reported topline results from the first cohort of its randomized, double-blind, placebo-controlled Phase…
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Pfizer and BioNTech initiated sudy to evaluate COVID-19 booster and new vaccine variants
On Feb. 25, 2021, Pfizer and BioNTech announced they had begun an evaluation of the safety and immunogenicity…
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IDMC found clear efficacy for REGEN-COVﾙ in phase 3 COVID-19 outpatient outcomes trial
On Feb. 25, 2021, Regeneron announced changes to the phase 3 trial assessing investigational REGEN-COVﾙ (casirivimab with imdevimab)…
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UTSW researchers identified mechanism by which exercise strengthens bones and immunity
On Feb. 25, 2021, scientists at the Childrenﾒs Medical Center Research Institute at UT Southwestern announced they had…
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Overall deaths did not increase for most Chinese regions during the initial COVID-19 outbreak
On Feb. 24, 2021, scientists at the University of Oxford reported that overall deaths did not increase in…
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COVID-19 vaccine doses shipped by the COVAX Facility head to Ghana, marked beginning of global rollout
On Feb. 24, 2021, Ghana became the first country outside India to receive COVID-19 vaccine doses shipped via…
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XPhyto placed first order for 25-minute COVID-19 RT-PCR tests
On Feb. 24, 2021, XPhyto announced that it has placed the first order for its rapid point-of-care SARS-CoV-2…
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Quest Diagnostics introduced new COVID-19 semi-quantitative serology test service
On Feb. 24, 2021, Quest Diagnostics introduced a new COVID-19 testing service that aids in providing insight into…
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NeuroRx announced that ZYESAMI (Aviptadil) had successfully demonstrated accelerated recovery from Covid-19 respiratory failure
On Feb. 24, 2021, NeuroRx, announced that the phase 2b/3 trial of ZYESAMI for the treatment of Respiratory…
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PerkinElmer changed COVID-19 rapid testing with highly sensitive point of care antigen test for mass screening
On Feb. 23, 2021, PerkinElmer announced the launch of the PerkinElmerﾮ COVID-19 Antigen Test for the qualitative detection…
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Study demonstrated macrolide-resistance in S pneumoniae in the US exceeded 25 percent threshold set in CABP guidelines
On Feb. 23, 2021, Nabriva Therapeutics announced publication of a study documenting the high rates of macrolide-resistant Streptococcus…
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Cue received CE Mark for Its molecular point-of-care COVID-19 test
On Feb. 23, 2021, Cue Health announced that its molecular point-of-care COVID-19 Test had received the CE mark,…
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Monoclonal antibodies against MERS Coronavirus showed promise in phase 1 NIH-sponsored trial
On Feb. 23, 2021, the NIH announced that a randomized, placebo-controlled Phase 1 clinical trial of two monoclonal…
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No-fault compensation programme for COVID-19 vaccines was a world first
On Feb. 22, 2021, the World Health Organization (WHO) and Chubb signed an agreement on behalf of the…
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Amyris announced positive pre-clinical results for COVID-19 RNA vaccine platform
On Feb. 22, 2021, Amyris announced highly promising preliminary data in a pre-clinical study of its ribonucleic acid…
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Biohaven’s multimodal antibody therapy demonstrated effective neutralization of multiple strains of COVID-19
On Feb. 22, 2021, Biohaven Pharmaceutical announced that a hyperimmune globulin mimic (HGM) developed with Biohaven’s proprietary MATE…
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BD announced collaboration for at-home rapid test for COVID-19
On Feb. 22, 2021, BD (Becton, Dickinson) and Scanwell Health, a leader in smartphone-enabled at-home medical tests, announced…
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Novavax completed enrollment of PREVENT-19, COVID-19 vaccine pivotal phase 3 trial in the US and Mexico
On Feb. 22, 2021, Novavax announced it had completed enrollment of PREVENT-19, its pivotal Phase 3 study in…
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First identification of human cases of avian influenza A(H5N8) infection
On Feb. 20, 2021, Russian authorities reported the detection of influenza A(H5N8) virus infection in seven poultry workers…
