Novavax initiated phase 1/2 clinical trial of combination vaccine for COVID-19 and seasonal influenza
On Sept. 8, 2021, Novavax announced enrollment of the first participants in a Phase 1/2 study to evaluate…
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Data from phase 2 trial of Fostamatinib in hospitalized COVID-19 patients published in Clinical Infectious Diseases
On Sept. 1, 2021, Rigel Pharma announced the publication of results from a Phase 2 clinical trial evaluating…
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NIH launched study of extra COVID-19 vaccine dose in people with autoimmune disease
On Aug. 27, 2021, The National Institutes of Health announced that it had begun a clinical trial to…
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clinical trial tested donated antibodies for effectiveness in fighting infection caused by Coronavirus
On Aug. 19, 2021, Oregon Health & Science University (OHSU) announced that it was part of a randomized,…
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COVID-19 | FDA | Life Science History | NIH
FDA declined to issue Rigel Pharma EUA for fostamatinib for teatment of COVID-19 in hospitalized adults
On Aug. 13, 2021, Rigel Pharma announced that the U.S. Food and Drug Administration (FDA) had informed the…
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Innovation Pharmaceuticals’ phase 2 clinical trial of Brilacidin for COVID-19 trial database under review in preparation for lock
On Aug. 12, 2021, Innovation Pharma released information regarding the status of its randomized, double-blind, placebo-controlled Phase 2…
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Monoclonal antibody prevented malaria in small NIH trial
On Aug. 11, 2021, the National Institutes of Health (NIH) announced that one dose of a new monoclonal…
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INOVIO and Advaccine receive regulatory allowance for prime-boost clinical trials in China using INO-4800, COVID-19 DNA vaccine candidate
On Aug. 9, 2021, Inovio Pharma announced that it had received regulatory allowance for two clinical trials investigating…
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Novavax and EC finalized advance purchase agreement for up to 200 million doses of COVID-19 vaccine
On Aug. 4, 2021, Novavax announced that it had reached an agreement with the European Commission (EC) for…
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CytoDyn received clearance from Brazil’s FDA (ANVISA) to commence pivotal phase 3 trial in critically ill COVID-19 patients
On Aug. 3, 2021, CytoDyn announced that Brazil’s regulatory authority ANVISA (Agência Nacional de Vigilância Sanitária) has approved…
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FDA cleared Vaxart’s IND application for S-only oral tablet COVID-19 vaccine candidate
On Aug. 2, 2021, Vaxart announced that the U.S. Food and Drug Administration had cleared Vaxart’s Investigational New…
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NIH unveiled new online tool to improve Alzheimer’s clinical trials recruitment
On Jul. 29, 2021, the National Institutes of Health announced it had launched a new online research tool…
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Vaxart reported boosting immune responses in subjects previously vaccinated by a Vaxart vaccine
On Jul. 29, 2021, Vaxart announced that it has shown for the first time in clinical trials that…
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Corvus discontinued phase 3 study of mupadolimab for COVID-19 due to vaccine effectiveness in reducing hospitalizations
On Jul. 15, 2021, Corvus Pharmaceuticals announced that it had discontinued its Phase 3 study of mupadolimab for…
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WHO recommended interleukin-6 receptor blockers for COVID-19 and urged producers to join efforts to rapidly increase access
On Jul. 6, 2021, the World Health Organization (WHO) announced updated patient care guidelines to include interleukin-6 receptor…
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HDT Bio received notice to proceed from FDA for U.S. phase 1 clinical trial of RNA COVID-19 vaccine
On Jul. 1, 2021, HDT Bio announced the U.S. Food and Drug Administration had reviewed the companyﾒs Investigational…
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Novavax published results of UK phase 3 clinical trial demonstrating high levels of COVID-19 vaccine efficacy
On Jun. 30, 2021, Novavax announced the publication of results from the final analysis of a pivotal Phase…
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Investigational malaria vaccine gives strong, lasting protection
On Jun. 30, 2021, the National Institutes of Health announced two U.S. Phase 1 clinical trials of a…
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Altimmune announced update on AdCOVID phase 1 clinical trial
On Jun. 29, 2021, Altimmune provided an update on its AdCOVID investigational vaccine for the prevention of COVID-19….
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Disease | FDA | Neurology | Therapeutics
Eisai and Biogen announced FDA granted Breakthrough Therapy Designation for Lecanemab for treatment of Alzheimer’s disease
On Jun. 23, 2021, Biogen and Eisai announced that the U.S. Food and Drug Administration (FDA) had granted…
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Relief Therapeutics reported that NRx Pharma announced additional results from Aviptadil expanded access protocol for patients with COVID-19
On Jun. 16, 2021, RELIEF THERAPEUTICS reported that its collaboration partner, NRx Pharmaceuticals (NRx) had announced additional results…
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KPWHRI announced volunteers needed for COVID-19 vaccine-booster trial
On Jun. 14, 2021, Kaiser Permanente Washington Health Research Institute (KPWHRI) announced that was recruiting volunteers in the…
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Merck announced supply agreement with U.S. Government for molnupiravir, an Investigational oral antiviral treatment of COVID-19
On Jun. 9, 2021, Merck announced it had entered into a procurement agreement with the United States government…
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RECOVERY trial found aspirin does not improve survival for patients hospitalised with COVID-19
On Jun. 8, 2021, the University of Oxford announced the RECOVERY trial was established as a randomised clinical…
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Senolytics reduced COVID-19 symptoms in preclinical studies
On Jun. 8, 2021, Mayo Clinic researchers and colleagues at the University of Minnesota showed that COVID-19 exacerbates…
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Innovation Pharma completed enrollment in phase 2 clinical trial for COVID-19
On Jun. 3, 2021, Innovation Pharma announced that it had achieved full patient enrollment in its randomized, double-blind,…
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NIH clinical trial evaluating mixed COVID-19 vaccine schedules began
On Jun. 1, 2021, the National Institutes of Health (NIH) announced that it had started a Phase 1/2…
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Biotechnology | Diagnostics | Disease | FDA | Oncology | Radiology | Therapeutics
FDA approved LUMAKRAS for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
On May 28, 2021, Amgen announced that the U.S. Food and Drug Administration (FDA) had approved LUMAKRAS (sotorasib)…
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Novartis and Molecular Partners announced start of EMPATHY clinical trial for ensovibep for treatment of COVID-19
On May 27, 2021, Novartis and Molecular Partners announced the start of the clinical trial EMPATHY, a Phase…
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AstraZeneca COVID-19 vaccine Vaxzevria authorised for emergency use in Japan
On May 21, 2021, AstraZeneca announced that it had been granted a special approval for emergency use in…
