NIH launched study of third COVID-19 vaccine dose in kidney transplant recipients
On Aug. 10, 2021, the National Institutes of Health (NIH) announced that a pilot study had begun to…
West Africa’s first-ever case of Marburg virus disease confirmed in Guinea
On Aug. 9, 2021, health authorities in Guinea confirmed a case of Marburg virus disease in the southern…
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…
Australian Therapeutic Goods Administration granted provisional registration for Moderna’s COVID-19 vaccine
On Aug. 9, 2021, Moderna announced that the Therapeutic Goods Administration (TGA) had granted provisional registration to the…
FDA approved new treatment for Pompe Disease
On Aug. 6, 2021, the U.S. Food and Drug Administration approved Genzyme’s Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion…
BD and CerTest Biotec announced CE Mark for molecular test to detect, identify certain SARS-CoV-2 variants
On Aug. 6, 2021, BD (Becton, Dickinson) and CerTest Biotec announced the CE mark for a molecular test…
CDC reported vaccination offers higher protection than previous COVID-19 infection
On Aug. 6, 2021, the Centers for Disease Control and Prevention (CDC) annouced in MMWR that a study…
Novavax announced COVID-19 vaccine booster data demonstrating four-fold Increase in neutralizing antibody
On Aug. 5, 2021, Novavax announced preliminary data demonstrating that a single booster dose of its recombinant nanoparticle…
NIH-funded study discovered gene involved in male infertility
On Aug. 5, 2021, an international team of researchers announced that a mutation in a single gene appeared…
NEJM published positive phase 3 trial results for REGEN-COV to prevent SARS-CoV-2 infection
On Aug. 4, 2021, Regeneron announced that the New England Journal of Medicine (NEJM) had published positive detailed…
Bio-Techne’s RNAscopeﾙ aids in tissue diagnosis of COVID-19 in cases with no previous SARS-CoV-2 testing
On Aug. 4, 2021, Bio-Techne announced that scientists at the U.S. Centers for Disease Control and Prevention (CDC)…
Lenzilumab treatment may provide enhanced likelihood of survival without ventilation in hospitalized black and African-American COVID-19 patients
On Aug. 4, 2021, Humanigen announced analysis of results from its Phase 3 LIVE-AIR study of lenzilumab in…
INOVIO dosed first participant in phase 2 trial for its DNA vaccine against MERS, a Coronavirus Disease
On Aug. 4, 2021, Inovio Pharma announced that the company had dosed the first Phase 2 trial subject…
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…
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…
Lilly and Incyte’s baricitinib reduced deaths among patients with COVID-19 receiving invasive mechanical ventilation
On Aug. 3, 2021, Eli Lilly and Incyte announced results from an additional cohort of 101 adult patients…
Illumina donated US $1 Million in sequencing capabilities for COVID-19 genomic surveillance in India
On Aug. 3, 2021, Illumina announced it had donated US $1 million in sequencing capabilities to the Molecular…
Vanda closed enrollment in ODYSSEY study comparing tradipitant and placebo In COVID-19 pneumonia patients
On Aug. 3, 2021, Vanda Pharmaceuticals announced that enrollment had closed in the ODYSSEY study comparing tradipitant and…
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…
NIH advanced ACTIV-5/BET-B trial evaluating lenzilumab from phase 2 study to phase 2/3 trail for treatment of COVID-19
On Jul. 30, 2021, Humanigen announced that the NIH had advanced the ACTIV-5/BET-B study to a Phase 2/3…
MPP, WHO, AFRIGEN, BIOVAC, SAMRC and Africa CDC announced LOI for tech transfer hub in South Africa
On Jul. 30, 2021, the Medicines Patent Pool and the World Health Organization, Afrigen Biologics, the Biologicals and…
FDA expanded authorized use of REGEN-COVﾙ (casirivimab and imdevimab)
On Jul. 30, 2021, Regeneron announced that the FDA had updated the Emergency Use Authorization (EUA) for the…
COVID-19 | FDA | Therapeutics
FDA broadened existing EUA of Lilly and Incyte’s baricitinib in patients hospitalized with COVID-19
On Jul. 29, 2021, Incyte announced the U.S. Food and Drug Administration (FDA) had broadened the Emergency Use…
FDA Approved Expanded BOTOX® Label to Include Eight New Muscles to Treat Adults with Upper Limb Spasticity
On Jul. 29, 2021, BOTOX(R) Allergan, an AbbVie company, announced that the U.S. Food and Drug Administration (FDA)…
Emergent BioSolutions resumed manufacturing COVID-19 vaccine at Bayview facility
On Jul. 29, 2021, Emergent BioSolutions announced that the FDA had begun allowing Emergent’s Bayview manufacturing facility to…
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…
Oxford vaccine reached one billion doses released
On Jul. 29, 2021, the University of Oxfordﾒs and AstraZeneca announced that one billion doses of the ChAdOx1…
Cocrystal’s SARS-CoV-2 3CL protease lead CDI-45205 demonstrated broad-spectrum activity against SARS-CoV-2 Delta and Gamma variants
On Jul. 29, 2021, Cocrystal Pharma announced that its SARS-CoV-2 3CL protease lead CDI-45205 and several analogs showed…
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…
SIGA announced collaboration with Oxford University to expanded Access Protocol for Use of TPOXX in Central African Republic
On Jul. 29, 2021, SIGA Technologies announced that it had entered into a collaboration with Oxford University in…