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mRNA-1273 / ModernaModerna advances late-stage development of its vaccine (mRNA-1273) against Covid-19 (Businesswire) - Jun 11, 2020 - "Moderna has finalized the Phase 3 study protocol based on feedback from the U.S. Food and Drug Administration (FDA). The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants enrolled in the U.S....The Company expects dosing in the Phase 3 study to begin in July....The first cohort of healthy adults ages 18-54 years (n=300) in the Phase 2 study of mRNA-1273 is fully enrolled....Funding from the Biomedical Advanced Research and Development Authority (BARDA)...partially supported the planning for the Phase 2 and Phase 3 studies of mRNA-1273..."mavrilimumab (KPL-301) / KiniksaKiniksa announces 28-day clinical outcomes data from mavrilimumab treatment protocol in severe Covid-19 pneumonia and active U.S. IND for phase 2/3 clinical trial (GlobeNewswire) - Jun 8, 2020 - P=NA, N=39; "The company also announced an active investigational new drug application...for its global placebo-controlled Phase 2/3 clinical trial....Investigator-initiated placebo-controlled study in the U.S. is enrolling patients....28-day clinical outcomes data from the open-label treatment protocol....Death occurred in 0% (n=0/13) of mavrilimumab-treated patients by Day 28....Representative mavrilimumab-treated patients showed significant improvement in lung opacification on computerized tomography (CT) scans, consistent with the overall improvement in their clinical status."Yeliva (opaganib) / RedHillRedhill Biopharma submits Covid-19 Clinical Trial Application for phase 2/3 study with opaganib (GlobeNewswire) - Jun 10, 2020 - "RedHill Biopharma Ltd....today announced that it has submitted a Clinical Trial Application (CTA) with the Ministry of Health of the Russian Federation for a Phase 2/3 clinical study evaluating opaganib (Yeliva®, ABC294640)....The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study is planned to enroll 270 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygenation."REGN10933/REGN10987 / RegeneronRegeneron begins first clinical trials of anti-viral antibody cocktail REGN-COV2 for the treatment and prevention of Covid-19 (PipelineReview) - Jun 11, 2020 - "Regeneron Pharmaceuticals, Inc....announced initiation of the first clinical trial of REGN-COV2....The REGN-COV2 clinical program will consist of four separate study populations....The placebo-controlled trials will be conducted at multiple sites....The first two adaptive Phase 1/2/3 studies are evaluating REGN-COV2 (REGN10933+REGN10987) as a treatment for hospitalized and non-hospitalized patients with COVID-19. The Phase 1 portion will focus on virologic and safety endpoints, and the Phase 2 portion will focus on virologic and clinical endpoints."Vyrologix (leronlimab) / CytoDyn, Vyera PharmaCytoDyn receives BLA acknowledgment letter from the FDA (GlobeNewswire) - Jun 8, 2020 - "CytoDyn Inc....announced today the U.S. Food and Drug Administration (FDA) advised the Company, subject to its ongoing review, it could receive its 'PDUFA date' on July 10, 2020."anti-SARS-CoV-2 hyperimmune globulin therapy / GrifolsGrifols starts production of its hyperimmune immunoglobulin as a potential passive immune therapy against Covid-19 (PRNewswire) - Jun 11, 2020 - "Grifols...today announced the start of production of its anti-SARS-CoV-2 hyperimmune immunoglobulin....The first doses are expected to be available in July 2020 as part of a clinical trial....Grifols is moving forward with its clinical trial in Spain to assess the effectiveness of high-dose intravenous immunoglobulin....Trial aims to assess the action of neutralizing antibodies...as well as determine the immunomodulatory potential..."AZD1222 / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of OxfordAstraZeneca to supply Europe with up to 400 million doses of Oxford University’s vaccine at no profit (AstraZeneca Press Release) - Jun 13, 2020 - "AstraZeneca has reached an agreement with Europe’s Inclusive Vaccines Alliance (IVA), spearheaded by Germany, France, Italy and the Netherlands, to supply up to 400 million doses of the University of Oxford’s COVID-19 vaccine, with deliveries starting by the end of 2020. With today’s agreement, the IVA aims to accelerate the supply of the vaccine and to make it available to other European countries that wish to participate in the initiative. The IVA is committed to providing equitable access to all participating countries across Europe."PiCoVacc / SinovacSinovac announces positive preliminary results of phase I/II clinical trials for inactivated vaccine candidate against Covid-19 (Businesswire) - Jun 13, 2020 - P1/2, N=743; "Sinovac Biotech Ltd....today announced positive preliminary results of phase I/II clinical trial for the Company’s COVID-19 vaccine candidate, named CoronaVac, which showed favorable immunogenicity and safety profiles....There have been no severe adverse event reported in either the phase I or phase II trials....Vaccine induces neutralizing antibodies 14 days after the vaccination with a 0,14 day schedule. The Company expects to submit...phase III clinical study protocol to China’s National Medical Products Administration..."Johnson & Johnson announces acceleration of its Covid-19 vaccine candidate; Phase 1/2a clinical trial to begin in second half of July (PRNewswire) - Jun 10, 2020 - "Johnson & Johnson...has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant....Phase 1/2a study will evaluate...Ad26.COV2-S, recombinant in 1045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. The study will take place in the U.S. and Belgium. The Company is in discussions...to start the Phase 3 SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, clinical trial ahead of its original schedule....The Company committed to the goal of supplying more than one billion doses globally through the course of 2021, provided the vaccine is a safe and effective."US To Fund And Conduct Key Studies On Three Possible COVID-19 Vaccines: Dr Anthony Fauci - Jun 11, 2020 - "'The coronavirus vaccine effort is progressing very well and we expect more than one candidate vaccine to be in advanced clinical testing by early summer,' Fauci...Fauci said the funding decision came from the Department of Health and Human Services, in consultation with the National Institutes of Health and other agencies."
