Akston Biosciences Doses First Participants in Phase II Clinical Trial for Shelf-Stable COVID-19 Booster


Up to 600 volunteers will participate in an AKS-452 COVID booster study in the Netherlands to investigate boosting the immune response of those previously vaccinated with EMA-registered vaccines AKS-452 has shown the ability to successfully neutralize the omicron variant of the SARS-CoV-2 virus Shelf stable at 25° Celsius (77° Fahrenheit) for at least 6 months,…

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KVK Tech Announces Phase II Trial of COVID-19 Oral Therapy is Currently Enrolling in Nepal


Excerpt from the Press Release: NEWTOWN, Pa., May 5, 2022 /PRNewswire/ — Sen-Jam Pharmaceuticals and KVK Tech are collaborating to develop a Covid-19 oral therapy. The companies will operate in parallel while they complete the Phase II clinical trials in Nepal. KVK Tech will offer formulation and chemistry, manufacturing and controls (CMC) for the oral therapy. Furthermore, KVK…

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EVUSHELD™ significantly protected against symptomatic COVID-19 for at least six months in PROVENT Phase III trial in high-risk populations


Pre-exposure prophylaxis (prevention) trial reduced risk of symptomatic COVID-19, with no severe disease or COVID-19-related deaths in EVUSHELD group Data published in the New England Journal of Medicine Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–Detailed results from the PROVENT Phase III pre-exposure prophylaxis (prevention) trial showed that AstraZeneca’s EVUSHELD™(tixagevimab and cilgavimab), formerly AZD7442, reduced…

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Celsion Corporation Highlighted its PLACCINE Vaccine Platform Technology During Oral Presentation at the World Vaccine Congress


Proprietary, Formulated DNA Plasmid Vaccine Candidate Shows NeutralizingActivity Against 2 Strains of the COVID-19 Virus The Goal to Provide Broader Range Protection within a Highly Flexible PlatformAppears to Show Promise Excerpt from the Press Release: LAWRENCEVILLE, N.J., April 21, 2022 (GLOBE NEWSWIRE) — Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, today presented…

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CureVac and GSK’s Bivalent Second-Generation mRNA Vaccine Candidate Shown to be Highly Effective Against SARS-CoV-2 Variants in Preclinical Study


– Vaccine candidate combining Beta- and Delta-specific mRNAs shows strong protection and immune responses during preclinical challenge study – Demonstrated neutralizing capacity against the Omicron variant in vaccinated animals – Technology adaptation for bivalent approach for COVID-19 vaccines potentially allows for broader protection against emerging variants Excerpt from the Press Release: TÜBINGEN, GERMANY and BOSTON,…

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Veru’s Novel COVID-19 Drug Candidate Reduces Deaths by 55% in Hospitalized Patients in Interim Analysis of Phase 3 Study; Independent Data Monitoring Committee Halts Study Early for Overwhelming Efficacy


— Independent Data Monitoring Committee Unanimously Recommends that Phase 3 Clinical Trial for Sabizabulin for Treatment of Hospitalized COVID-19 Patients at High Risk for ARDS Be Stopped Early Due to Overwhelming Evidence of Efficacy — — Sabizabulin Treatment Showed Statistically Significant and Clinically Meaningful 55% Reduction in Deaths Compared to Placebo in Moderate-Severe Hospitalized Patients…

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Akston Biosciences Doses First Volunteers in Phase II/III Clinical Trial of Low Cost, Shelf Stable COVID-19 Vaccine


1,500 healthy volunteers to participate in a Phase II/III double-blind placebo-controlled study in India Study results to be submitted for Emergency Use Authorization (EUA) Vaccine is shelf stable for over six months at room temperature at 25° Celsius (77° Fahrenheit) and maintains potency for one month at 37° Celsius (99° Fahrenheit) Excerpt from the Press…

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Proof Diagnostics Submits Request For Emergency Use Authorization Seeking First Approval Of Crispr-based Molecular Point-of-care Covid-19 Test


If authorized by the FDA, the Proof Lab Test System may be used to deliver accurate, actionable, lab-quality results for COVID-19 (SARS-CoV-2) in as little as 18 minutes Excerpt from the Press Release: CAMBRIDGE, Mass., April 7, 2022 /PRNewswire/ — Proof Diagnostics, Inc., an innovative healthcare technology company delivering innovative solutions in molecular diagnostics, today announced the submission…

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Talaris Therapeutics Presents Data on COVID-19 Outcomes Among Kidney Transplant Patients Treated with FCR001


Low rate of COVID-19 infection observed in vaccinated, durably chimeric patients off immunosuppression No evidence of acute kidney injury or impaired renal function in FCR001-treated patients with COVID-19 infection No patients lost chimerism as a result of COVID-19 vaccination or infection Excerpt from the Press Release: BOSTON and LOUISVILLE, Ky., April 06, 2022 (GLOBE NEWSWIRE) — Talaris Therapeutics,…

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Therapeutic Solutions International Completes Purchase of FDA Phase III JadiCell Stem Cell Investigational New Drug Application from University of Miami


Transfer of Trial Sponsorship Final Major Milestone before Initiation of Lung Failure Pivotal Clinical Trial Excerpt from the Press Release: CEANSIDE, Calif.–(BUSINESS WIRE)–Therapeutic Solutions International announced today the execution of a purchase agreement covering sponsorship and leadership of the FDA cleared Phase III pivotal trial assessing JadiCell adult stem cells for treatment of COVID-19 associated…

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