Infection

Direct Relief Donating 60 Million KN95 Masks to Combat Covid-19 Across the Americas

Retrieved on: 
Wednesday, January 19, 2022 - 9:47pm

The donations are coming from a purchase of 89 million masks by Direct Relief, among the largest single PPE purchases by a charitable nonprofit.

Key Points: 
  • The donations are coming from a purchase of 89 million masks by Direct Relief, among the largest single PPE purchases by a charitable nonprofit.
  • Direct Relief has built strong working relationships across Latin America with national health ministries, multilateral organizations and local health organizations.
  • In total, Direct Relief has helped ship more than 12 million Covid-19 vaccine doses to the Americas.
  • Direct Relief is also reserving 10 million masks for US safety-net health facilities, including Federally Qualified Health Centers and Free and Charitable Clinics .

DGAP-News: Mainz Biomed Engages DCN Dx to Support Clinical Study Evaluating Novel mRNA Biomarkers for Potential Integration into ColoAlert

Retrieved on: 
Wednesday, January 19, 2022 - 8:23pm

Under the terms of the engagement, DCN Dx will be responsible for the selection of additional clinical research organizations (CRO) and assist Mainz's management with the development of robust study protocols and associated clinical processes.

Key Points: 
  • Under the terms of the engagement, DCN Dx will be responsible for the selection of additional clinical research organizations (CRO) and assist Mainz's management with the development of robust study protocols and associated clinical processes.
  • Emily brings to the project over 20 years of clinical research experience as a scientist and executive.
  • Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates.
  • DCN Dx provides end-to-end support for rapid diagnostic test development and production in an array of applications.

Sorrento Announces Completion of Enrollment in US Phase 2 Clinical Trial for COVI-DROPS and Achievement of Interim Analysis Threshold in the UK

Retrieved on: 
Wednesday, January 19, 2022 - 3:35pm

Key secondary endpoints included the proportion of subjects with medically-attended visits or hospitalizations and the change from baseline in the WHO Clinical Progression Scale score.

Key Points: 
  • Key secondary endpoints included the proportion of subjects with medically-attended visits or hospitalizations and the change from baseline in the WHO Clinical Progression Scale score.
  • Additionally, Sorrento is pleased to announce that the UK Phase 2 study ( www.ClinicalTrials.gov NCT04900428) of intranasal COVI-DROPS treatment in COVID-19 outpatients who are asymptomatic or have mild symptoms has reached the interim analysis threshold of 50% enrollment (n=175).
  • We anticipate reporting on the results from both the US trial and the interim analysis of the UK trial in the coming months.
  • RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients.

Virginia Nonprofit Funds Transportation & Medication-Assisted Treatment for Patients Taking Part in Opioid Addiction Treatment Programs

Retrieved on: 
Wednesday, January 19, 2022 - 3:30pm

To help combat opioids deathly grip, the Albertus Project is partnering with West Virginia Comprehensive Treatment Centers (CTCs), which includes seven comprehensive treatment centers and opioid use disorder programs in West Virginia.

Key Points: 
  • To help combat opioids deathly grip, the Albertus Project is partnering with West Virginia Comprehensive Treatment Centers (CTCs), which includes seven comprehensive treatment centers and opioid use disorder programs in West Virginia.
  • The Albertus Project will fund a patients initial transportation to one of the treatment centers to obtain therapy and medication-assisted treatment (MAT).
  • The sooner a patient comes to one of our treatment centers, the more likely they are to achieve successful recovery from opioid addiction.
  • West Virginia Comprehensive Treatment Centers provide patients with multiple therapeutic interventions to complement the use of prescription medications in treating opioid use disorder.

AeroClean to Demonstrate Safe Air Technology at AHR Expo 2022

Retrieved on: 
Wednesday, January 19, 2022 - 1:30pm

PALM BEACH GARDENS, Fla., Jan. 19, 2022 (GLOBE NEWSWIRE) -- AeroClean Technologies (Nasdaq: AERC) will attend the 2022 International Air-Conditioning, Heating and Refrigerating ("AHR") Expo, taking place Jan. 31 through Feb. 2, 2022 in Las Vegas.

Key Points: 
  • PALM BEACH GARDENS, Fla., Jan. 19, 2022 (GLOBE NEWSWIRE) -- AeroClean Technologies (Nasdaq: AERC) will attend the 2022 International Air-Conditioning, Heating and Refrigerating ("AHR") Expo, taking place Jan. 31 through Feb. 2, 2022 in Las Vegas.
  • AeroClean plans to launch Prgo Lift in the first half of 2022.
  • The AHR Expo provides a unique forum where manufacturers of all sizes and specialties come together to share ideas and showcase the future of HVACR technology.
  • About AeroClean Technologies: AeroClean is a pathogen elimination technology company on a mission to keep work, play and life going with continuous air sanitization products called Prgo (pure-go).

Recce Pharmaceuticals Announces Positive Safety Data from Second Cohort of Phase I Clinical Trial Evaluating Healthy Subjects Intravenously Dosed with RECCE® 327

Retrieved on: 
Wednesday, January 19, 2022 - 1:00pm

SYDNEY, Australia, Jan. 19, 2022 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) (the Company), the company developing new classes of synthetic anti-infectives, is pleased to report further positive data from its Phase I intravenous (IV) clinical trial of RECCE® 327 (R327), demonstrating safety and tolerability among seven healthy male subjects in cohort two. Based upon these clinical data readouts, an Independent Safety Committee has approved a tenfold increase from the initial dosing of cohort one (50mg) and a threefold increase from cohort two (from 150mg to 500mg) among 7-10 healthy subjects (cohort three). Subjects are expected to be recruited this week and dosed immediately thereafter at Adelaide’s CMAX clinical trial facility.

Key Points: 
  • Subjects are expected to be recruited this week and dosed immediately thereafter at Adelaides CMAX clinical trial facility.
  • We are pleased to see R327 (150mg) was successfully tolerated as an intravenous infusion in cohort two subjects, said James Graham, Chief Executive Officer of Recce Pharmaceuticals.
  • The Phase I trial is an ascending dose, randomized, placebo-controlled, parallel, double-blind, single-dose study being conducted at Adelaide's CMAX clinical trial facility.
  • RECCE 327 is not yet market approved for use in humans with further clinical testing required to fully evaluate safety and efficacy.

Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19

Retrieved on: 
Wednesday, January 19, 2022 - 2:02am

The Studys expansion into Turkey complements the Companys global commercialization plan for Bucillamine as a potential treatment for mild to moderate COVID-19.

Key Points: 
  • The Studys expansion into Turkey complements the Companys global commercialization plan for Bucillamine as a potential treatment for mild to moderate COVID-19.
  • Also, the Company is preparing its regulatory package for submission to the FDA and international regulatory authorities for drug approvals thereafter.
  • Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19.
  • With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.

Spero Therapeutics Awarded up to an Additional $12.9 Million by BARDA to Support the Development of Orally Administered Tebipenem Pivoxil in Pediatric Patients

Retrieved on: 
Wednesday, January 19, 2022 - 1:05pm

BARDA added, and exercised, a new option on the contract originally awarded to Spero in 2018.

Key Points: 
  • BARDA added, and exercised, a new option on the contract originally awarded to Spero in 2018.
  • Theadditional $12.9Moption is expected to provide support for a clinical trial and related activities for orally administered tebipenem pivoxils use in treating pediatric patients with cUTI, including AP.
  • We are pleased to expand our relationship with BARDA and look forward to continuing our productive collaboration, said Ankit Mahadevia, M.D., Chief Executive Officer ofSpero Therapeutics.
  • However, while Spero may elect to update these forward-looking statements at somepoint in the future, it specifically disclaims any obligation to do so.

ADMA Biologics Announces Record Preliminary Fourth Quarter and Full Year 2021 Revenues and Provides 2022 Business Update

Retrieved on: 
Wednesday, January 19, 2022 - 12:00pm

RAMSEY, N.J. and BOCA RATON, Fla., Jan. 19, 2022 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced its preliminary unaudited fourth quarter and full year 2021 revenues. The Company also provided commercial updates for its immune globulin product portfolio as well as 2022 business updates.

Key Points: 
  • The Company also provided commercial updates for its immune globulin product portfolio as well as 2022 business updates.
  • Based on preliminary unaudited financial information, ADMA expects record fourth quarter 2021 revenues of approximately $26 million, compared to $14 million during the fourth quarter of 2020, reflecting an approximately 86% increase.
  • The preliminary results for the fourth quarter of 2021 represent the Companys highest quarterly revenue since its inception.
  • We believe ADMA enters 2022 from a position of strength, and the Company looks forward to continued execution as it enters the next phase of its profit-oriented business cycle.

Valneva’s Inactivated COVID-19 Vaccine Candidate Shown to Neutralize Omicron Variant

Retrieved on: 
Wednesday, January 19, 2022 - 5:20pm

100% of tested serum samples presented neutralizing antibodies against the ancestral virus and Delta variant, and 87% against the Omicron variant

Key Points: 
  • 100% of tested serum samples presented neutralizing antibodies against the ancestral virus and Delta variant, and 87% against the Omicron variant
    Saint Herblain (France), January 19, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced results from an initial laboratory study demonstrating that serum antibodies induced by three doses of Valnevas inactivated COVID-19 vaccine candidate, VLA2001, neutralize the Omicron variant.
  • All 30 samples (100%) presented neutralizing antibodies against the ancestral virus and Delta variant, and 26 samples (87%) presented neutralizing antibodies against the Omicron variant.
  • The mean fold reduction of neutralization relative to the ancestral virus was 2.7-fold for Delta and 16.7-fold for Omicron.
  • VLA2001 is produced on Valnevas established Vero-cell platform, leveraging the manufacturing technology for Valnevas licensed Japanese encephalitis vaccine, IXIARO.