TORONTO, April 23, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics and diagnostics for infectious diseases, medical countermeasures, and rare disorders, announced today that the U.S. Food & Drug Administration (“FDA”) has granted the Company’s Type C meeting request for the evaluation of a proposed... Read more
CAMBRIDGE, MA / ACCESSWIRE / April 22, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced a contract with the Ministry of Health in Brazil (Ministério da Saúde) to supply its mRNA COVID-19 vaccine as an integral part of Brazil's 2024 national vaccination campaign against COVID-19. This contract follows the Brazilian Health Regulatory Agency's (ANVISA) approval of Moderna's COVID-19 vaccine in March 2024, which encodes the spike protein of the XBB.1.5 sublineage of SARS-CoV-2... Read more
TORONTO, April 18, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R), a specialty life sciences company focused on the research and development of therapeutics and diagnostics for infectious diseases, medical countermeasures, and rare disorders, announced today that the U.S. Food & Drug Administration (“FDA”) has accepted the Company’s meeting request for the Revive LC POC Lateral Flow... Read more
Presentation Made During the 24th Annual World Vaccine Congress ATLANTA, GA, April 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that its Chief Scientific Officer, Mark Newman, PhD, presented data on GEO-CM04S1, the Company’s next-generation Covid-19 vaccine candidate, during the 24th Annual World Vaccine... Read more
Test Delivers on Company Commitment to Advance the Power of Diagnostics to Empower Patients with Rapid Results in Just 10 Minutes
Savanna® RVP4+ Assay Research and Development Update SAN DIEGO / Apr 02, 2024 / Business Wire / QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho" or the “Company”) has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its QuickVue COVID-19 test. This clearance allows the test to be used with accuracy and... Read more
GAITHERSBURG, Md., April 1, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, will showcase continued progress on data from its updated COVID-19 vaccine (NVX-CoV2601) and provide an overview of its influenza and COVID-19-Influenza Combination (CIC) vaccine candidates at the World Vaccine Congress 2024 (WVC) in Washington, DC, April 2 to 4, 2024.
New data from Novavax's... Read more
TORONTO, March 27, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced today that it has submitted a Type C meeting request package to the U.S. Food & Drug Administration (“FDA”) for the evaluation of a proposed clinical study of Bucillamine, an oral... Read more
Enrollment Reached Over 2,200 High-Risk Patients in Bemnifosbuvir Monotherapy Cohort
Results from SUNRISE-3 Expected in 2H’24 BOSTON, March 27, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that the company has completed enrollment of the global Phase 3 SUNRISE-3 trial evaluating... Read more
mRNA-1283 induced a more robust immune response compared to Spikevax® COVID-19 vaccine, mRNA-1273.222
Next-generation mRNA vaccine design offers the potential of longer shelf life and storage advantages, and paves the way for combination vaccine against influenza and COVID-19, mRNA-1083 CAMBRIDGE, MA / ACCESSWIRE / March 26, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that mRNA-1283, the Company's next-generation COVID-19 vaccine, has successfully met the... Read more
Analysis of secondary endpoint of symptomatic COVID-19 events in CANOPY is unrelated to regulatory filing or review, but may be hypothesis generating for future Invivyd discovery and development work
Today’s update on Day 67 and Day 90 event rates is the first of two planned public updates on symptomatic COVID-19 events in CANOPY; Invivyd plans to analyze all future events at Day 180
Further defining the relationship between serum virus neutralizing antibody titers... Read more
PEMGARDA (pemivibart) is authorized in the U.S. for PrEP of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise
Emergency use authorization based on positive immunobridging data and on safety data from the CANOPY clinical trial along with ongoing in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1
PEMGARDA is the first PrEP monoclonal antibody (mAb) to receive EUA from the U.S. FDA based on a novel, rapid,... Read more
TORONTO, March 19, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced today that the FDA advised the Company to submit a Type C meeting request to discuss evaluating a proposed Phase 2 clinical study of Bucillamine, an oral thiol-based drug with anti-inflammatory... Read more
British Medical Journal Open publishes paper detailing the results of the international Phase II human trial for LSALT peptide targeting acute lung and kidney inflammation in hospitalized patients infected with SARS-CoV-2 virus
Phase II findings previously disclosed support dipeptidase-1 (DPEP-1) as a relevant therapeutic target for diseases of the lung, kidneys and liver where inflammation plays a major role.
New biomarker data from the pandemic Phase II trial, provides... Read more
Veklury Was Associated With a Lower Risk of Developing Long-COVID in One Analysis
Veklury Was Associated With a Reduced Risk of Mortality Among People Who Are Immunocompromised in a Separate Analysis FOSTER CITY, Calif. / Mar 05, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from three real-world retrospective studies being presented at the 31st Conference on Retroviruses and Opportunistic Infections (CROI). One study... Read more
Murine Study by the Wistar Institute Builds Upon Favorable Results Previously Reported by IMUNON With its Prototype PlaCCine Vaccine Modality LAWRENCEVILLE, N.J., Feb. 29, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces positive results from a live virus challenge study conducted for IMUNON by the Wistar Institute with... Read more
First Medicinal chemistry of an antiviral drug made of sugars BOSTON, MASSACHUSETTS, Feb. 21, 2024 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (OTCQB: BIXT), (the “Company”), a clinical stage biotechnology company developing oral and intravenous drugs to treat viral diseases, announced that the first patients have been treated with ProLectin-M in its dose optimization trial. ProLectin-M is intended to become a first line treatment for standard risk COVID-19 patients,... Read more
EMERYVILLE, Calif., Feb. 12, 2024 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced that it is now preparing to launch the Phase 2b head-to-head trial of its next-generation COVID-19 vaccine in the Fall of 2024 rather than 1Q24. This is to allow use of fully GMP-grade raw materials in the vaccine, which is expected to increase the regulatory utility of the... Read more
Efficacy results offer preliminary evidence that Ampligen may reduce fatigue in subjects with Post-COVID conditions
Safety results show Ampligen is generally well tolerated in the treatment of Post-COVID Conditions OCALA, Fla., Feb. 08, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced positive topline results from the Company’s Phase 2 study evaluating the efficacy and safety of Ampligen®... Read more
Results Demonstrate Potential Protective Immunity Against Multiple SARS-CoV-2 Variants ATLANTA, GA, Feb. 06, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced positive initial safety and immune response findings from its Phase 2 clinical trial at one month following administration of its Covid-19 vaccine,... Read more
Study conducted by Meiji Seika Pharma in Japan
Short communication follows previously published data in The Lancet Infectious Diseases demonstrating Immunological Non-Inferiority to Wuhan Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster
New data demonstrates continuous advantage of sa-mRNA over conventional mRNA vaccine in terms of duration of immune response
These results follow approval... Read more
TORONTO, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced today its initiative in Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties, as a potential treatment for long COVID. The Company aims to advance the clinical... Read more
Retrospective observational study of electronic medical records of more than 90 million people living in the U.S.
Long COVID shares symptoms with chronic overlapping pain disorders like fibromyalgia and appears mechanistically related
Tonix is studying TNX-102 SL for both the management of fibromyalgia and management of fibromyalgia-type Long COVID. CHATHAM, N.J., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company),... Read more
Project NextGen Collaboration will Support Capricor’s StealthX™ Exosome Platform and Provide Non-Dilutive Support for Advancement into the Clinic SAN DIEGO, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, today announced that Capricor’s proprietary StealthX™ exosome-based multivalent vaccine (StealthX™... Read more
Placebo-Controlled Clinical Proof of Concept Data Expected in Mid-2024
Targeting Initiation of IMC-2 Phase 2 program in 2H 2024 ATLANTA, Jan. 22, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”) and Long-COVID (“LC”), today announced plans... Read more
Head-to-head comparison with licensed bivalent mRNA-based comparator vaccine confirms competitive immune responses at lower doses and favorable tolerability profile
Monovalent mRNA vaccine candidate, CV0601, encoding Omicron BA.4-5 variant and bivalent candidate, CV0701, encoding Omicron BA.4-5 variant as well as the original SARS-CoV-2 virus, successfully boosted antibody titers and were generally well tolerated across all tested dose levels TÜBINGEN, GERMANY and... Read more
EUA submission is based on positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial and ongoing in vitro neutralization activity against relevant SARS-CoV-2 variants
VYD222 demonstrates continued in vitro neutralization activity against major SARS-CoV-2 variants, including JN.1, currently the fastest growing variant in the U.S.
Company continues preparations for potential commercial launch if EUA is granted WALTHAM, Mass., Jan. 03, 2024 (GLOBE... Read more
ATLANTA, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on developing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”) and Long-COVID (“LC”), today announced receipt of the Food and Drug Administration’s (“FDA”) feedback on requirements for advancing IMC-2 (combination of valacyclovir + celecoxib)... Read more
The Company's Emergency Use Authorization submission is for the new Co-Dx PCR Pro instrument and COVID-19 test kit, designed for point-of-care and at-home. The menu of tests in development for the platform includes TB, HPV, and a multiplex respiratory panel for flu A/B, COVID-19, and RSV SALT LAKE CITY, Dec. 27, 2023 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for... Read more
Study conducted by Meiji Seika Pharma in Japan
Data follow approval of the world's first self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine for adults by Japan Ministry of Health, Labor and Welfare
The randomized, double-blind, active-controlled study, conducted at 11 sites in Japan, was designed to compare the immunogenicity and tolerability of the sa-mRNA vaccine ARCT-154 with Comirnaty®
Phase 3 Study published in The Lancet Infectious Diseases KING... Read more
LONDON, Dec. 21, 2023 /PRNewswire/ -- Virax Biolabs Group Limited (NASDAQ: VRAX) ("Virax" or the "Company"), an innovative biotechnology company focused on the detection of immune responses and diagnosis of viral diseases, today announced a strategic collaboration with the University of Manchester and the Northern Care Alliance Foundation Trust, who have a track record in working together to deliver translational immunology research for respiratory viral infections.... Read more
ATLANTA, GA, Dec. 19, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it has amended a previously executed Patent and Biological Materials License Agreement (the “License Agreement”) with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), in support... Read more
Novavax's updated vaccine will be available at vaccination centers across Taiwan GAITHERSBURG, Md., Dec. 18, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the Taiwan Food and Drug Administration has granted emergency use authorization for Nuvaxovid™ XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) for active immunization... Read more
VYD222 produced high serum virus neutralizing antibody titer levels in immunocompromised participants
Data supportive of an immunobridging approach to the EVADE study of adintrevimab
Overall favorable safety and tolerability profile of VYD222 including no study drug-related serious adverse events (SAEs) to date
VYD222 demonstrates continued in-vitro neutralization activity against major SARS-CoV-2 variants, including against HV.1, the currently dominant variant in... Read more
WOBURN, Mass., Dec. 12, 2023 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) reported the recent presentation of data from a clinical trial of Quell wearable neuromodulation technology in patients with post-acute COVID-19 syndrome (PACS), commonly called Long COVID. The presentation was made at the National Science Foundation (NSF) funded Center to Stream Healthcare In Place (C2SHIP) annual meeting in Washington DC. The trial was conducted at the Baylor College of... Read more
CAMBRIDGE, MA / ACCESSWIRE / December 12, 2023 / Moderna, Inc. (NASDAQ:MRNA) today announced changes to its operating model to bring focus to its short- and long-term business goals.
The Company is focused on driving continued sales of its COVID-19 vaccine and launching its RSV vaccine in 2024, while also preparing to launch multiple products per year from 2025 forward. The Company has decided to increase executive focus on driving sales of Spikevax and the expected launch... Read more
Novavax's updated protein-based non-mRNA COVID-19 vaccine will be available in Canada for individuals aged 12 and older in the coming days GAITHERSBURG, Md., Dec. 5, 2023 /CNW/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that Health Canada has granted expanded authorization for Nuvaxovid™ XBB.1.5 Vaccine (Recombinant protein, Adjuvanted) (NVX-CoV2601) for active immunization to... Read more
The new non-dilutive external funding, additional to the previously announced U.S. Government non-dilutive funding, now covers the entirety of the RHB-107 (upamostat)[1] arm of the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment
This additional funding amounts to approximately $4.8M directed towards evaluation of RHB-107 in the PROTECT study
In addition to the platform's Master Protocol, the 300-patient Phase 2 RHB-107 arm has... Read more
Exclusive Partner in Japan, Meiji Seika Pharma advances regulatory approval
This historic approval of the world's first Self-Amplifying messenger RNA (sa-mRNA) COVID-19 Vaccine underscores CSL's promise to develop and deliver innovations when there is a public health need
First marketing approval milestone for CSL and Arcturus Therapeutics since closing the Global Collaboration and Licensing agreement in 2022
With the approval of ARCT-154, CSL now offers an even... Read more
GAITHERSBURG, Md., Nov. 28, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that Nuvaxovid™ XBB.1.5 COVID-19 Vaccine (NVX-CoV2601) has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for active immunization to prevent COVID-19 in individuals aged 12 and older. The EUL assists WHO member states in assessing vaccines with the aim... Read more
Presentation of Data from Phase 2 Open-Label Study of GEO-CM04S1
Next-Generation COVID-19 Vaccine Demonstrates Potent Antibody and Cellular Immunity in Immunocompromised Patients ATLANTA, GA, Nov. 28, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the presentation of data from the active development... Read more
No severe adverse events reported to date
Topline data expected as early as Q1 2024 OCALA, Fla., Nov. 21, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the last subject has completed treatment in the Company’s Phase 2 study evaluating Ampligen® as a potential therapeutic for people with the Post-COVID condition of fatigue (“AMP-518”).
AIM Chief Executive Officer Thomas K. Equels commented,... Read more
SHELTON, CT / ACCESSWIRE / November 14, 2023 / NanoViricides, Inc. (AMEX:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reports that its broad-spectrum antiviral drug candidate, NV-387 was highly effective in an animal model that is used in drug development for MPox and Smallpox virus infections in humans.
NV-387 is currently in Phase 1a/1b human clinical trials for COVID-19 indication... Read more
Potential world-first patented biomarker for long COVID
Evaluating diagnostic companion with Bucillamine for long COVID TORONTO, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, newly-formed subsidiary, Revive Diagnostics Inc., today announced that it... Read more
COVID-19 Phase 2 clinical trial fully enrolled Study compares mono- and bivalent vaccine candidates against licensed comparator COVID-19 vaccine First participant dosed in seasonal flu Phase 2 part of combined Phase 1/2 study Study compares a potentially differentiated, multivalent vaccine candidate with broad antigen coverage against licensed comparator vaccine TÜBINGEN, GERMAN and BOSTON, MA / ACCESSWIRE / November 1, 2023 / CureVac N.V. (NASDAQ:CVAC)... Read more
Novavax's updated COVID-19 vaccine is the only updated protein-based non-mRNA COVID-19 vaccine available in the European Union for individuals aged 12 and older
Novavax is working closely with EU member states to bring its updated COVID-19 vaccine to those that have requested doses through the advance purchase agreement GAITHERSBURG, Md., Oct. 31, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™... Read more
Designed to Protect Immunocompromised Patients Against Severe COVID-19 ATLANTA, GA, Oct. 30, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it has commenced the planned site expansion for the Phase 2 clinical trial investigating its next-generation SARS-CoV-2 vaccine, GEO-CM04S1, as a primary vaccine in immun... Read more
PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / October 30,2023 / Biophytis SA (Nasdaq CM:BPTS) (Euronext Growth Paris:ALBPS), («Biophytis»), a clinical-stage biotechnology company specialized in the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, announces the signature of a partnership with Innovation Solutions Pharma, a company... Read more
Lead formulations evaluated in the Phase 1/2 study demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains
Safety profile of the mRNA-based combination vaccine candidates consistent with the companies’ COVID-19 vaccine
The companies plan to start a pivotal Phase 3 trial in the coming months NEW YORK & MAINZ, GERMANY / Oct 26, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive... Read more
mRNA-1083 is Moderna's first respiratory combination vaccine candidate to enter a Phase 3 trial
Phase 3 initiation follows data from a Phase 1/2 trial where mRNA-1083 showed strong immunogenicity against influenza and COVID-19, with an acceptable reactogenicity and safety profile, compared to licensed standalone vaccines
Company has multiple programs in Phase 3 development across several areas, including respiratory diseases, latent viruses, and oncology CAMBRIDGE,... Read more
Toronto, Ontario--(Newsfile Corp. - October 23, 2023) - Justera Health Ltd. (CSE: VTAL) (OTCQB: SCRSF) ("Justera" or the "Company") is actively evaluating the possibility of resuming its COVID-19 testing operations, driven by a surge in interest from the film and production industries.
As COVID-19 cases continue to surge, the film and production sector has exhibited an increasing demand for testing solutions to ensure the safety of their workforce.
The Public Health Agency... Read more
