Virios projects releasing top line results from this groundbreaking Proof of Concept study in October 2024 Published data indicates increased Epstein-Barr herpes virus in Long-COVID patients, highlighting potential for antiviral therapy to treat fatigue and other Long-COVID symptoms ATLANTA, July 23, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology...Read more
This study aims to enhance U.S. public health preparedness through Walgreens community pharmacy network, improving access and diversity in clinical trials via a $25m award DEERFIELD, Ill. / Jul 23, 2024 / Business Wire / Walgreens today announced it received a project award valued up to $25 million through the Rapid Response Partnership Vehicle (RRPV) to conduct a Phase IV observational clinical study focused on assessing Correlates of...Read more
CAMBRIDGE, MA AND OSAKA, JAPAN / ACCESSWIRE / July 8, 2024 / Moderna, Inc. (Nasdaq:MRNA) and Mitsubishi Tanabe Pharma Corporation today announced that the companies have entered into a joint agreement regarding the co-promotion of Moderna's mRNA respiratory vaccine portfolio in Japan, including Moderna's COVID-19 vaccine, Spikevax®. Under the agreement, Moderna will handle the manufacturing, sales, medical education and distribution of...Read more
Novavax's COVID-19 vaccine would be the only protein-based option available in Canada, if authorized Novavax's filing is aligned with NACI, U.S. FDA, EMA and WHO recommendations on vaccine composition GAITHERSBURG, Md., July 2, 2024 /CNW/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, announced that it has filed for authorization with Health Canada for its...Read more
The updated COVID-19 vaccine is tailored to the Omicron JN.1 lineage of SARS-CoV-2 and is recommended for individuals 6 months of age and older Recommendation is based on pre-clinical and epidemiological data showing that the JN.1-adapted monovalent COVID-19 vaccine generates an improved immune response against multiple JN.1 sublineages Doses will be ready to ship to applicable EU member states immediately upon authorization by the...Read more
Novavax's JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3 GAITHERSBURG, Md., June 24, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that it has filed for a type II variation of existing Marketing Authorization with the European Medicines Agency (EMA) for its JN.1 COVID-19 vaccine...Read more
Novavax's updated JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3 Novavax's JN.1 COVID-19 vaccine would be the only protein-based option available in the U.S. Novavax's filing is aligned with FDA, EMA and WHO global recommendations on vaccine composition Novavax intends to have its vaccine in pre-filled syringes available in the U.S. for immediate release post-authorization and following...Read more
10,000-subject Phase 2b study will evaluate Vaxart’s next generation oral pill COVID-19 vaccine against an approved mRNA vaccine comparator Vaxart anticipates initiating enrollment as early as summer 2024 SOUTH SAN FRANCISCO, Calif., June 13, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) announced today that it received a project award valued at up to $453 million through the Rapid Response Partnership Vehicle...Read more
mRNA-1283 met its primary vaccine efficacy endpoint in a Phase 3 trial, demonstrating non-inferior vaccine efficacy against COVID-19 compared to Spikevax® in participants 12 years of age and older Higher efficacy was observed in mRNA-1283 compared to Spikevax in adults 18 years of age and older CAMBRIDGE, MA / ACCESSWIRE / June 13, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that its Phase 3 trial of mRNA-1283, an...Read more
TORONTO, June 12, 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 an update on the Type C meeting written responses received by the Company from the U.S. Food & Drug...Read more
Pioneering partnership advances innovative health monitoring, setting the stage for future enterprise opportunities. PLEASANTON, Calif., June 10, 2024 /PRNewswire/ -- In a strategic move that could reshape the understanding of long COVID and chronic Lyme disease, the Massachusetts Institute of Technology (MIT) has forged a partnership with Movano Health for its MAESTRO study to harness the medical grade continuous health monitoring...Read more
TORONTO, June 10, 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 an update on the meeting written responses received by the Company from the U.S. Food & Drug Administration...Read more
mRNA-1083 met its primary endpoints, eliciting higher immune responses against influenza virus and SARS-CoV-2 than licensed flu and COVID vaccines in adults 50 years and older, including an enhanced influenza vaccine in adults 65 years and older CAMBRIDGE, MA / ACCESSWIRE / June 10, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that its Phase 3 trial of mRNA-1083, an investigational combination vaccine against influenza and...Read more
Manufacturing is underway and doses of Moderna's Spikevax 2024-2025 formula will be ready to ship as early as August, pending regulatory approval CAMBRIDGE, MA / ACCESSWIRE / June 7, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2024-2025 formula, targeting the SARS-CoV-2 variant JN.1. "For four years, Moderna has...Read more
Newly outlined pathway provides a practical, expedient, repeatable immunobridging approach to potential emergency use authorization of serial, novel monoclonal antibodies (mAbs) to prevent and treat COVID-19 Pathway provides for the establishment of a master, registrational clinical trial protocol that is anticipated to streamline the evaluation of new mAbs in compact clinical programs Utilizing this framework, Invivyd plans to...Read more
JENA, Germany, May 21, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, announced data presented at the American Thoracic Society (ATS) 2024 International Conference that is being held from May 17-22, 2024 in San Diego. InflaRx is presenting a poster at the thematic poster session at the ATS conference today from 11:30...Read more
Data follow the approval of the world's first self-amplifying (sa-mRNA) COVID-19 vaccine for adults in Japan. These results add to recently published data on ARCT-154 demonstrating superior immunogenicity to Omicron BA 4/5 compared to conventional mRNA COVID-19 vaccine booster and follow-up data demonstrating longer duration of immunity compared to traditional COVID-19 mRNA vaccine booster. KING OF PRUSSIA, Pa. and SAN DIEGO,...Read more
Proof-of-concept study for Imunon’s first vaccine utilizing its proprietary PlaCCine platform is now open for enrollment Topline results expected this year LAWRENCEVILLE, N.J., May 13, 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, today announced that DM Clinical Research in Philadelphia is the...Read more
Agreement provides individuals with broader access to a protein-based non-mRNA adjuvanted COVID-19 vaccine through combined commercial strength, from 2025 onwards Provides Novavax with cash and an equity investment totalling approximately $1.2 billion (upfront payment of $500 million and up to $700 million in additional development, regulatory and launch milestones), plus tiered royalties Novavax is entitled to additional launch and...Read more
Pathway leverages immunobridging approach via serum virus neutralizing antibody (sVNA) titers enabled by prior successful COVID-19 treatment clinical trial “STAMP” conducted with prototype antibody adintrevimab Company anticipates submitting a COVID-19 treatment EUA application for PEMGARDA™ (pemivibart) imminently COVID-19 treatment EUA pathway offers a novel, rapid pathway to potential second EUA for pemivibart Invivyd leaves 2024...Read more
IgG levels and neutralizing antibodies against variants of concern persisted for at least 12 months, consistent with previous findings Antigen-specific T cell responses increased in the majority of participants studied, including those living with HIV, after administration of any of the samRNA constructs Comprehensive data set demonstrates a consistent and strong immunogenicity profile across multiple patient populations...Read more
Increasing evidence supports a role for viral persistence, chronic inflammation and immune and metabolic dysregulation in driving long COVID Bezisterim, an anti-inflammatory and insulin-sensitizer that permeates the blood brain barrier, could represent a novel oral treatment targeting an underlying cause of long COVID symptoms CARSON CITY, Nev., April 29, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the...Read more
First patient enrolled in the global, 300-patient, Phase 2 adaptive platform trial arm of RHB-107 (upamostat)1 for early COVID-19 outpatient treatment, funded through non-dilutive external sources, including the U.S. Department of Defense The study is expected to be completed by the end of 2024 RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, including marked...Read more
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...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...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...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,...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...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,...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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)...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,...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...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...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)...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...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...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...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...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...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...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.,...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...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...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,...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...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:...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...Read more
Novavax's updated COVID-19 vaccine is now available at a wide range of retailers, including Costco, CVS Pharmacy, Giant, Publix, Rite Aid, Stop & Shop and Topco Novavax's vaccine is the only protein-based non-mRNA COVID-19 vaccine option in the U.S. Novavax's vaccine finder is available at us.novavaxcovidvaccine.com GAITHERSBURG, Md., Oct. 13, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company...Read more
VANCOUVER, British Columbia and BASEL, Switzerland, Oct. 12, 2023 (GLOBE NEWSWIRE) -- Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust and expansive lipid nanoparticle (LNP) patent portfolio, today announced the use of its LNP technology in Gritstone bio’s (Nasdaq: GRTS) self-amplifying mRNA (samRNA) vaccine candidate against COVID-19 in its CORAL program. Gritstone was recently awarded a...Read more
mRNA-1083 showed strong immunogenicity against influenza and COVID-19, with an acceptable reactogenicity and safety profile, compared to licensed standalone vaccines Company to begin Phase 3 trial of mRNA-1083 in adults 50 years and above CAMBRIDGE, MA / ACCESSWIRE / October 4, 2023 / Moderna, Inc. (NASDAQ:MRNA) today announced positive interim results from the Phase 1/2 trial of mRNA-1083, an investigational combination vaccine...Read more
In largest-of-its-kind clinical study on asymptomatic people, Cue demonstrated 99.4% accuracy compared to lab-based PCR SAN DIEGO / Oct 04, 2023 / Business Wire / Cue Health (Nasdaq: HLTH), a healthcare technology company, announced today the peer-reviewed publication of an independent clinical study - the largest of its kind on asymptomatic people - finding that Cue’s molecular COVID-19 test provides comparable accuracy to centralized...Read more
This Emergency Use Authorization and CDC recommendation makes Novavax's vaccine the only protein-based non-mRNA COVID vaccine option in the U.S. Novavax expects doses will be available in thousands of locations across the U.S. in the coming days, including CVS Pharmacy and Rite Aid Find Novavax's vaccine at us.novavaxcovidvaccine.com or vaccines.gov GAITHERSBURG, Md., Oct. 3, 2023 /CNW/ -- Novavax, Inc. (Nasdaq: NVAX), a...Read more
NIAID contract will support conducting nonclinical and clinical studies to advance ALG-097558 into future Phase 2/3 studies This is the second NIH-funding received to advance the development of ALG-097558 First in human Phase 1 study evaluating single/multiple doses of ALG-097558 in healthy volunteers is ongoing Aligos plans to continue to seek external funding to advance ALG-097558 beyond the ongoing Phase 1 first in...Read more
COMIRNATY Omicron XBB.1.5-adapted monovalent COVID-19 vaccine is now authorized in Canada for individuals 6 months of age and older New Omicron XBB.1.5-adapted COVID-19 vaccine is administered as a single dose for individuals 5 years of age and older, regardless of COVID-19 vaccination history. In children 6 months through 4 years of age the vaccine is administered as a three-dose series in those without a history of completion of a...Read more
WESTON, Fla. and ANN ARBOR, Mich., Sept. 27, 2023 /PRNewswire/ -- Cantex Pharmaceuticals, Inc., a clinical stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed, and Michigan Medicine, a part of the University of Michigan and one of the nation's leading academic medical centers, announced today the initiation of...Read more
BOTHELL, Wash., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), announces dosing of the first subjects in a Phase 1 clinical trial with its oral, first-in-class pan-norovirus and pan-coronavirus 3CL protease inhibitor CDI-988. This pan-viral protease inhibitor was discovered using the Company’s proprietary structure-based drug discovery platform technology. The Phase 1 study will...Read more
10,000 participant randomized Phase 2b study will evaluate Gritstone’s self-amplifying mRNA (samRNA) vaccine candidate containing Spike plus other viral targets with an approved vaccine against COVID-19 Contract is part of ‘Project NextGen,’ an initiative by the U.S. Department of Health and Human Services to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for...Read more
First clinical data from a pan-coronavirus vaccine candidate Elicited high and sustained neutralizing responses against a panel of COVID-19 variants, including Wuhan, Delta, Beta, Omicron BA.5, as well as multiple animal coronaviruses including bat and pangolin variants Durability of protective titers maintained through interim data point at six months – substantially more persistent compared to published durability of responses to a...Read more
SAN DIEGO / Sep 21, 2023 / Business Wire / QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted CLIA Waiver from the U.S. Food and Drug Administration (FDA), applying to its new Sofia® 2 SARS Antigen+ FIA. The Sofia 2 SARS Antigen+ FIA is the first rapid...Read more
This Positive Opinion Reinforces Veklury’s Strong Safety Profile FOSTER CITY, Calif. / Sep 19, 2023 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion for the use of Veklury® (remdesivir) to treat people with COVID-19 with mild to severe hepatic impairment. The European Commission (EC)...Read more
Late-breaking data presented at 9th ESWI Influenza Conference in Valencia SAN DIEGO / Sep 19, 2023 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced the results of a phase 1/2 study showing that...Read more
Data Published From Phase 2 Open-Label Study of GEO-CM04S1 ATLANTA, GA, Sept. 19, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing human vaccines and immunotherapies against infectious diseases and cancer, announced today the publication of data from the ongoing Phase 2 trial of its next-generation COVID-19 vaccine (GEO-CM04S1) in the journal Vaccines. The article,...Read more
Prompted by advice from FDA regarding study design, 60P Australia Pty Ltd, a majority-owned subsidiary of 60 Degrees Pharmaceuticals, has withdrawn its IND for ACLR8-LR, a Phase IIB study of the use of tafenoquine in treating COVID-19; Company plans to resubmit a revised IND later in 2023, pending a feasibility assessment 60P has paused further study start-up preparations related to ACLR8-LR, decreasing the Company’s short-term burn...Read more
The positive opinion follows the recommendation from regulators and global public health bodies to develop monovalent XBB.1.5 COVID-19 vaccines for autumn/winter 2023 vaccination campaigns Clinical trial data from research assay confirmed Moderna's updated COVID-19 vaccine showed an 8.7 to 11-fold increase in neutralizing antibodies against circulating variants, including BA.2.86, EG.5, and FL.1.5.1 variants CAMBRIDGE, MA /...Read more
DVX201, a first-ever allogeneic, cord-blood derived, natural killer (NK) cell therapy, has been administered to 16 patients with no dose limiting toxicities, cytokine release syndrome or infusion toxicities to date at all dose levels WEXFORD, Pa., Sept. 14, 2023 /PRNewswire/ -- Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for...Read more
Recursion Pharmaceuticals is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest....
CLICK TO LEARN MORE