Preliminary data showed Novavax's non-mRNA JN.1 COVID-19 vaccine induced lower frequency and severity of short-term side effects and impact on daily life compared with Pfizer-BioNTech mRNA vaccine Full results will be submitted for publication later this year GAITHERSBURG, Md., April 15, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced preliminary results from the SHIELD-Utah study (Study of Healthcare Workers and...Read more
Broader protection induced by combination of COVID adenovirus vaccine plus CiVax™ compared to 2-shot mRNA vaccination series PRINCETON, N.J., March 25, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today a publication describing the...Read more
Preclinical and Phase 1 data suggest that ratutrelvir can be used without ritonavir and may reduce the likelihood of COVID rebound and the risk of long COVID due to a longer treatment regimen Preparations are underway for FDA interactions and initiation of Phase 2 studies Data presentation to be provided at the Investor Event on March 31, 2025 at 10:00 AM ET NEWTOWN, Pa., March 25, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc....Read more
Long-lasting in vivo antibody production: DMAb levels remained stable for 72 weeks in all participants (n=24) who have reached that timepoint No anti-drug antibodies (ADA): no immune rejection of the DMAbs was detected across ~1,000 blood samples, unlike other gene-based antibody delivery approaches where ADA formation has been a challenge Well-tolerated: most common side effects were mild, temporary injection site reactions...Read more
BERWYN, Pa. / Mar 07, 2025 / Business Wire / Virpax Pharmaceuticals, Inc. (Nasdaq: VRPX) (“Virpax” or the “Company”), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and anti-viral barrier indications, is looking to use Molecular Envelope Technology (MET) or a similar technology to deliver a mRNA COVID vaccine. Virpax currently uses its...Read more
New in vitro neutralization data show continued, consistent neutralizing activity of PEMGARDA™ (pemivibart) against LP.8.1 Centers for Disease Control reports LP.8.1, XEC and KP.3.1.1 together constitute the majority of current national SARS-CoV-2 variants; current dominant variants are all susceptible to PEMGARDA Pemivibart antiviral activity remains within the range of expected assay variability since Omicron BA.2; affirms...Read more
Results of IMNN-101 Proof-of-Concept study demonstrate persistent immunogenicity in trial participants and further validate PlaCCine® technology IMNN-101 induced 2- to 4-fold increase in neutralizing antibody (NAb) titers from baseline through Week 4 IMNN-101 continues to show an acceptable safety profile LAWRENCEVILLE, N.J., Feb. 26, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on...Read more
NEW YORK, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that a nasal anti-CD3 (foralumab) preclinical study is nearing completion, and that foralumab could offer a novel and effective...Read more
FDA’s reasoning appears to center on a belief that COVID-19 treatment immunobridging analyses for a monoclonal antibody (mAb) must meet a standard of superior antiviral activity rather than equivalent antiviral activity to past, highly effective, previously authorized and now inactive COVID-19 mAbs in a bridging analysis of sVNA1 titer levels, otherwise the Agency is “unable to reasonably conclude that the known and potential benefits...Read more
The Company is withdrawing current submission based on FDA feedback related to shelf-life stability of a test component SALT LAKE CITY, Feb. 21, 2025 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that, following a collaborative and informative dialogue with the Food...Read more
KOSTAIVE represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials WALTHAM, Mass. & SAN DIEGO / Feb 14, 2025 / Business Wire / Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) and sa-mRNA pioneer Arcturus Therapeutics (Nasdaq: ARCT) today announced that the...Read more
Recruitment completed and all doses administered for VYD2311 ongoing Phase 1/2 clinical trial (40 subjects) evaluating 3 routes of administration Phase 1/2 clinical data for VYD2311 to date are positive for both safety and pharmacokinetics, and are supported by antiviral activity data from Invivyd's standard virologic assessments Pooled, blinded adverse events (AEs) to date are mild or moderate and thus far deemed unrelated to study...Read more
TOKYO / Jan 31, 2025 / Business Wire / Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan, President and Representative Director: Daikichiro Kobayashi) announced today that it has received approval for a partial amendment to the manufacturing and marketing approval of “KOSTAIVE® for Intramuscular Injection,” a self-amplifying mRNA vaccine for protection against COVID-19, to include domestic manufacturing sites in Japan. Meiji Seika...Read more
Treatment immunobridging analysis, routinely updated for contemporary SARS-CoV-2 variants, compares pemivibart antiviral titers to adintrevimab antiviral titers from the company’s previous Phase 2/3 clinical trial of adintrevimab for the treatment of COVID-19 (STAMP), in which adintrevimab conferred a 66% to 74% reduction in risk of hospitalization or death from COVID-19 compared to placebo depending on time of therapy start Most...Read more
The Agreement provides participating countries with the opportunity to diversify their mRNA COVID-19 vaccine supply and gain access to pre-filled syringe vaccine formats CAMBRIDGE, MA / ACCESS Newswire / January 24, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has been awarded a tender for the supply of its mRNA COVID-19 vaccine in the European Union (EU), Norway and North Macedonia. Under the resulting agreement, 17...Read more
COVID-19 Phase 2b study poised to initiate 10,000 participant portion of trial pending U.S. Food and Drug Administration (FDA) review of sentinel cohort 30-day safety data Norovirus program to proceed with Phase 1 study following scientific advisory board and FDA feedback; Trial to initiate the first half of 2025 with topline data expected as early as mid-2025 New avian influenza vaccine candidate being tested in preclinical...Read more
Independent Data Safety Monitoring Board (DSMB) recommends study to proceed without modifications based on initial safety assessment of 400 participant 30-day data The company plans to progress the trial to enrollment of 10,000 participants, upon favorable review from the U.S. Food and Drug Administration (FDA) and upon Biomedical Advanced Research and Development Authority (BARDA) approval SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025...Read more
Company continuing to work with the U.S. FDA on potential for accelerated approval pathway Novavax intends to partner on both candidates to advance to filing and commercialization GAITHERSBURG, Md., Dec. 10, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the first participants have been dosed in its COVID-19-Influenza...Read more
FORT LAUDERDALE, FL / ACCESSWIRE / December 9, 2024 / Sunshine Biopharma Inc. (NASDAQ:SBFM) (the "Company"), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals today announced that it has developed an orally active protease inhibitor with dose-dependent antiviral activity in mice infected with SARS Coronavirus (SARS-CoV-2). There are still unmet...Read more
MOVe-NOW will build on existing LAGEVRIO data to assess efficacy in the current COVID-19 environment and support applications for licensure RAHWAY, N.J. & MIAMI / Dec 05, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of the Phase 3 MOVe-NOW clinical trial to evaluate LAGEVRIOTM (molnupiravir), an investigational oral antiviral COVID-19 medicine, for...Read more
SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced completion of enrollment of the sentinel cohort of a Phase 2b clinical trial evaluating Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA vaccine comparator. The sentinel cohort comprised of 400 participants, with 200 receiving Vaxart’s COVID-19 vaccine candidate and 200 receiving an approved mRNA vaccine...Read more
GEO-CM04S1 Improved Immune Response vs mRNA Vaccine ATLANTA, Nov. 19, 2024 (GLOBE NEWSWIRE) -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the completion of an interim data review by the Data Safety Monitoring Board (DSMB) for the ongoing Phase 2 clinical trial of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19...Read more
CANOPY manuscript preprint includes six-month off-drug follow-up period that highlighted strong protection by pemivibart versus placebo in the immunocompetent Cohort B during KP.3 and KP.3.1.1 dominant wave CANOPY exploratory clinical efficacy data, to date, reconfirm a high level of risk reduction from developing symptomatic COVID-19 in immunocompetent participants Preprint describes Invivyd scientists’ novel method for predicting...Read more
GAITHERSBURG, Md., Nov. 11, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The FDA has cleared the Company to begin...Read more
Study results demonstrate the safety and feasibility of adoptive immunotherapy using allogeneic off-the-shelf NK cells in hospitalized patients with COVID at high risk for progression of disease DVX201, the first allogeneic NK cell therapy derived from pooled donor cord blood CD34+ cells, was administered to 9 patients with no dose limiting toxicities, cytokine release syndrome or infusion toxicities WEXFORD, Pa., Nov. 7, 2024...Read more
Following strong protection (84% relative risk reduction versus placebo) demonstrated through month 6 with pemivibart, CANOPY clinical trial participants were followed for an additional six-month period (months 7-12), with no additional doses, to assess safety and efficacy as drug concentrations declined over time In the six-month off-drug follow-up period (months 7-12), substantially reduced concentrations of PEMGARDA reduced the risk...Read more
GAITHERSBURG, Md., Oct. 16, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The clinical hold is due to a...Read more
GAITHERSBURG, Md., Oct. 9, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the European Commission granted Marketing Authorization for Novavax's updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2705), dispersion for injection, for use in individuals aged 12 and older for the prevention of COVID-19 in...Read more
400 subject sentinel portion of Phase 2b study will evaluate the safety, immunogenicity and efficacy of Vaxart’s next generation oral pill COVID-19 vaccine compared to an approved mRNA vaccine comparator The sentinel cohort is being funded as part of the Phase 2b NextGen COVID-19 clinical trial, valued at up to $456 million through the Rapid Response Partnership Vehicle under the U.S. government’s Project NextGen SOUTH...Read more
Head-to-head data, presented at OPTIONS XII for the Control of Influenza Conference, demonstrates advantage of sa-mRNA over conventional mRNA in duration of immune response; Results highlight CSL and Arcturus Therapeutics' commitment to advancing COVID-19 vaccine innovation to protect public health. WALTHAM, Mass. and SAN DIEGO, Sept. 30, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and self-amplifying...Read more
Ratutrelvir was well-tolerated for 10 days and achieved consistent plasma levels in the predicted therapeutic window, without the need for co-administration of ritonavir Phase 2a study expected to begin in H1 2025 in patients with COVID Improving COVID care is an ongoing need, with approximately 50,000 US deaths in 2023 NEWTOWN, Pa., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or...Read more
Independent evaluation of KP.3.1.1 and LB.1 variants shows in vitro pseudovirus neutralization potency of PEMGARDA in-line with prior variants tested Proprietary, ongoing SARS-CoV-2 spike analyses demonstrate consistent structural stability of the pemivibart binding site to date, which has routinely predicted sustained pemivibart in vitro neutralization activity Potential emerging variants, such as XEC and LP.1, encode mutations that...Read more
Upon authorization by the European Commission, the Omicron KP.2-adapted COVID-19 vaccine will be available for individuals 6 months of age and older Data demonstrate that the Omicron KP.2-adapted COVID-19 vaccine generates a substantially improved response against multiple circulating Omicron JN.1 sublineages as did the Omicron JN.1-adapted COVID-19 vaccine authorized by the European Commission in July 2024 Doses will be ready to...Read more
SPIKEVAX® is the first updated COVID-19 vaccine authorized in Canada for 2024-2025, offering a timely solution to help protect Canadians this fall and winter season. Moderna will promptly begin delivery of updated COVID-19 vaccines to the Public Health Agency of Canada, so there is robust supply available in time for provincial and territorial vaccination campaigns. CAMBRIDGE, MA / ACCESSWIRE / September 17, 2024 / Moderna Inc...Read more
Doses of Novavax's 2024-2025 Formula COVID-19 vaccine now available at thousands of locations nationwide Novavax's updated vaccine is the only protein-based option available in the U.S. this fall for individuals aged 12 and older GAITHERSBURG, Md., Sept. 13, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that doses of the Novavax...Read more
Approval underscores CSL and Arcturus Therapeutics’ commitment to delivering disruptive technologies to combat COVID-19 and other respiratory viral diseases to protect public health KOSTAIVE®, the world’s first self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, was approved for adults 18 years of age and older in November 2023 The updated sa-mRNA COVID-19 vaccine is tailored to protect against the JN.1 lineage of Omicron...Read more
BOSTON, Sept. 13, 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 the outcome of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, versus placebo for the treatment of COVID-19. The trial did not meet...Read more
OCALA, Fla., Sept. 11, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”) today announced that an analysis of the complete clinical patient data from the AMP-518 clinical trial supported the Company’s belief in Ampligen as a potential therapeutic for people with the moderate-to-severe Post-COVID condition of fatigue, and that this would be the likely subject population for AIM’s planned follow-up clinical...Read more
Partnership funded by BARDA and other US government agencies TFF formulation may provide flexibility of delivery and improve storage and distribution conditions FORT WORTH, Texas, Sept. 11, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc (Nasdaq: TFFP) (the “Company” or “TFF Pharmaceuticals”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin...Read more
Moderna's updated COVID-19 mRNA vaccine will be available for the 2024-2025 vaccination season, pending a European Commission authorization decision CAMBRIDGE, MA / ACCESSWIRE / September 5, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for an updated formulation of...Read more
Current Test Positivity Rate for Coronavirus Infection in the U.S. is 18% Development of a novel antiviral compound, XR8-23 (Compound 10), targeting SARS-CoV-2 papain-like protease (PLpro) with both submicromolar potency and animal model efficacy XR8-23 (Compound 10) showed significant drug accumulation in lung of mice and favorable pharmacokinetic properties Research was conducted in collaboration with the University of...Read more
Approval follows recommendation from global public health bodies to develop JN.1 COVID-19 vaccines At present, the JN.1 group of subvariants remain dominant in the UK The updated vaccine will be available for eligible groups as part of the NHS autumn vaccination program, and will also be available to purchase privately in the UK for the first time CAMBRIDGE, MA / ACCESSWIRE / September 3, 2024 / Moderna, Inc. (Nasdaq:MRNA) today...Read more
Authorization expands use of bezisterim in a Phase 2, placebo-controlled, multicenter trial assessing bezisterim’s impact on neurological symptoms associated with long COVID Key milestone reached ahead of schedule, with BioVie on track to receive additional $12.6 million of award from the U.S. Department of Defense and initiate the Phase 2 trial Recent Centers for Disease Control and Prevention survey estimated over 5% of U.S. adults...Read more
New pseudovirus in vitro neutralization data show continued neutralizing activity of PEMGARDA™ (pemivibart) against KP.3.1.1, LB.1, and other SARS-CoV-2 variants tested Center for Disease Control reports KP.3.1.1 is the only major variant increasing in proportionality nationally Variants confirmed as susceptible to pemivibart in independent analyses contain key Q493E, s31del, and other mutations that are prominent in circulating...Read more
CAMBRIDGE, MA / ACCESSWIRE / September 2, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the Taiwan Food & Drug Administration (FDA) has approved an updated formulation of the COVID-19 mRNA vaccine Spikevax, targeting the SARS-CoV-2 variant JN.1., for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older. In April 2024, the World Health Organization (WHO) Technical Advisory...Read more
Novavax expects pre-filled syringes will be broadly available in thousands of locations across the U.S. Novavax's vaccine is the only protein-based option available in the U.S. for use in individuals aged 12 and older to prevent COVID-19 GAITHERSBURG, Md., Aug. 30, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced the Novavax...Read more
LA JOLLA, Calif., Aug. 29, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), announces that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application, which covers MN-166 (ibudilast) for post-COVID conditions. The Method of...Read more
In all-comer cohort of immunocompetent individuals at risk of contracting symptomatic COVID-19 in their everyday social interactions, participants receiving pemivibart experienced a 1.9% rate of confirmed symptomatic COVID-19 compared to an 11.9% rate for participants receiving placebo, an 84% relative risk reduction (nominal p= 0.000061) In immunocompromised participants, pemivibart demonstrated a rate of 3% of confirmed symptomatic...Read more
CAMBRIDGE, MA / ACCESSWIRE / August 23, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for a partial change application for an updated formulation of its COVID-19 mRNA vaccine Spikevax, targeting the SARS-CoV-2 variant JN.1. "We appreciate the Ministry of Health, Labour and Welfare approval decision for our updated COVID-19 mRNA vaccine,"...Read more
The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older The KP.2 adaptation is based on FDA guidance, which stated that KP.2 is the preferred strain for COVID-19 vaccines for the US 2024-2025 fall and winter season, if feasible Shipping will begin immediately to ensure robust supply and rapid access of this season’s vaccine in...Read more
Spikevax 2024-2025 formula expected to be available in pharmacies and care settings across the U.S. in the days immediately following approval CAMBRIDGE, MA / ACCESSWIRE / AUGUST 22, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax® (2024-2025 formula) for individuals 12 years and above. Emergency Use...Read more
In a Phase 3 trial, Pfizer and BioNTech’s combination vaccine candidate against influenza and COVID-19 met one of its two primary immunogenicity objectives The trial did not meet one of its primary immunogenicity objectives of non-inferiority against the influenza B strain despite obtaining higher influenza A responses and comparable COVID-19 responses versus the comparator vaccines The companies are evaluating adjustments to the...Read more
Fibromyalgia is a “diagnosable condition” in people suffering from Long COVID according to NASEM1 Diagnosing fibromyalgia in Long COVID patients is expected to expand the potential addressable market for Tonmya relative to pre-COVID-19 pandemic estimates2 Tonmya is a potential new first-line non-opioid analgesic under development for the management of fibromyalgia with Fast Track designation: NDA submission target is second half of...Read more
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
Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...
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