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The companies today reported findings on one secondary objective from the Phase 2a study, showing a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. About Molnupiravir.
This new monoclonal antibody therapy is designed to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV) in neonates and infants born during or entering their first RSV season. Key results from the CLEVER trial include: A 60.5% Octavio Ramilo, Chair of the Department of Infectious Diseases at St.
Grifols’ BT524 Fibrinogen Therapy Shows Promise in Phase 3 Trial Published in The Lancet’s eClinicalMedicine Grifols , a globally recognized healthcare company and a leader in the production of plasma-derived therapies, has marked a significant advancement in the treatment of acquired fibrinogen deficiency (AFD).
Johnson & Johnson (J&J) announced that it has restarted all clinical trials in Europe evaluating its COVID-19 vaccine, Ad26.COV2.S, S, following a pause last month to investigate an adverse event. Source link.
Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36
Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.
Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial.
Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.
Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. The full set of results will be published once the complete Phase 1/2a trial data are available.
Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.
Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.
EMERYVILLE, Calif. and CHENGDU, China , Feb.
The gene therapy demonstrated that it increased Factor IX (“FIX”) plasma levels at 6 months, the original primary endpoint of the Phase 3 trial. This was despite the 6-month data also demonstrating clinical benefits in reduction of bleeding events and declines in the use of FIX replacement therapy.
.–(BUSINESS WIRE) December 5, 2020 — Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, today announced new clinical data from its Phase 2 trial evaluating SY-1425, its first-in-class selective retinoic acid receptor alpha (RAR?)
Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. and Roche will develop, manufacture and distribute it outside the U.S. .
Medicago received approval from Canadian and US regulatory authorities to proceed with enrolment of healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results. “We The Phase 2 portion of the trial is approaching completion and results are expected to be made publicly available in April 2021.
As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. There were no serious adverse safety events.
Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. Furthermore, in clinical trials, even though the number of thrombotic events was small, these were lower in the vaccinated group.
efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. “These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. All cases observed in the vaccine group were mild as defined by the trial protocol.
Member States will be provided with regular delivery schedules, and capped rebates will apply in the event of any delayed doses. In clinical trials, Vaxzevria demonstrated 100% efficacy against severe disease and hospitalisation after two doses. To date, AstraZeneca and its partners have supplied more than 1.1
Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. Data from the event-driven trial could support global authorization and approval, including in the U.S. and globally.”. About NVX-CoV2373. and Australia. billion from the U.S. government.
The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.
Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine.
In addition to the single-dose regimen ENSEMBLE study, Janssen has now initiated the two-dose regimen ENSEMBLE 2 trial. The ENSEMBLE and ENSEMBLE 2 trials will run in parallel. These statements are based on current expectations of future events. PHASE 3 ENSEMBLE 2 STUDY. Source: Johnson & Johnson . Posted: November 2020.
Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from a rolling review of trial data from the primary analysis of the Phase III programme led by the University of Oxford.
Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from a rolling review of trial data from the primary analysis of the Phase III programme led by the University of Oxford.
from Janssen Vaccines and Prevention in Leiden, Netherlands, and colleagues conducted a phase 1-2a trial involving healthy adults ages 18 to 55 years (cohort 1) and 65 years or older (cohort 3). Fever was the most frequent systemic adverse event. Jerald Sadoff, M.D., Participants were randomly assigned to receive Ad26.COV2.S
This regimen was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose. We would like to thank our many colleagues at AstraZeneca, Oxford University, the UK government and the tens of thousands of clinical trial participants.”.
Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.
11, 2020 — More than 15 million Americans have been infected by the COVID-19 virus, and many may be questioning whether they need to receive one of the two coronavirus vaccines now on the verge of approval from U.S. The trials included some people who had already been infected. FRIDAY, Dec. regulators. Short answer: Yes.
30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified.
The large number of ongoing clinical trials of recombinant AAV (rAAV)-based therapies highlights their promise for addressing a wide variety of human genetic disorders. Adeno-associated virus as a delivery vector for gene therapy of human diseases. Adeno-associated virus-based gene therapy for lifelong correction of genetic disease.
NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. In the initial 275 patients, rates of adverse events (AEs) were similar among groups.
Canadian biopharmaceutical company Medicago has announced that its investigational COVID-19 vaccine generated “significant antibody and cellular immune responses” after two doses in all subjects in an early-stage clinical trial. Based on the promising phase 1 data, the company plans to proceed with a phase 2/3 clinical trial. “We
Moleculin recently announced that the FDA had allowed its request for Investigational New Drug (IND) status for Annamycin, allowing Moleculin to begin a Phase 1B /2 clinical trial in the US for patients with soft tissue sarcoma (STS) that has metastasized to the lungs after first-line therapy for their disease. .
S, prevented severe clinical disease in Syrian golden hamsters, upon challenge with SARS-CoV-2, the virus that causes COVID-19 in people. Four weeks later, the animals were exposed to a high dose of SARS-CoV-2 virus. These statements are based on current expectations of future events. Source link.
21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,
2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7). After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body. 3,4,5,6,7). United Nations.
Hasan Jafri , Chief Medical Officer of Aridis Pharmaceuticals, will be a speaker on a panel entitled “Direct Antivirals and Other Agents Against SARS-CoV2 Virus.” ” Panel: Direct Antivirals and Other Agents Against SARS-CoV2 Virus
Date: Wednesday, October 28, 2020
Time: 10:30AM- 11:50AM ET.
Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.
. “In collaboration with our partner, Novartis, our team continues to move at extraordinary speed from idea to bench to clinical trials, driven by a common desire to help patients against this devastating disease and help bring the world back closer to normalcy.” About Molecular Partners’ anti-COVID-19 program.
INCHEON, South Korea–( BUSINESS WIRE )– Celltrion Group today announced top-line results from its randomised, double-blind, and placebo controlled global Phase II/III clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. days compared to placebo [6.6 days; 95% C.I, reported with placebo.
He also hears about a trial in the US to test whether prayer can help Covid patients in intensive care. We know from the dark days of the peak of the pandemic that religious settings hosted some of the super-spreading events that fed the transmission of infection: weddings, funerals and even choirs.
As an antiviral drug, Veklury works to stop replication of SARS-CoV-2, the virus that causes COVID-19. reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against COVID-19. to 2.48; p=0.017).
With the COVID-19 pandemic this year redacting the world into a state of panic, TLC aspired to make a difference, and investigated the idea of encapsulating hydroxychloroquine, which has shown antiviral effects toward the SARS-CoV-2 virus, into TLC’s proprietary liposome formulation, using only ~1% of the oral dosage needed. Source link.
Phase 1 trial for the BNT162b2 vaccine candidate, which at 30 ?g The companies are continuing to analyze data from the Phase 1 trials in the U.S. The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials. and Germany.
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