Codon

JANUARY 21, 2024

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Why are challenge trials becoming more popular?

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Quanticate

JUNE 16, 2020

The leading cause of death in patients with coronavirus disease 2019 (COVID-19), caused by the virus ‘severe acute respiratory syndrome coronavirus 2’ (SARS‑CoV‑2), is respiratory failure from acute respiratory distress syndrome. [1]

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The Pharma Data

OCTOBER 28, 2020

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

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The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

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The Pharma Data

JANUARY 31, 2021

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.

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The Pharma Data

APRIL 3, 2021

The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.

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The Pharma Data

JANUARY 17, 2021

The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. BARCELONA, Spain , Jan. 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P,

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Drug Target Review

OCTOBER 26, 2023

1 Adeno-associated virus (AAV) vectors are the leading platform for in vivo gene delivery for the treatment of various human diseases. It has been well established that exposure to wild-type AAV results in priming of the immune system against the virus. Adeno-associated virus vector as a platform for gene therapy delivery.

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Drug Discovery World

AUGUST 14, 2023

These advanced therapies are revolutionising treatment options and opening new avenues for targeted and individualised healthcare, offering tremendous promise to patients worldwide, including those living with life-threatening or debilitating diseases. Despite this step, there remain divergent views on other regulatory aspects.

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The Pharma Data

OCTOBER 19, 2020

New Guidance: The FDA issued and implemented new guidance, Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. The assay targets on coronavirus-specific nanobodies and tests affinity and efficacy to prevent the virus infection. .

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The Pharma Data

SEPTEMBER 12, 2020

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.

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The Pharma Data

JANUARY 11, 2021

In clinical trials, it could detect COVID-19 with 90%+ accuracy in about two minutes. . By the end of January, Johnson & Johnson is expected to deliver preliminary trial results for its one-dose COVID-19 vaccine candidate. . DalCor Pharmaceuticals initiated the Phase II dal-COVID trial of dalcetrapib for COVID-19.

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis).

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The Pharma Data

NOVEMBER 13, 2020

Centers for Disease Control and Prevention analysis finds. The death toll of 207,500 in 2019 was 50% higher than just three years earlier, The New York Times reported. No measles deaths were reported in the United States in 2019, but the country had the highest number of cases since 1992.

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The Pharma Data

MARCH 25, 2021

TAK-003 is Being Studied for the Prevention of Dengue Due to any Dengue Virus Serotype in Individuals Ages Four to 60. With limited options to prevent the disease, there is a pressing need for widely available dengue vaccines. About TAK-003. 4,5 Efficacy varied by serotype.

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The Pharma Data

MARCH 14, 2023

Based on our clinical trial results, we are hopeful that QDENGA could have a positive impact on the incidence of symptomatic dengue in Brazil, including dengue cases that require hospitalization. The TIDES trial met its primary endpoint of overall vaccine efficacy (VE) by preventing 80.2% 2 In 2022 Brazil saw more than 1.4

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The Pharma Data

FEBRUARY 24, 2022

Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) today announced that Health Canada has granted approval for COVIFENZ®, COVID-19 vaccine, (plant-based virus-like particles [VLP], recombinant, adjuvanted). This vaccine is indicated for active immunization to prevent coronavirus disease 2019 (COVID?19)

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The Pharma Data

AUGUST 16, 2021

Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable. We continuously strive to stay at least one step ahead of the virus. adult participants from the Phase 1 trial of the two-dose series.

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Drug Discovery World

FEBRUARY 3, 2023

A research group from the National Institutes of Health has successfully developed a vaccine against Sudan virus (SUDV) based on the licensed Ebola virus (EBOV) vaccine. SUDV, identified in 1976, is one of the four viruses known to cause human Ebolavirus disease.

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The Pharma Data

JANUARY 3, 2021

InspirMed is a newly established subsidiary of TLC specializing in the development of inhalable liposome formulation programs, such as TLC19 for the treatment of Coronavirus disease 2019 (COVID-19) as well as other programs for severe acute and chronic pulmonary diseases. Cautionary Note on Forward-Looking Statements.

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PLOS: DNA Science

OCTOBER 12, 2023

In the final chapter of my 2012 book The Forever Fix: Gene Therapy and the Boy Who Saved It , I predicted that the technology would soon expand well beyond the rare disease world. Gene therapy clearly hasn’t had a major impact on health care, offering extremely expensive treatments for a few individuals with rare diseases.

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The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and around the world.

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PerkinElmer

FEBRUARY 28, 2022

In early 2019, no one could have predicted that a novel coronavirus would sweep around the globe and cause one of the most significant health crises of recent times. Fast-forward to today, and thousands of scientists have turned their attention to studying SARS-CoV-2, the virus responsible for the current COVID-19 pandemic.

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The Pharma Data

SEPTEMBER 17, 2020

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. 3 Knowing a given population’s seroprevalence is important in understanding how to contain the spread of the virus, as well as how to safely ease lockdown restrictions.

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The Pharma Data

NOVEMBER 9, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. GAITHERSBURG, Md., 09, 2020 (GLOBE NEWSWIRE) — Novavax, Inc.

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The Pharma Data

NOVEMBER 1, 2020

Highly innovative first-in-class study for treating COVID-19 disease with nasally administered drug. Trial facilitated with coll a boration of Harvard Medical School and one of the world’s top Neurologist, Dr. Howard Weiner. The clinical data from this trial is expected to available by the end of this year.

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The Pharma Data

DECEMBER 16, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced an Advance Purchase Agreement with the government of New Zealand for the purchase of 10.7 NVX-CoV2373 is being evaluated in an ongoing Phase 3 trial in the U.K. GAITHERSBURG, Md., About NVX-CoV2373.

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The Pharma Data

NOVEMBER 30, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. 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.

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The Pharma Data

OCTOBER 30, 2020

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.

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The Pharma Data

DECEMBER 10, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. Chief Medical Officer and Co-founder of BioNTech. There were no COVID-19 related deaths.

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The Pharma Data

SEPTEMBER 1, 2020

This can help healthcare professionals identify a SARS-CoV-2 infection in people suspected to carry the virus with results typically ready in 15 minutes. Roche has an ongoing clinical trial program evaluating the role of Actemra©/RoActemra© (tocilizumab) in COVID-19 pneumonia.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2). i,ii,iii,iv.

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The Pharma Data

JANUARY 12, 2021

“Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D. . Have chronic kidney disease. Have diabetes.

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The Pharma Data

JUNE 24, 2021

“This is a meaningful moment for adolescents, parents and entire families who are seeking protection from this virus and a return to normalcy,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We The EU decision is based on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years.

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The Pharma Data

SEPTEMBER 26, 2021

With MS, finding the proper treatment option is the maximum amount about managing the clinical aspects of the disease because it is about how treatment fits into a person’s life,” said Simon Faissner, M.D., Food and Drug Administration in October 2019 and is currently the amount one prescribed oral MS therapy within the country.

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The Pharma Data

NOVEMBER 29, 2020

Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease. Antiviral therapies are used to help control disease, but they are limited by toxicity and the emergence of viral resistance.

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The Pharma Data

NOVEMBER 5, 2020

billion versus third quarter 2019 (4). billion versus third quarter 2019. billion versus third quarter 2019. REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints. TARRYTOWN, N.Y. , 5, 2020 /PRNewswire/ — Third quarter 2020 revenues increased 32% to $2.29 Schleifer , M.D.,

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