The Pharma Data

JUNE 25, 2021

(Nasdaq: NVAX), today announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. 94.6), achieving its primary endpoint. Government.”

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Delveinsight

JANUARY 5, 2021

SCONE Medical Solutions Inc. The idea is to provide protection to healthcare workers taking care of infected patients during Aerosol Generating Procedures (AGPs), particularly in the acute care/triage setting. While secondary endpoints did manage to improve from baseline but were not statistically significant versus control.

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Cloudbyz

APRIL 6, 2023

eCOA Platforms: eCOA platforms allow for the capture of clinical outcomes electronically, including clinical assessments, quality of life measures, and other clinical endpoints. Ensure Data Security Data security is critical in clinical trials to protect patient privacy and prevent data breaches.

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The Pharma Data

JUNE 18, 2021

Aubagio was initially approved in the EU in 2013 for the treatment of adult patients with RRMS and the EC approval for the pediatric indication provides an additional year of marketing protection in the European Union. This decreased study power for the primary endpoint. Aubagio Efficacy and Safety in Pediatric Patients. 0.37, 0.87

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The Pharma Data

JUNE 7, 2023

As scientists, we have been trying to find a solution for over 60 years. I am proud to have been part of the innovation that has resulted in a vaccine now being available to help protect eligible older adults across Europe from severe RSV disease for the first time.” In addition, efficacy was 94.6% (95% CI, 65.9–99.9,

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The Pharma Data

MARCH 24, 2021

The primary endpoint, vaccine efficacy at preventing symptomatic COVID-19 was 76% (confidence interval (CI): 68% to 82%) occurring 15 days or more after receiving two doses given four weeks apart. A key secondary endpoint, preventing severe or critical disease and hospitalisation, demonstrated 100% efficacy. BARDA, ASPR, HHS.

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XTalks

SEPTEMBER 5, 2023

Maria Reyes Boceta-Muñoz Clinical Operations Head of Development R&D GSK Spain, Portugal & Israel Boceta-Muñoz will be serving as the Chairperson for the Xtalks Vaccine Development Peer Circle , a high-level community of professionals focused on finding collaborative solutions to shared challenges in vaccine research.

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Delveinsight

JANUARY 28, 2021

Nirogy plans to use the proceeds to improve its drug discovery platform for generating a pipeline of small-molecule drugs designed to aim the solute carrier family of transporter proteins (SLCTs) embedded in the cell membrane. Gut Bacteria proffer insight into molecules protective against asthma and COVID-19. Nirogy Therapeutics Inc.,

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The Pharma Data

JANUARY 29, 2021

January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints.

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Clinical Trial Podcast

FEBRUARY 23, 2021

Once all patients have completed their primary endpoint visit and the data has been cleaned, the final step is to lock the database. Life revolves around designing a trial that meets the primary endpoint. Along the same lines, the success of any clinical trial is determined on whether or not it meets a pre-specified primary endpoint.

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The Pharma Data

SEPTEMBER 1, 2021

The primary endpoints of the trial include percentage of participants with COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14, percentage of participants with an adverse event and percentage of participants who discontinued study intervention due to an adverse event. Source link: [link].

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Cloudbyz

APRIL 8, 2024

By closely monitoring adverse events and protocol deviations, action can be taken promptly to protect patient well-being. Endpoint assessments Monitor for endpoint assessments to ensure that they are conducted according to the protocol, and that data is collected accurately and consistently.

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The Pharma Data

MARCH 22, 2021

The 2,400 mg and 1,200 mg doses tested in the phase III study had similar efficacy across all endpoints. Casirivimab and imdevimab also met all key secondary endpoints in the phase III REGN-COV 2067 trial, including the ability to reduce symptom duration from 14 to 10 days (median numbers).

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The Pharma Data

APRIL 25, 2021

Nirsevimab demonstrate d protect ion against respiratory syncytial virus disease in healthy infants in Phase 3 trial. Nirsevimab is being investigated as a first-in-class single dose immunization to provide protection for all infants entering their first RSV season. 1 – 5.

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The Pharma Data

MARCH 2, 2021

We believe our COVID-19 vaccine candidate has the potential to help change the trajectory of the pandemic and stand ready to make it available to protect the public as soon as possible.”. We are confident our COVID-19 vaccine candidate will have a significant impact in protecting people around the world,” said Mathai Mammen, M.D.,

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The Pharma Data

MARCH 2, 2021

This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

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The Pharma Data

SEPTEMBER 1, 2020

Point of care testing increases access to high quality diagnostics solutions for the detection of a current SARS-CoV-2 infection, regardless of laboratory testing infrastructure or patient mobility. All trademarks used or mentioned in this release are protected by law. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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The Pharma Data

JULY 21, 2021

Just as there are a multitude of factors and causes behind racial disparities in health and education, there is no single solution to this critical challenge. Each organization will bring its own expertise and resources to design and implement enduring solutions in these areas.

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The Pharma Data

FEBRUARY 18, 2022

In the mid- to long-term, the best way to address health emergencies and reach universal health coverage is to significantly increase the capacity of all regions to manufacture the health products they need, with equitable access as their primary endpoint.”.

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The Pharma Data

DECEMBER 21, 2020

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. ,

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Cloudbyz

JUNE 1, 2023

It’s a powerful tool for both administrators and developers to create tailored solutions for their unique business processes. This ensures sensitive information is protected even if a malicious actor is able to gain access to the physical hardware on which the data is stored.

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XTalks

FEBRUARY 5, 2024

Price of Opdivo: An intravenous solution (10 mg/mL) is around $1,297 for a supply of 4 mL. In a chronic phase CML study comprising 186 enrolled patients (one of the trials that led to the FDA approval), the findings demonstrated efficacy in the primary endpoint. Price of Somatuline: Somatuline Depot subcutaneous solution (60 mg/0.2

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Delveinsight

DECEMBER 10, 2020

The paper includes the detail that protection against the symptomatic disease after at least one standard dose was 64%. The treatment also increased FIX activity to an average of 37.2%, up from less than 2% at the beginning of the trial, meeting its primary endpoint. and Brazil, the efficacy of two doses of the vaccine was 70%.

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The Pharma Data

NOVEMBER 9, 2020

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.

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XTalks

JULY 13, 2021

They also talked about leveraging critical to quality factors to create focused indicators of quality that can be used to identify and manage risks to support robust decision-making while protecting patients. This includes details around IT security and data protection, and who has the responsibility to ensure that data is fit for purpose.

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The Pharma Data

JULY 21, 2021

Lyme disease continues to be a major concern and is prevalent in children 1 , it is therefore extremely important for us to potentially offer a vaccine that could protect both adults and children as rapidly as we can. Vaccinees receive VLA15 at a dose of 180µg, which was selected based on data generated in the two previous Phase 2 studies.

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The Pharma Data

JANUARY 5, 2021

RAD011 is a pivotal-trial ready synthetic cannabidiol oral solution with potential utilization in multiple endocrine and metabolic orphan diseases. s (“Benuvia”) synthetic cannabidiol oral solution (“RAD011”). Acquisition and associated PWS trial costs to be funded from existing operations.

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WCG Clinical

JULY 17, 2023

Now, we’ll look at some solutions. We know that protocols developed with the insights of a patient advisory board had simpler protocols and more targeted designs, including: a 30% reduction in clinical endpoints, 20% fewer inclusion/exclusion criteria and a 50% reduction in the amount of data collected.

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The Pharma Data

MARCH 26, 2021

Results of the interim analysis, based on data from 583 patients enrolled in the trial, demonstrated an 85% (p=0.002) reduction in hospitalisation or death in those receiving VIR-7831 compared to placebo, the primary endpoint of the trial. The interim analysis included 291 patients in the treatment arm and 292 patients in the placebo arm.

Antibody 52

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XTalks

FEBRUARY 5, 2024

Price of Opdivo: An intravenous solution (10 mg/mL) is around $1,297 for a supply of 4 mL. In a chronic phase CML study comprising 186 enrolled patients (one of the trials that led to the FDA approval), the findings demonstrated efficacy in the primary endpoint. Price of Somatuline: Somatuline Depot subcutaneous solution (60 mg/0.2

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The Pharma Data

JULY 29, 2021

The clinical effect of treatment with lecanemab was assessed via the adjusted mean change of the AD Composite Score (ADCOMS), the primary clinical endpoint of the core study. Additional clinical endpoints included Clinical Dementia Rating-Sum of Boxes (CDR-SB) and AD Assessment Scale – Cognitive Subscale (ADAS-Cog).

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The Pharma Data

SEPTEMBER 16, 2020

The primary endpoint for the Phase 1 study is safety, and key secondary endpoints include objective response rate (assessed every six weeks), duration of response and progression-free survival. Patients were enrolled in four dose cohorts: 180 mg, 360 mg, 720 mg and 960 mg, taken orally once a day.

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The Pharma Data

DECEMBER 11, 2020

All trial participants will continue to be monitored to assess long-term protection and safety for an additional two years after their second dose. Secondary endpoints include prevention of severe COVID-19 in those groups. The Pfizer BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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XTalks

FEBRUARY 6, 2024

Dr. Srivastava discusses the significant advancements made toward 24-hour urine collections for endpoint protection, where lab parameters can quickly identify potentially inappropriate 24-hour collections for medical monitor evaluation, thus ensuring the integrity of study results.

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Advarra

JUNE 16, 2022

Do you need endpoint adjudication? . More than a list of sites, Advarra’s SiteIQ solution provides detailed site performance metrics synthesized from actual completed studies, providing performance metrics and insights. . Now is the time to thoroughly consider all the potential tasks and associated fees required.

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Drug Discovery World

AUGUST 4, 2022

Failure of a late-stage batch represents not only the cost of the material, but lost time under patent protection and the possibility of missing the window for introduction of a first-in-class product. New solutions have been introduced, or are under development, to help manufacturers rapidly obtain data with more confidence.

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The Pharma Data

MAY 7, 2021

Results of the interim analysis, based on data from 583 randomised patients, demonstrated an 85% (p=0.002) reduction in hospitalisations over 24 hours or deaths in those receiving sotrovimab compared to placebo, the primary endpoint of the trial. Among those studied, 63% were Hispanic or Latinx and 7% were Black or African American.

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