Clinical Development, Government, Immune Response and Trials

Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

NOVEMBER 30, 2020

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.

Clinical Development

Clinical Development Vaccine Clinical Trials Immune Response

Sanofi, GSK launch early trial for COVID-19 vaccine

The Pharma Data

SEPTEMBER 2, 2020

. Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. The vaccine candidate, developed in partnership by the firms, is based on the recombinant protein-based technology used in Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology.

Vaccine

Vaccine Trials Immune Response Clinical Trials

Europe: Where is the drug discovery innovation?

Drug Discovery World

MAY 6, 2024

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. The city is host to many innovative biotech companies, including relative newcomers Orexa, a company that recently launched its first Phase II clinical trial.

Drugs

Drugs Science Molecular Biology Clinical Trials

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

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 analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Regeneron Pharmaceuticals, Inc.

Hospitals

Hospitals Trials Clinical Trials Production

Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA

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. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant.

Vaccine

Vaccine FDA Clinical Trials Immune Response

Women in Stem with Dr Christine Schuberth-Wagner

Drug Target Review

APRIL 3, 2024

Our research demonstrated that GDF-15 acts as a versatile tool for tumours to inhibit the mounting of an effective antitumoral immune response at various steps of its process, including antigen presentation, immune cell activation, and their migration and infiltration into the tumour. in North America) in late 2017.

Science

Science Clinical Development DNA Treatment

Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population

The Pharma Data

MARCH 29, 2022

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 1-3 Evusheld was generally well-tolerated in the trial. 1-3 Evusheld was generally well-tolerated in the trial.

Vaccine

Vaccine Virus Immune Response Government

ImmunityBio’s hAd5 T-Cell COVID-19 Vaccine Candidate Shows Complete Protection of Airways in Non-Human Primates

The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates. link] 1. About ImmunityBio.

Vaccine

Vaccine Immune Response Virus Clinical Trials

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

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. Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4

Virus

Virus Trials Clinical Trials Production

Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

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.

Vaccine

Vaccine Trials Clinical Trials Therapies

Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

The Pharma Data

SEPTEMBER 9, 2020

“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”. “As About the Phase 2/3 Study. billion doses by the end of 2021.

Vaccine

Vaccine Clinical Trials Trials Government

Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19

The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. All trial participants will continue to be monitored to assess long-term protection and safety for an additional two years after their second dose. government’s Operation Warp Speed program goal to deliver doses of a vaccine for COVID-19. immediately.

Vaccine

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PFIZER AND BIONTECH ANNOUNCE COLLABORATION WITH BIOVAC TO MANUFACTURE AND DISTRIBUTE COVID-19 VACCINE DOSES WITHIN AFRICA

The Pharma Data

JULY 21, 2021

The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with global governments as well as global health partners with the aim to provide 2 billion doses to low and middle income countries in 2021 and 2022 – 1 billion each year.

Vaccine

Vaccine Clinical Trials Licensing Licensing

Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19

The Pharma Data

AUGUST 20, 2020

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. T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication.

Vaccine

Vaccine Clinical Trials Trials Immune Response

Pfizer and BioNTech to Provide COVID-19 Vaccine Doses for Olympic Athletes at the 2020 Tokyo Games

The Pharma Data

MAY 6, 2021

Under the MoU framework, NOCs and their local governments are expected to coordinate the administration of vaccinations to eligible Games participants. Doses provided under this MoU would be in addition to doses provided under supply agreements with governments worldwide.

Vaccine

Vaccine Clinical Trials Licensing Licensing

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

The Pharma Data

MAY 7, 2021

Government,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.

Licensing

Licensing Licensing Vaccine FDA Approval

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

DECEMBER 17, 2020

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. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

Hospitals

Hospitals Production Clinical Trials Virus

Biopharma Leaders Unite To Stand With Science

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

Science

Science Vaccine Clinical Trials Pharmaceutical Companies

Biopharma Leaders Unite To Stand With Science

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. About AstraZeneca. AstraZeneca.

Science

Science Vaccine Clinical Trials Pharmaceutical Companies

The Year Ahead: 2023 Trends Shaping Diagnostics & Life Sciences

PerkinElmer

JANUARY 25, 2023

To help make more timely and informed clinical candidate decisions going forward, scientists need to be able to securely, intuitively, and quickly find, analyze and share critical discovery-stage data, as well as do reliable predictive analysis. These same challenges and needs also extend from research and discovery to clinical development.

Science

Science Laboratories Immune Response Disease

Pfizer and BioNTech Announce Data from Preclinical Studies of mRNA-based Vaccine Candidate Against COVID-19

The Pharma Data

SEPTEMBER 9, 2020

producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN? The study is an event-driven trial. Argentina and Brazil.

Vaccine

Vaccine RNA Clinical Trials Immune Response

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

Therapies

Therapies Trials Disease Treatment

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

SEPTEMBER 15, 2020

Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. In the blinded data presented, 50% of trial participants received placebo and 50% received BNT162b2. Protease Inhibitor Program.

Vaccine

Vaccine Therapies Trials Clinical Trials

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

The Pharma Data

OCTOBER 14, 2020

(Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. About TNX-1800.

Vaccine

Vaccine Pharmaceuticals Small Molecule Virus

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

The Pharma Data

AUGUST 11, 2020

The safety profiles of Opdivo and chemotherapy in this trial are reflective of the known safety profiles of Opdivo and chemotherapy in first-line gastric and esophageal cancers. The company remains blinded to data from this arm and the trial continues in follow-up to allow the data to mature. PRINCETON, N.J.–( About Opdivo.

Treatment

Treatment Trials Therapies Clinical Trials

Transgene Announces Detailed Results From Clinical Study of TG4001 in Combination With Avelumab in Advanced HPV-positive Cancers

The Pharma Data

OCTOBER 26, 2020

The purpose of this exploratory Phase 1b/2 trial was to evaluate the safety and efficacy of the combination of TG4001 and an immune checkpoint inhibitor in a heterogeneous group of patients with aggressive, recurrent and/or metastatic HPV16-positive cancers. Key findings of the trial: .

Vaccine

Vaccine Virus Trials Treatment

Drug Discovery Digest

Novavax Announces COVID-19 Vaccine Clinical Development Progress

Sanofi, GSK launch early trial for COVID-19 vaccine

Trending Sources

Europe: Where is the drug discovery innovation?

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA

Women in Stem with Dr Christine Schuberth-Wagner

Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population

ImmunityBio’s hAd5 T-Cell COVID-19 Vaccine Candidate Shows Complete Protection of Airways in Non-Human Primates

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19

PFIZER AND BIONTECH ANNOUNCE COLLABORATION WITH BIOVAC TO MANUFACTURE AND DISTRIBUTE COVID-19 VACCINE DOSES WITHIN AFRICA

Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19

Pfizer and BioNTech to Provide COVID-19 Vaccine Doses for Olympic Athletes at the 2020 Tokyo Games

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

Biopharma Leaders Unite To Stand With Science

Biopharma Leaders Unite To Stand With Science

The Year Ahead: 2023 Trends Shaping Diagnostics & Life Sciences

Pfizer and BioNTech Announce Data from Preclinical Studies of mRNA-based Vaccine Candidate Against COVID-19

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

CheckMate -649, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Chemotherapy vs. Chemotherapy, Meets Primary Endpoints Demonstrating Superior Overall Survival and Progression-Free Survival in First-Line Treatment of Gastric and Esophageal Cancers

Transgene Announces Detailed Results From Clinical Study of TG4001 in Combination With Avelumab in Advanced HPV-positive Cancers

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