Allergies, Immune Response, Licensing and Trials

Kaiser Permanente Joins Late-Stage Trial for Pfizer and BioNTech’s Lead COVID-19 Vaccine Candidate

XTalks

AUGUST 13, 2020

and BioNTech’s lead vaccine candidate in a Phase III trial being conducted at sites in California and Oregon. The company announced that it commenced the Phase III clinical trial to evaluate the investigational COVID-19 vaccine this week. Related: Pfizer and BioNTech’s COVID-19 Vaccine Shows Positive Early Trial Results.

Vaccination

Vaccination Vaccine Trials Clinical Trials

Biopharma Update on the Novel Coronavirus: October 27

The Pharma Data

OCTOBER 26, 2020

Novavax will present data from an ongoing Phase I/II clinical trial, including new Phase II reactogenicity data from its COVID-19 vaccine candidate. CoV2373 on Friday during the CDC’s Advisory Committee on Immunization Practices’ (ACIP) meeting. They expect to launch a Phase III trial of the drug in the first quarter of 2021. .

Antibody

Antibody Vaccination Vaccine Manufacturing

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design

Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. Emergency Use Authorization . has a fever.

Vaccination

Vaccination Vaccine Protein Immune Response

Unshackling TP53 in leukaemia with a novel combo; Merus receives funds for cancer research pact; Vera Therapeutics bags $80M; Gritstone appends COVID-19 to the pipeline.

Delveinsight

JANUARY 21, 2021

Vera Therapeutics bags USD 80 Million for trials. Vera Therapeutics has raised USD 80 million to take a drug licensed from Merck KGaA into a phase 2b kidney disease clinical trial. The drug, atacicept, has flunked multiple autoimmune clinical trials, but Vera contemplates that it is a prospect in IgA nephropathy.

Research

Research Protein Clinical Trials Clinical Trials

FDA Action Alert: Merck, Aurinia and Amgen

The Pharma Data

JANUARY 17, 2021

The NDA was built on data from the Phase III VICTORIA trial. The NDA was supported by results from two pivotal trials, Phase III AURORA and Phase II AURA-LV. By inhibiting calcineurin, the drug blocks IL-2 expression and T-cell mediated immune responses. HFrEF was formerly known as systolic heart failure.

Manufacturing

Manufacturing Immune Response Allergies Drugs

INOVIO Announces Publication of Phase 1 Data from its COVID-19 DNA Vaccine Candidate, INO-4800 in The Lancet’s EClinicalMedicine

The Pharma Data

DECEMBER 23, 2020

Joseph Kim , President and CEO of INOVIO, said, “We are very pleased to share peer-reviewed Phase 1 clinical data for INO-4800 published in The Lancet’s EClinicalMedicine , and are grateful for the support of all participants and investigator staff involved in the clinical trial.” mg and 2.0 mg and 2.0 The 1.0

DNA

DNA Vaccination Vaccine Immune Response

Top 5 Most Promising FDA New Drug Approvals Expected in the Second Half of 2024

XTalks

MAY 2, 2024

Some treatments already on the market have grabbed additional approvals in 2024, including Novo Nordisk’s Wegovy (semaglutide) for cardiovascular risk reduction, Dupixent (dupilumab) for eosinophilic esophagitis (EoE) in young children and Xolair (omalizumab) for food allergies. Karuna also has ongoing long-term extension trials.

Drugs

Drugs FDA Approval Sales Vaccination

Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®

Pfizer

JULY 8, 2022

The submission included data from a Phase 2/3 randomized, controlled trial that included 4,526 children 6 months to less than 5 years of age. In the trial, children received the third 3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant. About the Phase 1/2/3 Trial in Children.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age

Pfizer

JULY 8, 2022

Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. Food and Drug Administration (FDA) approved the companies’ supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY® (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age.

FDA Approval

FDA Approval Vaccination Vaccine Clinical Trials

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate

Pfizer

JULY 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system.

Vaccination

Vaccination Vaccine Medicine Clinical Trials

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19

Pfizer

NOVEMBER 2, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the advancement of an mRNA-based combination vaccine candidate for influenza and COVID-19 to a Phase 1 trial with the aim to address two severe respiratory diseases with one vaccine. are immunocompromised or are on a medicine that affects the immune system. have a fever.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Experimental vaccine protects against deadly Sudan virus

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.

Vaccination

Vaccination Vaccine Genetic Engineering Protein

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

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.

Trials

Trials Production Sales Manufacturing

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

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. ,

Trials

Trials Production Sales Manufacturing

Tezepelumab granted Priority Review by U.S. FDA

The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. 8) There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial.(8)

Allergies

Allergies Trials In-Vivo Medicine

Sanofi delivered close to double-digit Q4 2020

The Pharma Data

FEBRUARY 8, 2021

We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. Allergy Cough & Cold. at CER) to €2,276 million.

Sales

Sales Vaccination Vaccine Production

Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER

The Pharma Data

FEBRUARY 4, 2021

We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. Allergy Cough & Cold. at CER) to €2,276 million.

Sales

Sales Vaccination Vaccine Production

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

APRIL 27, 2021

reflecting increased competition partially offset by demand growth partly related to clinical trial supply and price upside in Europe. to €24 million, primarily due to the COVID-19 pandemic, which has led to a decrease in infused immune reconstitution therapies such as Lemtrada ®. Aubagio ® sales decreased 1.1% Consumer Healthcare.

Sales

Sales Vaccination Vaccine Medicine

DBV sets course on regulatory journey for peanut allergy patch

Pharmaceutical Technology

APRIL 20, 2023

Following a tumultuous development cycle, DBV Technologies will now have to conduct an additional safety study of its peanut allergy Viaskin patch in toddlers ages 1–3 years, based on written correspondence from the US Food and Drug Administration (FDA). However, the French company will not be required to run a further efficacy study.

Allergies

Allergies Trials Immune Response Licensing

Clinical Research Informer

Kaiser Permanente Joins Late-Stage Trial for Pfizer and BioNTech’s Lead COVID-19 Vaccine Candidate

Biopharma Update on the Novel Coronavirus: October 27

Trending Sources

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design

Unshackling TP53 in leukaemia with a novel combo; Merus receives funds for cancer research pact; Vera Therapeutics bags $80M; Gritstone appends COVID-19 to the pipeline.

FDA Action Alert: Merck, Aurinia and Amgen

INOVIO Announces Publication of Phase 1 Data from its COVID-19 DNA Vaccine Candidate, INO-4800 in The Lancet’s EClinicalMedicine

Top 5 Most Promising FDA New Drug Approvals Expected in the Second Half of 2024

Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®

Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19

Experimental vaccine protects against deadly Sudan virus

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

Tezepelumab granted Priority Review by U.S. FDA

Sanofi delivered close to double-digit Q4 2020

Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

DBV sets course on regulatory journey for peanut allergy patch

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