Allergies, Immune Response, Licensing and Production

GreenLight and US NIH partner to develop Covid-19 vaccine for variants

Pharmaceutical Technology

AUGUST 1, 2022

The company will jointly design and analyse messenger ribonucleic acid (mRNA) Covid-19 vaccines in partnership with the NIH unit National Institute of Allergy and Infectious Diseases’ Vaccine Research Center (VRC). They intend to develop vaccines that provide lasting immune responses compared to existing vaccines.

Vaccination

Vaccination Vaccine Development RNA

Biopharma Update on the Novel Coronavirus: October 27

The Pharma Data

OCTOBER 26, 2020

The National Institute of Allergy and Infectious Diseases (NIAID), the study sponsor, could not verify the safety issue, but their analysis also indicated there was little likelihood the antibody would help the hospitalized patients. Eli Lilly halted a separate study of its LY-COV555 antibody against COVID-19 in hospitalized patients.

Antibody

Antibody Vaccination Vaccine Manufacturing

FDA Action Alert: Merck, Aurinia and Amgen

The Pharma Data

JANUARY 17, 2021

By inhibiting calcineurin, the drug blocks IL-2 expression and T-cell mediated immune responses. On December 17, 2020, Aurinia inked a collaboration and license deal with Japan’s Otsuka Pharmaceutical Co. The bone marrow suppression inhibits the production of blood cells.

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

All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immune responses following the second dose of INO-4800. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. About INOVIO.

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. to develop and commercialize acoramidis in Japan.

Drugs

Drugs FDA Approval Sales Vaccination

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

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. has a fever.

Vaccination

Vaccination Vaccine Medicine 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

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. Tell your vaccination provider about all of your medical conditions, including if you: have any allergies.

FDA Approval

FDA Approval Vaccination Vaccine Clinical Trials

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

Following a third dose in this age group , the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. IMPORTANT SAFETY INFORMATION Tell your vaccination provider about all the vaccine recipient’s medical conditions, including if the vaccine recipient: has any allergies.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

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

Specifically, tezepelumab targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.

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

Specifically, tezepelumab targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.

Trials

Trials Production Sales Manufacturing

Sanofi delivered close to double-digit Q4 2020

The Pharma Data

FEBRUARY 8, 2021

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. Cardiovascular and Established Rx Products. Total Cardiovascular and Established Rx Products. Allergy Cough & Cold. Full-year 2020 Soliqua ® sales increased 36.1%

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

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. Cardiovascular and Established Rx Products. Total Cardiovascular and Established Rx Products. Allergy Cough & Cold. Full-year 2020 Soliqua ® sales increased 36.1%

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

up 60%) driven by increase disease and product awareness as well as adoption of new ISTH (International Society on Thrombosis and Haemostasis) TTP guidelines. Globally, diagnosis of the disease and product awareness remain impacted by the COVID-19 environment. . Cardiovascular and Established Rx Products. Net sales (€ million).

Sales

Sales Vaccination Vaccine Medicine

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

Pfizer

NOVEMBER 2, 2022

The influenza virus is subject to constant mutations to evade the host immune response, causing a seasonal variation in circulating strains. Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. are immunocompromised or are on a medicine that affects the immune system.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Clinical Research Informer

GreenLight and US NIH partner to develop Covid-19 vaccine for variants

Biopharma Update on the Novel Coronavirus: October 27

Trending Sources

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

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

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

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

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

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

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