Allergies, Immune Response, Licensing and Manufacturing

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. On December 17, 2020, Aurinia inked a collaboration and license deal with Japan’s Otsuka Pharmaceutical Co.

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. Department of Defense have contributed significant funding to the advancement and manufacturing of INO-4800. ClinicalTrials.gov identifier: NCT04336410.

DNA

DNA Vaccination Vaccine Immune Response

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 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

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

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. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.(24,25) About Amgen. Busse WW.

Allergies

Allergies Trials In-Vivo Medicine

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

AstraZeneca continues to lead development and Amgen continues to lead manufacturing. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. All aspects of the collaboration are under the oversight of joint governing bodies.

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

AstraZeneca continues to lead development and Amgen continues to lead manufacturing. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. All aspects of the collaboration are under the oversight of joint governing bodies.

Trials

Trials Production Sales Manufacturing

Sanofi delivered close to double-digit Q4 2020

The Pharma Data

FEBRUARY 8, 2021

At the same time we want to make a more immediate contribution to help saving lives, which is why we have decided to provide manufacturing support to BioNTech and Pfizer. 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. 39.2 . %.

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

At the same time we want to make a more immediate contribution to help saving lives, which is why we have decided to provide manufacturing support to BioNTech and Pfizer. 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. 39.2 . %.

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

to €283 million, reflecting growth of Digestive and Mental Wellness categories as well as Allergy partially offset by the decline of the Pain category. Development for Dupixent ® for grass allergy has been discontinued. At CER, BOI increased 48.6%. The ratio of BOI to net sales was 40.5% (and 27.5% Consumer Healthcare. Change at CER.

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 flexibility and manufacturing speed of the mRNA technology has demonstrated that it is well-suited for other respiratory diseases. The influenza virus is subject to constant mutations to evade the host immune response, causing a seasonal variation in circulating strains. EMERGENCY USE AUTHORIZATION. have a fever.

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

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 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

Tezepelumab granted Priority Review by U.S. FDA

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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