Allergies, Development, Immune Response and Licensing

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

Pharmaceutical Technology

AUGUST 1, 2022

GreenLight Biosciences has entered a partnership with the US National Institutes of Health (NIH) for the development of Covid-19 vaccines, which offer broader protection against new variants and with durable effects. They intend to develop vaccines that provide lasting immune responses compared to existing vaccines.

Vaccination

Vaccination Vaccine Development RNA

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

XTalks

AUGUST 13, 2020

In a press statement , Kaiser Permanente outlined that in this phase of the trial, data will be collected about the safety, immune response and efficacy of the vaccine candidate as required for regulatory review.

Vaccination

Vaccination Vaccine Trials Clinical Trials

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. Histogen and Amerimmune signed a deal to develop and commercialize emricasan for the treatment of COVID-19.

Antibody

Antibody Vaccination Vaccine Manufacturing

FDA Action Alert: Merck, Aurinia and Amgen

The Pharma Data

JANUARY 17, 2021

The drug is being developed for several indications, but the NDA is for lupus nephritis (LN), a serious inflammation of the kidneys the result of systemic lupus erythematosus (SLE). By inhibiting calcineurin, the drug blocks IL-2 expression and T-cell mediated immune responses.

Manufacturing

Manufacturing Immune Response Allergies Drugs

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

These will come out of Merus’ so-called Biclonics platform that develops CD3-engaging, T-cell redirecting bispecific antibody therapies. chief operating officer of Loxo Oncology, said that CD3-engaging bispecific antibodies are soon becoming one of the most transformative immune-modulating modalities used for cancer treatment.

Research

Research Protein Clinical Trials Clinical Trials

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. INOVIO has assembled a global coalition of collaborators, partners and funders to rapidly advance the development of INO-4800. Department of Defense.

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

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

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. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. Emergency Use Authorization. has a fever.

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. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca. executive vice president of Research and Development at Amgen. Reese, M.D., About Tezepelumab.

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

executive vice president of Research and Development at Amgen. 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. Reese , M.D.,

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

executive vice president of Research and Development at Amgen. 4 Tezepelumab is being developed by AstraZeneca in collaboration with Amgen (see AstraZeneca and Amgen collaboration below). AstraZeneca continues to lead development and Amgen continues to lead manufacturing. Reese , M.D.,

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. Allergy Cough & Cold. to €238 million, reflecting growth in the Allergy (Allegra ® and Xyzal ® ) and Digestives categories. at CER) to €2,276 million. Consumer Healthcare.

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. Allergy Cough & Cold. to €238 million, reflecting growth in the Allergy (Allegra ® and Xyzal ® ) and Digestives categories. at CER) to €2,276 million. Consumer Healthcare.

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

Developed as part of a joint-partnership between Sanofi and Merck, Vaxelis ® is the first and only hexavalent combination vaccine approved in the U.S. to €283 million, reflecting growth of Digestive and Mental Wellness categories as well as Allergy partially offset by the decline of the Pain category. In the U.S., PPH sales were up 40.4%

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 vaccine candidate combines Pfizer’s quadrivalent modRNA-based influenza vaccine candidate, qIRV (22/23), which is currently in Phase 3 clinical development , and Pfizer and BioNTech’s authorized Omicron-adapted bivalent COVID-19 BNT162b2 (Original/Omicron BA.4/BA.5) The companies will share the development costs. Ugur Sahin, M.D.,

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

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

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

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

Trending Sources

Biopharma Update on the Novel Coronavirus: October 27

FDA Action Alert: Merck, Aurinia and Amgen

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.

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

Experimental vaccine protects against deadly Sudan virus

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

DBV sets course on regulatory journey for peanut allergy patch

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