Allergies, Antibody, Immune Response and Licensing

Biopharma Update on the Novel Coronavirus: October 27

The Pharma Data

OCTOBER 26, 2020

Diagnostics Update : To-date the FDA has authorized 284 individual EUAs, which include 221 molecular tests, 56 antibody tests and 7 antigen tests. . Only a fraction of intravenous antibody treatments will make their way to the lungs of COVID-19 patients, which is where the infection is primarily located. Please read more here. .

Antibody

Antibody Vaccination Vaccine Manufacturing

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

Eli Lilly, via its Loxo Oncology biotech unit, is enlisting to a three-therapy pact with Merus concentrated on T-cell redirecting bispecific antibody work. These will come out of Merus’ so-called Biclonics platform that develops CD3-engaging, T-cell redirecting bispecific antibody therapies. billion in total for three drugs.

Research

Research Protein Clinical Trials Clinical Trials

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. It is also entering late into the market.

Drugs

Drugs FDA Approval Sales Vaccination

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

Stanley Plotkin , Professor Emeritus at The Wistar Institute, said, “INOVIO’s DNA vaccine appeared to be quite safe with few significant reactions but yet induced both antibody and T cell responses to SARS-CoV-2.” mg dose group and 84% demonstrating neutralizing antibodies in the 2.0 mg and 2.0 The 1.0

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

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) Reese, M.D., Busse WW.

Allergies

Allergies Trials In-Vivo Medicine

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 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

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

About Tezepelumab Tezepelumab is an investigational, potential first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants, and other environmental insults. 10 World Allergy Organization (WAO). 11 Busse WW.

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

About Tezepelumab Tezepelumab is an investigational, potential first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants, and other environmental insults. J Allergy Clin Immunol. Outside the U.S.,

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

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 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

Biopharma Update on the Novel Coronavirus: October 27

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.

Trending Sources

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

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

Tezepelumab granted Priority Review by U.S. FDA

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 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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