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.

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FDA Approval Vaccination Vaccine Clinical Trials 102

Pfizer

SEPTEMBER 28, 2022

Emergency uses of the original and bivalent vaccines have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in: . • individuals 6 months of age and older (original vaccine). • individuals 12 years of age and older (bivalent vaccine)

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Vaccination Vaccine Medicine Clinical Trials 101

The Pharma Data

DECEMBER 8, 2020

and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. About Moderna.

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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.

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Pfizer

JULY 19, 2022

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The booster schedule is based on the labeling information of the vaccine used for the primary series.

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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

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Pfizer

JULY 8, 2022

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The booster schedule is based on the labeling information of the vaccine used for the primary series.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

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.,

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The Pharma Data

JANUARY 4, 2021

The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center.

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pharmaphorum

FEBRUARY 9, 2021

An international trial led by US experts is to begin testing AstraZeneca’s long-acting antibody combination therapy to treat COVID-19. It is sponsored by the US-government funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

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Pharmaceutical Technology

JUNE 9, 2023

The FDA accepted nirsevimab’s biologics license application (BLA) in January, with a PDUFA date penned for Q3 2023. Also known as palivizumab, Sobi ‘s Synagis was the first FDA-approved monoclonal antibody used in children at high risk of RSV disease. The single seasonal dosing of the drug is a large advance, he noted.

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FDA Approval Antibody Allergies Packaging 147

The Pharma Data

APRIL 14, 2021

government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. Lilly’s bamlanivimab was the first neutralizing monoclonal antibody to receive emergency use authorization from the U.S. Eli Lilly and Company (NYSE: LLY) today announced changes to the purchase agreements with the U.S.

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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. Ann Allergy Asthma Immunol. World Allergy Organization (WAO). EMJ Allergy Immunol. J Allergy Clin Immunol. Amgen (NASDAQ:AMGN) announced that the U.S.

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The Pharma Data

JULY 29, 2021

today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). However, polyps have a strong tendency to reoccur often leading to repeat surgery. About mepolizumab.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

Pfizer

DECEMBER 8, 2022

Emergency uses of the vaccines have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older. Tell your vaccination provider about all of your medical conditions, including if you: have any allergies.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

Pfizer

NOVEMBER 2, 2022

Emergency uses of the vaccines have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

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The Pharma Data

JULY 8, 2021

AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the US Food and Drug Administration (FDA). Tezepelumab is being developed by AstraZeneca in collaboration with Amgen.

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The Pharma Data

FEBRUARY 13, 2022

About Dupixent Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. If approved, Dupixent will be the first biologic medicine available in the U.S.

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The Pharma Data

APRIL 4, 2022

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. If approved, Dupixent would be the first medicine available in the U.S. indicated to treat eosinophilic esophagitis There are approximately 160,000 patients in the U.S.

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The Pharma Data

APRIL 8, 2021

The COV-BARRIER trial was designed to complement the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Baricitinib, an oral JAK inhibitor, was discovered by Incyte and licensed to Lilly.

FDA Approval 52

FDA Approval HR Trials Medicine 52

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.

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The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. Bamlanivimab remains an investigational drug and has not been approved under a Biologics License Application (BLA). INDIANAPOLIS, Nov.

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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. .

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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.

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Sales Vaccination Vaccine Production 52

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.

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Sales Vaccination Vaccine Production 52

The Pharma Data

APRIL 16, 2021

that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together.” . “With the growing prevalence of variants in the U.S. spanning four continents.

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The Pharma Data

JANUARY 26, 2021

. “These exciting results, which replicate positive Phase 2 data in a much larger set of patients, add valuable clinical evidence about the role neutralizing antibodies can play in fighting this pandemic. Lilly’s chief scientific officer and president of Lilly Research Laboratories. have reached record highs.

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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. SAR440234 , T cell engaging multi specific antibody, has been discontinued in leukemia. Consumer Healthcare.

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Sales Vaccination Vaccine Medicine 52

Pfizer

SEPTEMBER 16, 2022

The third dose was well tolerated with a favorable safety profile and generated neutralizing antibodies against both Omicron and the original wild-type virus, regardless of prior COVID-19 diagnosis. Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. EMERGENCY USE AUTHORIZATION.

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XTalks

AUGUST 2, 2023

2) Darzalex (daratumumab) Darzalex is a targeted monoclonal antibody that slows or stops the progression of multiple myeloma (a blood cancer) by binding to the CD38 protein on multiple myeloma cells. The monoclonal antibody targets CD20, a protein found on the surface of B lymphocytes (B cells). billion in 2022, a 32.44

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The Pharma Data

MARCH 5, 2021

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. Lilly Antibody Therapies Around the World. Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2.

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The Pharma Data

MAY 4, 2021

About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

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Antibody Medicine FDA Approval Licensing 52

The Pharma Data

JANUARY 24, 2021

It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. National Institute of Allergy and Infectious Diseases (NIAID), of bamlanivimab (LY-CoV555) decreased the risk of COVID-19 among residents and staff of long-term care facilities, i.e., nursing homes. Non-COVID-19-Related.

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Pfizer

OCTOBER 19, 2022

Emergency uses of the vaccines have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

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The Pharma Data

MARCH 11, 2021

In this data set, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase 1, Phase 2 and Phase 3 trials evaluating these antibodies. Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2.

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The Pharma Data

FEBRUARY 12, 2022

Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant, Eli Lilly and Company (NYSE: LLY) announced today. “As a global pharmaceutical company, Lilly has worked hard to fight this pandemic. About bebtelovimab.

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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.

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