The Pharma Data

FEBRUARY 12, 2022

.” The data supporting this EUA are primarily based on analyses from the Phase 2 BLAZE-4 trial (NCT04634409), treatment arms 9-14. Lilly has licensed and developed bebtelovimab after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.

Antibody 40

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The Pharma Data

APRIL 4, 2022

To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. If approved, Dupixent would be the first medicine available in the U.S. Dupilumab Development Program.

Medicine 52

Medicine Trials Allergies FDA Approval 52

The Pharma Data

MARCH 4, 2021

Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. In children younger than 12 years of age, Dupixent should be administered by a caregiver.

Genetics 52

Genetics Medicine Antibody Trials 52

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.

Vaccination 40

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The Pharma Data

JULY 29, 2021

Evaluation of baricitinib’s efficacy and safety as a treatment for COVID-19 is ongoing in clinical trials. Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. In the COVID-19 clinical trials, adverse drug reactions in the safety population occurring in ? In the U.S.,

HR 52

HR Licensing Licensing FDA Approval 52

The Pharma Data

FEBRUARY 13, 2022

To date, dupilumab has been studied across 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. If approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled moderate-to-severe atopic dermatitis for these young children.

Medicine 40

Medicine Genetics Antibody Allergies 40

Drug Discovery World

FEBRUARY 20, 2023

Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, according to a recent report by analytics company Phesi. AstraZeneca’s Evusheld became the first antibody combination for pre-exposure prophylaxis (PrEP) against Covid-19 licensed in the UK.

Drug Trials 52

Drug Trials Trials Clinical Trials Clinical Trials 52

Pfizer

JULY 26, 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 111

Vaccination Vaccine Protein Immune Response 111

Pfizer

JULY 8, 2022

Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age. NEW YORK and MAINZ, GERMANY, July 8, 2022 — Pfizer Inc. have completed a primary series.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

The Pharma Data

APRIL 14, 2021

Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg alone or placebo were nausea (3% vs 4%), diarrhea (1% vs 5%), dizziness (3% vs 2%), headache (3% vs 2%), pruritus (2% vs 1%) and vomiting (1% vs 3%). Bamlanivimab alone. patients who recovered from COVID-19.

Antibody 52

Antibody Protein Scientist Development 52

Pfizer

JULY 8, 2022

The Phase 1/2/3 trial has enrolled more than 10,000 children ages 6 months to under 12 years of age in the United States, Finland, Poland, Spain and Brazil from more than 90 clinical trial sites. The booster schedule is based on the labeling information of the vaccine used for the primary series. Emergency Use Authorization.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

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.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

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)

Vaccination 101

Vaccination Vaccine Medicine Clinical Trials 101

Pfizer

OCTOBER 19, 2022

The Phase 1/2/3 trial ( NCT04816643 ) has enrolled more than 10,000 children ages 6 months to under 12 years of age in the United States, Finland, Poland, Spain and Brazil from more than 90 clinical trial sites. Tell your vaccination provider about all of your medical conditions, including if you: have any allergies.

Vaccination 40

Vaccination Vaccine Clinical Trials Clinical Trials 40

Pfizer

SEPTEMBER 16, 2022

Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine. EMERGENCY USE AUTHORIZATION. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5),

Marketing 75

Marketing Vaccination Vaccine Clinical Trials 75

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. 8) There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial.(8) Ann Allergy Asthma Immunol.

Allergies 52

Allergies Trials In-Vivo Medicine 52

The Pharma Data

NOVEMBER 4, 2020

In addition, Amarin recognized licensing and royalty revenue of approximately $1.3 This compares with licensing and royalty revenue of $0.2 It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. commercial team. “In million and $8.9

Sales 40

Sales Production Cardiology Marketing 40

The Pharma Data

JULY 8, 2021

Tezepelumab is the first and only biologic to consistently and significantly reduce asthma exacerbations in a broad population across Phase II and III clinical trials. The BLA was based on results from the PATHFINDER clinical trials programme, including results from the pivotal NAVIGATOR Phase III trial.

Trials 52

Trials Medicine Sales Clinical Trials 52

The Pharma Data

JANUARY 24, 2021

With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. The drug was licensed from Immutep Limited.

Trials 52

Trials Allergies In-Vitro Antibody 52

The Pharma Data

NOVEMBER 9, 2020

NAVIGATOR and the PATHFINDER clinical trial program Building on the Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, NAVIGATOR and SOURCE. 4,5 The program includes additional planned mechanistic and long-term safety trials. 10 World Allergy Organization (WAO). 11 Busse WW.

Trials 52

Trials Production Sales Manufacturing 52

pharmaphorum

OCTOBER 4, 2022

She regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products, including licensing agreements, collaboration agreements, clinical trial agreements, and an array of services agreements.

Development 103

Development Regulation Cosmetics Life Science 103

Druggist

NOVEMBER 6, 2020

The best evidence for or against the effectiveness of medicines comes from well designed clinical trials. Diphenhydramine is a first-generation antihistamine, which is used to in the symptomatic treatment of allergies but more commonly as over the counter temporary sleeping aid medicines.

Medicine 69

Medicine Containment Pharmacy Production 69

The Pharma Data

DECEMBER 21, 2020

PATHFINDER Clinical Trial Program Building on the positive Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, the registrational NAVIGATOR study and SOURCE. 12-15 The program includes additional planned mechanistic and long-term safety trials. J Allergy Clin Immunol.

Trials 40

Trials Production Sales Manufacturing 40

The Pharma Data

JANUARY 26, 2021

In the trial, 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. Serious adverse events were reported at a similar frequency in the bamlanivimab and etesevimab together and placebo groups.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

The Pharma Data

JULY 12, 2021

EUA Statement on All Materials: The Janssen COVID-19 Vaccine has not been approved or licensed by the U.S. The Janssen COVID-19 Vaccine is still being studied in clinical trials. For further information on the safety of authorized COVID-19 vaccines, please visit: [link]. Statement updated 9:00pm ET].

Vaccination 52

Vaccination Vaccine FDA Approval Allergies 52

The Pharma Data

FEBRUARY 8, 2021

We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks. 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. Consumer Healthcare.

Sales 52

Sales Vaccination Vaccine Production 52

The Pharma Data

FEBRUARY 4, 2021

We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks. 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. Consumer Healthcare.

Sales 52

Sales Vaccination Vaccine Production 52

The Pharma Data

NOVEMBER 30, 2020

and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), 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.

Vaccination 52

Vaccination Vaccine Medicine Clinical Trials 52

XTalks

AUGUST 2, 2023

Late in 2022, AbbVie partnered with HotSpot Therapeutics and announced an exclusive worldwide collaboration and option to license agreement for their interferon regulatory factor 5 (IRF5) inhibitor program for autoimmune disease treatment. This partnership will expand the company’s immunology pipeline. billion ($3.65 billion ($2.85

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

NOVEMBER 9, 2020

We thank those who have contributed to this medical advancement, particularly the clinical trial investigators and participants around the country.” Bamlanivimab remains an investigational drug and has not been approved under a Biologics License Application (BLA). See Limitations of Authorized Use.

Antibody 52

Antibody Medicine Manufacturing Trials 52

The Pharma Data

APRIL 27, 2021

reflecting increased competition partially offset by demand growth partly related to clinical trial supply and price upside in Europe. to €283 million, reflecting growth of Digestive and Mental Wellness categories as well as Allergy partially offset by the decline of the Pain category. Aubagio ® sales decreased 1.1% In the U.S.,

Sales 52

Sales Vaccination Vaccine Medicine 52

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.

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

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

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.

Vaccination 52

Vaccination Vaccine Medicine Containment 52

The Pharma Data

MAY 8, 2021

The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021. On April 21, 2021, Johnson & Johnson announced the publication of primary data from the Phase 3 ENSEMBLE clinical trial in the New England Journal of Medicine. Serious and unexpected effects may occur.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 23, 2020

24, 2020 /PRNewswire/ — COVAXX’s UB-612 is the first multitope, synthetic peptide-based COVID-19 vaccine candidate in clinical trials and it utilizes normal refrigeration (no freezing required) for distribution. COVAXX is currently conducting a Phase 1 clinical trial for the vaccine candidate. .

Vaccination 52

Vaccination Vaccine Development Manufacturing 52

The Pharma Data

DECEMBER 23, 2020

Aurobindo Pharma and COVAXX are partnering on clinical development, manufacturing and marketing of COVAXX’s vaccine candidate, UB-612. Under the signed license agreement, Aurobindo Pharma has obtained the exclusive rights to commercialize in India and to UNICEF and non-exclusive rights in other select emerging and developing markets.

Vaccination 52

Vaccination Vaccine Manufacturing Antibody 52