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.

Antibody 40

Antibody Trials Clinical Trials Clinical Trials 40

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.

Medicine 40

Medicine Genetics Antibody Allergies 40

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.

Medicine 52

Medicine Trials Allergies FDA Approval 52

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.

Antibody 52

Antibody Medicine FDA Approval Licensing 52

The Pharma Data

DECEMBER 8, 2020

Swiss vaccine supply will be sourced from Moderna’s European production capacity with its strategic manufacturing partner Lonza of Switzerland, and ROVI of Spain for fill-finish services. against COVID-19 and 100% efficacy against severe disease. The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the U.S.

Vaccination 40

Vaccination Vaccine Manufacturing Containment 40

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 40

DNA Vaccination Vaccine Immune Response 40

Drug Discovery World

NOVEMBER 9, 2023

Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. Kielczewska will present: ‘Discovery of antibody-based therapeutics to challenging targets: Platform considerations’.

Engineer 52

Engineer Antibody Protein In-Vivo 52

The Pharma Data

JULY 29, 2021

Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. For media resources, including product images and fact sheets, please click here. OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. BC HCP EUA ISI 28JUL2021. About OLUMIANT ® (baricitinib).

HR 52

HR Licensing Licensing FDA Approval 52

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.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

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.

Antibody 52

Antibody Medicine Manufacturing Trials 52

Pfizer

JANUARY 27, 2023

This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. and around the world. AUTHORIZED USE The U.S.

Research 112

Research Vaccination Vaccine Drugs 112

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. Amgen will record sales in the U.S. Outside the U.S.,

Trials 52

Trials Production Sales Manufacturing 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

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

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 102

FDA Approval Vaccination Vaccine Clinical Trials 102

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. Amgen will record sales in the U.S. Outside the U.S.,

Trials 40

Trials Production Sales Manufacturing 40

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

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

Pfizer

SEPTEMBER 28, 2022

The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. . EMERGENCY USE AUTHORIZATION. IMPORTANT SAFETY INFORMATION.

Vaccination 101

Vaccination Vaccine Medicine Clinical Trials 101

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.

Marketing 75

Marketing Vaccination Vaccine Clinical Trials 75

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. Cardiovascular and Established Rx Products. Total Cardiovascular and Established Rx Products. Allergy Cough & Cold. Full-year 2020 Soliqua ® sales increased 36.1%

Sales 52

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. Cardiovascular and Established Rx Products. Total Cardiovascular and Established Rx Products. Allergy Cough & Cold. Full-year 2020 Soliqua ® sales increased 36.1%

Sales 52

Sales Vaccination Vaccine Production 52

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.

Vaccination 40

Vaccination Vaccine Clinical Trials Clinical Trials 40

The Pharma Data

APRIL 27, 2021

up 60%) driven by increase disease and product awareness as well as adoption of new ISTH (International Society on Thrombosis and Haemostasis) TTP guidelines. Globally, diagnosis of the disease and product awareness remain impacted by the COVID-19 environment. . Cardiovascular and Established Rx Products. Net sales (€ million).

Sales 52

Sales Vaccination Vaccine Medicine 52

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). AstraZeneca will record all sales outside of the US as product sales and recognise Amgen’s share of gross profit as cost of sales.

Trials 52

Trials Medicine Sales Clinical Trials 52

The Pharma Data

JANUARY 27, 2021

The rules, drafted under the Public Readiness and Emergency Preparedness Act, will also be adapted to allow licensed doctors, nurses and health practitioners to administer shots across state lines, Zients said. Speeding up the production of low-dead-space syringes that can squeeze an extra sixth dose out of Pfizer vaccine vials.

Nurses 52

Nurses Doctors Doctor Vaccination 52

The Pharma Data

JANUARY 4, 2021

The authorization is given according to Regulation 29 (A)(9): Medical product designated for pharmaceutical treatment of local citizens in case of epidemic or contagious disease or protection from chemical or radioactive substances, according to Regulation 29 of the Pharmacists’ Regulations (Medical preparations) – 1986.

Vaccination 52

Vaccination Vaccine Medicine Containment 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

The Pharma Data

MARCH 5, 2021

Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab. Lilly Antibody Therapies Around the World.

Antibody 40

Antibody Medicine Regulation Trials 40

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

MARCH 11, 2021

Food and Drug Administration (FDA) and a positive scientific opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). For media resources, including product images and fact sheets, please click here. About bamlanivimab.

Trials 40

Trials Antibody Medicine Protein 40

The Pharma Data

DECEMBER 23, 2020

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. COVAXX will supply the bulk product and Aurobindo will manufacture the finished doses at its facilities in Hyderabad, India.

Vaccination 52

Vaccination Vaccine Manufacturing Antibody 52

The Pharma Data

DECEMBER 23, 2020

The company’s robust product portfolio is spread over major therapeutic areas encompassing CVS, CNS, Antibiotics, Anti-Retrovirals, Gastroenterology, Anti-Allergies and Anti-Diabetics, supported by an outstanding R&D, manufacturing and distribution set-up. Aurobindo Pharma has several WHO prequalified products.

Vaccination 52

Vaccination Vaccine Development Manufacturing 52