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. Dupilumab development program.

Genetics 52

Genetics Medicine Antibody Trials 52

The Pharma Data

FEBRUARY 13, 2022

If approved, Dupixent will be the first biologic medicine available in the U.S. Dupixent remains the only biologic medicine approved for patients 6 years of age and older in this indication. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

Medicine 40

Medicine Genetics Antibody Allergies 40

The Pharma Data

DECEMBER 8, 2020

As we continue to progress the development of mRNA-1273, our COVID-19 vaccine candidate, we appreciate the continued confidence and support shown by the Swiss Federal Government as they increase their supply agreement with us,” said Stephane Bancel, Moderna’s Chief Executive Officer. “As .–(BUSINESS WIRE)–Dec. million to 7.5

Vaccination 40

Vaccination Vaccine Manufacturing Containment 40

The Pharma Data

JULY 29, 2021

Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. See Warnings and Precautions in the FDA-approved full Prescribing Information and Medication Guide for additional information on risks associated with longer-term treatment with baricitinib. It is approved in the U.S. Serious Side Effects.

HR 52

HR Licensing Licensing FDA Approval 52

Pharmaceutical Technology

JUNE 9, 2023

Although AdCom verdicts are considered by the FDA when it comes to approvals, they are not binding. The FDA accepted nirsevimab’s biologics license application (BLA) in January, with a PDUFA date penned for Q3 2023. The European Commission approved nirsevimab in November 2022.

FDA Approval 147

FDA Approval Antibody Allergies Packaging 147

The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. It is approved in the U.S.

Antibody 52

Antibody Medicine FDA Approval Licensing 52

The Pharma Data

AUGUST 17, 2021

approval of pump use for Lilly’s novel insulin is latest development designed to help people with diabetes manage blood sugar levels. Lyumjev, a novel formulation of insulin lispro developed to speed the absorption of insulin into the bloodstream and reduce A1C levels, was approved by the FDA in June 2020.

Insulin 52

Insulin FDA Approval Doctors Doctor 52

Pfizer

JULY 26, 2022

The Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine. Emergency Use Authorization .

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

XTalks

AUGUST 2, 2023

is a global pharmaceutical company, working across both developed and emerging markets. 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. Pfizer Inc. billion.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Pfizer

JULY 19, 2022

Food and Drug Administration (FDA) to support a potential variant-adapted vaccine and continue to submit additional data as advised by the agency. The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. Emergency Use Authorization. INTERCHANGEABILITY.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

Pfizer

JULY 8, 2022

Food and Drug Administration (FDA) which granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine as a three 3-µg dose series in this age group on June 17. COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. Emergency Use Authorization. has a fever.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

Pfizer

JANUARY 27, 2023

In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research. Pfizer Responds to Research Claims carterda Fri, 01/27/2023 - 19:48 Pfizer Responds to Research Claims Friday, January 27, 2023 - 08:00pm Share New York, N.Y.,

Research 112

Research Vaccination Vaccine Drugs 112

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 Research and development (R&D) expense for the three and nine months ended September 30, 2020 were $10.2 million and $8.9 million and $5.7 million and $1.1 million and $346.5

Sales 40

Sales Production Cardiology Marketing 40

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. Warnings and Precautions ?in

FDA Approval 52

FDA Approval HR Trials Medicine 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. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) in individuals 18 years of age and older.

Vaccination 52

Vaccination Vaccine FDA Approval Allergies 52

The Pharma Data

APRIL 27, 2021

At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. 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. Rare Blood Disorder.

Sales 52

Sales Vaccination Vaccine Medicine 52

The Pharma Data

JANUARY 26, 2021

Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. Junshi Biosciences leads development in Greater China, while Lilly leads development in the rest of the world.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 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. 75A50120C00034.

Vaccination 52

Vaccination Vaccine Medicine Containment 52

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 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

Pfizer

DECEMBER 8, 2022

Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and COVID-19, which aims to help prevent two respiratory diseases with a single injection. Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus. .

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81