Allergies, FDA Approval, Licensing and Production

Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

The Pharma Data

APRIL 14, 2021

Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. Roche’s Chief Medical Officer and Head of Global Product Development. today announced that the U.S. indications.

FDA Approval

FDA Approval Clinical Development Allergies Medicine

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

XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

Drugs

Drugs FDA Approval Sales Vaccination

Biopharma Update on the Novel Coronavirus: October 27

The Pharma Data

OCTOBER 26, 2020

FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). News information is not all-inclusive and updates are published once a week on Tuesdays. . . Other Industry News.

Antibody

Antibody Vaccination Vaccine Manufacturing

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

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. COMIRNATY was previously FDA approved for individuals 16 years and older in August 2021. Fri, 07/08/2022 - 11:48.

FDA Approval

FDA Approval Vaccination Vaccine Clinical Trials

FDA accepts Dupixent® (dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis

The Pharma Data

APRIL 4, 2022

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. living with eosinophilic esophagitis who are currently treated, of whom approximately 48,000 have failed multiple treatments.

Medicine

Medicine Trials Allergies FDA Approval

First Single-Shot Vaccine in Fight Against Global Pandemic

The Pharma Data

MARCH 2, 2021

The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021. “We The Janssen COVID-19 vaccine has not been approved or licensed by the U.S. have a fever. are breastfeeding.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

FDA accepts Dupixent® (dupilumab) for review in children with moderate-to-severe asthma

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.

Genetics

Genetics Medicine Antibody Trials

FDA accepts Dupixent® (dupilumab) for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis

The Pharma Data

FEBRUARY 13, 2022

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

Medicine Genetics Antibody Allergies

FDA broadens existing emergency use of Lilly and Incyte’s baricitinib in patients hospitalized with COVID-19 requiring oxygen

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. It is approved in the U.S. Serious Side Effects.

HR

HR Licensing Licensing FDA Approval

Switzerland Exercises Increased Option for 7.5 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)

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. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. against COVID-19 and 100% efficacy against severe disease. Source: Moderna, Inc. .

Vaccination

Vaccination Vaccine Manufacturing Containment

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

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

Antibody Medicine FDA Approval Licensing

FDA approves Lyumjev® (insulin lispro-aabc injection) 100 units/mL for use in insulin pumps

The Pharma Data

AUGUST 17, 2021

If your doctor decides to give your child any insulin products, he or she may give you special instructions. All Lyumjev and Humalog products contain insulin lispro. Your doctor may need to change or stop treatment with TZDs and your insulin lispro product.

Insulin

Insulin FDA Approval Doctors Doctor

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

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

Sales Manufacturing FDA Approval Life Science

Pfizer Responds to Research Claims

Pfizer

JANUARY 27, 2023

and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. It is important to note that these studies are required by U.S. and around the world. INDICATION & AUTHORIZED USE Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) AUTHORIZED USE The U.S.

Research

Research Vaccination Vaccine Drugs

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

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. a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

Vaccination

Vaccination Vaccine Protein Immune Response

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate

Pfizer

JULY 19, 2022

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. a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

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

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. a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Amarin Reports Third Quarter 2020 Financial Results and Provides Business Update

The Pharma Data

NOVEMBER 4, 2020

The third quarter was a productive but challenging quarter for Amarin as total net revenue grew to record levels reflecting increased prescription levels for VASCEPA, despite many patients not yet returning to their doctors’ offices for preventative healthcare due to the global pandemic,” stated John F. “In million and $9.5 million and $446.8

Sales

Sales Production Cardiology Marketing

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

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. up 60%) driven by increase disease and product awareness as well as adoption of new ISTH (International Society on Thrombosis and Haemostasis) TTP guidelines. Rare Blood Disorder.

Sales

Sales Vaccination Vaccine Medicine

Johnson & Johnson Statement on COVID-19 Vaccine (7/12)

The Pharma Data

JULY 12, 2021

The safety and well-being of the people who use our products is our number one priority. EUA Statement on All Materials: The Janssen COVID-19 Vaccine has not been approved or licensed by the U.S. There is no FDA-approved vaccine to prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19.

Vaccination

Vaccination Vaccine FDA Approval Allergies

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

The Pharma Data

NOVEMBER 30, 2020

Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA). and other jurisdictions, the Company’s anticipated production of mRNA-1273, and the timing of the initial shipments of mRNA-1273. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. Source: Moderna, Inc. .

Vaccination

Vaccination Vaccine Medicine Containment

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

JANUARY 26, 2021

Breastfeeding There are no available data on the presence of bamlanivimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science (IMCAS).

Antibody

Antibody Trials Clinical Trials Clinical Trials

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19

Pfizer

NOVEMBER 2, 2022

*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. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for use in individuals 6 months and older to provide: Primary Series. INDICATION. have a fever.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza

Pfizer

DECEMBER 8, 2022

*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. . Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. COMIRNATY® (COVID-19 Vaccine, mRNA). INDICATION. EMERGENCY USE AUTHORIZATION.

Vaccination

Vaccination Vaccine Clinical Trials Clinical Trials

Clinical Research Informer

Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

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

Trending Sources

Biopharma Update on the Novel Coronavirus: October 27

Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age

FDA accepts Dupixent® (dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis

First Single-Shot Vaccine in Fight Against Global Pandemic

FDA accepts Dupixent® (dupilumab) for review in children with moderate-to-severe asthma

FDA accepts Dupixent® (dupilumab) for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis

FDA broadens existing emergency use of Lilly and Incyte’s baricitinib in patients hospitalized with COVID-19 requiring oxygen

Switzerland Exercises Increased Option for 7.5 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

FDA approves Lyumjev® (insulin lispro-aabc injection) 100 units/mL for use in insulin pumps

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

Pfizer Responds to Research Claims

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design

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®

Amarin Reports Third Quarter 2020 Financial Results and Provides Business Update

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

Johnson & Johnson Statement on COVID-19 Vaccine (7/12)

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19

Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza

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