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. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

The Pharma Data

NOVEMBER 25, 2020

FDA’s approval of remdesivir (Veklury) was supported by the agency’s independent, in-depth analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19. Researchers evaluated the clinical status of subjects on Day 14. Source: FDA.

Trials 52

Trials Clinical Trials Clinical Trials Drugs 52

The Pharma Data

MARCH 4, 2021

Adverse events in the Phase 3 trial that were more commonly observed with Dupixent included injection site reactions, viral upper respiratory tract infections and eosinophilia. Detailed results from this Phase 3 trial will be published later this year. Dupilumab development program.

Genetics 52

Genetics Medicine Antibody Trials 52

The Pharma Data

FEBRUARY 19, 2022

Study A of clinical program evaluated the efficacy and safety of Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone in 138 patients aged 6 years and older with CSU who remained symptomatic despite antihistamine use and were not previously treated with omalizumab. About Dupixent.

Genetics 40

Genetics Antibody Trials Medicine 40

The Pharma Data

FEBRUARY 13, 2022

In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of severe atopic dermatitis (in children aged 6 months to 11 years). 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.

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. There are approximately 160,000 patients in the U.S. living with EoE who are currently treated, of whom approximately 48,000 have failed multiple treatments. About Dupixent.

Medicine 52

Medicine Trials Allergies FDA Approval 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. About Moderna. Source link.

Vaccination 40

Vaccination Vaccine Manufacturing Containment 40

The Pharma Data

JULY 29, 2021

baricitinib has not been approved by the FDA to treat COVID-19, and the efficacy, safety and optimal duration of treatment of baricitinib for COVID-19 has not been established. Evaluation of baricitinib’s efficacy and safety as a treatment for COVID-19 is ongoing in clinical trials. It is approved in the U.S.

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. Important Information about bamlanivimab Bamlanivimab has not been approved by the FDA for any use. .

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 10, 2021

Neutralizing Antibody Conversion with OnabotulinumtoxinA from Global Studies Across Multiple Indications with a Focus on Movement Disorders: A Meta-Analysis. About BOTOX ® BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. BOTOX ® Abstracts.

Botox 52

Botox Doctors Doctor Medicine 52

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Pfizer

JULY 26, 2022

FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use. INTERCHANGEABILITY.

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

Pfizer

JULY 19, 2022

FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use. INTERCHANGEABILITY.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

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. INTERCHANGEABILITY. has a fever. has bleeding disorder or is on a blood thinner. has received another COVID-19 vaccine.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

XTalks

OCTOBER 26, 2023

The US Food and Drug Administration (FDA) approved new updated COVID-19 vaccines from both Pfizer-BioNTech and Moderna that target the Omicron XBB.1.5 In May, the FDA approved GSK’s Arexvy as the first RSV vaccine, which was shortly followed by the approval of Pfizer’s RSV vaccine Abrysvo.

Vaccination 105

Vaccination Vaccine RNA Manufacturing 105

The Pharma Data

AUGUST 30, 2021

These results add to the extensive LIBERTY AD clinical program – the largest Phase 3 clinical trial program in atopic dermatitis involving approximately 3,500 children, adolescents, and adults to date. It is not an immunosuppressant and does not require lab monitoring. Dupilumab Development Program.

Trials 52

Trials Medicine Genetics Antibody 52

The Pharma Data

SEPTEMBER 8, 2021

Results from a post-hoc analysis of the Phase 3 PREEMPT trials evaluating the use of BOTOX ® for chronic migraine will also be presented. Related Peptide Monoclonal Antibody Therapy Added to OnabotulinumtoxinA Treatment. Adult Patients treated for overactive bladder due to neurologic disease: In clinical trials, 30.6%

Botox 52

Botox Doctors Doctor Medicine 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. At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. Aubagio ® sales decreased 1.1% In the U.S.,

Sales 52

Sales Vaccination Vaccine Medicine 52

The Pharma Data

OCTOBER 27, 2020

27, 2020 — Testing of Eli Lilly’s antibody drug for hospitalized COVID-19 patients has been halted because the treatment doesn’t help them recover from their infection. A similar, two-antibody cocktail from Regeneron Pharmaceuticals Inc. Remdesivir gets full FDA approval to treat COVID-19. TUESDAY, Oct.

Antibody 52

Antibody Trials Drugs Clinical Trials 52

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

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

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. have a fever.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

XTalks

DECEMBER 24, 2020

Most antibody drugs and vaccines have been developed to target parts of the spike protein. These include remdesivir, baricitinib, dexamethasone and three antibody drugs. Antibody drugs were also developed as targeted COVID-19 treatments.

Life Science 111

Life Science Vaccination Vaccine Gene 111

The Pharma Data

JULY 15, 2021

Antibody and T-cell immune responses strong and stable at eight months after immunization Demonstrated neutralizing antibody activity against the Delta variant (B.1.617.2) Mature B-cells produce antibodies, which can help fight the virus that causes COVID-19. Data from the study conducted in collaboration with Dan Barouch, M.D.,

Immune Response 52

Immune Response Medicine Vaccination Vaccine 52

pharmaphorum

NOVEMBER 10, 2020

Eli Lilly has said it will start shipping supplies of its COVID-19 drug bamlanivimab immediately, after claiming emergency-use authorisation (EUA) for the antibody. The NIAID is also running another study of Lilly’s antibody, ACTIV-2, which involves outpatients with mild-to-moderate COVID-19 symptoms.

Drugs 105

Drugs Antibody Allergies FDA Approval 105