The Pharma Data

DECEMBER 17, 2020

In a pivotal head-to-head Phase III SOPHIA clinical trial, it became the first HER2-targeted therapy to improve progression-free survival (PFS) versus Herceptin® (trastuzumab), when each was combined with chemotherapy. The FDA approval of Klisyri is a significant milestone for Athenex. When Pigs Fly Allergy-friendly.

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Pharmaceutical Technology

JANUARY 8, 2023

In December 2021, AstraZeneca’s anti- thymic stromal lymphopoietin (TSLP) antibody Tezspire (or tezepelumab) became the latest biologic to be FDA-approved as an add-on treatment for patients with severe asthma without phenotype or biomarker limitations. Still, patients require an individual-led approach.

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The Pharma Data

JULY 29, 2021

BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Patients treated for overactive bladder: In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX ® compared to 2 of the 542 treated with placebo.

Botox 52

Botox FDA Approval Doctors Doctor 52

XTalks

DECEMBER 20, 2023

And this year Eli Lilly stepped into the obesity drug market with its own GLP-1 weight loss drug Zepbound (tirzepatide), which the US Food and Drug Administration (FDA) approved in November of this year. There has been significant growth in the number of registered clinical trials globally, with a focus on interventional studies.

Life Science 59

Life Science Clinical Trials Clinical Trials FDA Approval 59

Drug Discovery World

FEBRUARY 26, 2024

The US Food and Drug Administration (FDA) has approved monoclonal antibody Xolair (omalizumab) for immunoglobulin E-mediated food allergy in some adults and children one year or older for the reduction of allergic reactions (Type I).

FDA Approval 52

FDA Approval Allergies Protein Antibody 52

The Pharma Data

NOVEMBER 20, 2020

The janus kinase inhibitor baricitinib is currently FDA-approved for treating moderately to severely active rheumatoid arthritis. ” The FDA granted the EUA based on data from the ACTT-2 trial, a randomized, double-blind, placebo-controlled clinical trial conducted by the National Institute of Allergy and Infectious Diseases.

Allergies 52

Allergies FDA Approval Clinical Trials Clinical Trials 52

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.

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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. . .

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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

OCTOBER 22, 2020

With today’s FDA approval, and regulatory approvals or temporary authorizations in approximately 50 additional countries around the world, Veklury® (remdesivir) is one of the tools available today. ii] The ACTT-1 study sets a high bar for clinical evidence that must be considered as new data emerge.

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Clinical Trials Clinical Trials Trials FDA Approval 52

The Pharma Data

MARCH 2, 2021

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021. “We We are thankful for the efforts of all those who have volunteered to participate in our clinical trials, our scientists, collaborators, clinical trial sites and investigators. Phase 3 ENSEMBLE Study Design.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

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. Dupilumab Development Program. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

Medicine 52

Medicine Trials Allergies FDA Approval 52

The Pharma Data

MARCH 4, 2021

To date, dupilumab has been studied in more than 10,000 patients across 50 clinical trials in various chronic diseases driven by type 2 inflammation. These potential uses are under clinical investigation, and the safety and efficacy of dupilumab in these conditions have not been fully evaluated by any regulatory authority.

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. Source: Moderna, Inc. .

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The Pharma Data

FEBRUARY 19, 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. Dupilumab Development Program. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

Genetics 40

Genetics Antibody Trials Medicine 40

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. 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

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.

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HR Licensing Licensing FDA Approval 52

The Pharma Data

JUNE 18, 2021

BOTOX ® Cosmetic is the first and only product of its kind FDA-approved to treat three areas, temporarily improving the appearance of moderate to severe forehead lines, glabellar lines and crow’s feet in adults. Data on File, Allergan, 2016; Clinical Study Report Satisfaction Table. . . .

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Botox Cosmetics Doctors Doctor 52

The Pharma Data

NOVEMBER 16, 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. Posted: November 2020.

Vaccination 52

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The Pharma Data

SEPTEMBER 10, 2021

About BOTOX ® BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Adult Patients treated for overactive bladder due to neurologic disease: In clinical trials, 30.6% Current Perspectives on the Management of Cervical Dystonia Among Global Clinicians.

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Botox Doctors Doctor Medicine 52

The Pharma Data

MARCH 30, 2021

The study results were announced in a July 2020 press release and presented at the 2020 Virtual Migraine Trust International Symposium.

Botox 52

Botox Drugs Doctors Doctor 52

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.

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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

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.

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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.

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Sales Manufacturing FDA Approval Life Science 98

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. Dupilumab Development Program.

Trials 52

Trials Medicine Genetics Antibody 52

The Pharma Data

JULY 12, 2021

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. There is no FDA-approved vaccine to prevent COVID-19. What Is the Janssen COVID-19 Vaccine?

Vaccination 52

Vaccination Vaccine FDA Approval Allergies 52

The Pharma Data

NOVEMBER 4, 2020

VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (?500 Patients with such allergies should discontinue VASCEPA if any reactions occur. commercial team. “In

Sales 40

Sales Production Cardiology Marketing 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. Bamlanivimab FDA Approval History. See Limitations of Authorized Use. It was identified from a blood sample taken from one of the first U.S.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

Drug Discovery World

AUGUST 1, 2023

In drug discovery, its potential has skyrocketed following its use in a number of Covid-19 vaccines, with Pfizer’s Covid-19 vaccine becoming the first mRNA product to achieve full FDA approval in the US 6. The metaphorical drug discovery floodgate which opened thereafter includes Moderna’s exploration of an mRNA HIV vaccine, and in June 2022, (..)

RNA 52

RNA Drugs Gene Silencing Vaccination 52

The Pharma Data

SEPTEMBER 8, 2021

About BOTOX ® BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Adult Patients treated for overactive bladder due to neurologic disease: In clinical trials, 30.6% Atogepant is currently under review by the U.S. versus 0.4%, respectively).

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

NOVEMBER 30, 2020

Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA). I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. Source link.

Vaccination 52

Vaccination Vaccine Medicine 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.

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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.

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Vaccination Vaccine Clinical Trials Clinical Trials 81

XTalks

DECEMBER 24, 2020

As of November, the WHO has discouraged the use of the drug as the agency’s review of data from four different clinical trials yielded no worthy effect on mortality, need for mechanical ventilation, time to clinical improvement or any other important patient outcomes. Vaccine Considerations. CRISPR Therapeutics.

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