The Pharma Data

AUGUST 11, 2020

It has not received general approval to treat the virus in the US, but has in several European countries and Japan. The request for approval comes nearly two months after a study from the National Institute of Allergy and Infectious Diseases which showed positive results, with the drug effectively blocking the virus from replicating.

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Pharmaceutical Technology

JANUARY 8, 2023

There are at least six different biologics being studied in Phase III trials in COPD clinical programmes around the world. Results from a Phase III trial with Sanofi and Regeneron Pharmaceuticals’ IL-4/IL-13 monoclonal antibody (mAb) Dupixent (dupilumab) are expected by mid-2023, followed by others. Ongoing efforts.

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XTalks

JANUARY 17, 2023

While albuterol rescue inhalers are currently used to alleviate symptoms of an asthma attack, they don’t treat underlying inflammation, explained Bradley Chipps, MD, former president of the American College of Allergy, Asthma and Immunology, in a statement issued by AstraZeneca.

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FDA Approval Containment Allergies Drugs 97

The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 37% of trial volunteers are from racial and ethnic minorities.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

XTalks

DECEMBER 20, 2022

There are now 40 FDA approved biosimilars in the US. Register for this free webinar to learn about drug testing in humanized mouse models in two therapeutic areas: food allergy and inflammatory bowel diseases (IBD). Hence, companies that manufacture biosimilars do not need to run as many expensive clinical trials.

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FDA Approval Allergies Manufacturing Clinical Trials 98

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.

FDA Approval 52

FDA Approval Genome Genomics Production 52

The Pharma Data

JULY 29, 2021

Tonya Winders, CEO & President, Allergy and Asthma Network (AAN) and President of Global Allergy and Airways Patient Platform (GAAPP) commented: “Patients with chronic rhinosinusitis with nasal polyps experience unpleasant symptoms across a range of severities. Most common adverse reactions (incidence ?5%)

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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.

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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

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

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.

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Life Science Clinical Trials Clinical Trials FDA Approval 59

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.

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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). Food and Drug Administration greenlit the restart of AstraZeneca’s Phase III COVID-19 vaccine trial, the U.K.-based

Antibody 52

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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

NOVEMBER 25, 2020

Background Randomized, controlled trials are the gold standard for evaluating the safety and effectiveness of drugs. 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.

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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. This type of study reduces the potential for bias and provides the highest quality scientific evidence.

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Clinical Trials Clinical Trials Trials FDA Approval 52

The Pharma Data

APRIL 4, 2022

The target action date for the FDA decision on this investigational use is August 3, 2022. The sBLA is supported by data from two Phase 3 trials evaluating the efficacy and safety of Dupixent 300 mg weekly in patients aged 12 years and older with EoE ( Part A and Part B ), and data from an active long-term extension trial.

Medicine 52

Medicine Trials Allergies FDA Approval 52

The Pharma Data

FEBRUARY 19, 2022

A Phase 3 trial (CUPID STUDY B) evaluating Dupixent® (dupilumab) in patients with chronic spontaneous urticaria (CSU), who were refractory to omalizumab, will stop due to futility based on a pre-specified interim analysis. The safety data were generally consistent with the known safety profile of Dupixent in its approved indications.

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The Pharma Data

MARCH 4, 2021

In the trial, Dupixent significantly reduced severe asthma attacks and rapidly improved lung function within two weeks in children aged 6 to 11 years. Safety results were generally consistent with the well-established safety profile of Dupixent in the approved indication for patients aged 12 and older with moderate-to-severe asthma.

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Genetics Medicine Antibody Trials 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. There is no FDA-approved vaccine to prevent COVID-19.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

Pharmaceutical Technology

JUNE 9, 2023

Also known as palivizumab, Sobi ‘s Synagis was the first FDA-approved monoclonal antibody used in children at high risk of RSV disease. After a long period without any new approvals, in May, the FDA approved GSK’s vaccine Arexvy for the prevention of LRTD caused by RSV in individuals 60 and older.

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FDA Approval Antibody Allergies Packaging 147

The Pharma Data

FEBRUARY 13, 2022

The sBLA is supported by data from the pivotal Phase 3 trial evaluating the efficacy and safety of Dupixent added to standard-of-care topical corticosteroids (TCS) in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis.

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Medicine Genetics Antibody Allergies 40

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

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

MARCH 30, 2021

About the Phase 3 ADVANCE Study The pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was designed to evaluate the efficacy, safety, and tolerability of oral atogepant for the preventive treatment of migraine in those with 4 to 14 migraine days per month.

Botox 52

Botox Drugs Doctors Doctor 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. Department of Health and Human Services FDA Approval Letter for BOTOX® Cosmetic for Glabellar Lines, 2002.

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Botox Cosmetics Doctors Doctor 52

The Pharma Data

AUGUST 30, 2021

Results reinforce well-established safety profile of Dupixent – the first ever biologic medicine for atopic dermatitis currently approved for patients as young 6 years old. The trial demonstrated similar safety results to the known safety profile of Dupixent in atopic dermatitis. Yancopoulos, M.D., In 2016, the U.S.

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Trials Medicine Genetics Antibody 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. ages 18 and older.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

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. It is approved in the U.S. Olumiant was recently approved in Japan for the treatment of pneumonia associated with COVID-19 in hospitalized adult patients.

Antibody 52

Antibody Medicine FDA Approval Licensing 52

The Pharma Data

SEPTEMBER 10, 2021

Levodopa/Carbidopa Intestinal Gel (LCIG) Reduces Fluctuations and Shortens Time to On Without Troublesome Dyskinesia in Advanced Parkinson’s Disease: Post-Hoc Analyses of 54-week LCIG-Monotherapy Trial. Adult Patients treated for overactive bladder due to neurologic disease: In clinical trials, 30.6% versus 0.4%, respectively).

Botox 52

Botox Doctors Doctor Medicine 52

Pfizer

JULY 8, 2022

The submission included data from a Phase 2/3 randomized, controlled trial that included 4,526 children 6 months to less than 5 years of age. In the trial, children received the third 3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant. About the Phase 1/2/3 Trial in Children.

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Vaccination Vaccine Clinical Trials Clinical Trials 81

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

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 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 1 as compared to the companies’ current COVID-19 vaccine. INTERCHANGEABILITY. has a fever.

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Vaccination Vaccine Medicine Clinical Trials 100

The Pharma Data

DECEMBER 31, 2020

These reactions can be treated, and most patients with allergies can still get the vaccine. In mid-December, the FDA approved Orgovyx (relugolix), the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer. of men, compared with 88.8% Posted: December 2020.

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Vaccination Vaccine FDA Approval Hormones 52

The Pharma Data

APRIL 8, 2021

The trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28. .

FDA Approval 52

FDA Approval HR Trials Medicine 52

The Pharma Data

NOVEMBER 4, 2020

Reaffirmed c linical trial results from study of VASCEPA in China are expected by year end 2020 : Assuming positive results from this study conducted by Amarin’s commercial partner for VASCEPA in China, regulatory submission in China could follow promptly thereafter. commercial team. “In 500 mg/dL) hypertriglyceridemia.

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