The Pharma Data

DECEMBER 30, 2020

billion acquisition of immuno-oncology company Forty Seven and its lead asset, magrolimab, a monoclonal antibody in the clinic for several cancers, including myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) and diffuse large B-cell lymphoma (DLBCL). It began in May with the $4.9 Magrolimab targets CD47. Most Read Today.

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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). Aridis Chief Executive Officer Vu Truong believes his company has a better solution – an inhaled antibody.

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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. Xolair is the only approved antibody designed to target and block immunoglobulin E (IgE). indications. In the U.S.,

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The Pharma Data

NOVEMBER 16, 2020

and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. About the COVID-19 Prevention Network: The COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. Source: NIH. Posted: November 2020. Source link.

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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. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age.

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The Pharma Data

MARCH 4, 2021

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. Detailed results from this Phase 3 trial will be published later this year.

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The Pharma Data

FEBRUARY 19, 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. About Dupixent. Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

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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.

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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.

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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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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.

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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. Source: FDA. Related Articles: Veklury (remdesivir) FDA Approval History. Source link.

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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.

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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. .

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The Pharma Data

JULY 29, 2021

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. It is also approved for the treatment of certain hospitalized patients with COVID-19 in Japan.

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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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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.

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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.

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The Pharma Data

JANUARY 6, 2021

Studies Show Cyto-111 Enables Delivery of Antibodies to Previously Inaccessible Intraneuronal Targets without the need for a Viral Vector or Transfection. The complete text of the article titled, “Neuronal Delivery of Antibodies has Therapeutic Effects in Animal Models of Botulism,” can be found h e re. NEW YORK, Jan.

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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). OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. Warnings and Precautions ?in

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The Pharma Data

AUGUST 30, 2021

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. It is not an immunosuppressant and does not require lab monitoring. Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

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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

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

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

JANUARY 27, 2023

This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. This work is undertaken once a new variant of concern has been identified by public health authorities.

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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. First-quarter sales in the U.S.

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The Pharma Data

SEPTEMBER 8, 2021

Related Peptide Monoclonal Antibody Therapy Added to OnabotulinumtoxinA Treatment. Real-World Evidence for the Safety and Efficacy of CGRP Monoclonal Antibody Therapy Added to OnabotulinumtoxinA Treatment for Migraine Prevention in Adult Patients with Chronic Migraine. September 8, 2021. BOTOX ® (onabotulinumtoxinA).

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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.

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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. There is no FDA-approved vaccine to prevent COVID-19.

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XTalks

DECEMBER 24, 2020

Most antibody drugs and vaccines have been developed to target parts of the spike protein. Drug Approvals. So far, the FDA has approved a handful of drugs for the treatment of COVID-19. These include remdesivir, baricitinib, dexamethasone and three antibody drugs.

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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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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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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.

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The Pharma Data

OCTOBER 30, 2020

Gilead’s Veklury (remdesivir) is First Approved Treatment for COVID-19 . In October, the US Food and Drug Administration (FDA) approved the first treatment for COVID-19, Gilead’s antiviral drug Veklury (remdesivir). Rash, allergy and infusion site reactions may also occur. Professional. 2018. .

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