STAT News

NOVEMBER 14, 2022

The Food and Drug Administration on Monday approved a new treatment for patients with advanced ovarian cancer — an antibody that delivers a targeted dose of chemotherapy directly to cancer cells. market in more than seven years, and the first approval of a wholly owned medicine in Immunogen’s 41-year history.

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Medicine FDA Approval Antibody Drugs 98

Pharmaceutical Technology

APRIL 17, 2023

Pharmaceutical company Genmab is entering a partnership with argenx to develop antibody therapies for oncology and immunology. This collaboration is being made to combine the companies’ capabilities to develop novel therapeutic antibodies with applications in the two disease areas.

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Antibody Engineer FDA Approval Development 130

XTalks

OCTOBER 16, 2024

Regulatory filings for Europe are also in progress, with a marketing authorization application submitted to the European Medicines Agency (EMA) in 2023. If approved, the biosimilar will be marketed in the European Union (EU). Dong-A ST plans to expand Imuldosa’s global footprint, aiming to secure additional regulatory approvals.

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FDA Approval Marketing Pharmacy Development 103

XTalks

JULY 3, 2024

They also both harbor a boxed warning for the risk of amyloid-related imaging abnormalities (ARIA), which are known side effects of antibodies that target beta-amyloid aggregates. The agency announced in 2022 that it will cover monoclonal antibodies directed against amyloid for Alzheimer’s disease provided they have full FDA approval.

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FDA Approval Antibody Drugs Life Science 98

XTalks

MAY 26, 2022

The US FDA approved Dupixent (dupilumab) developed by Regeneron as the first treatment for eosinophilic esophagitis, a chronic immune disorder that damages the esophagus. It is already approved for three other diseases, and EoE is the first gastrointestinal disease included in this group.

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FDA Approval Antibody Clinical Trials Clinical Trials 105

XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. Results from the ALPINE study have been published in the New England Journal of Medicine. Brukinsa is also indicated to treat adults with Mantle cell lymphoma, Waldenström’s macroglobulinemia and relapsed or refractory marginal zone lymphoma.

FDA Approval 97

FDA Approval Life Science Clinical Trials Clinical Trials 97

XTalks

FEBRUARY 26, 2024

Xolair is the first medication approved by the FDA to reduce allergic reactions to more than one type of food after accidental exposure. Xolair is a monoclonal antibody that binds to IgE, a type of antibody in the body that triggers allergic reactions, to block it from binding to its receptors.

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Allergies FDA Approval Drugs Protein 100

Pharmaceutical Technology

JANUARY 10, 2023

On November 17, 2022, the FDA approved Provention Bio’s Tzield (teplizumab) , making it the first and only treatment to delay the onset of type 1 diabetes (T1D). The FDA approval paves the way for the immunotherapy to undergo review in other countries. With up to 2.3

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Insulin FDA Approval Research Development 246

Pharmaceutical Technology

SEPTEMBER 2, 2022

lenalidomide) + a steroid ± an anti-CD38 antibody. Last month, the European Medicines Agency's (EMA) approval of Johnson & Johnson’s (J&J) anti-CD3/BCMA bispecific antibody Tecvayli (teclistamab) marked the fourth anti-BCMA biologic to enter the R/R MM market. Should CAR-T cells, or antibodies be used first?

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Pharmaceutical Technology

OCTOBER 26, 2022

The treatment is indicated for such patients who had received four or more previous lines of therapy, including an immunomodulatory drug, proteasome inhibitor and anti-CD38 monoclonal antibody. Based on the response rate from a trial, the regulatory agency approved the indication under an accelerated approval process.

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Antibody FDA Approval Clinical Trials Clinical Trials 130

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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FDA Approval Vaccination Vaccine Clinical Trials 102

XTalks

AUGUST 14, 2024

The US Food and Drug Administration (FDA) has approved Galderma’s monoclonal antibody Nemluvio (nemolizumab) for the treatment of adult patients with the chronic skin condition prurigo nodularis. Monoclonal antibody therapy has been found to have fewer side effects when compared to immunosuppressant drugs.

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Drug Delivery Systems Dermatology Drug Delivery Antibody 111

XTalks

JULY 10, 2023

UCB specializes in the discovery and development of innovative medicines for severe diseases that affect the immune system or central nervous system. Rystiggo (rozanolixizumab) is a medication indicated for the treatment of gMG in adult patients who test positive for AChR or MuSK antibodies. What Is Generalized Myasthenia Gravis (gMG)?

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FDA Approval Antibody Protein Engineer 98

Pharmaceutical Technology

NOVEMBER 9, 2022

After its approval, bluebird had set Zynteglo’s price at roughly EUR1.6 Since its FDA approval in August 2022, the beta-thalassemia therapy was launched in the US with a $2.8 The European Commission withdrew the marketing authorisation of Zynteglo, at the request of bluebird bio, in March 2022. million ($1.8 million price tag.

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Gene Therapy Gene FDA Approval Medicine 278

XTalks

MAY 9, 2024

Genmab, a trailblazer in the field of antibody therapeutics, celebrates this milestone by reflecting on its impressive journey from a small-scale startup to a global leader in cancer treatment and beyond. Since then, innovative science has been at Genmab’s core, as we harness the power of human antibodies to improve the lives of patients.

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XTalks

JANUARY 3, 2025

In the fourth quarter of 2023, Eylea HD generated impressive US net sales of $123 million, reflecting a robust market launch following its FDA approval in August 2023. FDA approval was granted following promising results from several trials. Related: Top 30 Drugs to Watch in 2024: Insights from 2023 Sales Data 1.

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Pharmaceutical Technology

NOVEMBER 13, 2022

A human monoclonal antibody (mAb), Imfinzi attaches to the PD-L1 protein and hinders its interaction with the PD-1 and CD80 proteins, preventing the immune-evading strategy of the tumour. Imjudo (tremelimumab) is also a mAb that acts on the cytotoxic T-lymphocyte-associated protein 4’s (CTLA-4) activity.

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Protein FDA Approval Antibody Trials 130

XTalks

APRIL 17, 2023

Monoclonal antibodies are gaining attention as alternative or additive treatments for atopic dermatitis. Lebrikizumab is a new and investigational monoclonal antibody designed to selectively inhibit IL-13. “In Most TEAEs were mildly or moderately severe and resulted in a low frequency of treatment discontinuation.

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Dermatology Antibody Clinical Trials Clinical Trials 97

Delveinsight

NOVEMBER 26, 2020

About 35% of the animals were cleared of their tumors as reported in Science Translational Medicine. However, Urovant progressed quickly for filing for FDA approval earlier this year in a bid to set vibegron as a rival to beta-3 agonist Myrbetriq of Astellas. Genmab discards antibody-drug conjugate after the early-phase fiasco.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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Pharmaceutical Technology

AUGUST 23, 2022

According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1, The companies have also commenced rolling submission for conditional marketing authorization from the European Medicines Agency (EMA) for this Omicron BA.4/BA.5-adapted

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Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system. 1 Adapted Bivalent Vaccine Candidate. Tue, 07/19/2022 - 11:22. INTERCHANGEABILITY.

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XTalks

NOVEMBER 1, 2024

Price of Ocrevus: $78,858 annually Why it sold so well: Ocrevus is a therapeutic monoclonal antibody that offers a unique scientific approach to treating MS. Why it sold so well: Botox is FDA-approved for the treatment of chronic migraines and that is currently the only chronic condition for which it has received approval.

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FDA Approval Drugs Botox Sales 85

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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pharmaphorum

OCTOBER 31, 2022

s Inmazeb (consisting of the monoclonal antibodies atoltivimab, maftivimab, and odesivimab-ebgn). It is the first FDA-approved treatment for Zaire ebolavirus. The “normal and robust” immune response exhibited has become what is considered to be the “gold standard” for developing human antibody therapeutics.

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Production FDA Approval Antibody Gene 52

pharmaphorum

SEPTEMBER 20, 2022

Findings from the litifilimab trial, undertaken by Northwell Health’s Division of Rheumatology and The Feinstein Institutes for Medical Research, have been published in the New England Journal of Medicine and show promise for those who have been diagnosed with systemic lupus erythematosus (SLE). Sponsored by Biogen Inc.,

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Trials Clinical Trials Clinical Trials FDA Approval 111

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

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Pharmaceutical Technology

FEBRUARY 24, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Amivantamab overview Amivantamab-vmjw (Rybrevant) is a low-fucose human immunoglobulin G1-based bispecific antibody developed using recombinant DNA technology. It is based on DuoBody technology platform.

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Recombinant DNA Technology Production Antibody FDA Approval 100

XTalks

JANUARY 20, 2025

This strategic move transformed Actavis into one of the largest pharma companies globally, with a strong presence across branded, generic and over-the-counter (OTC) medicines. The integration of Shire strengthened Takedas R&D pipeline, increasing its focus on innovative medicines and transformative therapies.

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Marketing Botox Life Science Pharma Companies 104

The Pharma Data

JUNE 7, 2022

New Indication for Amgen’s Fifth FDA-approved Biosimilar. Now Approved to Treat All Available Rituxan ® Indications. There are currently five biosimilars approved in the U.S. and three approved in the European Union (EU) in Amgen’s portfolio. Amgen (NASDAQ:AMGN) today announced that the U.S.

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FDA Approval Antibody Medicine Manufacturing 52

pharmaphorum

AUGUST 19, 2022

If approved, garadicimab will slot into CSL’s product line alongside two C1 esterase inhibitor medicines, namely Berinert which is administered by intravenous injection to treat HAE attacks, and Haegarda which is given twice-weekly as a subcutaneous injection for prevention. It is administered as an intravenous injection.

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Antibody Sales FDA Approval Genetics 52

pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. Novartis added inclisiran to its pipeline after buying The Medicines Company – which had licensed the drug from Alnylam – for $9.7 It has a long way to go.

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Drugs Sales Antibody FDA Approval 105

XTalks

JUNE 30, 2023

It’s been a big week for cell and gene therapy approvals in the US, including a much-awaited approval for one to treat hemophilia A, the most common form of hemophilia. The approval came after a couple of setbacks, including a rejection in 2020 and a delay earlier this year.

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Gene Therapy Gene FDA Approval Antibody 98

Scienmag

SEPTEMBER 28, 2021

Oncotarget published “Tissue biodistribution and tumor targeting of near-infrared labelled anti-CD38 antibody-drug conjugate in preclinical multiple myeloma” which reported that Daratumumab is an FDA-approved high-affinity monoclonal antibody targeting CD38 that has shown promising therapeutic efficacy in double refractory multiple myeloma (..)

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FDA Approval Antibody Drugs Medicine 52

Pharmaceutical Technology

APRIL 24, 2023

Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages. This intersection will be remembered as one of the most significant achievements in science and medicine”. This design protects antibodies from the innate immune system.

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Drug Delivery Vaccination Vaccine Research 147

The Pharma Data

OCTOBER 14, 2021

Roche announced that gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s disease (AD).

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Antibody Medicine In-Vitro Trials 52

The Pharma Data

AUGUST 31, 2020

Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. Current serology-based testing methods rely on the ability to detect an antibody or antigen response.

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FDA Approval In-Vitro Antibody Medicine 52