Drug Discovery World

DECEMBER 20, 2023

The US Food and Drug Administration (FDA) has approved antibody-drug conjugate (ADC) enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial cancer (la/mUC). ” Enfortumab vedotin-ejfv was co-developed by Pfizer and Astellas.

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XTalks

FEBRUARY 26, 2024

Today’s approval builds on 20 years of patient experience and an established efficacy and safety profile since Xolair was first approved in allergic asthma. Xolair is the first medication approved by the FDA to reduce allergic reactions to more than one type of food after accidental exposure.

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Pharmaceutical Technology

NOVEMBER 14, 2022

The US Food and Drug Administration (FDA) has granted accelerated approval for ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) to treat adults with folate receptor alpha (FR?)-positive, binding antibody, a cell-surface protein which is greatly expressed in ovarian cancer, as well as the maytansinoid payload DM4.

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FDA Approval Antibody Clinical Trials Clinical Trials 246

XTalks

OCTOBER 25, 2022

The FDA clearance is the first for tremelimumab, which faced an uphill battle after having suffered several failures in trials for other cancer types over the past two decades of its development, including non-small cell lung cancer, head and neck cancer and bladder cancer.

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XTalks

NOVEMBER 16, 2022

has won US Food and Drug Administration (FDA) approval for its antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine-gynx) for the treatment of platinum-resistant ovarian cancer. The drug was approved under the FDA’s accelerated pathway and is indicated for adult patients with folate receptor alpha (FR?)-positive

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XTalks

MARCH 9, 2023

The approval was granted for its use as a non-immunosuppressive therapy for the reduction of proteinuria (protein in urine) in IgA nephropathy in adults. Filspari is the first single molecule dual endothelin angiotensin receptor antagonist (DEARA) approved for this indication. g/g and be at risk of rapid disease progression.

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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

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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XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. Tyrosine Kinase Inhibitors for Cancer Treatment Tyrosine kinases, or TKs, are a group of signaling molecules that affect multiple downstream proteins.

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pharmaphorum

MARCH 29, 2021

The modified cells recognise and bind to B-cell maturation antigen (BCMA), a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of cells expressing it. The delay was caused by coronavirus restrictions delaying the site inspections necessary for approval.

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XTalks

APRIL 11, 2024

After backing from the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) last month, Johnson and Johnson (J&J) and Bristol Myers Squibb (BMS) scored FDA approvals for the use of their B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies as earlier line treatment options for multiple myeloma.

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XTalks

OCTOBER 14, 2022

Prior to the development of vaccinations for the condition, whooping cough was thought to be a childhood disease. Since infant immune systems are still developing, they are more susceptible to complications. Initially, Boostrix was approved by the FDA in 2005 as a single booster Tdap vaccine for individuals aged 10 to 18.

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XTalks

JULY 10, 2023

Euronext Brussels (UCB), a biopharma company headquartered in Brussels, Belgium, recently announced that the US Food and Drug Administration (FDA) has granted approval for its drug, Rystiggo (rozanolixizumab), for the treatment of generalized myasthenia gravis (gMG). How Does Rystiggo (Rozanolixizumab) Work?

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FDA Approval Antibody Protein Engineer 98

XTalks

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. The drug is being jointly developed and commercialized by AstraZeneca and Japan’s Daiichi Sankyo.

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Pharmaceutical Technology

FEBRUARY 21, 2023

Currently, there are no approved treatments for CHAPLE, a life-threatening hereditary immune disease caused by an overactivation of the complement system. The investigational, fully human monoclonal antibody, Pozelimab has been designed to block the complement factor C5 activity.

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XTalks

FEBRUARY 5, 2024

This article serves as a resource for healthcare professionals, life sciences researchers and industry enthusiasts seeking to stay informed of the latest developments and success stories in oncology therapeutics. Pharmacyclics requested to voluntarily withdraw the approvals and decided to forgo an opportunity for a hearing.

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pharmaphorum

FEBRUARY 11, 2021

Shares in Swiss biotech AC Immune have risen sharply after it said a vaccine in development for Alzheimer’s disease (AD) hit the mark in a phase 1/2 trial. . The vaccine stimulated antibodies against the protein in all 32 patients with early-stage AD in the study at levels that AC Immune thinks should have a therapeutic effect.

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XTalks

JUNE 5, 2023

Abrysvo is an unadjuvanted vaccine and is composed of two preF proteins selected to optimize protection against RSV A and B strains. “A While most people usually recover within a few weeks, infants and older adults are at a higher risk of developing severe complications. percent and severe RSV-associated LRTD by 94.1

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XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

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The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). It was developed with Genmab.

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Pharmaceutical Technology

AUGUST 23, 2022

It comprises messenger ribonucleic acid (mRNA) that encodes for the initial spike protein of SARS-CoV-2 along with mRNA that encodes for Omicron BA.4/BA.5 5 variant spike protein. According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1,

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The Pharma Data

DECEMBER 17, 2020

Lupus causes the production of proteins called autoantibodies in the immune system, which attack tissues and organs, including the kidneys. Farber extended congratulations to GSK on behalf of the alliance: “An effective treatment developed specifically for lupus nephritis has been desperately needed. Athenex, Inc.

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XTalks

FEBRUARY 5, 2024

This article serves as a resource for healthcare professionals, life sciences researchers and industry enthusiasts seeking to stay informed of the latest developments and success stories in oncology therapeutics. Pharmacyclics requested to voluntarily withdraw the approvals and decided to forgo an opportunity for a hearing.

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Drug Discovery World

FEBRUARY 7, 2024

Professor Jonathan Blackburn, Chief Scientific Officer (CSO) of Sengenics, featured in a sponsored DDW Sitting Down With podcast to discuss the advantages of functional protein microarrays, challenges to overcome for biomarker discovery, Sengenics’ new i-Ome Discovery chip, and more. He elaborates in the podcast.

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Medicine Protein FDA Approval DNA 59

pharmaphorum

NOVEMBER 5, 2021

Novartis has chalked up another successful trial for its targeted factor B inhibitor iptacopan, an orally-active drug trying to challenge antibody-based therapies for diseases associated with the complement pathway. The first-in-class drug also being tested in another rare kidney disease, idiopathic membranous nephropathy, in phase 2.

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XTalks

FEBRUARY 20, 2024

have announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for sibeprenlimab, an investigational drug intended for treating immunoglobulin A (IgA) nephropathy, commonly known as Berger’s disease. Consequently, this damage causes blood and protein leakage into the urine.

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Clinical Trials Clinical Trials FDA Approval Trials 59

XTalks

JUNE 28, 2023

DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells. The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile. It is injected into a patient’s muscle tissue.

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The Pharma Data

NOVEMBER 30, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. About NVX-CoV2373 NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease.

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Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

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XTalks

FEBRUARY 24, 2023

The US Food and Drug Administration (FDA) granted accelerated approval to Genentech’s Lunsumio (mosunetuzumab) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have undergone two or more lines of systemic therapy. Read Dr. Laport’s responses below to learn more!

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The Pharma Data

JANUARY 12, 2021

million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization.

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XTalks

NOVEMBER 30, 2023

Global entities such as the WHO, the Global Fund and the Joint United Nations Programme on HIV/AIDS (UNAIDS) have developed comprehensive strategies aligned with Sustainable Development Goal (SDG) target 3.3, This marked the first FDA-approved injectable, complete regimen for HIV-infected adults, administered once a month.

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XTalks

FEBRUARY 22, 2024

AstraZeneca and Daiichi Sankyo announced the US Food and Drug Administration’s (FDA) approval of their Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd). TROP2 is a protein that is widely present in most tumors associated with NSCLC. This antibody guides the therapy to the cancer.

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XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. While the exact causes of ALS are not fully understood, research suggests that the mutation of SOD1 may be linked to the development of the condition. What is SOD1 -ALS?

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FDA Approval Gene Genetics Protein 89

The Pharma Data

DECEMBER 29, 2020

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. futility analysis).

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XTalks

JUNE 15, 2022

The Novavax candidate NVX-CoV2373 is a protein-based vaccine developed using recombinant nanoparticle technology. protein that triggers the immune system to generate antibodies against the virus. If approved, NVX-CoV2373 would become the first available protein-based vaccine against COVID-19 in the US.

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XTalks

MAY 24, 2024

Due to its aggressive nature, it has a poor prognosis and quickly develops resistance to chemotherapy. Imdelltra is a novel immunotherapy, where a bispecific antibody binds to both CD3 on T cells and DLL3 on tumor cells. Alisertib is being investigated in a Phase II study for its efficacy and safety.

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