XTalks

JANUARY 5, 2021

These include monoclonal antibody drugs, which are attractive therapeutic agents owing to their targeted specificity. Eli Lilly’s bamlanivimab and Regeneron’s monoclonal antibody cocktail REGEN-COV2 which consists of two monoclonal antibodies, casirivimab and imdevimab, were approved in 2020 for use in the treatment of COVID-19 patients.

Life Science 98

Life Science Clinical Trials Clinical Trials Trials 98

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.

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

XTalks

JULY 10, 2023

Rystiggo received FDA approval under the Priority Review designation, specifically for the treatment of gMG in adult patients who have tested positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. How Does Rystiggo (Rozanolixizumab) Work?

FDA Approval 98

FDA Approval Antibody Protein Engineer 98

XTalks

AUGUST 2, 2022

Benlysta (belimumab) is a biologic therapy, a human monoclonal antibody. Autoreactive B cells release antibodies like other B cells do, except they release autoantibodies. B cells require a specific protein for growth called BLyS (B-lymphocyte stimulator), which is implicated in the pathogenesis of SLE.

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FDA Approval Antibody Bacteria Protein 94

XTalks

FEBRUARY 20, 2024

IgA nephropathy is an autoimmune condition characterized by the deposition of clusters of antibodies in the kidneys, resulting in inflammation and kidney impairment. These clusters, primarily comprised of IgA and other antibodies, harm the glomeruli, which are small blood vessels responsible for filtering blood in the kidneys.

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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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Gene Therapy Gene Protein FDA Approval 98

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.

Antibody 59

Antibody Clinical Trials Clinical Trials Trials 59

XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. aiming to end the HIV epidemic by 2030.

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FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

XTalks

JANUARY 8, 2024

Initially receiving accelerated approval in December 2021 based on proteinuria as a surrogate marker, Tarpeyo has now achieved the status of being the first treatment for IgAN to receive full FDA approval predicated on evaluations of kidney function.

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FDA Approval Clinical Trials Clinical Trials Nurses 64

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.

Drugs 52

Drugs FDA Approval Sales Vaccination 52

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. New treatment options are critically needed for FL.

FDA Approval 52

FDA Approval Drugs Antibody Medicine 52

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. The disorder primarily affects males.

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Gene Therapy Gene FDA Approval Antibody 98

XTalks

MAY 1, 2023

Qalsody contains tofersen, an antisense oligonucleotide that specifically targets the mRNA made from mutated SODI genes to prevent the formation of toxic SOD1 proteins. Tegoprubart is an anti-CD40L antibody designed to inhibit the CD40 and CD11 costimulatory signaling pathways. How Does Qalsody Work?

FDA Approval 89

FDA Approval Gene Genetics Protein 89

XTalks

MARCH 28, 2024

Furthermore, the introduction of multi-targeted kinase inhibitors and monoclonal antibodies is also being examined as a possible form of therapy. Building Cancer Awareness and Empowering Métis Youth: Featuring Jordyn Playne, President, Métis Nation of Ontario Youth Council – Xtalks Life Science Podcast Ep.

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Gene Editing Life Science Clinical Trials Clinical Trials 59

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.

Vaccination 59

Vaccination Vaccine Immune Response Protein 59

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

XTalks

MARCH 6, 2024

Despite the disappointing launch of Aduhelm and questions around Leqembi, companies like Eli Lilly are continuing to pursue their beta-amyloid monoclonal antibody therapies. Lilly is currently conducting a Phase III trial evaluating its beta-amyloid targeting monoclonal antibody, donanemab.

FDA Approval 69

FDA Approval In-Vitro Research Marketing 69

XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

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FDA Approval Drugs Sales Development 101

XTalks

MAY 2, 2023

In December 2021, AstraZeneca and Amgen’s Tezspire (tezepelumab) was approved by the FDA for patients 12 years of age and older with severe asthma that is not controlled by their current asthma medicine. Tezspire is the first treatment for asthma that targets thymic stromal lymphopoietin, a protein involved in airway inflammation.

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Protein FDA Approval Clinical Trials Clinical Trials 109

XTalks

NOVEMBER 26, 2020

In addition to innovative new antibody drugs and mRNA vaccines, researchers have found that the sleep-regulating hormone melatonin may also offer protection against COVID-19. This approach allowed them to find disease conditions similar to COVID-19 for which approved treatments were available.

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Research Hormones Protein Regulation 98

Drug Discovery World

DECEMBER 13, 2023

This article is sponsored by Fortis Life Sciences. In the ever-evolving landscape of therapeutic development, the role of antibodies has become increasingly apparent. Antibodies are used as therapeutics, components of therapeutics such as antibody-drug conjugates (ADC) and CAR-T cells, and as companion diagnostic tools.

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Life Science Antibody Manufacturing In-Vivo 59

The Pharma Data

DECEMBER 8, 2020

December is bringing frost in the North and plenty of cold hard cash for these life sciences companies. . European venture capital firm Forbion rounded up $545 million for its fifth life sciences fund. The rest will be invested in “highly impactful existing companies.” The promise to partners is to “move quickly.

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RNA Antibody Life Science Protein 52

XTalks

MAY 10, 2023

GSK’s Benlysta (belimumab) is a monoclonal antibody that was approved by the US Food and Drug Administration (FDA) in 2011 for the treatment of SLE. What’s special about Benlysta is that it was the first and only approved biologic for SLE in over five decades.

Drugs 52

Drugs Clinical Trials Clinical Trials Antibody 52

XTalks

AUGUST 17, 2020

protein-based biologics) and vaccine treatments. Monoclonal antibodies : these are antibodies that are designed to bind to specific targets on cells. protein-based biologics) : are those which bind to specific components (i.e. chimeric receptor antigen [CAR] T cell) immune modulators (i.e. Immune system modulators (i.e.

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Protein Engineer Immune Response In-Vivo 98

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.

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

FDA Approval 52

FDA Approval Drugs Sales Development 52

XTalks

OCTOBER 25, 2022

Imjudo is an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) monoclonal antibody that blocks the action of CTLA-4. Inhibition of the protein aids in T-cell activation to prime the immune system against cancer cells to induce their death.

FDA Approval 98

FDA Approval Trials Immune Response Drugs 98

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

FDA Approval 98

FDA Approval Antibody Drugs Trials 98

XTalks

OCTOBER 14, 2022

Register for this free webinar to learn about total protein analysis, and quality control of vaccines and other protein-based therapeutics by total nitrogen determination. When Boostrix is administered during pregnancy, protective antibodies are boosted in the mother and are then transferred to the developing baby.

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FDA Approval Vaccination Vaccine Protein 98

XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Another method to isolate CTCs is by antibody targeting of white blood cells for removal, followed by collection of untagged CTCs.

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Clinical Trials Clinical Trials Trials FDA Approval 98

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 The genetic material of RSV (respiratory syncytial virus) encodes 11 proteins. The F-protein facilitates the fusion of the virus with the membrane of the host cell. billion by 2028.

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Vaccination Vaccine FDA Approval Protein 98

XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax. Malaria Vaccine Phase II Trial. Vaccine efficacy was sustained at one year in the high-dose adjuvant group.

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Vaccination Vaccine Immune Response Trials 105

XTalks

MAY 25, 2021

Biosimilar and interchangeable products can expand treatment options and lower drug and healthcare costs by offering a cheaper alternative with the same effectiveness; essentially a non-branded version of a biologic such as monoclonal antibodies, proteins and vaccines. million in 2019, according to Fortune Business Insights.

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Production Drugs Marketing Sales 98

XTalks

MAY 31, 2023

One of its notable candidates is izokibep, a small protein inhibitor of interleukin-17A (IL-17A). Another noteworthy candidate from Acelyrin’s pipeline is lonigutamab, an anti-IGF-1R monoclonal antibody administered via subcutaneous delivery.

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Clinical Trials Clinical Trials Trials Production 97

XTalks

SEPTEMBER 17, 2020

Nizoral is prescribed off-label, while the others are FDA approved. Dietary changes, including restriction of salt and animal protein, are also recommended. It’s caused by mutations in the DMD gene, which encodes the dystrophin protein; dystrophin plays an important role in supporting muscle fibers.

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Trials Gene Hormones Clinical Trials 98

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

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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FDA Approval HR Hormones Antibody 98