FDA Approval, In-Vivo and Protein - Clinical Research Informer

This week in drug discovery (18-22 March)

Drug Discovery World

MARCH 22, 2024

This has been an interesting week for cell and gene therapies, with two landmark FDA approvals, two significant fundraising efforts and potentially ground-breaking study results in glioblastoma. The post This week in drug discovery (18-22 March) appeared first on Drug Discovery World (DDW).

Gene Therapy

Gene Therapy In-Vivo FDA Approval Drugs

Lyfgenia and Casgevy Become First FDA-Approved Gene Therapies for Sickle Cell Disease

XTalks

DECEMBER 13, 2023

The landmark approvals were awarded to bluebird bio’s Lyfgenia (lovo-cel) and Vertex Pharmaceuticals and CRISPR Therapeutics’ jointly developed Casgevy (exa-cel). Both gene therapies are approved for individuals 12 years of age and older with sickle cell disease. It also affects Hispanic Americans, but at a lower prevalence.

Gene Therapy

Gene Therapy FDA Approval Gene In-Vivo

FDA-approved drug sensitises brain cancer cells to radiotherapy

Drug Discovery World

JANUARY 23, 2023

This action sensitised GBM cells to radiotherapy both in vitro and in vivo (in mouse models). “Our research has revealed cladribine as a radiosensitiser for GBM treatment by drug repurposing, which can offer multiple advantages,” says Prof Youn. “Our GBM is a WHO grade IV brain tumour with dismal prognosis.

FDA Approval

FDA Approval Drugs In-Vivo In-Vitro

Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor

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

FDA Approval Manufacturing In-Vivo Trials

Lilly, Novo Nordisk and Vertex lead on market capitalisation growth

Drug Discovery World

FEBRUARY 22, 2024

Lilly’s growth was further fuelled by Mounjaro’s FDA approval for the treatment of obesity received in Q3, with Mounjaro forecasted to reach global forecast sales of $4.7 in 2023, fuelled by the FDA approval of its CRISPR-based ex vivo cell therapy Casgevy. market capitalisation growth to $3.67 billion for 2023.

Marketing

Marketing FDA Approval In-Vivo Sales

AI company raises $3m to develop antibodies targeting GPCRs

Drug Discovery World

MARCH 1, 2023

Antiverse has successfully identified functional antibody clusters targeting two G-protein-coupled receptors (GPCRs), both displaying versatile binding profiles and nanomolar affinity. The company has raised $3 million in funding, which will enable in-house development of the antibodies showing the highest affinity blocking function.

Antibody

Antibody Development In-Vivo FDA Approval

Biologics – The Next Step in Revolutionary Medication

Roots Analysis

JANUARY 14, 2024

Given the ongoing scientific advancements and the rise of FDA-approved biologics, the pharmaceutical industry seems to be approaching the era of biologics. In fact, biologics are anticipated to play a significant role in shaping the pharmaceutical industry and will eventually serve as an integral part of traditional medicines.

Contract Manufacturing

Contract Manufacturing Manufacturing Protein Bacteria

Company Spotlight: Cue Biopharma Innovates in the Immunotherapy Space with its Immuno-STAT Platform

XTalks

AUGUST 17, 2020

protein-based biologics) and vaccine treatments. This typically involves taking T cells from the body, engineering chimeric receptor antigens (CAR) and inserting them into the cells, expanding the cells ex vivo and injecting them back into the body. protein-based biologics) : are those which bind to specific components (i.e.

Protein

Protein Engineer Immune Response In-Vivo

Taking a new approach to tackle neurodegenerative diseases

Drug Discovery World

OCTOBER 4, 2022

New York-based Oligomerix is an emerging clinical-stage biotechnology company focused on developing disease-modifying therapeutics for neurodegenerative diseases characterised by aberrant tau protein ranging from rare tauopathies such as progressive supranuclear palsy (PSP) and frontotemporal dementia (FTD) to Alzheimer’s disease (AD).

Development

Development In-Vivo Compound Screening Clinical Development

What the Glycome Can Tell Us About Persistent HIV Infection

XTalks

AUGUST 12, 2020

Related: FDA Approves Rukobia for HIV Patients with Limited Treatment Options. Studies have identified the presence of two types of HIV-infected CD4+ T cells: ‘Transcriptionally inactive’ cells that do not typically produce viral RNA or viral proteins. The research study was published in Cell Reports.

RNA

RNA Protein DNA In-Vivo

Bluebird’s $2.8M Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta Thalassemia

XTalks

AUGUST 19, 2022

Along with beti-cel, there is one being developed for sickle cell (approved in Europe as Skysona or eli-cel) and another being jointly developed with Bristol Myers Squibb for melanoma. The road to Zynteglo’s approval was a bit rocky and included an FDA delay (the most recent in June) over production test concerns.

Gene Therapy

Gene Therapy FDA Approval Gene Clinical Trials

ImmunityBio’s hAd5 T-Cell COVID-19 Vaccine Candidate Shows Complete Protection of Airways in Non-Human Primates

The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response.

Vaccination

Vaccination Vaccine Immune Response Protein

Fortis Life Sciences leads the way in custom antibody discovery

Drug Discovery World

DECEMBER 13, 2023

Custom antibodies can be developed for pharmacokinetic assays and biodistribution assays, supporting therapeutic development by giving researchers data about the behaviour of their novel therapeutic in vivo. This article is sponsored by Fortis Life Sciences.

Life Science

Life Science Antibody Manufacturing In-Vivo

Can liquid biopsies transform precision medicine?

Drug Discovery World

JANUARY 17, 2024

Brett Swansiger, Chief Commercial Officer at ANGLE discusses the importance of liquid biopsies in precision medicine trials for cancer. As such there is a need to develop fast and accurate methods to assess drug safety and efficacy, facilitating early success or failure.

Medicine

Medicine DNA Genome Genomics

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

APRIL 27, 2021

Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% at CER driven by growth drivers Dupixent ® and Vaccines. Specialty Care sales grew 15.3%, due to strong Dupixent ® performance (+45.6% to €1,047 million) and oncology launches. General Medicines core assets grew 4.4%, while GBU sales were down 3.8%.

Sales

Sales Vaccination Vaccine Medicine

Transgene Announces Detailed Results From Clinical Study of TG4001 in Combination With Avelumab in Advanced HPV-positive Cancers

The Pharma Data

OCTOBER 26, 2020

Following the unauthorized download of all abstracts on the SITC website, Transgene is communicating the content of the late-breaking poster abstract that will be presented at the SITC 35th Anniversary Annual Meeting (SITC 2020), to be held virtually November 9-14, 2020. Key findings of the trial: .

Vaccination

Vaccination Vaccine Trials Containment

Advances in neuroscience drug discovery

Drug Discovery World

FEBRUARY 22, 2024

According to Medicine Discovery Catapult, these include: “Navigating the complexity of the CNS; understanding the disease pathology, and accessing predictable in vitro and in vivo cell models 2 ”. Dementia is the only major cause of death without a treatment to prevent, slow or stop disease progression. “In In 2019, dementia accounted for 1.8

Drugs

Drugs Gene Clinical Trials Clinical Trials

Clinical Research Informer

This week in drug discovery (18-22 March)

Lyfgenia and Casgevy Become First FDA-Approved Gene Therapies for Sickle Cell Disease

Trending Sources

FDA-approved drug sensitises brain cancer cells to radiotherapy

Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor

Lilly, Novo Nordisk and Vertex lead on market capitalisation growth

AI company raises $3m to develop antibodies targeting GPCRs

Biologics – The Next Step in Revolutionary Medication

Company Spotlight: Cue Biopharma Innovates in the Immunotherapy Space with its Immuno-STAT Platform

Taking a new approach to tackle neurodegenerative diseases

What the Glycome Can Tell Us About Persistent HIV Infection

Bluebird’s $2.8M Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta Thalassemia

ImmunityBio’s hAd5 T-Cell COVID-19 Vaccine Candidate Shows Complete Protection of Airways in Non-Human Primates

Fortis Life Sciences leads the way in custom antibody discovery

Can liquid biopsies transform precision medicine?

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

Transgene Announces Detailed Results From Clinical Study of TG4001 in Combination With Avelumab in Advanced HPV-positive Cancers

Advances in neuroscience drug discovery

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