Delveinsight

FEBRUARY 11, 2021

Verily collaborates with Janssen to launch COVID-19 immune response study. Verily is partnering with Johnson & Johnson’s Janssen division to witness the body’s earliest immune responses to a coronavirus infection, with people participating in the research from within their homes. .

Gene Therapy 52

Gene Therapy Gene Immune Response In-Vivo 52

Camargo

DECEMBER 13, 2021

The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. CBER regulates products under a variety of regulatory authorities: INDs for CBER-regulated products. Section 351(a) is the traditional pathway for approving biologics under the PHS Act. BLA process (CBER).

Development 161

Development Production Immune Response Licensing 161

Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. Bivalent vaccines work by stimulating an immune response against two different antigens, whereas monovalent vaccines only target one antigen. 1 sub-lineage on 19 July.

Manufacturing 130

Manufacturing Vaccination Vaccine Packaging 130

Drug Discovery World

AUGUST 2, 2023

Palmitoyl transferases are a zinc finger Asp-His-His-Cystype (ZDHHC) family containing 23 distinct mammalian genes (excluding ZDHHC10) that catalyse this reaction 1. The intracellular storage of PD-L1 and its active redistribution to the cell membrane was shown to play an important role in response to checkpoint inhibitors.

Protein 52

Protein Immune Response In-Vitro Regulation 52

Drug Discovery World

MAY 6, 2024

A more established Amsterdam-based enterprise is gene therapy company uniQure, developer of etranacogene dezaparvovec, the first gene therapy for haemophilia B, which was approved for use in the US in November 2022 and in the EU in February 2023. The rights for etranacogene dezaparvovec were subsequently sold to CSL Pharmaceuticals.

Drugs 59

Drugs Life Science Gene Editing Gene 59

pharmaphorum

MAY 18, 2021

.” The interim phase 2 results show that two doses of the plant-derived jab stimulated neutralising antibody levels that are around 10 times higher than those in a panel of sera from patients recovering from COVID-19, with a similar response seen in adults and the elderly.

Immune Response 62

Immune Response Vaccination Vaccine Gene Sequencing 62

XTalks

APRIL 26, 2021

This is because there are thousands of genes in malaria parasites compared to only about a dozen or so in coronaviruses. Moreover, a very strong immune response is needed to fend off the disease. That’s a real technical challenge,” said Hill, “The vast majority of vaccines haven’t worked because it’s very difficult.”.

Vaccination 105

Vaccination Vaccine Immune Response Trials 105

Advarra

JANUARY 11, 2024

As researchers continue to identify better cellular targets and expand and improve upon immunotherapy approaches, they become better able to predict patient response and better able to learn from cancer cells’ attack strategies. Monoclonal Antibodies Monoclonal antibodies are lab-engineered immune system proteins.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

pharmaphorum

FEBRUARY 9, 2021

InteRNA is focusing on the development of gene-silencing drugs based on microRNA, naturally occurring, non-coding strands of RNA that are thought to regulate gene expression in cells.

Trials 57

Trials Gene Silencing RNA Gene Expression 57

The Pharma Data

JULY 6, 2021

PGRN is a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, making it one of the most attractive genetically validated targets for the development of new immuno-neurology treatments. In one form, FTD-GRN, people have a mutation in the progranulin gene.

Genetics 52

Genetics Gene Antibody Development 52

Delveinsight

SEPTEMBER 23, 2021

858’s drug candidates include proteins, which regulate RNA and immune response. Novartis is expanding its optogenetics portfolio with the acquisition of gene therapy company Arctos Medical. Mutations can cause IRDs in more than 100 genes. The financial terms of the deal were not revealed.

RNA 61

RNA Gene Therapy Gene Protein 61

Drug Discovery World

AUGUST 1, 2023

According to the company, a single nucleotide substitution in the PNPLA3 gene results in a mutation that impairs the breakdown of fat in liver cells which raises the risk of NASH. This Phase I trial will test the experimental vaccine, known as H1ssF-3928 mRNA-LNP, for safety and its ability to induce an immune response.

RNA 52

RNA Drugs Gene Silencing Vaccination 52

pharmaphorum

MAY 20, 2021

billion, said that results will be used as the basis for filings with the FDA and other regulators. PD-1 inhibitors have a low response rate in this form of cancer, working in only around a fifth of patients as their tumours aren’t easily targeted by the immune system. Favezelimab.

Drugs 52

Drugs Immune Response Trials Regulation 52

The Pharma Data

MARCH 25, 2021

“The results of this study suggest that targeting the LAG-3 pathway in combination with PD-1 inhibition may be a key strategy to enhance the immune response and help improve outcomes for these patients.”. Lymphocyte-activation gene 3 (LAG-3) is a cell-surface molecule expressed on effector T cells and regulatory T cells (Tregs).

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

Roots Analysis

OCTOBER 30, 2023

These RNA based therapeutics play a crucial role in protein production and regulation of gene functions. Self-amplifying RNA (saRNA): Self amplifying RNA is an engineered form of RNA, combining the amplifying genome (native to certain viruses) to the therapeutic gene of interest.

RNA 40

RNA Vaccination Vaccine Development 40

WCG Clinical

MAY 28, 2024

This proliferative capacity allows a rapid response to an incoming threat, such as a viral infection. T cells and B cells also express specialized antigen receptors that impart specificity to the immune response, directing immune attack against foreign “non-self” targets while sparing “self” targets expressed by healthy tissue.

In-Vivo 52

In-Vivo Clinical Trials Clinical Trials FDA Approval 52

Pharmaceutical Technology

APRIL 24, 2023

With early nanoparticle studies, researchers often found the human body’s innate immune response to drugs and the short-lasting effects of drugs challenging, as they can also reduce a drug’s efficacy. Conde says the use of nanoparticle delivery for gene therapies has become more common over recent years.

Drug Delivery 147

Drug Delivery Vaccination Vaccine Research 147

XTalks

SEPTEMBER 17, 2020

Often, the potential patient pool for a given trial is small and the unmet need is high, incentivizing drugmakers and regulators to find innovative ways to make game-changing therapeutics available to those who need them most. Treatment: The standard of care for treating patients with DMD involves the use of corticosteroids.

Trials 98

Trials Gene Hormones Clinical Trials 98

Drug Discovery World

FEBRUARY 15, 2023

Cancer is a complex heterogenous multistep disease characterised by uncontrolled cell proliferation combined with a dysregulated immune response. A healthy immune system is naturally primed to eliminate malignant and abnormal cells through a synchronised and dynamic interplay between adaptive and innate immunity.

Research 52

Research In-Vitro In-Vivo Development 52

Drug Discovery World

APRIL 12, 2023

According to a McKinsey & Company article 2 , new drug modalities (such as RNA therapeutics, protein degraders, cyclopeptides, ADCs, cell and gene therapies) have almost doubled from 11% to 21% of the drug pipeline. For some pharmaceutical companies, like AstraZeneca 3 , 30% of their early pipeline consists of new drug modalities.

Development 52

Development In-Vivo Drugs In-Vitro 52

Drug Discovery World

JANUARY 20, 2023

According to a McKinsey & Company article 2 , new drug modalities (such as RNA therapeutics, protein degraders, cyclopeptides, ADCs, cell and gene therapies) have almost doubled from 11% to 21% of the drug pipeline. For some pharmaceutical companies, like AstraZeneca 3 , 30% of their early pipeline consists of new drug modalities.

Development 52

Development In-Vivo Drugs In-Vitro 52

Drug Discovery World

NOVEMBER 3, 2022

Ten years ago, cell and gene therapy (CGT) was really finding its feet as success stories such as that of Emily Whitehead began to hit the news. They also do not have the potential of causing a severe immune response if they are administered to the wrong patient. TrakCel recently announced the launch of its latest platform.

Gene Therapy 52

Gene Therapy Production Development Business Development 52

The Pharma Data

OCTOBER 21, 2020

Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, today announced the pricing of its public offering of 4,687,500 shares of its common stock at a public offering price of $40.00 BOSTON, Oct. 22, 2020 (GLOBE NEWSWIRE) — Replimune Group, Inc.

Gene Therapy 40

Gene Therapy Immune Response Sales Gene 40

Pharma Marketing Network

JANUARY 20, 2021

It’s widely acknowledged that optimal vaccine immunity results from engaging both humoral and cellular responses, but less attention has been given to the role of mucosal immunity in protecting against COVID-19, which is surprising considering SARS-CoV-2 enters the human body primarily through the mucosal surfaces of the upper respiratory tract.

Vaccination 52

Vaccination Vaccine In-Vivo Genetics 52

Drug Discovery World

APRIL 14, 2023

He is being recognised for his revolutionary contributions to developing the first gene-edited cell-based therapy for cancer that involves the genetic re-engineering of a patient’s own T cells to combat their disease, and for demonstrating that adoptive T-cell therapy can induce remission and in some cases cure patients with advanced cancer.

Genetics 52

Genetics Research Medicine Clinical Research 52

The Pharma Data

OCTOBER 14, 2020

(Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic.

Vaccination 40

Vaccination Vaccine Development Medicine 40

Drug Discovery World

NOVEMBER 13, 2023

Enkelejda Miho, PhD, Professor, University of Applied Sciences and Arts Northwestern Switzerland, and Managing Director, aiNET, on: ‘The singular immune response to dengue and machine learning identification of antibodies in high-throughput sequences’.

Protein 59

Protein Antibody Engineer Scientist 59

The Pharma Data

NOVEMBER 9, 2020

Specifically, tezepelumab targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma. EMJ Allergy Immunol. 2018; 3: 60-9. J Allergy Clin Immunol.

Trials 52

Trials Production Sales Manufacturing 52

XTalks

SEPTEMBER 14, 2020

It was recently reported that the addition of an adjuvant to their vaccine led to enhanced immune responses that exceeded responses in convalescent serum from symptomatic COVID-19 patients. Novavax has also tested its recombinant SARS-CoV-2 nanoparticle adjuvanted vaccine in a Phase I/II trial.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92