BioSpace

MARCH 21, 2024

Tegoprubart, Eledon Pharmaceuticals’ experimental anti-CD40L antibody, was part of the immunosuppressive treatment regimen used following the first-ever transplant of a kidney from a genetically modified pig to a human.

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Pharmaceutical Technology

APRIL 14, 2023

Both libraries feature up to 10,000 gene fragment combinations, and allow the high-throughput screening and characterisation of new and known sequence variants to develop therapeutic solutions. In July last year, Twist announced a partnership with Ildong to develop antibodies for use in immuno-oncology.

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Development Gene Therapy Gene Antibody 246

Pharmaceutical Technology

JANUARY 19, 2023

AOC 1020 has been designed for the treatment of the underlying cause of FSHD, which is caused by the abnormal expression of a gene known as double homeobox 4 or DUX4. This DUX4 protein abnormal expression leads to modifications in gene expression in muscle cells which are associated with progressive muscle function loss in FSHD patients.

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Pharmaceutical Technology

JANUARY 17, 2023

The STAb therapy is based on a special type of bispecific antibody secretion. This antibody can detect targets on the tumour cell and the T cell. An artificial bridge created by these antibodies gets therapeutic T cells and tumour cells into contact. By Cytiva Thematic.

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Development Gene Therapy Antibody Gene 276

pharmaphorum

AUGUST 26, 2022

BioMarin Pharma has its landmark first approval for Roctavian – the first for a haemophilia gene therapy – and will now have to see if that can convert that into a viable business in Europe. If approved will price the gene therapy at $2 to $3 million after discounts, saying the price there will reflect the higher price of current treatments.

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Gene Therapy Gene Antibody Marketing 112

pharmaphorum

JUNE 27, 2022

The EMA’s human medicines advisory committee has recommended that BioMarin Pharmaceutical’s haemophilia A gene therapy Roctavian be approved in the EU, removing one of the last barriers to launch. The post BioMarin gene therapy for haemophilia on course for EU approval appeared first on.

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Gene Therapy Gene Antibody Marketing 97

BioPharma Reporter

MAY 9, 2023

Hansa Biopharma and Genethon have entered a research and development collaboration to test imlifidase as a gene therapy treatment in patients with pre-existing neutralizing antibodies.

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Gene Therapy Gene Antibody Development 94

pharmaphorum

JULY 20, 2022

Shares in VBL Therapeutics have lost around 78% of their value in pre-market trading after the company reported a phase 3 trial of its lead gene therapy VB-111 for ovarian cancer failed a pivotal trial. The post VBL craters as ovarian cancer gene therapy fails phase 3 test appeared first on.

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Gene Therapy Gene Immune Response Antibody 98

Pharmaceutical Technology

JULY 15, 2022

According to the positive interim findings from the Phase II/III KidCOVE clinical trial, a two-dose primary series of mRNA-1273 offered a strong neutralising antibody response in the young children with a favourable safety profile. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Vaccination Vaccine Gene Therapy Antibody 264

pharmaphorum

SEPTEMBER 13, 2021

AbbVie has expanded its ophthalmology pipeline via a licensing deal with Regenxbio, paying $370 million upfront to get its hands on a gene therapy for wet age-related macular degeneration (AMD) and other eye diseases. The post AbbVie spies potential in Regenxbio eye disease gene therapy appeared first on.

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Gene Therapy Gene Sales Trials 97

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. Hemophilia A is a rare genetic bleeding disorder that is caused by a mutation in the gene that encodes the key blood clotting protein factor VIII (FVIII).

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Gene Therapy Gene FDA Approval Antibody 98

XTalks

AUGUST 30, 2022

The hemophilia A gene therapy Roctavian delivers a functional gene to enable the body to make an essential blood clotting protein on its own. Last week, the first gene therapy for severe hemophilia A , Roctavian (valoctocogene roxaparvovec), developed by BioMarin Pharmaceutical Inc.,

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Gene Therapy Gene Clinical Trials Clinical Trials 98

Pharmaceutical Technology

NOVEMBER 14, 2022

In a field dominated by antibodies and small molecules, two cell-therapy based approaches have come under the spotlight for showing early signs of efficacy in treating lupus. Apart from the monoclonal antibodies and small molecules, researchers have long held an interest in exploring cell therapies for autoimmune conditions.

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Antibody Gene Therapy Manufacturing Trials 362

FDA Law Blog

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Gene Therapy Gene FDA Approval Production 119

Pharmaceutical Technology

APRIL 19, 2023

“Evidence is now available that most of the US population five years of age and older have antibodies to SARS-CoV-2, the virus that causes Covid-19, either from vaccination or infection, that can serve as a foundation for the protection provided by the bivalent vaccines.”

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Pharmaceutical Technology

JUNE 14, 2023

Inobrodib is an oral first-in-class cancer drug, indicated for patients who have previously received four or more lines of therapy, including an anti-CD38 monoclonal antibody, an immunomodulatory agent and a proteasome inhibitor. It inhibits p300 and CBP by binding into the conserved bromodomain of the twin proteins.

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Protein Antibody Gene Trials 243

Pharmaceutical Technology

JULY 2, 2024

On 30 June 2024, at the tenth Congress of the European Academy of Neurology (EAN) 2024, during an e-presentation session on the topic of 'Headaches', Danilo Antonio Montisano, MD, presented real-world evidence findings from a retrospective, observational multicentre cohort study (RAMO) comparing the effectiveness of monoclonal antibodies against calcitonin (..)

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Pharmaceutical Technology

JUNE 29, 2022

These subjects received a minimum of two lines of systemic therapy previously, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. FL is a kind of indolent non-Hodgkin lymphoma (iNHL).

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Gene Therapy Clinical Trials Clinical Trials Genetics 278

Pharmaceutical Technology

AUGUST 15, 2022

In baseline seronegative subjects, the updated vaccine offered a superior neutralising antibody response against Omicron (BA.1) Irrespective of previous infection or age, the vaccine-induced potent neutralising antibody responses against the BA.4 Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

The post Leading API biologics (cell, gene, vaccine and virus) companies in contract marketing appeared first on Pharmaceutical Technology. The increasing number of approvals of biologics over the years has increased the volume of contracts for innovator APIs and biologic-dose outsourcing.

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pharmaphorum

NOVEMBER 30, 2020

Cure Rare Disease’s Rich Horgan discusses the importance of preclinical NAbs screening and helping rare disease patients better understand their eligibility for gene therapies. Neutralising antibodies (NAbs) present a unique challenge to researchers looking to treat patients with AAV treatment.

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Gene Therapy Gene Antibody Clinical Trials 106

Medical Xpress

MARCH 8, 2023

A pilot trial by investigators from Brigham and Women's Hospital, a founding member of the Mass General Brigham health care system, tested the nasal administration of the drug Foralumab, an anti-CD3 monoclonal antibody.

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BioTech 365

FEBRUARY 10, 2021

Launch of Novel Gene Therapy Company, VectorY, to Develop Innovative Vectorized Antibodies Launch of Novel Gene Therapy Company, VectorY, to Develop Innovative Vectorized Antibodies Fully integrated gene therapy offering, including platform technology, pipeline development, and manufacturing capabilities Targeting muscular and … Continue reading (..)

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XTalks

JANUARY 21, 2025

The liquid portion of the blood (serum or plasma) containing antibodies is separated and tested using the Liason Biotrin parvovirus B19 IgG plus test on a Liason XL analyzer. If parvovirus B19 antibodies are present, they bind to the chemicals and particular particles in the test, producing a light signal.

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pharmaphorum

APRIL 16, 2021

The 2 nd Gene Therapy Immunogenicity Summit is the industry’s definitive forum enabling you to better modulate, measure and predict immune response to your gene therapy candidate. The impact of innate and anti-transgene immunogenicity on AAV vector-mediated gene transfer with Genethon.

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Gene Therapy Gene Immune Response Antibody 52

pharmaphorum

OCTOBER 4, 2022

AstraZeneca’s rare disease firm Alexion is set to expand its genomic medicine portfolio with the acquisition of gene editing specialist LogicBio Therapeutics, in a deal worth approximately $68 million. The post AstraZeneca pays record 660% premium for gene editing company LogicBio appeared first on.

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Gene Editing Gene Genomics Genome 65

Pharmaceutical Technology

MAY 10, 2023

TYVYT is a PD-1 immunoglobulin G4 monoclonal antibody jointly developed by Innovent Biologics and Eli Lilly and Company. The approval was given to TYVYT (sintilimab injection) plus bevacizumab and chemotherapy (pemetrexed and cisplatin). This is the seventh indication of TYVYT (sintilimab injection) to be cleared by NMPA.

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BioTech 365

DECEMBER 1, 2020

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Wilson, Penn ink Regeneron pact to use gene therapy tech to deliver COVID-19 antibodies.Wilson, Penn ink Regeneron pact to use gene therapy tech to deliver COVID-19 antibodies … Continue reading →

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Gene Therapy Gene Antibody Research 40

Medical Xpress

FEBRUARY 27, 2023

In a recently published editorial in the journal Genes & Cancer, researcher Tatsuro Jo from the Japanese Red Cross Nagasaki Genbaku Hospital's Department of Hematology discussed aggressive type adult T-cell leukemia/lymphoma (ATLL).

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Antibody Gene Research 96

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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Antibody Clinical Trials Clinical Trials Medicine 52

Pharmaceutical Technology

MAY 9, 2023

FibroGen has signed an exclusive licence agreement with Fortis Therapeutics for the FOR46 antibody-drug conjugate (ADC) that targets a new epitope on CD46, a protein-coding gene. FOR46 is currently being investigated in a Phase I trial as a potential treatment for metastatic castration-resistant prostate cancer (mCRPC).

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Drugs Clinical Development Antibody Protein 130

Pharmaceutical Technology

APRIL 27, 2023

Columvi is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD20 on the B-cells’ surface and CD3 on the T-cells’ surface. If approved, the fixed-duration Columvi will become the first CD20xCD3 T-cell-engaging bispecific antibody to treat individuals with this type of aggressive lymphoma in Europe.

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Gene Therapy Antibody Gene Medicine 130

Pharmaceutical Technology

JANUARY 18, 2023

The monoclonal antibody selectively attaches to calcitonin gene-related peptide (CGRP). Under the latest agreement, AffaMed Therapeutics will get exclusive rights for importing, marketing, promoting, distributing, and detailing Galcanezumab after receiving approval in Mainland China.

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Antibody FDA Approval Gene Production 130

pharmaphorum

JUNE 28, 2022

billion partnership with US biotech Sutro Biopharma for a series of antibody-drug conjugates for cancer, focusing on applications in patients who don’t respond to current immunotherapies. Astellas has agreed a $1.36 The alliance includes an upfront payment of $90 million, backed by $422.5

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Antibody Immune Response Gene Therapy Drugs 106

pharmaphorum

MARCH 8, 2022

Voyager Therapeutics has signed another big pharma partner for its TRACER adeno-associated virus (AAV) vector technology, designed to improve the safety of gene therapies, with Novartis taking an option on three neurological disease programmes. billion including fees and milestones.

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Gene Therapy Gene Antibody Development 52

Roots Analysis

NOVEMBER 30, 2021

Bioassay – A Prerequisite for the Cell and Gene Therapy Development. Over the past few years, investigational new drug (IND) filings for cell and gene therapy product have significantly increased. Companies Offering Bioassay Services for Cell and Gene Therapies. How Players are Complying with Developing Market?

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Bioassay Gene Therapy Gene Development 52

pharmaphorum

NOVEMBER 12, 2020

UCB has made a new foray into the gene therapy space, buying fellow Belgium-based company Handl to get control of its adeno-associated virus (AAV) capsid delivery platform and two research programmes in neurodegenerative diseases. The post UCB revs up its gene therapy drive with Handl acquisition appeared first on.

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