Pharmaceutical Technology

NOVEMBER 9, 2022

On November 2, the Institute for Clinical and Economic Review (ICER) released its updated evidence aimed at measuring the clinical effectiveness and cost of the two haemophilia gene therapies. An approval decision on the gene therapy, also known as EtranaDez, is expected by the end of this month. million price tag.

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Gene Therapy Gene FDA Approval Medicine 278

Pharmaceutical Technology

FEBRUARY 15, 2023

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: IgG gene expressing animal models. IgG antibody responses are a useful marker of antigen exposure to diagnose immunodeficiency.

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Gene Expression Gene Genetic Engineering Antibody 130

Pharmaceutical Technology

JUNE 8, 2023

GenScript ProBio has collaborated with the New York Blood Center Enterprises’ business unit, called Comprehensive Cell Solutions (CCS), to accelerate the development and manufacture of cell and gene therapies. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Gene Therapy Gene Development Antibody 130

Drug Discovery World

APRIL 15, 2024

Join DDW for this free event ‘ Where is the opportunity in the therapeutic antibody market? ’, which is co-sponsored by Bio-Rad and Benchling. Dr Milind Nigam will discuss the role of software in accelerating the pace of discovery of antibody therapeutics. What effect has antibody engineering had on drug discovery and development?

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Antibody Marketing Gene Therapy Engineer 52

Drug Discovery World

APRIL 8, 2024

Join DDW for this free event ‘ Where is the opportunity in the therapeutic antibody market? ’, which is co-sponsored by Bio-Rad and Benchling. Dr Milind Nigam will discuss the role of software in accelerating the pace of discovery of antibody therapeutics. What effect has antibody engineering had on drug discovery and development?

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Antibody Marketing Gene Therapy Engineer 52

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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Pharmaceutical Technology

SEPTEMBER 16, 2022

The US Food and Drug Administration (FDA) has granted fast track designation to Jasper Therapeutics’ antibody, JSP191, for the treatment of severe combined immunodeficiency (SCID) patients who undergo allogeneic hematopoietic stem cell transplant. . The antibody was also analysed in a total of more than 110 healthy subjects and patients. .

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Antibody Clinical Trials Clinical Trials Licensing 130

Drug Discovery World

DECEMBER 8, 2023

ONK Therapeutics and NAYA Biosciences have agreed to develop a combination therapy of ONK’s optimally-engineered natural killer (NK) cell therapies and NAYA’s FLEX-NK bispecific antibodies. The post Partners explore NK cell therapy and bispecific antibodies combination appeared first on Drug Discovery World (DDW).

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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 97

Drug Discovery World

MAY 7, 2024

DDW Editor Reece Armstrong speaks to David Chau , Global Bioprocess Application Specialist, Separation and Purification Sciences Division, 3M, about challenges in producing monoclonal antibodies (mAbs) and how single-use technologies can simplify processes. RA: What are some of the current limitations for producing mAbs? He earned his Ph.D

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Antibody Production Manufacturing Engineer 59

Bio Pharma Dive

DECEMBER 1, 2020

Working with University of Pennsylvania researcher Jim Wilson, Regeneron aims to develop a nasal spray version of the coronavirus treatment recently cleared by the Food and Drug Administration.

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Gene Therapy Antibody Gene Drugs 266

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

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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Gene Therapy Antibody Gene Development 52

pharmaphorum

APRIL 22, 2022

Astellas has said it will book a $170 million impairment charge in its fourth quarter results as a result of a decision to halt the development of three gene therapy candidates for Duchenne muscular dystrophy in preclinical development. The post Astellas takes $170m charge as it drops DMD gene therapies appeared first on.

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Gene Therapy Gene DNA Licensing 105

Drug Discovery World

AUGUST 7, 2023

The collaboration will work on developing exosome-encapsulated AAV (exoAAV) vectors as a novel gene delivery technology aimed at improving treatments for heart disease. Susmita Sahoo, Associate Professor of Medicine, Cardiology at Icahn Mount Sinai has been exploring the use of exosomes in gene therapy for several years.

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Gene Therapy Gene Research In-Vivo 52

Drug Discovery World

FEBRUARY 21, 2024

We are delighted to be further backing MIP as they are making significant technical progress.” The post £7M financing to drive commercialisation in cell and gene therapy appeared first on Drug Discovery World (DDW).

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Gene Therapy Gene Reagent Production 52

XTalks

JUNE 28, 2023

Gene therapies for Duchenne muscular dystrophy (DMD) have been an area of intense research and Sarepta’s Elevidys is now the first one to be approved by the US Food and Drug Administration (FDA). 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.

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Gene Therapy Gene Protein FDA Approval 98

Drug Discovery World

DECEMBER 8, 2023

Andrew Busey , Co-Founder, Form Bio discusses why vertical AI is set to reshape the cell and gene therapy sector. The cell and gene therapy industry is no exception to this digital transformation. General AI tools such as ChatGPT have acted as a catalyst, igniting a wave of AI innovation akin to the early days of the internet era.

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Gene Therapy Gene In-Vitro Development 64

Drug Discovery World

NOVEMBER 13, 2023

She speaks with Megan Thomas about the future for Janssen’s investigational medicine nipocalimab and antibody therapeutics at large. This is a fully human monoclonal antibody (mAb) which selectively binds to the FcRn receptor with high-affinity and blocks it, thus leading to a decrease in IgG autoantibodies.

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Antibody Engineer Medicine Development 59

Drug Discovery World

JANUARY 10, 2023

For over 50 years, Bethyl Laboratories (now a Fortis Life Sciences brand) has been dedicated to improving lives by supporting scientific discovery through qualified antibody products and custom services. All of our antibodies are highly validated using six pillars of validation, meaning that our antibodies do what we say they’ll do.

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Antibody Protein Reagent Scientist 52

Drug Discovery World

APRIL 3, 2023

I quickly recognised the commercial value of aptamers as being able to address the gap in the market where antibodies fail to perform, and together we established the business to begin aptamer development. What advantages do they offer over antibodies?   DS: The company now has clients across big pharma.

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Antibody Gene Therapy Gene In-Vitro 52

pharmaphorum

OCTOBER 6, 2021

Voyager Therapeutics has just landed a new gene therapy alliance with Pfizer that could go some way towards easing the pain of losing three other partners in the space of a couple of years. Voyager meanwhile has had its own difficulties, albeit not related to safety. The Pfizer deal is a fillip for Voyager after a turbulent couple of years.

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Gene Therapy Gene Antibody Manufacturing 105

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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Antibody Gene Expression Gene Trials 75

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

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

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

pharmaphorum

JUNE 17, 2021

Biogen has four other Alzheimer’s candidates in its clinical pipeline behind recently-approved Aduhelm, but one of them – anti-tau antibody gosuranemab – has just been canned. The post Biogen abandons tau antibody for Alzheimer’s after phase 2 miss appeared first on.

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Antibody Protein Licensing Licensing 98

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

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 Genome Genomics 64

XTalks

SEPTEMBER 30, 2020

The research shows that the activity of the immune messenger type 1 interferon (IFN) protein is diminished, either by genetic mutations or an autoimmune attack by neutralizing antibodies against it, in a subset of COVID-19 patients. These rogue antibodies blocked interferon action and were not present in patients with mild COVID-19 cases.

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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

FDA Law Blog

MARCH 13, 2023

This meeting will host a panel of rare disease patients, caregivers, and advocates to have a focused discussion on the emerging field of gene therapy (regulated at the FDA by OTP). At least some (if not all) of the panelists will have had experience participating in gene therapy trials. One family’s daughter was the first U.S.

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Gene Therapy Gene Trials Clinical Trials 98

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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Gene Expression Gene Protein RNA 246

Drug Discovery World

DECEMBER 21, 2023

In a record year for gene therapy approvals, it isn’t surprising that cell & gene therapy (CGT) has been a hot topic. Other biotechnologies coming to the fore this year were antibody-drug conjugates and CRISPR gene editing. This well-read article featured in the DDW Winter 22/23 issue’s Cell & Gene Therapy Guide.

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Gene Therapy Gene Antibody FDA Approval 59

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

Pharmaceutical Technology

JULY 6, 2022

The researchers found evidence that antibodies are linked to an attack on the cells lining the blood vessels in the brain, causing inflammation and damage. The researchers also observed that antibodies produced in response to Covid-19 may wrongly act on cells vital to the blood-brain barrier.

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Immune Response Antibody Gene DNA 162

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