Pharmaceutical Technology

JANUARY 5, 2023

Capsida Biotherapeutics and Eli Lilly and Company ’s wholly owned subsidiary Prevail Therapeutics have announced a partnership for the development of non-invasive gene therapies for central nervous system (CNS) diseases. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. By Cytiva Thematic.

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Gene Therapy Gene Development Engineer 237

XTalks

JUNE 8, 2023

Over the past few years, there has been a significant expansion in the cell and gene therapy landscape, with an increasing number of therapies entering clinical trials and receiving regulatory approvals. “I think if we all go into these relationships with this mindset, we’ll achieve great things together.”

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Gene Therapy Gene Production Development 98

Pharmaceutical Technology

JUNE 19, 2023

Although only a small number of gene therapies have reached the market thus far, the industry is poised to grow quickly over the next few years. According to GlobalData’s clinical trials database, there are currently 1,231 planned and ongoing trials for gene therapies and gene-modified cell therapies alone.

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Gene Therapy Gene Packaging Packaging 130

Pharmaceutical Technology

JULY 7, 2022

For many decades, investigators have been working on innovative therapeutic modalities known as cell and gene therapies, which use modified versions of the body’s own cellular and genetic material to treat and potentially cure these diseases. A new frontier in cancer research. Cold chain logistics, meanwhile, have never been so important.

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Gene Therapy Gene Medicine Genetics 245

Pharmaceutical Technology

DECEMBER 14, 2022

Merck and Synplogen have signed a non-binding Memorandum of Understanding (MoU) to expedite the development and manufacturing of viral vector-based gene therapy applications. The firms intend to merge their expertise to provide simplified viral vector gene therapy development, production and testing in Japan. By Cytiva Thematic.

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Gene Therapy Gene Development Manufacturing 130

Pharmaceutical Technology

FEBRUARY 23, 2023

Moderna has entered a strategic research and development partnership with ElevateBio’s Life Edit Therapeutics to discover and develop new in-vivo mRNA gene editing therapies. The company will also receive tiered royalties on the worldwide net sales of products developed from the collaboration.

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Gene Editing Gene In-Vivo Gene Therapy 147

BioPharma Reporter

FEBRUARY 22, 2024

MIP Discovery, a developer of non-biological affinity reagents designed to accelerate the production of cell and gene therapies, has closed a Â7 million Series A financing round, led by Mercia Ventures.

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Gene Reagent Gene Therapy Production 97

Drug Discovery World

JUNE 23, 2023

Sarepta Therapeutics’ Elevidys has become the first gene therapy for Duchenne muscular dystrophy (DMD) to gain marketing authorisation in the US. It is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene.

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Gene Therapy FDA Approval Gene Protein 97

Pharmaceutical Technology

JANUARY 19, 2023

Acute myeloid leukemia (AML) is part of a market of blood malignancies that commercial cell therapies have not managed to penetrate yet. GlobalData’s Pharma Intelligence Center shows 19 autologous CAR-T cell products in Phase I, and nine products in Phase II, globally.

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Marketing Gene Editing Production Sales 130

Bio Pharma Dive

OCTOBER 24, 2022

Read how IP-simplified products can transform your speed to market without needing to reassess operations midway through to commercialization.

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Gene Therapy Gene Production Marketing 190

BioPharma Reporter

AUGUST 10, 2023

AGC Biologics, a global contract development and manufacturing organization (CDMO), has completed the expansion of its manufacturing space at its Milan Cell and Gene Center of Excellence production site.

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Gene Therapy Gene Manufacturing Production 98

Pharmaceutical Technology

DECEMBER 15, 2022

The congenital fibrinogen deficiency (CFD) market is expected to grow at a compound annual growth rate (CAGR) of 1.7% through 2031, reaching over $800m across the three major markets (3MM: US, Germany, and Japan), according to GlobalData’s recent report: Congenital Fibrinogen Deficiency: Opportunity Assessment and Forecast.

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Marketing Production Genotype Development 130

BioTech 365

SEPTEMBER 22, 2021

Global Advanced Therapy Medicinal Products (ATMPs) Market to 2028: Focus on CAR-T, Gene, Cell, Stem Cell Therapy – ResearchAndMarkets.com Global Advanced Therapy Medicinal Products (ATMPs) Market to 2028: Focus on CAR-T, Gene, Cell, Stem Cell Therapy – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The … Continue reading (..)

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Drug Discovery World

FEBRUARY 21, 2024

Liz Klein, Investment Director at Calculus, added: “MIP Discovery’s synthetic affinity reagents hold huge potential to overcome bottlenecks in CGT development and production.

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Gene Therapy Gene Reagent Production 52

Drug Discovery World

MAY 7, 2024

Where the bottlenecks of achieving higher cell density and higher titers were once thought to be issues of the past, hurdles have now shifted to achieving speed and scale in mAb production without sacrificing quality. DC: Antibodies have and remain a large product class within the biopharmaceutical market.

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Antibody Production Manufacturing Engineer 59

Roots Analysis

FEBRUARY 27, 2024

The global genome editing market is anticipated to grow at a CAGR of 12.6% How is the genome editing market landscape evolving: Currently, there is an evident increase in demand for complex biological therapies (including regenerative medicine products), which has created an urgent need for robust genome editing techniques.

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Genome Genomics Gene Gene Editing 40

XTalks

OCTOBER 4, 2023

Health economics and outcomes research (HEOR) and market access strategies play a critical role in ensuring that newly approved therapies are made available to patients. Professionals in these roles are facing new challenges when it comes to negotiating coverage for many of the new, innovative treatments that are coming to market.

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Marketing Development Drugs Gene Therapy 105

Pharmaceutical Technology

SEPTEMBER 15, 2022

The increase in the production of biological drugs such as vaccines, gene and cell therapies, and monoclonal antibodies, is increasing the volume of injectable drug products in the global healthcare market. Discover the top commercial dose injectables companies in contract marketing.

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Marketing Containment Production Sales 130

XTalks

DECEMBER 13, 2023

The US Food and Drug Administration (FDA) has approved the first gene therapies for the treatment of sickle cell disease, approving two on the same day. 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.

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Gene Therapy FDA Approval Gene In-Vivo 98

Drug Discovery World

FEBRUARY 8, 2024

In 2023, DDW hosted a webinar, ‘A comprehensive guide to using adeno-associated virus (AAV) vectors in gene therapy’, supported by Azenta Life Sciences. AAV is optimal for gene therapy due to its efficiency and safety in humans; however, AAV processes can present obstacles for researchers. How is the titer determined?

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Gene Therapy Gene Bioinformatics Life Science 59

BioTech 365

SEPTEMBER 20, 2021

Global Gene Expression Market Size, Share & Trends Analysis 2021-2028 by Product (DNA Chip/Microarray, Kits & Reagents), Technique (Promoter Analysis, RNA Exp.) – ResearchAndMarkets.com Global Gene Expression Market Size, Share & Trends Analysis 2021-2028 by Product (DNA Chip/Microarray, Kits & … Continue reading → (..)

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Gene Expression Reagent DNA RNA 40

BioPharma Reporter

JUNE 23, 2022

BIO, the worldâs largest trade association for the biotech industry, has responded to the US Food and Drug Administration's draft guidance on developing human gene therapy products that incorporate genome editing (GE) of human somatic cells.

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Gene Therapy Genome Genomics Gene 59

Pharmaceutical Technology

NOVEMBER 23, 2022

Innovations in biotechnology are advancing the biopharmaceutical market, enabling the treatment of complex diseases with next-generation therapeutics synthesised or extracted from a biological source. From the new site at MIP, OmniaBio will manufacture cell and gene therapies for commercial stage use for its growing customer base.

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Marketing Gene Therapy Life Science Manufacturing 130

BioPharma Reporter

SEPTEMBER 16, 2020

CPhIâs Annual Report 2020 predicts impending cell and gene capacity shortages for the US market, and possible mAb production growth in China.

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Gene Therapy Gene Marketing Production 111

Drug Discovery World

NOVEMBER 27, 2023

A complex journey Biotherapeutics discovery and development upstream encounters challenges in cell line development (CLD), clone screening and characterisation, scale up, and eventually production. Next-generation engineering tools, such as gene editing have enabled knock-out cell lines with enhanced characteristics.

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Production Engineer Gene Editing Gene 59

Drug Discovery World

MAY 16, 2023

New South African company NewBiologix has launched with the aim of developing a proprietary and breakthrough platform for the advanced engineering of cell lines used to manufacture gene and cell therapies. NewBiologix is currently focused on recombinant adeno-associated virus (rAAV) vectors, the preferred delivery vehicle for gene therapies.

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Production Gene Therapy Gene Bioinformatics 52

BioSpace

NOVEMBER 15, 2023

s Medicines and Healthcare products Regulatory Agency on Thursday provided conditional marketing authorization for Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy exa-cel.

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Gene Editing Gene Medicine Production 133

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

XTalks

APRIL 24, 2023

Awareness of rare diseases is growing, and with a better understanding of the pathophysiology of many rare diseases, innovative treatment options are emerging, like gene therapies that can treat the root cause of rare genetic diseases and potentially provide long-term symptom relief, or even a definitive cure.

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Gene Therapy Gene Trials Clinical Trials 95

XTalks

MAY 17, 2023

The Foundation for the National Institutes of Health (FNIH) announced this week that the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (AMP BGTC) has selected eight rare diseases for its clinical trial portfolio. As such, rare disease patients and their families often face little hope for effective treatments.

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Gene Therapy Clinical Trials Clinical Trials Gene 98

BioPharma Reporter

APRIL 6, 2022

The FDA has released two draft guidance documents: for human gene therapy products incorporating human genome editing, and for CAR T cell products.

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Gene Therapy Gene Genome Genomics 98

Drug Discovery World

SEPTEMBER 28, 2023

Both GTPs and GMPs must be followed to get cell-based advanced therapies or tissue-based therapy products to market. Can a manufacturer of a cell or gene therapy switch suppliers midstream in clinical development? How will not having a GMP supplier impact the speed a therapy gets to market?

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Marketing Gene Therapy Clinical Development Gene 52

Drug Discovery World

MAY 16, 2023

What are the global innovations in cell and gene therapy? What opportunities and challenges are emerging and can therapies get to market faster? The deeper the understanding of product and process from a characterisation standpoint, the smoother the regulatory conversations and development pathway will be.”

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Gene Therapy Gene Manufacturing Marketing 52

Drug Discovery World

OCTOBER 3, 2023

Earlier this year, DDW hosted a webinar, ‘A comprehensive guide to using adeno-associated virus (AAV) vectors in gene therapy’, supported by Azenta Life Sciences. AAV is optimal for gene therapy due to its efficiency and safety in humans; however, AAV processes can present obstacles for researchers.

Gene Therapy 52

Gene Therapy Gene Life Science Bioinformatics 52

STAT News

APRIL 17, 2023

Genetic engineering has the potential to transform how we raise animals for meat and other products, making food safer, improving animal health and welfare, and shrinking animal agriculture’s environmental footprint.  Salmon that reach market size in 18 months instead of 30.

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Genome Genomics Genetic Engineering Production 98

Drug Discovery World

SEPTEMBER 6, 2022

Cell and gene therapies are not only transforming the way diseases are treated but are also aiming to cure entirely new patient populations. As researchers and developers work to transform the way we treat diseases, cell and gene therapies will continue to be the centre of innovation in the coming years. . billion raised.

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Gene Therapy Gene Gene Editing Manufacturing 52

Drug Discovery World

DECEMBER 11, 2023

The US Food and Drug Administration (FDA) has approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD), Casgevy and Lyfgenia. Casgevy, from Vertex Pharmaceuticals and CRISPR Therapeutics, is also the first FDA-approved treatment to use CRISPR gene editing technology.

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Gene Therapy FDA Approval Gene Gene Editing 52