Cloudbyz

JULY 31, 2024

This revolution is enabling the growth of innovative biomarker-based precision medicine and cell and gene therapy, transforming both clinical research and post-market care. This allows for the selection of patients who are most likely to respond to a particular therapy, optimizing treatment efficacy and minimizing adverse effects.

Gene Therapy 52

Gene Therapy Gene Medicine In-Vitro 52

Pharmaceutical Technology

MAY 24, 2023

The TME modulators have been designed for addressing one of the main causes of acquired resistance to immunotherapies, including checkpoint inhibitors or cellular therapies such as CAR-T. It is building many MDSC-targeted, bi-functional ADCs for in vitro and in vivo characterisation, with lead selection expected by the end of next year.

Gene Therapy 130

Gene Therapy In-Vivo In-Vitro Immune Response 130

BioPharma Reporter

JUNE 29, 2021

The New York based company said the deal will expand its in vitro diagnostic, cell and gene therapy support capabilities.

Reagent 52

Reagent In-Vitro Gene Therapy Gene 52

pharmaphorum

JANUARY 16, 2023

Last year, IQVIA predicted that 2022 would be the crunch year for Alzheimer’s therapies: it is with a sense of déjà vu that the exact same prediction is contemplated for 2023. The hard problem: innovation for high prevalence, chronic diseases of ageing.

Gene Therapy 98

Gene Therapy In-Vitro Gene Medicine 98

XTalks

JANUARY 21, 2025

Abbotts SCS devices deliver its proprietary BurstDR stimulation waveform, a superior therapy designed to more closely mimic how pain signals travel to the brain and treat the emotional suffering related to pain. In this process, the sample is mixed with specific test chemicals.

FDA Approval 105

FDA Approval Manufacturing Development RNA 105

pharmaphorum

DECEMBER 1, 2022

Exploring the implementation of complex in-vitro models for drug development. The pharmaceutical industry globally is realising the growing potential of in vitro tissue models for drug discovery, pathology modelling and validation, safety and toxicity. Billion by 2028. Billion by 2028. Event Hashtag: #3DCellCulture2023.

In-Vitro 52

In-Vitro Scientist Engineer Gene Therapy 52

XTalks

APRIL 13, 2021

Now, thanks to a study funded by the National Institutes of Health Intramural Research Program, scientists have discovered that ?-synuclein, synuclein, a protein involved in the formation of amyloid deposits in the brain characteristic of Parkinson’s disease and other neurodegenerative disorders, is also implicated in melanoma. Excessive levels of

Research 98

Research Protein In-Vitro Scientist 98

Delveinsight

JANUARY 12, 2021

The companies believe that their candidate in its original IgG format has shown potent neutralization activity in in vitro assays and in an in vivo animal model. Bluebird spins off to two companies, cleaving off its gene therapy, and cancer units. Further, Birinapant also complements the anti-tumor activity of the immune system.

Licensing 52

Licensing Licensing Antibody Gene Therapy 52

FDA Law Blog

MARCH 31, 2024

Committee Chair Rodgers expressed her concerns that FDA regulation of LDTs would substantially increase the regulatory and financial burden on labs, causing them to stop offering many tests, such as those that are used in oncology and cell and gene therapies. This seems to have been the outcome that many lawmakers desired.

Regulation 64

Regulation In-Vitro Development Gene Therapy 64

Roots Analysis

MARCH 16, 2023

Messenger ribonucleic acid (mRNA) is a single-stranded molecule that is complementary to a gene’s DNA. In the last few years, researchers have become interested in using in vitro transcribed (IVT) mRNA as a drug delivery agent. mRNA-based therapeutics and vaccines can be delivered via the below-mentioned approaches.

Vaccine 52

Vaccine Vaccination DNA Protein 52

Pharmaceutical Technology

AUGUST 26, 2008

” According to Chris Reilly, global vice president of discovery, strategy and performance for AstraZeneca, it is now recognised that biotechnology unquestionably offers important benefits for the pharmaceuticals industry by presenting alternatives to other therapies. “Biotechnology has exploded across the industry. .

Antibody 100

Antibody Licensing Licensing Production 100

Delveinsight

JANUARY 18, 2021

Usually, only a single copy of the gene is required that too from the mother, however, in cases of AS, either the child does not get any copy, or the child receives two copies – each from mother and father. GeneTx and Ultragenyx are co-developing the therapy.

Marketing 52

Marketing Gene Drugs Protein 52

The Pharma Data

DECEMBER 9, 2020

The Chinese biopharmaceutical industry is growing in leaps and bounds, but there is still a huge unmet need when it comes to getting patients access to the breakthrough therapeutic modalities and platforms like RNAi, cell and gene therapy and others. A solution could be at hand with Overland Pharmaceuticals.

In-Vivo 52

In-Vivo In-Vitro Antibody Development 52

XTalks

SEPTEMBER 20, 2024

Vittoria Biotherapeutics is a clinical-stage cell therapy company that incorporates the latest advancements in cell therapy and gene editing with a unique approach that potentially overcomes some of the issues with this therapeutic modality. Its therapeutic pipeline targets unmet needs in oncology and autoimmune disease.

Gene Editing 52

Gene Editing Manufacturing Gene In-Vivo 52

Roots Analysis

JANUARY 14, 2024

Moreover, the exuberant development of biologics has revolutionized the treatment of a range of therapeutic conditions, which has further contributed to the exponential growth in the current demand for biologic therapies developed by biologics manufacturing companies.

Contract Manufacturing 40

Contract Manufacturing Protein Manufacturing Production 40

The Pharma Data

MAY 15, 2023

The sBLA is based on results from the phase III BALATON and COMINO studies that demonstrated treatment with Vabysmo provided early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept. 1,2 Vabysmo’s safety profile was consistent with previous trials.

Antibody 40

Antibody In-Vitro Clinical Development Medicine 40

The Pharma Data

APRIL 12, 2023

The abstracts showcase the strength and breadth of Roche’s Ophthalmology portfolio, including post-hoc data from phase III Vabysmo® (faricimab) studies that support its benefit in drying retinal fluid in neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).

Antibody 40

Antibody In-Vitro Development Trials 40

Pharmaceutical Technology

MAY 26, 2023

Tripling its production capacity, Touchlight can now manufacture 8kg plasmid DNA, a key component for mRNA gene therapies and vaccines. As per the company, dbDNA is suitable for rapid, scalable manufacture of GMP DNA and can incorporate gene sequences of sizes ranging from 500bp to 20kb, which are typically unstable as pDNA.

DNA 130

DNA Manufacturing Gene Gene Therapy 130

Pharmaceutical Technology

FEBRUARY 20, 2023

This level of homogeneity within the clinical trial population may prevent the identification of variable therapy responses within population subgroups. This may sound obvious, but it is still a major hurdle in drug development. of the clinical trial population globally. of the clinical trial population globally.

Research 130

Research Clinical Trials Clinical Trials Trials 130

XTalks

JANUARY 6, 2025

For example, antisense oligonucleotide (ASO)-based therapies have gained traction, with 100 Phase I clinical trials initiated and around 25 percent of these advancing to Phase II or Phase III trials in recent years. Related: Biotech IPOs in 2024: Navigating the New Wave of Innovation 1.

Gene Therapy 111

Gene Therapy RNA Gene Editing Gene 111

FDA Law Blog

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. Section #1: FDA Interactions Given the wide range of sponsors (i.e., The draft guidance recommends that no more than 15 questions are included in the briefing package.

Gene Therapy 59

Gene Therapy Gene Production In-Vivo 59