XTalks

AUGUST 8, 2024

Tecelra is the first cell therapy engineered for a solid tumor cancer in the US, offering a new option for patients with specific genetic markers who have previously undergone chemotherapy. It is also the first new treatment for adults with synovial sarcoma in over a decade. The trial showed a 43 percent response rate with 4.5

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Engineer Clinical Trials Clinical Trials FDA Approval 52

Scienmag

FEBRUARY 9, 2021

The work, led by NYU Tandon and the New York Stem Cell Foundation Research Institute, could lead to efficient, detailed artificial bone tissue, opening doors to disease modeling, in vitro cell research on targeted therapies, drug screening and more.

In-Vitro 75

In-Vitro Research Drugs Engineer 75

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

FDA Law Blog

FEBRUARY 19, 2024

Loloei tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions. While at FDA, Ms. During her FDA tenure, Ms. Gibbs , HP&M Director.

In-Vitro 59

In-Vitro Engineer Production Regulation 59

pharmaphorum

FEBRUARY 13, 2022

Quris’ BioAI safety prediction platform – which is based on human tissue samples on chips, nanosensors and machine learning – will be compared to traditional in vitro and in vivo laboratory techniques for spotting toxicity. The post Merck will assess Quris’ AI ‘patient-on-a-chip’ drug safety appeared first on.

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Drugs In-Vivo In-Vitro Pharma Companies 98

pharmaphorum

OCTOBER 5, 2022

It has been shown in vitro to cover all major influenza A strains that have arisen since the 1918 ‘Spanish flu’ pandemic and is designed as a universal prophylactic for influenza A. Additionally, the incorporated Xencor Xtend Technology is half-life engineered, meaning a single dose could potentially last an entire flu season.

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Antibody In-Vitro Radiology Development 110

pharmaphorum

JANUARY 18, 2022

Developing Complex, Translatable and Physiologically-Relevant Cellular Models in vitro. Key Benefits of Attending: • Discuss the uses of advanced cell technologies to construct in vitro models of human tissues. Workshop Leader: Kenny Dalgarno, Professor of Manufacturing Engineering, Newcastle University. Who Should Attend?

In-Vitro 52

In-Vitro Engineer Drugs Pharma Companies 52

XTalks

JANUARY 21, 2025

From non-invasive cancer diagnostics to life-saving cardiovascular implants, the latest medical devices cleared or approved by the FDA in 2024 reflect the remarkable strides in science and engineering. TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR).

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FDA Approval Manufacturing Development RNA 105

pharmaphorum

OCTOBER 12, 2020

Over the past few years, 3D Cell Culture has gained momentum within the pharmaceutical industry due to the benefits that this model offers for in vitro applications patient-derived tissues, drug discovery, predictivity and validation, and safety and toxicity. 3D-cellculture.com/PR1. . Workshop B – 13.30 – 17.30

In-Vitro 52

In-Vitro Development Pharma Companies Engineer 52

The Pharma Data

DECEMBER 22, 2020

A2’s Tmod engineered T cells uniquely combine a potent activating mechanism to kill tumor cells with a blocking mechanism that protects normal cells from harm by exploiting the loss of genetic material in tumors. Perlmutter, President, Merck Research Laboratories. This transaction extends our cash runway on the heels of our successful $71.5M

Development 52

Development Engineer Manufacturing In-Vitro 52

pharmaphorum

JANUARY 16, 2023

The present article focuses on opportunity, the unmet need which lies at the heart of better healthcare provision, and two areas of growth and opportunity: Point of Care Diagnostics, and the new pharmacotherapy classes which will commercialise for the first time in 2023. The hard problem: innovation for high prevalence, chronic diseases of ageing.

Gene Therapy 98

Gene Therapy In-Vitro Gene Medicine 98

pharmaphorum

JANUARY 25, 2022

For example, there is no need for in vivo animal or in vitro pre-clinical or non-clinical studies. The area of digital therapeutics is growing rapidly, and in this piece Ben Hargreaves examines why this is the case, how broadly these therapies can be applied and why investment in the area is mounting. This equated to $21.3

Medicine 111

Medicine In-Vivo In-Vitro Development 111

pharmaphorum

JUNE 24, 2022

Fujifilm’s Irvine Scientific unit has licensed rights to an artificial intelligence-powered technology developed to improve the success rate of in vitro fertilisation (IVF) techniques. “Development and testing of applications to support the selection of oocytes, sperm, and genetic assessment are in progress,” he added.

In-Vitro 52

In-Vitro Licensing Licensing Genetics 52

Roots Analysis

AUGUST 18, 2023

In order to fasten the discovery of innovative drugs and personalized medication, improved in vitro simulation of human biology and pathologies is required. In order to fasten the discovery of innovative drugs and personalized medication, improved in vitro simulation of human biology and pathologies is required.

Production 52

Production In-Vitro Branding Drugs 52

Roots Analysis

NOVEMBER 30, 2021

Most of the facilities are providing in vitro bioassay services for cell and gene therapies. Over the past few years, investigational new drug (IND) filings for cell and gene therapy product have significantly increased. Bioassays are biochemical procedures that are used to evaluate the potency, purity and efficacy of a drug substance.

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Bioassay Gene Therapy Gene Development 52

The Pharma Data

JANUARY 4, 2021

The companies will use ViGeneron’s proprietary vgAAV, novel engineered AAV capsids, to efficiently transduce retinal cells via intravitreal injections. Within the collaboration, ViGeneron will optimize and validate in vitro therapeutic candidates for an undisclosed target to treat inherited eye disease.

Gene Therapy 52

Gene Therapy Gene Development In-Vivo 52

The Pharma Data

AUGUST 15, 2021

Polymersomes trigger robust T cell immunity, and the researchers wondered if they could further improve the antibody response by engineering the nanoparticles to mimic viruses by displaying multiple copies of the RBD on their surfaces. Although the first vaccines to receive Emergency Use Authorization by the U.S.

Protein 52

Protein Vaccination Vaccine Antibody 52

Roots Analysis

MARCH 16, 2023

In the last few years, researchers have become interested in using in vitro transcribed (IVT) mRNA as a drug delivery agent. The IVT mRNAs are structurally similar to natural mRNAs, these synthetic mRNAs can be used to express proteins through genetic engineering.

Vaccination 52

Vaccination Vaccine DNA Protein 52

pharmaphorum

OCTOBER 27, 2022

Websites – Companies can use appropriate search engine optimisation (SEO) and marketing tools to ensure that their websites are displayed high on the list of results for relevant key word searches. What is the scope of the Guidance? Companies can sponsor website content if the role of the company is made clear.

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Life Science Medicine Regulation Compliance 98

The Pharma Data

JANUARY 11, 2021

Our antibody clones in their original IgG format have shown potent neutralization activity in in vitro assays and, in the case of our lead clone, in an in vivo animal model. Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies.

Antibody 52

Antibody Licensing Licensing Development 52

Cloudbyz

JULY 31, 2024

The landscape of modern medicine is rapidly evolving, driven by groundbreaking advancements in diagnostics. 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.

Gene Therapy 52

Gene Therapy Gene Medicine In-Vitro 52

pharmaphorum

JUNE 9, 2022

Antimicrobial resistance (AMR) is an issue of global concern, killing roughly 1.2 million 1 people per year and projected to rise to 10 million people by 2050 2. It occurs when bacterial pathogens adapt over time to develop resistance to traditional antibiotics, resulting in “superbugs” that are near impossible to treat.

Bacteria 104

Bacteria Development In-Vitro Drugs 104

XTalks

DECEMBER 11, 2023

Medical device companies continue to maintain a crucial role in enhancing patient care and diagnostic precision in 2023. Let’s examine the list of the top ten fastest growing medical device companies in 2023, ranked by their compound annual growth rate (CAGR). In 2021, Axonics achieved an impressive revenue of $180.3

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Production Sales In-Vitro Development 110

The Pharma Data

JUNE 17, 2022

“The broadly neutralizing antibodies we described were more efficient in vitro than many anti–SARS-CoV-2 monoclonals previously approved by the FDA for treatment or prevention. A modified version of the Cv2.1169 antibody was also effective at treating SARS-CoV-2 infection in mice and hamsters.

Antibody 52

Antibody In-Vivo In-Vitro Immune Response 52

Pfizer

JANUARY 27, 2023

and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., In a limited number of cases when a full virus does not contain any known gain of function mutations, such virus may be engineered to enable the assessment of antiviral activity in cells. and around the world.

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Research Vaccination Vaccine Drugs 112

The Pharma Data

DECEMBER 29, 2020

The academic partners of the consortium have been awarded €350,000 from Health Holland under the Eureka Program to develop a SARS-CoV-2-specific therapeutic nanomedicine that is administered via nasal inhalation and that can also be used for in vitro diagnostics. About Radboudumc.

Antibody 52

Antibody In-Vitro Engineer Development 52

pharmaphorum

NOVEMBER 2, 2021

They are also designed to have a short in vitro half-life, meaning that they will be cleared from a patient’s system within several hours. They are also designed to have a short in vitro half-life, meaning that they will be cleared from a patient’s system within several hours. Engagement of immune cells to the tumour cell.

Antibody 52

Antibody Immune Response Production Engineer 52

The Pharma Data

NOVEMBER 12, 2021

” Stupp is Board of Trustees Professor of Accoutrements Science and Engineering, Chemistry, Medicine and Biomedical Engineering at Northwestern, where he’s launching director of the Simpson Querrey Institute for BioNanotechnology (SQI) and its related exploration center, the Center for Regenerative Nanomedicine. .”

Engineer 40

Engineer In-Vitro Medicine Scientist 40

The Pharma Data

OCTOBER 14, 2021

Roche today announced European Medicines Agency (EMA) approval of a new, shorter 90-minute Gazyvaro® (obinutuzumab) infusion time, administered in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma (FL). Roche’s Chief Medical Officer and Head of Global Product Development.

Medicine 52

Medicine In-Vitro Antibody Genomics 52

The Pharma Data

JANUARY 17, 2021

Dalcetrapib is a potential anti-viral treatment that binds to the catalytic site of 3CLMpro of SARS-CoV-2 in vitro. The year is starting to pick up in terms of clinical trial announcements. Here’s a look at last week’s news. COVID-19-Related. The data showed that the vaccine induced an immune response and was generally well-tolerated.

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Immune Response Antibody Trials Clinical Trials 52

The Pharma Data

MAY 27, 2022

It is engineered to have two ‘Fab’ regions which bind to CD20, and one ‘Fab’ region which binds to CD3. The pivotal phase II NP30179 expansion study included patients with heavily pre-treated and highly refractory DLBCL, with 58.3% After a median follow-up of 12.6 months, 39.4% months, not evaluable]). of patients.

Antibody 52

Antibody In-Vitro Medicine Engineer 52

XTalks

MARCH 6, 2024

This includes discussions on cutting-edge technologies and methodologies in brain research, such as neuroimaging, genetic engineering and artificial intelligence. It also emphasizes the importance of brain health across the lifespan, advocating for strategies to maintain brain function, improve mental health and enhance quality of life.

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FDA Approval In-Vitro Research Marketing 69

FDA Law Blog

DECEMBER 6, 2023

Part 11, the need to hire new laboratory personnel, and engage outside experts such as Contract Research Organizations, biostatisticians, lawyers, and software engineers. Javitt — On Monday, Hyman, Phelps & McNamara, P.C. Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation.

Regulation 59

Regulation Genetics Cosmetics In-Vitro 59

Roots Analysis

DECEMBER 12, 2022

In order to fasten the discovery of innovative drugs and personalized medication, improved in vitro simulation of human biology and pathologies is required. In order to fasten the discovery of innovative drugs and personalized medication, improved in vitro simulation of human biology and pathologies is required.

Production 40

Production In-Vitro Marketing Branding 40

The Pharma Data

MAY 3, 2021

Many in the regulatory profession have transitioned from an established previous career such as engineering, law, or bench research. Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . .

Development 52

Development Contamination In-Vitro Production 52

The Pharma Data

JANUARY 24, 2021

Brilacidin has shown in vitro to be have antiviral properties against different SARS-CoV-2 strains and other human coronaviruses. With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. Read on to see. COVID-19-Related. Non-COVID-19-Related.

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Trials Allergies In-Vitro Antibody 52

The Pharma Data

DECEMBER 9, 2020

With the launch of Overland, we are creating a robust research and development engine in parallel with the significant growth and opportunity presented by Asia’s evolving biotech industry. A solution could be at hand with Overland Pharmaceuticals.

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In-Vivo In-Vitro Antibody Development 52