XTalks

AUGUST 8, 2024

The US Food and Drug Administration (FDA) has approved Adaptimmune Therapeutics’ Tecelra (afamitresgene autoleucel) for adults with unresectable or metastatic synovial sarcoma who have specific HLA types and have undergone prior chemotherapy. It is also the first new treatment for adults with synovial sarcoma in over a decade.

Engineer 52

Engineer Clinical Trials Clinical Trials FDA Approval 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. Agent drug-coated balloon. Photo courtesy of Boston Scientific. In this process, the sample is mixed with specific test chemicals.

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FDA Approval Manufacturing Development RNA 105

pharmaphorum

JANUARY 18, 2022

Developing Complex, Translatable and Physiologically-Relevant Cellular Models in vitro. 3D Cell Culture is gaining momentum in the pharmaceutical industry on account of the advantages such models pose for in drug discovery, from improved clinical translation and predictivity, to patient safety and sustainability. Who Should Attend?

In-Vitro 52

In-Vitro Engineer Drugs Pharma Companies 52

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. 3D-cellculture.com/PR1. Stephen J. .

In-Vitro 52

In-Vitro Development Pharma Companies Engineer 52

Roots Analysis

AUGUST 18, 2023

The process of drug development and safety testing is extremely expensive and time-consuming. Animal testing is a vital part of drug development process, which is beneficial for researchers in understanding the cause, diagnosis, and treatment of various medical conditions.

Production 52

Production In-Vitro Branding Drugs 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

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

NOVEMBER 30, 2021

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. Most of the facilities are providing in vitro bioassay services for cell and gene therapies.

Bioassay 52

Bioassay Gene Therapy Gene Development 52

pharmaphorum

JUNE 9, 2022

In order to reduce the global healthcare impact of the evolving AMR situation, companies such as Micreos Pharmaceuticals are taking a novel and highly innovative approach to antibacterial drug development by developing targeted antimicrobial products. The challenge with traditional antibiotics .

Bacteria 104

Bacteria Development In-Vitro Drugs 104

The Pharma Data

DECEMBER 14, 2020

”) platform to transform drug discovery and development, and identify patients who will benefit from its portfolio of targeted oncology therapeutics, announced today new scientific data that substantiates blood brain barrier permeability (BBB) for its drug candidate LP-184. . DALLAS , Dec. Lantern’s A.I.

Drugs 52

Drugs Genome Genomics DNA 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

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

Food and Drug Administration were based on mRNA, more conventional protein-based vaccines have also shown promise in clinical trials. Food and Drug Administration were based on mRNA, more conventional protein-based vaccines have also shown promise in clinical trials.

Protein 52

Protein Vaccination Vaccine Antibody 52

The Pharma Data

JANUARY 17, 2021

I-SPY COVID-19 is assessing multiple drugs for critical COVID-19 hospitalized or ICU patients. 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.

Immune Response 52

Immune Response Antibody Trials Clinical Trials 52

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

XTalks

DECEMBER 11, 2023

Their groundbreaking Tablo Hemodialysis System, cleared by the US Food and Drug Administration (FDA) for use from hospital to home, signifies a monumental leap in technology, revolutionizing the dialysis experience for patients while streamlining operational aspects for providers. In 2021, Axonics achieved an impressive revenue of $180.3

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Production Sales In-Vitro Development 110

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. The drug appears to inhibit IL-6, IL-1beta, TNF-alpha and other pro-inflammatory cytokines and chemokines. Read on to see. COVID-19-Related. It also has robust antimicrobial properties.

Trials 52

Trials Allergies In-Vitro Antibody 52

Roots Analysis

DECEMBER 12, 2022

The process of drug development and safety testing is extremely expensive and time-consuming. Animal testing is a vital part of drug development process, which is beneficial for researchers in understanding the cause, diagnosis, and treatment of various medical conditions.

Production 40

Production In-Vitro Marketing Branding 40

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.

Antibody 52

Antibody Immune Response Production 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.

FDA Approval 69

FDA Approval In-Vitro Research Development 69

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.

In-Vivo 52

In-Vivo In-Vitro Antibody Development 52

The Pharma Data

MAY 3, 2021

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

Development 52

Development Contamination In-Vitro Production 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

FDA Law Blog

DECEMBER 6, 2023

The Federal Food, Drug, and Cosmetic Act simply did not confer that power upon FDA. 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.

Regulation 59

Regulation Genetics Cosmetics In-Vitro 59

The Pharma Data

MAY 27, 2022

Food and Drug Administration (FDA), are planned this year. 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 of patients.

Antibody 52

Antibody In-Vitro Medicine Engineer 52

XTalks

SEPTEMBER 20, 2024

Such challenges highlight a significant unmet need and call for further advancements in the field. 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.

Gene Editing 52

Gene Editing Manufacturing Gene In-Vivo 52

XTalks

OCTOBER 1, 2020

Xtalks spoke with WeiQi Lin, MD, PhD, executive vice president, research & development, and principal scientist at DURECT Corporation — a company focused on developing drugs and drug delivery methods in therapeutic areas with significant unmet need — about her transition from academia to industry. Key Moments.

Scientist 52

Scientist In-Vitro Research Life Science 52

Roots Analysis

OCTOBER 22, 2023

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

RNA 40

RNA Protein Genetics Gene Expression 40

The Pharma Data

MARCH 26, 2021

New in vitro data from pseudotyped virus assays published online in bioRxiv in March 2021 support this hypothesis as they demonstrate that VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants. GlaxoSmithKline plc and Vir Biotechnology, Inc.

Antibody 52

Antibody Trials Vaccination Vaccine 52

XTalks

JUNE 12, 2023

The US Food and Drug Administration (FDA) granted approval to four of Medtronic’s cardiovascular product offerings, further expanding the company’s foothold in this sector. This article takes a comprehensive look at the top 10 medical device companies that are leading the charge in this rapidly evolving field.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

The Pharma Data

MAY 15, 2023

Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO). 1,2 Vabysmo’s safety profile was consistent with previous trials. In BALATON, vision gains were +16.9

Antibody 40

Antibody In-Vitro Clinical Development Medicine 40

The Pharma Data

APRIL 23, 2021

Roche announces positive CHMP opinion for Venclyxto-based combinations in certain patients with acute myeloid leukaemia. Venclyxto combinations significantly improved complete response rates in people with newly diagnosed acute myeloid leukaemia in two key studies (VIALE-A and M14-358). The median OS was 14.7 months (95% CI: 11.9, months (95% CI: 7.4,

Medicine 40

Medicine In-Vitro Antibody Development 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

Cloudbyz

AUGUST 19, 2024

Food and Drug Administration (FDA), the European Medicines Agency (EMA), and various other national and international organizations oversee the approval, monitoring, and post-market surveillance of medical devices. Food and Drug Administration (FDA): Oversees the safety and effectiveness of medical devices in the United States.

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Compliance Manufacturing Regulation Marketing 52

Roots Analysis

MAY 21, 2024

In allogeneic cell therapies, the cells are engineered ( to elicit a desired therapeutic response ) and amplified in-vitro. In April 2022, the US FDA granted orphan drug designation to ALLO-605 ( developed by Allogene Therapeutic ) for the treatment of advanced multiple myeloma.

In-Vitro 40

In-Vitro Development Engineer Medicine 40

Pharmaceutical Technology

JANUARY 6, 2023

It requires having access to proper techniques and skill sets, state-of-the-art equipment, process scientists and engineers who have a deep understanding of Quality by Design (QbD) principles, and methods for product and process characterisation. Expertise in analytical testing, validation, and quality control are also essential.

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Production Manufacturing Development Bioequivalency 130

Pharmaceutical Technology

FEBRUARY 28, 2023

It was engineered with an Fc-silent IgG1 isotype to avoid activation of Fc-receptor-mediated non-specific immune. The bispecific antibody was found to conditionally activate the immune pathway in the tumour microenvironment in vitro and in vivo trials. Topic sponsors are not involved in the creation of editorial content.

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In-Vivo Antibody In-Vitro Licensing 130