Genotoxicity and Research - Clinical Research Informer

#news #biotech PCR-test reveals risk of genotoxity of genome editing

BioTech 365

MARCH 10, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: PCR-test reveals risk of genotoxity of genome editing. from European Biotechnology – first and foremost in European biotech [link].

Genotoxicity

Genotoxicity Genome Genomics Research

A bioresorbable membrane for healing internal and external wounds

Medical Xpress

FEBRUARY 3, 2023

Fraunhofer researchers have succeeded in using the bioresorbable silica gel Renacer to produce an electrospun membrane that is neither cytotoxic to cells nor genotoxic.

Genotoxicity

Genotoxicity Research

Expert consortium comment on FDA report on risk of T-cell malignancy

Drug Discovery World

JANUARY 10, 2024

These therapies, which exhibit substantial long-term side effects, including genotoxicity and an increased predisposition to secondary cancers, have significantly higher rates of subsequent malignancies than the rate reported for patients following CAR-T cell immunotherapies.

Gene Therapy

Gene Therapy Genotoxicity Gene Genetics

IN FOCUS: Solvias

Pharmaceutical Technology

DECEMBER 9, 2022

M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. Pharmaceutical Technology Excellence Rankings – The Verdict.

Development

Development Manufacturing Production Vaccination

The Composition and Value of a Portfolio Analysis

Camargo

DECEMBER 22, 2021

Pediatric Research Equity Act (PREA) Requirements. A nonclinical safety evaluation program typically includes pharmacology, general toxicity, toxicokinetics, nonclinical PK, reproductive toxicity, genotoxicity, and carcinogenesis. Nonclinical Requirements. Chemistry, Manufacturing, and Controls (CMC) Strategies.

Bioequivalency

Bioequivalency Production Genotoxicity In-Vivo

The Future for Biotesting

Pharmaceutical Technology

SEPTEMBER 10, 2008

was established in 1999 in the process of privatisation of the State Research Institute for Pharmacy and Biochemistry in the Czech Republic. ” New projects we have been involved with have helped the company to accelerate its development in the field of pre-clinical research. .” Dr Ivana Surovà: Biotest s.r.o.

In-Vitro

In-Vitro Genotoxicity In-Vivo Clinical Research

Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

The Pharma Data

MARCH 8, 2021

The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in vivo mammalian systems. “We Animals were administered molnupiravir for longer and at higher doses (mg/Kg) than those employed in human studies. About Molnupiravir.

Trials

Trials In-Vivo Genotoxicity RNA

Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

MAY 13, 2022

Curia is a global contract research, development and manufacturing organization (CDMO) that specializes in drug discovery, spanning the entire product lifecycle from target to lead candidate identification, development, manufacturing feasibility, through to commercialization and post-marketing. Analytical Instrumentation.

Packaging

Packaging Packaging Containment Production

FIRST-LINE IBRANCE® (PALBOCICLIB) COMBINATION THERAPY IN HR+, HER2- METASTATIC BREAST CANCER

The Pharma Data

MARCH 25, 2021

These findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research. lead researcher and Professor in Breast Cancer Excellence in the Perelman School of Medicine at the University of Pennsylvania.

HR

HR Clinical Trials Clinical Trials Trials

PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

The Pharma Data

FEBRUARY 8, 2021

IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. Advise male patients to consider sperm preservation before taking IBRANCE.

HR

HR Clinical Trials Clinical Trials Containment

Moving off the critical path: Streamlining strategies for drug substance synthesis and manufacturing

Pharmaceutical Technology

JUNE 26, 2022

Placing traditionally siloed drug substance and drug product development activities within a single organization that also has commercial manufacturing capabilities accelerates clinical development and builds in quality and robustness of supply.

Manufacturing

Manufacturing Drugs Production Development

Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

MAY 10, 2023

While the discovery phase – which includes target discovery, target validation, lead compound identification, and lead compound optimisation – averages several years and $200 million, the majority of the research, time, and financial spend takes place downstream in drug development.

Bioassay

Bioassay Genotoxicity Drugs In-Vivo

Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

The Pharma Data

APRIL 7, 2021

“Women with triple-negative breast cancer have historically had very few effective treatment options and faced a poor prognosis,” said Aditya Bardia, MD, MPH, Director of Breast Cancer Research Program, Mass General Cancer Center and Assistant Professor of Medicine at Harvard Medical School, and global principal investigator of the ASCENT study.

HR

HR Genotype FDA Approval Genotoxicity

Let's Quit Sugar With Audiobook – Let's Quit Sugar

The Pharma Data

MAY 13, 2021

Experimental Diabetes Research. Effects of almond consumption on the reduction of LDL-cholesterol: a discussion of potential mechanisms and future research directions. Exposure to sorbitol during lactation causes metabolic alterations and genotoxic effects in rat offspring. Nutrition Research and Practice. 2014.09.007.

Insulin

Insulin Production Hormones Medicine

Clinical Research Informer

#news #biotech PCR-test reveals risk of genotoxity of genome editing

A bioresorbable membrane for healing internal and external wounds

Trending Sources

Expert consortium comment on FDA report on risk of T-cell malignancy

IN FOCUS: Solvias

The Composition and Value of a Portfolio Analysis

The Future for Biotesting

Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

FIRST-LINE IBRANCE® (PALBOCICLIB) COMBINATION THERAPY IN HR+, HER2- METASTATIC BREAST CANCER

PFIZER CONFIRMS U.S. PATENT TERM EXTENSION FOR IBRANCE UNTIL MARCH 2027

Moving off the critical path: Streamlining strategies for drug substance synthesis and manufacturing

Accelerating NDA filing through faster carcinogenicity assessment

Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

Let's Quit Sugar With Audiobook – Let's Quit Sugar

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