FDA Law Blog

MARCH 5, 2024

Gaulkin & Riëtte van Laack — As readers of this blog know, there is a lot of contention about the naming of alternative protein products (APPs), including both plant-based and cell-cultured alternatives for (traditional) animal products. By Sophia R. We’ve previously blogged about this ongoing battle here , here , here , and here.

Protein 59

Protein Production DNA Containment 59

Outsourcing Pharma

FEBRUARY 1, 2024

A company building a pipeline of small molecule drugs targeting novel proteins across the DNA mismatch repair (pathway) has announced a further extension to its series B financing round.

DNA 83

DNA Protein Drugs Regulation 83

BioTech 365

FEBRUARY 4, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Study uncovers structural features regulating mRNA processing.RNA is the central tenet of molecular biology, the stepping-stone between DNA and proteins.

Regulation 40

Regulation DNA Protein Research 40

The Pharma Data

MARCH 7, 2022

By combining CRISPR technology with a protein designed with artificial intelligence (AI), it is possible to awaken individual dormant genes by disabling the chemical “off switches” that silence them. The chemical modifications that regulate gene activity are called epigenetic markers. it can be reawakened.

Protein 52

Protein Gene Genome Genomics 52

Pharmaceutical Technology

APRIL 11, 2023

In August 2021, Zydus secured emergency use authorisation (EUA) from the Drugs Controller General of India for its Covid-19 deoxyribonucleic acid (DNA) plasmid vaccine, ZyCoV-D. The vaccine, which generates the SARS-CoV-2 viral spike protein on administration, induces the immune system’s cellular and humoral arm-mediated immune response.

FDA Approval 130

FDA Approval Drugs Immune Response Manufacturing 130

Scienmag

JANUARY 11, 2022

Enhancers are regions of DNA that do not code for proteins, but control how genes are expressed. Super-enhancers are clusters of enhancers that together regulate genes with important roles in cell identity. Scientists at St. Their assessment showed the super-enhancer has four […].

Development 80

Development DNA Gene Protein 80

Drug Discovery World

SEPTEMBER 27, 2023

Epigenetics: the software of gene regulation Gene activity is the driving force behind our biological processes, and disruptions in normal gene activity can trigger diseases. Unlike genetics, where DNA sequences remain constant, epigenetic modifications are cell type-specific and can change over time due to a balance of enzymatic processes.

DNA 115

DNA Genetics Gene Medicine 115

Drug Discovery World

JANUARY 26, 2023

The researchers believe smaller cells could be more vulnerable to DNA-damaging agents like chemotherapy combined with targeted drugs, while larger cancer cells might respond better to immunotherapy. In contrast, the larger NRAS-mutant cancer cells contained damage to their DNA instead of repairing it, accumulating mutations and enlarging.

DNA 52

DNA Protein Genetics Research 52

Drug Discovery World

MARCH 2, 2023

But the new findings answer a fundamental and longstanding question – how epigenetic proteins regulate the processes of transcription and gene expression, through which our genes are read and translated into proteins. The team found that H3K4me3 acts like a traffic light at a busy intersection.

Gene Expression 52

Gene Expression Gene DNA RNA 52

Scienmag

APRIL 15, 2021

Epigenetic regulator HPI1a drives de novo genome reorganization in early Drosophila embryos Credit: MPI of Immunobiology and Epigenetics, F. Zenk The DNA molecule is not naked in the nucleus. This […].

Genome 56

Genome Genomics DNA Genetics 56

Drug Discovery World

JULY 12, 2022

The research shows that AstraZeneca’s candidate drug AZD1390 can block the response to DNA damage in nerve cells and promote regeneration of damaged nerves, restoring sensory and motor function after spinal injury.? .

DNA 52

DNA Drugs Genome Genomics 52

Drug Discovery World

MARCH 26, 2024

More importantly, it also highlighted that significant challenges remain in selecting the right therapies for the right patients despite the progress made through genomic testing and implementation of circulating tumour (ct) DNA analyses.

RNA 64

RNA In-Vivo In-Vitro DNA 64

The Pharma Data

MARCH 30, 2021

Basel, March 30, 2021 — Novartis has obtained exclusive worldwide rights to develop and commercialize therapeutic applications for a library of Fibroblast Activation Protein (FAP) targeting agents including FAPI-46 and FAPI-74, through an assignment agreement with iTheranostics, Inc., an affiliate of SOFIE Biosciences, Inc.

Protein 52

Protein Licensing Licensing Containment 52

Drug Discovery World

AUGUST 2, 2023

Cancer cells unable to copy their DNA One of the ways PARP inhibitors work in cancer cells with changes in their BRCA genes is by preventing them from repairing their DNA, leading to a build-up of damage and causing the cells to die. Without CINP, cancer cells aren’t able to properly copy their DNA when treated with the drug.

Gene 52

Gene DNA Clinical Trials Clinical Trials 52

XTalks

MAY 4, 2021

The tool targets the epigenome, the collection of DNA modifications in a cell such as methylation and post-translational histone modifications. These modifications regulate gene expression without changing the sequence or structure of DNA. DNA methylation occurs endogenously in all mammalian cells in response to various stimuli.

DNA 98

DNA Gene Gene Silencing Genome 98

Drug Discovery World

APRIL 17, 2024

JMB: Regulatory RNAs (or regRNAS) are molecules that directly control the expression of nearby protein-coding genes. Recently, research published by Dr Richard (Rick) Young (Whitehead Institute) describes the key mechanism of how these regRNAs regulate gene expression. What are the challenges of drug discovery in this area?

Gene Expression 59

Gene Expression Gene Genetic Disease RNA 59

XTalks

SEPTEMBER 2, 2021

The AlzoSure Predict prognostic biomarker Alzheimer’s blood test detects levels of an unfolded conformational variant of the p53 protein in the blood using a proprietary antibody called U-p53AZ. It is known as the “guardian of the genome” given its central role in the DNA damage response. p53 in Alzheimer’s.

Protein 105

Protein DNA Antibody Genome 105

Pharmaceutical Technology

JUNE 4, 2023

Within the emerging innovation stage, cell therapy for ocular disorders, coronavirus vaccine components, and DNA polymerase compositions are disruptive technologies that are in the early stages of application and should be tracked closely.

Genetics 130

Genetics Gene Expression DNA Antibody 130

XTalks

APRIL 6, 2022

Cancerous cells and tumors release small fragments of DNA into the bloodstream called circulating tumour DNA (ctDNA). The researchers at the Cancer Research UK Cambridge Institute published this data from the LUng cancer CIrculating tumour DNA (LUCID) study in the journal Annals of Oncology.

DNA 105

DNA In-Vitro Doctors Doctor 105

Drug Discovery World

APRIL 5, 2023

It targets a pathway that cancer cells are highly dependent upon, involving the heat shock factor 1 protein (HSF1). Mechanism of action HSF1 is a transcription factor, meaning that it controls the production of other important proteins in the cell, through its regulation of the process of reading the genetic code stored in DNA.

Drugs 52

Drugs Scientist Clinical Trials Clinical Trials 52

Roots Analysis

JANUARY 14, 2024

Like all drugs, biologics are regulated by the FDA. Biologics activate certain proteins or cells in your immune system to create specific responses to targets, while many conventional systemic drugs activate the entire immune system in a more generalized manner. The most widely used bacterial host system is Escherichia coli (E.

Contract Manufacturing 40

Contract Manufacturing Manufacturing Protein Bacteria 40

Drug Discovery World

JANUARY 23, 2023

This, in turn, increased DAG accumulation and decreased fatty acid oxidation, reducing mitochondrial lipotoxicity (harmful lipid accumulation in non-adipose tissues) in GBM cells and contributing to their radioresistance.

FDA Approval 52

FDA Approval Drugs In-Vivo In-Vitro 52

XTalks

MAY 4, 2021

The tool targets the epigenome, the collection of DNA modifications in a cell such as methylation and post-translational histone modifications. These modifications regulate gene expression without altering the sequence or structure of DNA. DNA methylation occurs endogenously in all mammalian cells in response to various stimuli.

DNA 52

DNA Gene Gene Silencing Genome 52

Roots Analysis

OCTOBER 16, 2023

DNA cloning refers to the process of generating multiple copies of a particular DNA segment. DNA and Gene Cloning involves the isolation of a DNA sequence of any species ( often a gene ) and its insertion into a vector to enable growth without any alteration in the original DNA sequence.

DNA 40

DNA Gene Protein In-Vitro 40

XTalks

MARCH 13, 2024

Firstly, investigations into the lipidome in pseudoexfoliation glaucoma aim to understand how lipid metabolism influences the development or progression of this specific type of glaucoma, characterized by abnormal protein deposits in the eye.

Gene Therapy 111

Gene Therapy Gene Life Science DNA 111

pharmaphorum

JANUARY 29, 2021

‘Cutting edge’ is, for once, a truly apt description when it comes to gene editing – both because the field is pushing medicine into areas we might never have dreamed possible, and because these technologies involve literally cutting DNA at a specific point in the genome. The genomic medicine journey. Pragmatic genomics.

Gene Editing 143

Gene Editing Gene Gene Therapy In-Vivo 143

Drug Discovery World

JULY 5, 2023

For example, if a patient’s tumour has a particular protein present, called a checkpoint protein, this will reduce the response of T-cells. Of course, if a patient’s tumour does not have this protein, then this type of treatment won’t be effective. Biography Mark Garner received his Ph.D.

Research 98

Research Protein Scientist Immune Response 98

Drug Discovery World

APRIL 11, 2023

The molecule, known as lissodendoric acid A, appears to counteract other molecules that can damage DNA, RNA and proteins and even destroy whole cells. USP30 is a (de)ubiquitylation (DUB) implicated in neurodegenerative diseases that regulates the clearance of damaged mitochondria in a process called mitophagy.

Research 52

Research Drugs Life Science RNA 52

Drug Discovery World

SEPTEMBER 5, 2022

Several years ago, co-senior author Nicolas Reynoird, PhD, a Professor at Grenoble Alpes University, and his team discovered that a protein called RNF113A may play a role in small cell lung cancer but could not determine what the protein does.

Protein 52

Protein Drugs Medicine Research 52

pharmaphorum

MARCH 10, 2021

bluebird bio is to ask regulators to restart clinical studies of its LentiGlobin for sickle cell disease, after an investigation concluded that a case of acute myeloid leukaemia (AML) was “very unlikely” to be caused by the gene therapy. Shares in bluebird ticked up following the announcement.

Gene Therapy 52

Gene Therapy Gene Trials Gene Expression 52

Roots Analysis

MARCH 8, 2023

INTRODUCTION TO EXOSOMES Exosomes are extracellular vesicles, which have endosomal origin and may contain different biomolecules, including proteins, DNA, lipids, miRNA or RNA , based on the type of cell of their origin and its conditions. Exosomes convey a wide range of information to the target cells, depending on their source.

RNA 52

RNA Drug Delivery DNA Development 52

pharmaphorum

SEPTEMBER 6, 2021

The biotech said that the US regulator ordered the pause on the study after liver tumours were seen in mice given the therapy in preclinical testing. “For patients who have already received lower doses of these vectors, we will continue to carefully evaluate and monitor their health,” he added.

Gene Therapy 75

Gene Therapy Gene Genetic Disease DNA 75

XTalks

AUGUST 12, 2020

Studies have identified the presence of two types of HIV-infected CD4+ T cells: ‘Transcriptionally inactive’ cells that do not typically produce viral RNA or viral proteins. Fucosylation is the attachment of a specific sugar molecule called fucose to proteins on the surface of cells. T Cell Glycomic Signatures in HIV.

RNA 52

RNA Protein DNA In-Vivo 52

XTalks

JULY 1, 2021

Well, this study took new data into consideration that was not available prior to 2016 that posits titanium dioxide may cause cell mutations or damage DNA. Using it as an additive to dairy can also reduce calories, fat and protein compared to adding milk, cream or whey powders. Why the sudden change?

Branding 105

Branding Production DNA Containment 105

Drug Discovery World

FEBRUARY 6, 2024

However, many have cautioned against too great a reliance on these tools and emphasised the importance of checks and balances to ensure the systems are properly regulated and results are verified. The use of AI is rapidly developing in society and as regulators we see more and more applications in the field of medicines.

Marketing 69

Marketing Medicine Genome Genomics 69

Drug Discovery World

OCTOBER 18, 2023

What’s more, they are expensive, not readily available, and in many countries, there are a host of stringent regulations, as well as ethical and legal considerations around their use. Mouse models, on the other hand, are cost-effective and readily available, making them a favourite for many researchers.

Gene Therapy 64

Gene Therapy Gene Clinical Trials Clinical Trials 64

pharmaphorum

DECEMBER 21, 2020

But the tragic events of 2020 have meant these companies have become household names as their trailblazing mRNA vaccines became the first to be approved by regulators against the COVID-19 scourge. Their technology is based on synthetic messenger RNA – short for ribose nucleic acid – which is a short transcript of a longer DNA code.

Vaccination 86

Vaccination Vaccine Doctors Doctor 86