Drug Target Review

JULY 18, 2023

I think it is astonishing that The Human Genome Project was completed exactly 20 years ago and DNA was discovered by Franklin and published by Watson and Crick exactly 70 years ago, yet that 10 percent success rate has still not improved. This means that we are not doing something right.

Drug Development

Drug Target Review

DECEMBER 5, 2024

2 Structure and function of AAV capsids in gene therapy Wild-type AAV is composed of a protein shell (capsid) that contains a single-stranded DNA genome encoding proteins involved in viral replication, structure and assembly. Therefore, vectors based on these serotypes may enable targeted gene delivery and optimal transduction efficiency.

Therapies

The Pharma Data

OCTOBER 14, 2020

Assistant Professor of Medical Sciences at Columbia University Vagelos College of Physicians and Surgeons, is designed to generate DNA aptamer-based anti-idiotypes to selected monoclonal antibodies identified in Dr. Ilya Trakht’s study. The study led by Dr. Sergei Rudchenko, Ph.D.,

Vaccine

Agency IQ

AUGUST 11, 2023

EMA’s investigation ended up revealing even more causes of nitrosamine impurities in drugs, discovering, for example , that formation happened during the heat-sealing process of in certain products using blister-packaging. Since this discovery, it’s been unclear how regulators or sponsors might assess or address these potential risks.

FDA

Agency IQ

APRIL 12, 2024

The regulations also explain that this trait can be demonstrated via appropriate laboratory tests or adequately controlled clinical data. Additionally, six of these comments came from the same organization (Integrated DNA Technologies). However, only 40 of these comments have been posted to the docket for public review.

Production

Codon

FEBRUARY 13, 2024

Regulators traditionally want to see a single, stable, well-characterized drug before giving the green light for it to be tested in a clinical trial, not dozens of different viruses; let alone ones that are best found in unappealing places like sewage , hospital waste, or bird poop.

Therapies

Codon

APRIL 23, 2024

While astronauts are easily protected from UV by glass or a thin sheet of metal, microbes placed outside on Mars would be killed in mere minutes as the ultraviolet radiation shreds through DNA and destabilizes proteins that carry out important cellular processes. ” Those little packets keep foods dry to prevent spoilage.

Engineering

The Pharma Data

MARCH 7, 2022

The new technique controls gene activity without altering the DNA sequence of the genome by targeting chemical modifications that help package genes in our chromosomes and regulate their activity. The chemical modifications that regulate gene activity are called epigenetic markers. it can be reawakened.

RNA

Codon

APRIL 2, 2023

But now, by studying DNA extracted from microbes in the blood of almost 10,000 healthy people, this paper shows that there is no such thing. Read Transcription factors bind to DNA and control gene expression. Read Switchable hydrophobic pockets in DNA protocells enhance chemical conversion. Nature Microbiology. Meeussen J.V.W.

DNA

Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. 📎 Papers Strands of DNA can be used to build molecular logic gates. Stahl et al. on bioRxiv. Nature Communications. Nature Communications.

Vaccine

Codon

APRIL 23, 2023

Most people would take the two CRISPR gene-editing components (a Cas9 protein and guide RNA), package them up inside of a virus, and then inject the viruses into the skulls of mice. 📎 Papers Strands of DNA can be used to build molecular logic gates. Stahl et al. on bioRxiv. Nature Communications. Nature Communications.

Vaccine

Codon

JULY 27, 2023

They’ve just finished sequencing the patient’s genome, but they don’t have “DNA sorting” software. billion units of DNA code are transcribed into more than a hundred volumes, each a thousand pages long, in type so small as to be barely legible.” At least, that’s what every textbook says.

Therapies

Codon

JULY 27, 2023

They’ve just finished sequencing the patient’s genome, but they don’t have “DNA sorting” software. billion units of DNA code are transcribed into more than a hundred volumes, each a thousand pages long, in type so small as to be barely legible.” At least, that’s what every textbook says.

Therapies

Codon

JUNE 26, 2023

DNA sequences are designed on a computer, and it takes a dozen or more clicks to change a single nucleotide. DNA sequences are also checked by hand, so it’s easy to make a mistake. The tool outputs a DNA sequence that encodes all the required enzymes. plasmidsaurus @arjunrajlab (Regulation in biology is incredible.

DNA

Codon

JUNE 26, 2023

DNA sequences are designed on a computer, and it takes a dozen or more clicks to change a single nucleotide. DNA sequences are also checked by hand, so it’s easy to make a mistake. The tool outputs a DNA sequence that encodes all the required enzymes. plasmidsaurus @arjunrajlab (Regulation in biology is incredible.

DNA

The Pharma Data

AUGUST 3, 2021

The company confirmed the tirzepatide SURPASS program has met global regulatory submission requirements for evaluating cardiovascular risk and its intention to submit the registration package to regulatory authorities by the end of 2021.

Production

The Pharma Data

AUGUST 3, 2021

We are very pleased that our comprehensive nonclinical data package has addressed all issues identified related to DRG toxicity and the FDA has reached the decision that we may proceed with our OAV-101 IT clinical trial program and initiate the STEER trial,” said Shephard Mpofu, M.D., SVP, Chief Medical Officer, Novartis Gene Therapies.

Clinical Trials

The Pharma Data

JANUARY 21, 2021

CABENUVA, a co-packaged kit with two injectable medicines, offers people living with HIV a new approach for maintaining viral suppression. INSTIs, like cabotegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells).

FDA Approval

Agency IQ

MAY 31, 2024

Specifically , the sponsor is proposing an indication for the detection of “colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Blood Collection Kit.” Analysis & What’s Next Up front, the advisory committee panel meeting touched on several hot topics in diagnostics regulation.

FDA

Codon

APRIL 2, 2024

in physics at Princeton University, he had a remarkable idea: What if it were possible to build a circuit out of DNA, rather than electronics, and use it to “program” a living cell? So we engineered a system that allows the cell to package up RNAs and then secrete them in extracellular vesicles.

RNA

Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. Continuing this method may not scale.

Vaccine

The Pharma Data

MAY 13, 2021

FACT: A recent study conducted by the Grocery Manufacturer’s Association states that OVER 80% of packaged foods eaten in the U.S. food is “A food in which the gene from one species has been forced into the DNA of another species and the process itself creates all sorts of unpredicted side effects.”. A better definition of a G.M.O.

Production

Codon

MARCH 14, 2023

There are even differences in how their genomic DNA is packaged inside of neurons. ” About 6% of all mouse genes are regulated in sex-specific ways. DNA differences accumulate over generations of breeding. Nobody really knows why. ” Other scientists have said much the same thing since at least 2018.

DNA

The Pharma Data

MAY 13, 2021

Stimulates DNA and RNA synthesis. Carl was taking ibuprofen and opiates to manage the pain, but knew he had to be careful to regulate it because of the kidney and liver problems it could cause. You should apply the MindBody Matrix Pain Relief cream 3-4 times per day for the first week after you receive your package.

Pharmacy

Agency IQ

MARCH 29, 2024

What we expect the EPA to do in April 2024 The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. PFAS regulations for drinking water.

Regulations

Drug & Device Law

DECEMBER 19, 2022

2019), it simply misconstrued the FDA’s rather (that’s an understatement) complicated supplemental application/changes being effected regulation, 21 C.F.R. Sub-sub-sub-subsection (C) references the “highlights” part of the FDA’s general drug labeling regulation, 21 C.F.R. Albrecht , 139 S. Mensing , 564 U.S. a) of this chapter. . . .

FDA

Broad Institute

MAY 13, 2025

AI tool predicts potential drug targets by analyzing cell images By Corie Lok May 13, 2025 Breadcrumb Home AI tool predicts potential drug targets by analyzing cell images Researchers have developed a machine learning model that connects images of DNA structure to gene regulation. Paper cited: Paysan D, Radhakrishnan A, et al.

DNA

LifeSciVC

MAY 28, 2025

But with the rise of Chinas innovative sector, the proliferation of biologic drugs coded by DNA, and more than dozen years of abundant capital, to name just a few things – the challenge has only gotten worse. As illustrated in LEKs May 2025 report Is Biopharma Doing Enough to Advance Novel Targets ?

Production

Perficient: Drug Development

MARCH 8, 2025

Patagonia’s approach has redefined industry standards for sustainable business practices, serving as a compelling case study for organizations seeking to integrate responsible design into their operational DNA while achieving exceptional business results.

Compliance

Drug Target Review

MAY 8, 2025

While reducing mutant huntingtin is desirable, the wild-type huntingtin protein plays crucial roles in normal neuronal function, including vesicular transport, synaptic function and transcriptional regulation. To deliver our CRISPR editing system to the brain cells involved in the disease, we packaged it into AAV to make LETI-101.

Disease

Codon

MAY 15, 2025

Random mutations in DNA bring about this genetic variation, and mating between unrelated individuals mixes the mutations amongst the population. Most vertebrates in the study, including the lab mouse, Mus musculus , acquire one mutation for every 100 million DNA bases per generation. percent of the mouse’s DNA.

DNA

Codon

FEBRUARY 9, 2025

The connection between the destroyed lobe and Gage’s reduced capacity for emotional regulation was stark. To achieve this, E11 Bio synthesizes protein barcodes (short peptides with unique amino acid sequences), packages them into AAV vectors (engineered, non-harmful viruses for drug delivery), and delivers these into the brain tissue.

Research