Chemical Biology and Drug Design

JUNE 21, 2023

Hsa-miR-503-5p negatively regulates CTDSPL, suggesting its potential as a target to overcome cisplatin resistance in LUAD. The results showed that hsa-miR-503-5p showed high expression, while its target gene CTDSPL presented decreased expression in LUAD. Hsa-miR-503-5p also had high expression in cisplatin-resistant LUAD cells.

Regulations 100

Regulations Protein Expression Bioinformatics Drugs 100

Covalent Modifiers

OCTOBER 15, 2024

4c06459 Naturally, kinases exert their activities in a highly regulated fashion. Herein, we present a facile and potent method that takes advantage of recent developments in targeted covalent inhibitors and rapid light-mediated uncaging chemistry.

Regulations 147

Regulations Drugs 147

Covalent Modifiers

JANUARY 17, 2024

KRAS activity is closely coupled to protein dynamics and is regulated through two interconverting conformations: state 1 (inactive, effector binding deficient), and state 2 (active, effector binding enabled).

Small Molecule 195

Small Molecule Regulations Drugs 195

Covalent Modifiers

JANUARY 11, 2024

These two discrete activities are tightly regulated by both environmental stimuli and redox reactions. Herein, we present the design, synthesis, and evaluation of a new TG2 activity substrate based on a previously optimized inhibitor scaffold. Transglutaminase 2 (TG2) is one isozyme in this family whose role is multifaceted.

Regulations 173

Regulations Disease 173

Drug Target Review

SEPTEMBER 8, 2023

This receptor, referred to as retinoic acid receptor alpha (RARα), is recognised for its regulation of gene expression within the nucleus. Prior knowledge indicated that RA, present in the bloodstream and taken up by T cells, is transported to the nucleus through a molecule known as cellular retinoic acid binding protein 2 (CRABP2).

Regulations 98

Regulations Research DNA Immune Response 98

Covalent Modifiers

DECEMBER 22, 2023

2023.11.008 The TRF2 shelterin component is an essential regulator of telomere homeostasis and genomic stability. APOD53 forms a covalent adduct with a reactive cysteine residue present in the TRF2TRFH domain and induces phenotypes consistent with TRF2TRFH domain mutants. .; Chambery, Angela; Cesare, Anthony J.;

DNA 162

DNA Regulations Treatment 162

Chemical Biology and Drug Design

JANUARY 23, 2024

At present, the pathogenesis of NAFLD remains unclear. Abstract Nonalcoholic fatty liver disease (NAFLD) is a chronic liver disease associated with lipid deposition in liver cells and/or subsequent inflammation, excluding other known causes.

Production 100

Production Disease Regulations 100

Covalent Modifiers

OCTOBER 15, 2024

4c06459 Naturally, kinases exert their activities in a highly regulated fashion. Herein, we present a facile and potent method that takes advantage of recent developments in targeted covalent inhibitors and rapid light-mediated uncaging chemistry.

Regulations 130

Regulations Drugs 130

Chemical Biology and Drug Design

AUGUST 20, 2023

Abstract The present study was to investigate the underlying mechanism of the antitumor effect of curcumin in colorectal cancer cells, focusing on the M2 polarization of tumor-associated macrophages (TAMs). Curcumin is a promising compound for the treatment of colorectal cancer or a complement of current standard therapy modalities.

Regulations 100

Regulations Therapies Treatment Research 100

Cytel

JUNE 2, 2023

Data submissions are very regulated, but every drug and drug development are different. Therefore, the data presented in the Common Technical Document (CTD) needs to be tailored to the specific submission.

Regulations 52

Regulations Drug Development Drugs 52

Agency IQ

MARCH 25, 2024

BY CHELSEY MCINTYRE, PHARMD FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. This proposed rule has been in the works for over 20 years, during which time the regulation of drug compounding has gone through many changes.

FDA 59

FDA Drugs Regulations Production 59

PPD

MAY 7, 2024

The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies.

Regulations 52

Regulations Pharmaceutical Companies International Pharmaceuticals 52

FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

The CSA and regulations promulgated by DEA regulate the sale, import, and export of tableting machines the same as they regulate List I chemicals. The regulations also require detailed information about each transaction involving a tableting machine, including the date, name and address, quantity, method of transfer, etc.

Regulations 116

Regulations Government Compliance Production 116

ASPET

JULY 19, 2023

SGs protect critical mRNAs from various environmental stress conditions by regulating mRNA stability and translation to maintain regulated gene expression. Recent evidence suggests that G3BPs can also regulate mRNA expression through interactions with RNA outside of SGs.

RNA 100

RNA Virus Regulations Disease 100

The Premier Consulting Blog

DECEMBER 28, 2023

1] However, if certain criteria are met, many in vitro diagnostic (IVD) devices are released from IDE regulations. This blog post discusses how device studies are classified and explores scenarios where DVDs qualify for exclusion from IDE regulations. b) Exempt studies that do not require an IDE.

Regulations 52

Regulations FDA Production Compliance 52

Elrig

MARCH 25, 2025

In addition, the conference comprises poster presentations, networking sessions, a vendor exhibition and a tour of AstraZenecas R&D centre. After PhD and postdoctoral work in the UK and Singapore, Prof Johnson received a prestigious Ramn y Cajal fellowship at the Centre for Genomic Regulation (Barcelona).

RNA 59

RNA Bioinformatics Science Pharmacokinetics 59

Chemical Biology and Drug Design

MAY 25, 2023

PTP1B is a negative insulin signaling pathway regulator; hence, inhibiting PTP1B increases insulin sensitivity, glucose absorption, and energy expenditure. Oral hypoglycemic medicines presently available act in a variety of ways, targeting various organs and pathways.

Research 100

Research Regulations Drugs 100

Conversations in Drug Development Trends

NOVEMBER 12, 2024

The process, from patient coordination through manufacturing and administration, is intricate, time-sensitive, and highly regulated. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

Therapies 72

Therapies Clinical Supply Clinical Trials Trials 72

Chemical Biology and Drug Design

APRIL 29, 2023

MYC regulates main genes of exosome biogenesis in breast cancer. Furthermore, MYC regulates oncogenic roles of breast cancer cells-derived exosomes in breast cancer and MYC-expressing cancer cells-secreted exosomes induce higher cellular activity of recipient cells in breast cancer.

Regulations 100

Regulations Research 100

Chemical Biology and Drug Design

JANUARY 29, 2024

the yeast silent information regulator 2 (sir2) protein) in 2000, more and more sirtuin proteins have been identified and are currently known to be present in organisms from all the three kingdoms of life (i.e., Abstract Since the discovery of the sirtuin family founding member (i.e., bacteria, archaea, and eukarya).

Regulations 100

Regulations Research 100

SCIENMAG: Medicine & Health

JUNE 17, 2023

CHICAGO—Closed-loop insulin delivery systems improve glucose control in children with type 1 diabetes without causing adverse effects, according to a study presented Saturday at ENDO 2023, the Endocrine Society’s annual meeting in Chicago, Ill.

Regulations 87

Regulations 87

Chemical Biology and Drug Design

MAY 17, 2024

Among a wide range of tyrosinase-regulating compounds, natural and synthetic derivatives of furochromenones, such as 8-methoxypsoralen (8-MOP), are known to both activate and inhibit tyrosinase. In the present study, we investigated these compounds for their potential as antagonists or agonists of tyrosinase.

Biochemical Assays 100

Biochemical Assays Regulations Production Research 100

FDA Law Blog: Biosimilars

MARCH 12, 2023

The COVID-19 pandemic emergency forced federal regulators to take extraordinary measures to ensure that patients were permitted continued access to important medicines. John will present on considerations and his learned perspective for the future of teleprescribing. Hyman, Phelps & McNamara, P.C.’s

Regulations 98

Regulations Government FDA Drugs 98

Drug Target Review

JULY 24, 2023

Researchers from Tokyo Tech’s World Research Hub Initiative conducted a study to investigate the regulation of gene expression in the apicoplast of the malaria parasite Plasmodium falciparum. How is melatonin, the circadian signalling hormone, related to the regulation of gene expression in the apicoplast?

RNA 98

RNA Regulations Bioinformatics Laboratories 98

Chemical Biology and Drug Design

JUNE 5, 2023

It can present along the entire continuum of severity, from mild to well-differentiated disease to extremely malignant tumors with low survival rates. This study presents the biphenyl dihydropyrimidinone LaSOM 335 with high activity against T24 bladder cancer cells (IC 50  = 10.73 ± 0.53 μM)

Regulations 100

Regulations Treatment Disease Research 100

KIF1A

SEPTEMBER 23, 2023

While we usually think of this cause as KIF1A mutations, upstream regulators of motor proteins can also disrupt traffic. In a recent pre-print*, the Holzbaur Lab at University of Pennsylvania investigated how a protein called LRRK2 regulates the traffic of synaptic vesicle precursors, a type of KIF1A cargo. What’s a pre-print?

Regulations 111

Regulations Disease Science Production 111

Chemical Biology and Drug Design

APRIL 1, 2023

Berberine has been shown in in vitro and in vivo studies to inhibit various types of cancer by activating the p-53 and cyclin-B expression, targeting various cell signalling pathways, to regulate the cell cycle. It also inhibits the invasion and metastasis of cancer cells.

Therapies 100

Therapies RNA Regulations Research 100

Chemical Biology and Drug Design

DECEMBER 28, 2023

LINC00460 knockdown contributed to DDP sensitivity of cervical cancer by regulating TGFBI, providing a novel mechanism underlying the acquisition of DDP sensitivity. In present study, LINC00460 was screened out through bioinformatics analysis. However, its effect on DDP sensitivity in cervical cancer remains poorly understood.

Bioinformatics 100

Bioinformatics RNA Regulations Drugs 100

Chemical Biology and Drug Design

NOVEMBER 23, 2023

Multiple investigations prove that it is regulated genetically, and epigenetically, and is affected by environmental factors. The molecular and neural pathways linked to the regulation of schizophrenia have been extensively studied.

Therapies 100

Therapies DNA Regulations Disease 100

Drug Target Review

SEPTEMBER 25, 2024

BRAF and downstream mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors are combined to treat BRAF-mutated melanoma, for example. 5 Here, the original oncogene is still present but the transdifferentiated cancer cells are less dependent on it.

Small Molecule 105

Small Molecule Therapies Regulations Treatment 105

Chemical Biology and Drug Design

MAY 11, 2023

Epidermal growth factor receptor (EGFR), a central regulator of tumor progression is frequently overexpressed in NSCLC and is a key drug target along with its downstream pathways. Abstract Lung cancer is the deadliest human cancer globally, with non-small-cell lung cancer (NSCLC) being the most frequent type.

Regulations 100

Regulations Drugs Research 100

PPD

JULY 16, 2024

Staying current with PV-relevant regulations and regulatory guidance can be challenging and often requires an FSP PV RI team that spans multiple countries and languages. This includes everything from clarifications sought from individual regulatory authorities to Q&A documents, other professional publications and conference presentations.

Compliance 98

Compliance Regulations Production Trials 98

PPD

MARCH 11, 2025

This heterogeneity among small groups of patients presents substantial challenges for rare disease research, including clinical trial design, endpoint selection and the interpretation of study findings. With the new EU HTA Regulation impacting orphan medicines, navigating these pathways has become even more challenging.

Drug Development 52

Drug Development Clinical Trials Disease Trials 52

FDA Law Blog: Biosimilars

FEBRUARY 2, 2024

The announcement also states that FDA expects most future companion diagnostic and infectious disease IVDs would be regulated as class II devices, even if they are novel and require de novo classification. But there are reasons why this move will not lessen FDA’s workload nearly as much as it might seem at first blush.

FDA 116

FDA Regulations Laboratories Disease 116

PPD

OCTOBER 17, 2024

This expansion represents a significant opportunity for both drug developers and patients, while also presenting a new and diverse set of challenges for drug developers, particularly in clinical trial execution. Patient retention presents its own set of challenges as CGT trials often carry heavy patient and caregiver burden.

Therapies 97

Therapies Clinical Trials Clinical Research Trials 97

Chemical Biology and Drug Design

DECEMBER 1, 2023

In the present work, 11 bioactive components of PVL were screened out, which acted on 177 potential targets. In summary, PVL may regulate HCC progression by regulating core targets such as AKT1, EGFR, SRC, ESR1, and PPARG, and acting on PI3K-Akt signaling pathway.

Regulations 100

Regulations Treatment Research 100

KIF1A

SEPTEMBER 16, 2023

But once a protein is made, it can still be regulated by making additions or modifications to its structure; these post-translational modifications could be useful tools for altering a protein’s behavior in a directed way, an approach closely related to structure-based therapeutics.

Regulations 105

Regulations RNA Disease Research 105