Drug Target Review

DECEMBER 4, 2024

G protein-coupled receptors (GPCRs) represent a cornerstone of modern drug discovery due to their crucial role in regulating human physiology and their involvement in numerous diseases. In the early days, each GPCR target required its own structure-modulating ConfoBody to be identified before starting any drug discovery.

Pharmacokinetics

Drug Target Review

JUNE 19, 2025

In the field of drug discovery, few areas face a more pressing need for innovation than pain management. Instead, Bazan explains that the drug modulates genes involved in mechanical nociception – the body’s process of detecting harmful or painful stimuli such as pressure or injury – giving it a unique pain-relieving profile.

Clinical Trials

Elrig

MARCH 25, 2025

Prof Rory Johnson, Associate Professor, University College Dublin, and Dr Shalini Andersson, Vice President Nucleic Acid Therapeutics, AstraZeneca will lead this years event focussed on drugging the undruggable.

RNA

The Pharma Data

JUNE 25, 2025

These studies demonstrated that the BRUKINSA tablet formulation is bioequivalent to the existing capsule form, confirming that patients switching between formulations can expect comparable pharmacokinetics and clinical outcomes. Alignment with U.S. Earlier this month, the U.S.

Packaging

Alta Sciences

DECEMBER 31, 2024

One of the most important factors to consider during the course of your early-phase clinical research is drug-drug interactions (DDIs), which occurs when one drug alters the effect of another, either by reducing its effectiveness or elevating systemic concentrations to potentially dangerous levelsultimately causing side effects.

Therapies

DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global counterparts, set rigorous standards to ensure that drugs are safe, effective, and high-quality. Regulatory agencies, such as the U.S.

Drug Development

Drug Target Review

MARCH 17, 2025

Neuropsychiatric disorders, affecting millions worldwide, disrupt the brain’s intricate processes of mood regulation, cognition and behaviour. Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations.

Treatment

New Drug Approvals

JUNE 25, 2025

Several drugs in five major categories, each acting by different mechanisms, are available for treating hyperglycemia and subsequently, NIDDM (Moller, D. E., “New drug targets for Type 2 diabetes and the metabolic syndrome” Nature 414; 821 -827, (2001 )): (A) Insulin secretogogues, including sulphonyl-ureas (e.g.,

Small Molecule

PPD

APRIL 14, 2025

The SELECT trial set out to understand whether the drug has similar effect on patients without diabetes. Participant fatigue in GLP-1 clinical trials The success of GLP-1 drugs in SELECT and other trials has biotech and biopharma companies racing to find which indications respond well to similar treatment.

Clinical Trials

New Drug Approvals

AUGUST 4, 2025

Donafenib , sold under the brand name Zepsun , is a pharmaceutical drug for the treatment of cancer. 3] It is a deuterated derivative of sorafenib with improved pharmacokinetic properties. [4] 3] It is a deuterated derivative of sorafenib with improved pharmacokinetic properties. [4] Drugs 2021, 81, 1915−1920. 229) Li, C.;

Metabolic Stability

Drug Patent Watch

JANUARY 14, 2025

The Generic Drug Revolution: Setting the Stage Before we dive into the nitty-gritty, let’s take a moment to appreciate the impact of generic drugs. Did you know that generic drugs now make up about 90% of all prescription drug purchases in the United States, while accounting for only 20% of prescription drug spending[1]?

Drug Development

New Drug Approvals

JULY 18, 2025

D-ARABINOFURANOSYL)- 4′-C-Azido-2′-deoxy-2′-fluoro-b-D-arabinocytidine Azvudine is an antiviral drug which acts as a reverse transcriptase inhibitor. [3] In addition to its antiviral activity, concentration of the drug in the thymus has suggested immune-targeting activity; this dual function is unique among RdRp inhibitors.8

RNA

ASPET

AUGUST 21, 2024

ICH established S7B and E14 guidelines in 2005 to prevent drug-induced torsade de pointes (TdP), effectively preventing the development of high-risk drugs. However, those guidelines unfortunately hampered the development of some potentially valuable drug candidates despite not being proven to be proarrhythmic.

Compliance

ASPET

SEPTEMBER 16, 2024

GBM has a poor prognosis despite aggressive treatment, in part due to lack of adequate drug permeability at the BBB. Various DDR inhibitors, targeting the key regulators of these pathways such as ataxia telangiectasia mutated and Rad3-related (ATR), are being explored as radio- and chemo-sensitizers.

Pharmacogenetics

FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

FDA

Chemical Biology and Drug Design

DECEMBER 19, 2024

The results of invivo anti-inflammatory tests showed that compound 5k was the most potent of the mollugin derivatives with an inhibition rate of 81.77%, which was significantly more potent than or the positive control drugs (ibuprofen and mesalazine).

Pharmacokinetics

biobide

SEPTEMBER 29, 2023

Within the field of Drug Discovery and Development the term “ New Alternative Methodologies ” (NAMs) refers to the use of new and innovative testing methods that come to replace traditional animal models. The use of in silico models allows the fastening of the first steps of Drug Discovery, representing an immense advance in the field.

Animal Testing

ASPET

AUGUST 10, 2023

Pharmacokinetic half-lives ranged from 55 to 100 hours over the clinically relevant dose range, consistent with the expected half-life extension by glycoPEGylation. Significance Statement Fibroblast growth factor 21 (FGF21) is a stress-inducible hormone that has important roles in regulating energy balance and glucose and lipid homeostasis.

Cell Based Assays

Chemical Biology and Drug Design

MARCH 6, 2024

Abstract Targeting pro-inflammatory cytokines and their production is found to be of therapeutic benefit for the regulation of inflammation in various chronic autoimmune diseases. Computational analysis and in vitro studies corroborated the cytokines (TNF-α, IL-6 and IL-1β) inhibition potential of the new natural molecule polonilignan.

Pharmacokinetics

Drug Target Review

SEPTEMBER 25, 2024

While these approaches often produce encouraging initial results, the development of drug resistance remains a major obstacle for long-term patient survival. Classically, rational drug combinations are designed to target two nodes in the same oncogenic signalling pathway.

Small Molecule

LifeSciVC

APRIL 24, 2024

Is a novel target at the inflection point where enough evidence is available to suggest it may prove to be a compelling drug? Directionality and Druggability: Does the proposed “direction” of insult and therapeutic intervention make sense, and can we drug our novel target with a compelling modality? in the case of CFTR for Trikafta).

Production

DrugBank

APRIL 24, 2025

Epigenetics , the study of changes in gene activity that occur without altering the DNA sequence, has revolutionized our understanding of gene expression regulation. Epigenetic drugs, which target the enzymes and processes involved in these modifications, represent a novel approach to precision medicine.

DNA

The Premier Consulting Blog

MAY 31, 2023

As a cornerstone of the drug development process, nonclinical investigational new drug (IND)-enabling studies are essential for supporting first-in-human (FIH) dosing for novel therapeutics. Pharmacology A typical IND-enabling package includes information on the primary, secondary, and safety pharmacology of the drug.

Packaging

DrugBank

MARCH 7, 2024

The landscape of weight loss drugs has been rapidly evolving, and 2024 is poised to be another transformative year in this market. As we step into 2024, the momentum is expected to continue, with analysts projecting the weight loss drug market to reach remarkable heights, potentially hitting $100 billion by the end of the decade.

Pharmaceutical Companies

Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938.

Animal Testing

The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

Clinical Pharmacology

Conversations in Drug Development Trends

AUGUST 9, 2024

Managing this complexity highlights the importance of global communication plans and constant communication with global regulators and keeping all required documentation up to date. Harmonizing regulatory requirements and complying with all relevant regulations are crucial for the success of adaptive MRCTs.

Trials

Drug Target Review

JUNE 6, 2023

This suppressive mechanism involves a negative regulator – a protein called IL-18BP or IL-18 binding protein, that works as a “decoy receptor” by binding to IL-18 and preventing it from binding to its functional receptor. Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy.

Engineering

The Pharma Data

JANUARY 19, 2021

Dr. Clark Cheng, Chief Medical Officer and Executive Director of Aptorum Group, commented, “The clearance of our CTA application for ALS-4 drug represents a significant milestone for the company and one of a number of targeted strategic goals for 2021. About ALS-4.

Small Molecule

Drug Target Review

OCTOBER 3, 2024

Since the 1970s, when hybridoma technology enabling the generation of monoclonal antibodies (mAbs) was first developed, 1 antibody-based therapeutics have become one of the most rapidly growing drug categories, with applications across cancer indications, immune disorders and infections.

Molecular Biology

Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. Dermavant’s tapinarof is one such friend. 8 This is not the only point of interest.

Small Molecule

The Pharma Data

DECEMBER 20, 2020

Pending Health Canada’s approval, the Phase 1 trial is designed to test the safety, tolerability and pharmacokinetics of ALS-4 in healthy volunteers. ALS-4 is an orally administered drug and thereby aligning with global healthcare policy to actively promote the switch from an IV to oral based antimicrobial treatment 1,2,3. About ALS-4.

Small Molecule

Drug Target Review

JULY 1, 2024

Can you explain the mechanism of action of SRP-001 and how it differs from traditional analgesics like acetaminophen (ApAP) and non-steroidal anti-inflammatory drugs (NSAIDs) in treating acute, chronic and neuropathic pain? We set out to improve health by developing a novel non-opioid that avoids potential abuse.

Treatment

New Drug Approvals

OCTOBER 24, 2023

3] [4] [5] [6] [7] [8] Society and culture Legal status Velsipity was approved by the US Food and Drug Administration (FDA) in October 2023. [1] Food and Drug Administration (FDA). “FDA Approves New Drug for Ulcerative Colitis” Medscape. 1] [9] [10] Names Etrasimod is the international nonproprietary name. [11]

FDA

Metabolite Tales Blog

DECEMBER 13, 2023

N -glucuronidation: the human element By Julia Shanu-Wilson In our last blog of the year, we look at why N -glucuronidation of drugs is important in human drug metabolism. Glucuronidation is the most common phase II reaction observed in the metabolism of drugs in humans. In fact, rodents lack a human UGT1A4 homologue gene [3].

Small Molecule

Vial

MARCH 15, 2024

However, their scope of services has significantly broadened, now covering the entire research process, from drug discovery to clinical trials and beyond. Examples of vendors include: Laboratories : CROs often collaborate with specialized laboratories for various purposes, such as sample analysis or pharmacokinetic studies, among others.

Clinical Trials

The Pharma Data

DECEMBER 15, 2020

Many drug makers are investing in new science and hope to develop new therapeutics that address autoimmune disease. Scientists will be testing a drug class targeting the C-reactive protein (CRP) marker of acute inflammation in the body. They’ll use software that searches available drugs, as well as drug-like compounds.

Disease