Drug Target Review

APRIL 7, 2025

Involved in various physiological processes, such as vision, taste, smell, immune response and neurotransmission, GPCRs are activated by various molecules including hormones, neurotransmitters and environmental stimuli, which trigger a cascade of cellular events that help regulate bodily functions. References Sun D, et al. doi:10.1016/j.apsb.2022.02.002.

Fragment Screening

New Drug Approvals

APRIL 2, 2025

1] [2] It is a non- opioid , small-molecule analgesic that works as a selective inhibitor of Na v 1.8 This action and the agencys designations to expedite the drugs development and review underscore FDAs commitment to approving safe and effective alternatives to opioids for pain management. ESI-MS m/z calc.475.0922,

FDA

PPD

APRIL 14, 2025

This expansion is creating opportunities for clinical trials related to a range of new therapy areas and their subpopulations. The SELECT trial set out to understand whether the drug has similar effect on patients without diabetes.

Clinical Trials

BioPharma Drive: Drug Pricing

JULY 14, 2025

XH4D via Getty Images A group of private equity firms are pouring funding into PCI Pharma Services, betting the contract drug development and manufacturing organization’s business is poised to grow in the years ahead. You can unsubscribe at anytime. The company has 30 sites across Australia, Canada, North America, the U.K.

Production

DrugBank

OCTOBER 17, 2024

Data science has emerged as an innovative tool in the biopharmaceutical industry, leveraging the power of machine learning and artificial intelligence to drive innovation and efficiency across the entire drug development lifecycle.

Drug Development

Drug Target Review

JULY 4, 2023

Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 3D rendering of Antibody Drug Conjugate Molecules.

Small Molecule

Metabolite Tales Blog

APRIL 10, 2024

Where data was publicly available, the routes of human metabolism for each of the drugs in this subset is listed in Table 1. It is proposed that the decreased clearance of the drug observed in patients may be due to depletion of GSH in this population [10]. Similar or higher metabolite levels were observed in rodents.

Small Molecule

Drug Target Review

JULY 18, 2023

Artificial Intelligence (AI) is poised to transform the field of target discovery in drug development, offering immense potential to enhance efficacy, personalised medicine, and accelerate the development of innovative compounds.

Drug Development

DrugBank

JULY 24, 2024

Breaking New Ground with PROTACs One of the standout innovations in this space is the development of proteolysis-targeting chimeras, or PROTACs. These multifunctional small molecules are like tiny spies, hijacking the body’s natural protein degradation system to remove unwanted proteins.

Small Molecule

LifeSciVC

JANUARY 16, 2024

Small molecule GLP1s? Whether trial design, execution, or otherwise, drug development even where there is precedent is a challenging road and should not be taken for granted. Additional trials (e.g.,

Small Molecule

Alta Sciences

AUGUST 29, 2024

Engaging at the outset with a fully integrated and experienced drug development partner can ensure safety, with timely data sharing at every step of the drug development plan, and facilitate agile, flexible decision-making and planning.

Drug Development

Broad Institute

NOVEMBER 2, 2023

Combining Broad’s expertise in cancer biology and state-of-the-art drug discovery methods with Bayer’s expertise in drug development greatly increases our power to bring transformative medicines to cancer patients.” “We “Through this alliance, Broad and Bayer have done just that.

Therapies

Drug Target Review

SEPTEMBER 25, 2024

However, this will not be straightforward, given that non-oncogene resistance is driven by complex transcriptional networks, and the key drivers that determine how these mechanisms could be targets for drug development remain elusive. This orally available small molecule binds to the bromodomain of CBP/p300 in a highly specific manner.

Small Molecule

Conversations in Drug Development Trends

APRIL 4, 2024

Stability Tests: For small molecule, only -20°C stability testing is required, while large molecule need both -20°C and -70°C tests if samples are intended for storage at these temperatures. The post Demystifying the ICH M10 Bioanalytical Method Validation Guidelines appeared first on Worldwide Clinical Trials.

Small Molecule

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

Drug Development

Alta Sciences

FEBRUARY 10, 2025

Whether for a small or large molecule, we provide: Pharmacology, toxicology , and PK studies Analytical method development Formulation development and manufacturing Preclinical safety testing Clinical trial design Data reporting and documentation Want to know more before we get started?

Small Molecule

Drug Target Review

NOVEMBER 6, 2023

To bring us closer to curing cancer, a combination of effective drugs with non-overlapping mechanisms of action is required. 6 In all these examples, an effective backbone drug was first developed, before adding one or more drugs to establish the new regimens.

Small Molecule

Drug Target Review

NOVEMBER 1, 2023

I work in the Centre for Cancer Drug Discovery (CCDD) at The Institute of Cancer Research in London, which is an academic drug discovery centre. The mission of the CCDD is to discover novel small-molecule therapeutics for the treatment of cancer and progress them to hypothesis testing phase 1 clinical trials.

Fragment Screening

DrugBaron

JANUARY 31, 2024

Unfortunately, it takes a decade or more to know whether your predictions in the drug discovery and development game were correct. The ways in which the financing framework for drug discovery and development works creates, in effect, a straightjacket that constrains and diminishes decision-making quality throughout the R&D process.

Pharma R&D

The Pharma Data

OCTOBER 25, 2020

NASDAQ: PTCT), today announced the initiation of a registration-directed Phase 2/3 clinical trial to evaluate vatiquinone (PTC743) in patients with mitochondrial epilepsy, the highly morbid condition of refractory seizures in children with inherited mitochondrial disease. . SOUTH PLAINFIELD, N.J. , Peltz , Ph.D.,

Clinical Trials

The Premier Consulting Blog

NOVEMBER 20, 2024

For drugs with FDA Orphan Drug Designation (ODD), Breakthrough Therapy Designation (BTD), and EMA PRIority MEdicines designation (PRIME), all clinical, non-clinical, and CMC requirements are still required for regulatory approval, despite being on pathways for an expedited approval process.

Small Molecule

Drug Target Review

JUNE 19, 2024

That would provide wonderful information as we think about then going into a first-in-human clinical trial. Transplanting cells could prove to be more beneficial than treating a particular condition with a small molecule or an antibody, and that really speaks to the power of cell therapy. from May 2017 until December 2022.

Therapies

PPD

JUNE 27, 2024

In recent years, AA has followed in the footsteps of other dermatology indications — including psoriasis and atopic dermatitis — with growing research and clinical studies focusing on small molecules with broad cellular effects (JAK and PDE4 inhibitors) and cytokine-specific molecules antagonists (IL-23, Th2 and IL17) to treat the condition.

Treatment

KIF1A

JULY 22, 2023

Mutations that helped KIF1A process ATP also rescued synaptic development and movement symptoms. If these mutations change the structure of mutant KIF1A to help it perform better, this begs the question: Can we identify small molecules that fix the structure of mutant R9Q/R11Q KIF1A? Fisetin alleviates R9Q C.

Small Molecule

Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). In particular, regulations in both the U.S.

Clinical Trials

Alta Sciences

JANUARY 31, 2024

This article will explore the purpose of all three types of analysis, and how they are used in early drug development. The crucial influence PK/PD can have on modeling and simulation decision-making and drug development risk management depends on the quality of data accessible at specific stages of drug development.

Pharmacokinetics

The Pharma Data

NOVEMBER 26, 2020

As of today, Nanoform has two non-GMP lines on the biologics side in addition to the eight CESS ® small molecule nanoparticle technology non-GMP lines. Edward Hæggström, Nanoform CEO: “Small is powerful, also in Bio! ” Prof. ” Prof.

Small Molecule

The Premier Consulting Blog

APRIL 18, 2024

This blog will outline three characteristics of a successful nonclinical program to support entry into clinical trials for a cell or gene therapy product. As in all nonclinical drug development programs, the goal is to identify potential safety issues in humans. Can you identify a safe AND efficacious clinical dose?

Therapies

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

The Pharma Data

OCTOBER 18, 2020

DUBLIN–( BUSINESS WIRE )– Inflection Biosciences Ltd , a company developing innovative therapeutics for the treatment of cancer, today announced the appointment of industry veteran Gregory I. Greg possesses a wealth of experience in developing new cancer therapeutics across multiple U.S. Berk, MD, to its Board of Directors.

Small Molecule

The Pharma Data

JANUARY 10, 2021

(Nasdaq:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, today announced it has submitted an Investigational New Drug (IND) application with the U.S.

FDA

The Premier Consulting Blog

AUGUST 8, 2024

Typically, new drug development under the 505(b)(2) pathway requires less capital and time and has a higher success rate versus the 505(b)(1) pathway, where the Sponsor develops safety and effectiveness information from scratch. It can simply start with a strategic assessment of your drug product. [i] 89 FR 61474.

Drugs

Drug Target Review

MAY 1, 2024

At Zymeworks we apply a holistic approach to optimise each of the ADC components, leveraging insights gained from clinical trials and real-world clinical experience to inform the design of novel ADCs. Jamie Rich, PhD is Senior Director of Technology, ADC Therapeutic Development at Zymeworks Inc.

Drugs

Sygnature Discovery

OCTOBER 10, 2023

For further information, visit www.sygnaturediscovery.com About Axol Bioscience Ltd Axol Bioscience use iPSCs to build more relevant models of human disease, to expand understanding and de-risk drug development.

Small Molecule

The Pharma Data

DECEMBER 10, 2020

Lexicon is currently enrolling patients with diabetic peripheral neuropathic pain in a Phase 2 proof-of-concept study of LX9211 and is preparing to initiate a second Phase 2 clinical trial of LX9211 in post-herpetic neuralgia. The purpose of the designation is to expedite the timeline for bringing important new drugs to patients.

FDA

The Pharma Data

DECEMBER 9, 2020

Oncternal focuses drug development on promising yet untapped biological pathways implicated in cancer generation or progression.

Clinical Trials

NIH Director's Blog: Drug Development

JULY 20, 2017

Helping to fuel this optimism are preliminary results released this week from early-stage clinical trials of three next-generation, triple combination therapies that modulate the function of CFTR. According to preliminary data from one Phase 1 and two Phase 2 clinical trials reported by Vertex Pharmaceuticals Inc.,

Clinical Trials