PPD

JULY 29, 2024

AI also has the potential to incorporate real-world data (RWD) obtained from electronic health records (EHRs), medical claims or other data sources to inform the design and optimization strategy of clinical trials. A high-risk participant can be even excluded from the study based on the severity of the adverse event.

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Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

Trials 80

Trials Clinical Trials Regulations FDA 80

Drug Discovery World

APRIL 8, 2024

Their research signals a transformative leap in liver disease management, addressing both inflammation and fibrosis. It is progressing to Phase I clinical trials with JD Bioscience. 11c exhibited potent anti-inflammatory and fibrotic effects and high levels of safety in animal models.

Disease 130

Disease Treatment Pharmacokinetics Clinical Trials 130

Drug Discovery World

AUGUST 20, 2024

Research shows that companies could shorten this cycle by up to 30 months 2 over the course of the small molecule drug discovery process by applying AI. However, as with any application of AI in the life sciences, research organisations must follow guidelines to ensure AI models deliver accurate and trustworthy results.

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Drug Discovery World

OCTOBER 25, 2023

Iksuda Therapeutics has dosed the first patient in a Phase I trial of antibody drug conjugate (ADC) IKS014 in patients with advanced solid tumours that express HER2. This follows positive data from Phase I clinical trials through Fosun Pharma, which is now progressing FS-1502 (IKS014) through Phase II and Phase III trials in China.

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Drug Discovery World

NOVEMBER 3, 2023

We’re pleased to share these first clinical data from our clinical trial of NDI-101150. The data were presented at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego, CA.

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Pharmacokinetics Clinical Trials Trials Disease 130

Drug Discovery World

AUGUST 13, 2024

Animal models (AMs) have generally been seen as useful for drug development and biomedical research for many years. They are assumed to closely mimic human disease progression and act as a good testing ground for toxicology studies and pharmacokinetics 1. Are AMs always necessary and unavoidable? Possibly not.

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Drug Development Animal Testing Regulations Drugs 162

Broad Institute

JULY 17, 2024

Still, more than 90 percent of drug candidates fail in clinical trials, with even more that never make it to the clinical stage. Researchers at the Broad Institute of MIT and Harvard have developed AI models that can screen the potential biological effects of drugs before they ever enter a living organism. A fourth is in the works.

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Pharmacokinetics Molecular Biology Drugs FDA 84

Advarra

JUNE 20, 2023

According to a 10-year oncology research study conducted by the Biotechnology Innovation Organization (BIO), only 5.1% Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54

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Trials Clinical Trials FDA Approval Animal Testing 52

Drug Discovery World

NOVEMBER 10, 2023

CAN-2409 in non-metastatic pancreatic cancer Candel Therapeutics reported on initial positive interim data from its Phase II clinical trial of CAN-2409 that showed notable improvements in patients with borderline resectable pancreatic ductal adenorcarcinoma (PDAC). The estimated overall survival rate was 71.4%

Pharmacokinetics 130

Pharmacokinetics Clinical Trials Immune Response Treatment 130

Drug Discovery World

FEBRUARY 2, 2024

Phase I trial for first-in-class bispecific antibody for cancer Onward Therapeutics has announced the Phase I clinical trial of OT-A201, a first-in-class bispecific antibody targeting two immune checkpoints is in progress.

Pharmacokinetics 130

Pharmacokinetics Drugs International Clinical Trials 130

Drug Discovery World

AUGUST 23, 2022

The MAA is supported by results from a Phase III clinical trial investigating the pharmacokinetic (PK) exposure equivalence of the novel oral fixed-dose combination versus IV decitabine. Orally administered decitabine and cedazuridine showed an exposure equivalence to a standard five-day regimen of IV decitabine. References . ?

Treatment 130

Treatment Pharmacokinetics Clinical Trials DNA 130

Drug Discovery World

APRIL 10, 2023

Phase I data has already shown BPL-003 to be well-tolerated with consistent dose delivery, a reproducible and dose-linear pharmacokinetic profile, and a reliable induction of profound psychedelic experiences.

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Drug Discovery World

APRIL 5, 2023

The drug, which is now called NXP800 and has already entered a Phase I clinical trial, was discovered by scientists at The Institute of Cancer Research, London. We hope that our drug goes on to show effectiveness in clinical trials.” It also supports the drug’s potential to treat other cancers.

Clinical Trials 130

Clinical Trials Pharmacokinetics Drugs DNA 130

Drug Discovery World

MAY 31, 2023

Immuno-oncology company Aulos Bioscience has revealed interim results from an ongoing Phase I/II trial of monoclonal antibody AU-007 in solid tumours. The Phase I/II trial AU-007 is the first computationally designed human monoclonal antibody in a human clinical trial.

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Drug Discovery World

JULY 25, 2023

These guidelines facilitate open communication between regulators and researchers, enabling the industry to adapt and conduct more robust and efficient paediatric clinical studies, while avoiding unnecessary trials. The guidance is for pharmaceutical companies conducting paediatric clinical trials in the EU using the PIP procedure.

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Drug Development Clinical Pharmacology Pharmacokinetics Drugs 130

Drug Discovery World

JUNE 29, 2023

Recently, the US Food and Drug Administration (FDA) published new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs. The Phase IIa proof-of-concept trial will evaluate short-term changes in anxiety-related patient reported outcomes in approximately 50 healthy volunteers.

Drugs 130

Drugs Pharmacokinetics Trials FDA 130

Drug Discovery World

DECEMBER 14, 2023

PROTAC ER degrader vepdegestrant Arvinas and Pfizer presented interim data from a Phase Ib trial of vepdegestrant, a novel oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in combination with palbociclib (Ibrance). The data revealed an overall response rate of 42% and median progression-free survival of 11.1

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Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.

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Clinical Trials Treatment Trials Drug Development 52

Drug Discovery World

JANUARY 23, 2023

Researchers have discovered a clinical drug that sensitises glioblastoma (GBM) cells to radiotherapy and could replace the current standard of care. Armed with this understanding, the researchers further demonstrated that the genetic inhibition of DGAT1 suppresses radioresistance.

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Drug Discovery World

SEPTEMBER 6, 2022

Avacta has an ongoing Phase I clinical trial to assess the safety and pharmacokinetics of AVA6000, which has potential as a treatment for patients with a range of cancer types.

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FDA Pharmacokinetics Drugs Clinical Trials 130

Drug Discovery World

DECEMBER 4, 2023

QN-01 is currently being evaluated in the US by the FDA’s Center for Drug Evaluation and Research (CDER) and in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA). The results from Qnovia’s first in-human study demonstrate a superior pharmacokinetic profile compared to existing NRTs.

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Therapies Treatment Pharmacokinetics Clinical Development 130

Drug Discovery World

JANUARY 9, 2023

A PI3Kδ inhibitor, IOA-244 ( roginolisib) is being investigated in the DIONE-01 trial, a two-part, first-in-human Phase I study. Part A of the study investigated the safety and pharmacokinetics of continuous daily dosing of IOA-244 at 10, 20, 40 and 80mg. .

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FDA Drugs Pharmacokinetics Trials 130

Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

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Clinical Trials Treatment Trials Small Molecule 52

The Pharma Data

SEPTEMBER 7, 2021

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School. To learn more about the study or to review the volunteer qualifications, call 646-774-6243 or visit [link].

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Clinical Trials Vaccine Trials Medical Schools 52

Drug Discovery World

APRIL 3, 2024

A public-private consortium formed by the biotech Hemostatics, based at the Barcelona Science Park, the Clínica Universidad de Navarra (CUN) and the Institute of Chemical Research of Catalonia (ICIQ), has received €2.5 Our initial focus will be on the US FDA.

Therapies 130

Therapies Laboratories Pharmacokinetics Treatment 130

Drug Discovery World

JULY 20, 2023

What are benefits of drug repurposing and why do clinical drug trials so often fail? Repurposing and ‘repositioning’ medicines can be a very attractive strategy for the drug discovery industry, Oscar Della Pasqua explained, as researchers are not starting ‘from scratch’.

Clinical Pharmacology 100

Clinical Pharmacology Clinical Trials Drugs Trials 100

The Pharma Data

APRIL 11, 2023

Bayer is progressing novel research around its prostate cancer treatment darolutamide. A focus of the presentation will be on the target engagement results and pharmacokinetics from its ongoing monotherapy dose-escalation study to explore a potential optimal dose and schedule to effectively inhibit AhR.

Research 40

Research Clinical Trials Small Molecule Pharmacokinetics 40

Alta Sciences

OCTOBER 30, 2023

Discover the considerations and assessments necessary for performing preclinical research for ophthalmic therapies in this new eBook, that covers everything you need to know, from species selection and routes of administration, to preparing for first-in-human trials. Read it now. The Altascientist : Issue No. Read or listen now.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

Drug Target Review

NOVEMBER 1, 2023

2 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials. 1-5 Implication of ATX in a large range of human diseases have been highlighted by both fundamental research and clinical trials.

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Clinical Trials Small Molecule Trials Cell Biology 134

Drug Discovery World

NOVEMBER 29, 2022

This ranges from understanding disease processes and identifying possible drug targets, to organising testing, rolling out clinical trials, negotiating complex regulations and licensing and finally, treating patients. Pharmacokinetics: How the body handles drugs. Providing a broad view. Starting with the drug.

Clinical Pharmacology 130

Clinical Pharmacology Clinical Trials Drugs Drug Development 130

Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

Clinical Trials 40

Clinical Trials Treatment Trials Small Molecule 40

Drug Discovery World

AUGUST 3, 2023

With this in mind, the FDA claims to be committed to sound scientific research into the area and has a number of processes in place for those in the medical research community who intend to study cannabis 1. He said: “But for this market to become a reality, we need much more research into cannabis products and potential indications.

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Clinical Trials Regulations Production FDA 130

Vial

MARCH 15, 2024

A contract research organizations (CROs) is a third-party firm contracted by sponsors to deliver specialized services aimed at optimizing their research. This article explores the roles of CROs and highlights strategic partnerships between CROs and external vendors, designed to enhance research outcomes.

Clinical Trials 52

Clinical Trials Compliance Trials Laboratories 52

DrugBank

MARCH 7, 2024

Pharmaceutical researchers, in particular, have a keen interest in understanding the unfolding dynamics of this market. On the other hand, Amgen revealed early-stage trial data on a promising once-a-month, weight loss medication, signaling its entry into this competitive arena.

Pharmaceutical Companies 82

Pharmaceutical Companies Pharmaceuticals Clinical Trials Pharmacokinetics 82

Drug Discovery World

SEPTEMBER 26, 2022

Indeed, having a safety profile already established could entice patients to enter clinical trials more readily than with ‘unknown’ compounds. . Remote trials, wearable devices and advancements in genomic sequencing means that clinical data is now more abundant than ever and is only set to grow. . However, challenges remain.

Pharmaceutical Companies 130

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Alta Sciences

JANUARY 31, 2024

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified pmjackson Wed, 01/31/2024 - 14:55 Understanding the effects of a drug, and how it interacts with the body, and vice versa, is critical to ensure it is safe for human use. This is where pharmacokinetic (PK), pharmacodynamic (PD) , and toxicokinetic (TK) analyses step in.

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Pharmacokinetics Clinical Trials Drug Development Small Molecule 52