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. In addition, they discovered that cladribine, a clinical drug, activates DGKB and inhibits DGAT1. GBM is a WHO grade IV brain tumour with dismal prognosis.

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Drug Discovery World

JUNE 29, 2023

DDW’s Diana Spencer provides an overview of the latest innovations in drug discovery for mental health. To mark the occasion, this article summarises the most recent news about the ways drug discovery is improving wellbeing and mental health through innovative new treatments and therapies.

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Drug Discovery World

SEPTEMBER 26, 2022

DDW Editor Reece Armstrong explores the rise of drug repurposing and the benefits and disadvantages it brings to drug discovery and development. . Drug repurposing, the act of finding new clinical targets for both approved and unapproved drugs, has emerged as a viable alternative to traditional drug discovery approaches. .

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Drug Discovery World

NOVEMBER 29, 2022

The new Clinical Pharmacology degree was launched in 2019 by Professors Emma Baker and Iain Greenwood and aims to take a holistic view of the development of drugs and create graduates that will stand out in the job market. Starting with the drug. Pharmacokinetics: How the body handles drugs.

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Drug Discovery World

AUGUST 14, 2023

Research partners in the UK are progressing their orally available small molecule cancer immunotherapy drug into clinical development as a treatment for advanced solid tumours. HTL0039732 works by blocking signalling through a specific type of prostaglandin receptor, the prostaglandin E2 (PGE2)-type prostanoid receptor 4 (EP4).

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The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees.

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Drug Discovery World

OCTOBER 13, 2022

The DDW team spent 4-5 October, 2022 at ELRIG’s annual meeting, Drug Discovery 2022, which remains Europe’s largest meeting for life sciences industry professionals and took place at ExCel, London, UK. Drug Discovery 2022: The numbers . Drug Discovery 2022: The numbers . Of those delegates, 75% work in drug discovery.

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PPD

JULY 29, 2024

In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drug development.

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Fierce BioTech

MAY 1, 2024

Join us on Monday, June 19, 2024 for one hour all about oral cyclic peptide drug development. With “specialized for peptide” drug metabolism and pharmacokinetics (DMPK) and biological evaluation, we’re able to solve certain synthesis issues found across different cyclic peptides, complexes peptides and mimetic peptides.

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PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. When imaged, the hiPSC showed a stable beating rate.

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Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Read the blog. TOP MANUFACTURING AND ANALYTICAL RESOURCES The Altascientist : Issue No. Listen here. Watch it now.

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BMG Labtech

MARCH 11, 2024

They are often the method of choice to detect or measure specific biological molecules (analytes) for diagnostics, drug discovery or fundamental research. This type of application helps guide the development and optimization of therapeutics. Quality control is therefore another area that benefits from ELISA measurements.

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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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The Premier Consulting Blog

APRIL 15, 2024

By William Salminen , Madelyn Huang, & Andrew Emanuel Without concrete guidelines, it can be confusing when determining what nonclinical studies are needed for a Pre-Investigational New Drug application (PIND) meeting. neurotoxicity) that require special assessments.

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ASPET

JANUARY 31, 2024

First, we assessed the substrate potential of riboflavin towards other major drug transporters using established transfected cell systems. Overall, these data indicate that plasma riboflavin is a promising biomarker of BCRP that may offer a possibility to assess drug candidate as a BCRP modulator in early drug development.

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Drug Discovery World

AUGUST 22, 2023

In September 2021, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced the initiation of a pilot programme 1 to provide parallel scientific advice to pharma companies applying for marketing authorisation for generic versions of hybrid products and complex generic drug products.

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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.

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).

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Agency IQ

DECEMBER 1, 2023

FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version Last week, FDA published the third update to its guidance on the development of products to prevent or treat Covid-19. Lastly, the revised guidance briefly discussed trials meant to assess drugs intended for prevention of Covid-19.

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Drug Discovery World

APRIL 12, 2023

This paid-for advertorial by CN Bio appeared in DDW Volume 24 – Issue 2, Spring 2023 Despite advancements, the drug development process remains inefficient. Existing in vivo and in vitro models aren’t up to the challenge Preclinical tools exist for the evaluation and screening of potential drug candidates.

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Alta Sciences

SEPTEMBER 13, 2023

COMMONLY USED PAIN MODELS As pain models continue to expand, there are still many tried and tested ways to achieve the most accurate results possible, such as pain stimulation, pharmacodynamics (PD), and pharmacokinetics (PK) for early phase analgesic trials. At Altasciences , we have extensive experience testing various pain models.

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Drug Discovery World

JANUARY 20, 2023

This paid-for advertorial by CN Bio appeared in the SLAS 2023 Supplement, Volume 24 – Issue 1, Winter 2022/2023 Despite advancements, the drug development process remains inefficient. Existing in vivo and in vitro models aren’t up to the challenge Preclinical tools exist for the evaluation and screening of potential drug candidates.

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Alta Sciences

AUGUST 21, 2023

Efficient Characterization of ADME A critical feature of the bioanalytical platform selected for a drug development program is how well it characterizes the ADME (absorption, distribution, metabolism, excretion) of your molecule of interest. Why Partner With Altasciences for Your Bioanalytical Projects?

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FDA Law Blog: Drug Discovery

JANUARY 7, 2024

A review of FDA’s Postmarketing Requirements and Commitments database reveals that one of the most common reasons FDA requires postmarketing studies is to assess the impact of a drug on maternal and fetal outcomes when taken by pregnant women. For many drugs, both a registry and an outcomes study are required.

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PPD

MAY 11, 2023

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.

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Drug Target Review

OCTOBER 24, 2023

We have since leveraged our Platform to develop two candidate drugs; MB310 for treatment of ulcerative colitis and MB097 which is intended for use alongside immune-checkpoint inhibitors (ICIs) in melanoma patients to boost their responsiveness to the ICIs. How does it work and what are the potential benefits?

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Agency IQ

MAY 17, 2024

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. One of the core goals of the GDUFA program has been to increase the efficiency of the generic drug review program.

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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.

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Alta Sciences

AUGUST 12, 2024

Metabolic Drug Development: A to Z Solutions blussier Mon, 08/12/2024 - 18:07 HTML In the complex and dynamic field of metabolic drug development, partnering with an accomplished contract research organization is essential. We support data management both at our clinics and at external sites.

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Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol). What is the regulatory landscape of medical cannabis?

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Agency IQ

JULY 28, 2023

First, an audit of communications and meeting management under the Prescription Drug User Fee Act (PDUFA) Quick background: As AgencyIQ has previously discussed, the FDA collects user fees as part of an essential bargain between regulators and industry. This week, FDA posted several new special notice contract opportunities on SAM.

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Conversations in Drug Development Trends

AUGUST 9, 2024

The team must present data to the IDSMB accurately and promptly, especially when multiple trial arms progress at different rates, demanding comprehensive data management, including safety, pharmacokinetic (PK), or pharmacodynamic (PD) data, and statistical inputs.

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The Pharma Data

SEPTEMBER 7, 2021

Volunteers for the trial are being enrolled at Columbia University in New York City and Clinilabs Drug Development Corporation, based in Eatontown, New Jersey. “The long-term goal of this program is to develop a series of opioid vaccines that target other commonly used opioids, such as heroin and fentanyl.

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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.

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Drug Target Review

JULY 12, 2023

The clinical-stage oncology company develops medicines for broad populations of cancer patients and aims to achieve universal-RAS activity through deep cyclic inhibition of the mitogen-activated protein kinase (MAPK) pathway, selectively impacting cancer cells while sparing healthy cells.

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The Pharma Data

DECEMBER 9, 2020

The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. JERSEY CITY, N.J., 1) L iposomal IV formulation of ibrexafungerp entering Phase 1 study.

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The Pharma Data

NOVEMBER 5, 2021

With presently no approved treatments, there’s a major unmet need for curatives that can delay progression to order failure, “ said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis. About Novartis Novartis is reimagining drug to ameliorate and extend people’s lives.

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