Drug Discovery World

JUNE 20, 2024

Ahead of Motor Neurone Disease (MND) Awareness Day on 21 June, we take a look back over the latest developments in the treatment of MND and amyotrophic lateral sclerosis (ALS). This Phase II clinical trial of drug candidate NX210c in patients with ALS is the first to target the integrity of the blood brain barrier (BBB).

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BioPharma Drive: Drug Pricing

DECEMBER 9, 2023

Study results disclosed at the American Society of Hematology meeting Saturday suggested potential for cell therapy in lupus and pointed out drug trial limitations.

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Drug Discovery World

JUNE 9, 2023

There has been some interesting news related to clinical trials this week, with the announcement that the FDA has published draft guidance to modernise the design and conduct of studies, and the failure of Bellerophon Therapeutics’ Phase III study in fibrotic Interstitial Lung Disease.

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Drug Discovery World

NOVEMBER 29, 2023

Researchers have created a mathematical model that can accurately depict Alzheimer’s disease progression in individual patients, paving the way for personalised treatment and faster development of therapies. These findings closely matched the results of the corresponding real-life clinical trials.

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Drug Discovery World

FEBRUARY 10, 2023

Clinical drug trials have made the headlines this week, as it was revealed that breast cancer still tops the bill for number of clinical studies and the shortcomings in current methods to ensure representation of patient populations in trials were exposed.

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Drug Discovery World

NOVEMBER 3, 2023

News round-up for 30 October – 3 November by DDW Editor Reece Armstrong My news highlights this week feature a variety of exciting clinical trial results and launches that are examining therapies for much-needed disease areas, new drug approvals and even a space mission with a pharma twist.

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Drug Discovery World

MAY 3, 2023

Vicore Pharma, a Swedish clinical-stage pharmaceutical company unlocking the potential of angiotensin II type 2 receptor agonists (ATRAGs), has dosed its first patient with C21 in a clinical study of endothelial dysfunction. Vicore Pharma states that results from the trial are expected in Q4, 2023.

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Conversations in Drug Development Trends

NOVEMBER 3, 2022

In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. The challenge within rare disease is that we’re now ‘rarifying’ an already rare disease by expanding into rarer subtypes of the disease.”.

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Advarra

AUGUST 16, 2022

A rare, or orphan, disease by definition affects a small percentage of the population — fewer than 200,000 people in the U.S. But the numbers add up, and taken together, rare diseases impact an estimated 30 million Americans. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.

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Advarra

MARCH 21, 2023

While drugs require Phase I-III clinical trials—and are also subject to post-approval tracking—digital therapeutics, devices, and IVDs may be able to leverage bench testing, animal studies, pilot studies, and training sets. How do you determine if clinical trials are needed for your device?

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Drug Discovery World

FEBRUARY 20, 2023

Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, according to a recent report by analytics company Phesi. Here, we take a look at the top four disease areas and some of the key developments in 2022. The candidate demonstrated 64.7%

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Drug Discovery World

MAY 21, 2024

This remarkable progress in antibody modalities for disease treatment is a testament to the effectiveness of these methods, and they remain key for many use cases. These targets, along with many others, are universally deemed as ‘difficult-to-drug’ targets.

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The Pharma Data

NOVEMBER 10, 2020

Biomarkers will be critical to developing precision medicine for Alzheimer’s disease. Although a few are out there, phosphorylated tau (P-tau) may enable even earlier and more accurate detection, according to Eli Lilly-associated researchers speaking at the Clinical Trials on Alzheimer’s Disease (CTAD) virtual conference in early November.

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Drug Discovery World

JULY 20, 2023

What are benefits of drug repurposing and why do clinical drug trials so often fail? Diana Spencer summarises the key messages from the ‘Drug Repurposing: Challenges and Opportunities’ Symposium held at the 19th World Congress of Basic & Clinical Pharmacology (WCP) 2023.

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Codon

JANUARY 21, 2024

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Why are challenge trials becoming more popular?

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Advarra

JUNE 27, 2023

Clinical trials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. The goal is to identify safer, more effective methods of treating illnesses using new drugs or new combinations of existing drugs.

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Drug Discovery World

MARCH 7, 2023

In 2023, the company revealed data from a Phase III trial which showed that its vaccine candidate DCVax-L more than doubled overall survival in glioblastoma patients. Here at FAB our proprietary approach aims to overcome this fundamental challenge to human health as we work to discover and develop new drugs for age-associated diseases.”

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The Open Targets Blog

OCTOBER 31, 2023

The goal of MTP is to integrate the FDA’s Relevant Molecular Target List and enrich the platform with pre-clinical paediatric cancer datasets containing somatic variation, gene expression, and gene fusion data to aid in identifying new paediatric cancer-specific drug targets.

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Agency IQ

AUGUST 23, 2024

At a high level, the pilot program was intended to offer sponsors of certain drug products that would need a CDx with the opportunity to submit information about their Clinical Trial Assay (CTA) – the assay they’re using in a pivotal trial – to the FDA [see here for background on that topic].

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Agency IQ

MARCH 29, 2024

regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0:

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Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.

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Drug Discovery World

JANUARY 17, 2024

Brett Swansiger, Chief Commercial Officer at ANGLE discusses the importance of liquid biopsies in precision medicine trials for cancer. Furthermore, oncology clinical trials are frequently challenged by low enrolment rates, failure to achieve primary endpoints, study design complexity and limited funding 5.

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The Pharma Data

AUGUST 16, 2020

A number of diseases manifest differently depending on skin tone, but too little attention is given to this in training, according to Dr Joseph Hartland, who is helping to lead changes at the University of Bristol Medical School. . Life-or-death signs.

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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.

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Drug Discovery World

OCTOBER 6, 2022

In the cancer space alone over the last five years, clinical trials have increased 500% for new drugs and new drug combinations. Identifying the population subsets who will benefit is essential to the success of these therapies in both the clinic and in the clinical trials that will bring these drugs to market. .

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Drug Target Review

NOVEMBER 30, 2023

From an early age, I’ve been passionate about finding cures for difficult-to-treat diseases. I accepted and I’ve been CEO ever since; our goal, from the beginning, was to pioneer new ways to diagnose, treat and prevent neurodegenerative diseases. That’s missing the point – we have learned how to slow the disease.

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Agency IQ

MAY 3, 2024

Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections.

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Agency IQ

AUGUST 18, 2023

The subgroup continues to work through technical aspects of certificates, clinical trial and performance study applications, vigilance and trending reports and market surveillance. We’ve seen what’s been going on with the MDR, but the main concern we’ve heard of IVDR is the performance study application process is affecting drug trials.

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Codon

MARCH 14, 2023

They had “seen no evidence of [graft-versus-host disease] in any patient,” wrote surgeon Steven A. The ALS Therapy Development Institute, located just ten minutes from my home in Cambridge, once tested more than 100 potential drugs to slow ALS progression in mice, all of which had been reported to be helpful in other studies.

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Agency IQ

FEBRUARY 2, 2024

BY LAURA DIANGELO, MPH | JAN 30, 2024 10:25 AM CST Diagnostic regulation: A quick overview Diagnostics products are those intended to identify, signal or detect a specific health condition, infection or disease, or monitor a person’s health or health status. No IVDs achieved certification in under one year and 10% took longer than two years.

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The Pharma Data

MAY 17, 2021

Regeneron resumes enrollment in lymphoma drug trials ( Reuters ). Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ). Indian makers of Sputnik V may seek waiver for local Phase-3 trials ( Economic Times ). . Trump tax law cut what US drugmakers owed.

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