Drug Discovery World

MARCH 29, 2023

A Phase I clinical trial has begun evaluating Direct Biologics’ ExoFlo for the treatment of patients with medically refractory ulcerative colitis (UC). This is measured by changes in laboratory values including C-reactive protein and faecal calprotectin, and changes in validated clinical and endoscopic scoring systems.

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Drug Discovery World

JUNE 9, 2023

The REBUILD clinical trial was designed as a randomised, double-blind, placebo-controlled Phase III study evaluating the safety and efficacy of INOpulse for the treatment of patients with fILD. The post Phase III pulmonary fibrosis drug trial fails appeared first on Drug Discovery World (DDW).

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Drug Discovery World

OCTOBER 2, 2023

Sophie Winandy , Executive Director of Medical Imaging at ICON explores the benefits of AI and how it can be integrated throughout medical imaging within clinical trials. These advances are seen in many indications of imaging as it relates to drug trials – oncological, cardiovascular, metabolic, NASH, musculoskeletal and other.

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STAT News

DECEMBER 2, 2022

And a fragmented clinical trials industry has made it a prime target for private equity, which often consolidates markets by merging companies. To date, 11 of the 25 private equity firms identified by industry tracker PitchBook as the top investors in health care have bought stakes in clinical research companies.

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Outsourcing Pharma

APRIL 6, 2023

TWO US clinical investigator sites have been opened for a phase 1 clinical trial for patients with soft tissue sarcoma and the first patient has been dosed.

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BioSpace

JANUARY 28, 2021

Food and Drug Administration (FDA) has cleared an Investigational New Drug application that will allow Boston-based Vertex Pharmaceuticals to proceed with a clinical trial of its investigational stem cell-derived, fully differentiated pancreatic islet cell treatment for type 1 diabetes (.

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Scienmag

DECEMBER 20, 2021

A clinical trial in which two test drugs failed to help patients with mild COVID-19 nevertheless had a silver lining: It proved the viability of a study model in which a medication’s potential arrhythmic side effects are safely, effectively monitored without the participants ever setting foot in a hospital or clinic.

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STAT News

FEBRUARY 17, 2023

Pfizer and partner Valneva are scrapping data from roughly half of the participants in a Phase 3 trial of a Lyme disease vaccine candidate after uncovering quality issues with a third-party clinical trial operator.

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XTalks

SEPTEMBER 11, 2020

Expanding minority Americans’ access to care and clinical trials isn’t just the right thing to do. Clinical Trials Don’t Reflect Demographics. Disease doesn’t discriminate, and researchers understand different populations react differently to drugs. Why, then, are clinical trials so stubbornly homogeneous?

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pharmaphorum

MAY 7, 2021

DMT is a powerful hallucinogenic drug found in several plants including the South American plant chacruna and when used recreationally is mixed with the ayahuasca plant to make the shamanic brew of the same name. The goal of the trial is for proof of concept of the drug as a wrap-around therapy for Major Depressive Disorder.

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pharmaphorum

JANUARY 18, 2021

The need for diversity in clinical trial populations has been a topic of discussion across regulators and the industry in general for decades. The post A collaborative approach to greater diversity in clinical trials appeared first on.

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Scienmag

JUNE 15, 2022

A novel staging framework that assesses the progression of Huntington’s disease (HD), similar to the way cancer is staged 0 to 4, has been developed by UCL scientists as part of an international consortium; this ‘significant’ step paves the way for clinical trials of drugs in the earliest phase of disease.

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XTalks

AUGUST 4, 2022

Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. The Diversity of the US Population.

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XTalks

JULY 29, 2021

Just as clinical researchers in other therapeutic areas have renewed their commitment to improving participant diversity in clinical trials, so too have those working in Alzheimer’s research. What Factors Promote Alzheimer’s Clinical Trial Participation? Similarly, older Latino and Hispanic individuals are 1.5

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ACRP blog

JUNE 22, 2022

“Thanks to clinical trials and the grace of God, I’m alive today,” says Rhonda Long, who has battled a rare bile duct cancer for years. “A The next step was a clinical trial,” Long says, and was lucky when her oncologist found where she was eligible. “It I could continue my drug trial and treatment,” he says.

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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.

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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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XTalks

FEBRUARY 25, 2022

There has been increasing awareness around the need for improving inclusion and diversity in clinical trials. As such, there has been a growing emphasis on efforts to achieve better and more accurate representations of minority and underrepresented populations like Black people in clinical studies.

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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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Worldwide Clinical Trials

NOVEMBER 3, 2022

BioPharma Dive interviewed our Derek Ansel on how to conduct psychedelic clinical research. In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. Above all: Bringing more diversity to clinical trials is a slow process.

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pharmaphorum

MAY 14, 2021

China’s Kintor Pharmaceutical has begun late-stage US clinical development of its potential COVID drug proxalutamide – but there is scepticism over the company’s claims about its research. But Reuters reported that the doctor identified as its principal clinical trial investigator has said he is not in charge of the trial.

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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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Pharmaceutical Technology

SEPTEMBER 20, 2022

Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research. Finding the best clinical trial packaging services providers. Clinical trial packaging and labelling solutions.

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pharmaphorum

AUGUST 6, 2020

Lundbeck has axed a phase 2 trial of a schizophrenia drug, saying that the study was unlikely to meet its efficacy target. The company said it made the decision after a futility analysis indicated that the trial was not likely to succeed, when measured against a standard scale.

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STAT News

SEPTEMBER 30, 2022

… The results of a key Alzheimer’s drug trial on Wednesday have reignited decades-old hopes that targeting amyloid beta helps arrest the progression of the fatal brain disease, giving a big boost to similar studies being run by Roche and Eli Lilly , Reuters explains. Continue to STAT+ to read the full story…

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Drug Discovery World

NOVEMBER 29, 2023

The simulator could also be used by pharmaceutical companies to rapidly test multiple drug therapies and patient scenarios, increasing the speed and cost of drug development. These findings closely matched the results of the corresponding real-life clinical trials.

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Placebo Control

AUGUST 7, 2013

This is further complicated by infiltration of the commercial drug supply chain by counterfeit drugs. I have to admit to being a little floored by the idea that there is any sort of risk, in industry-run clinical trials, of counterfeit medication "infiltration". Emphasis added.] Either way, it could use some explaining.

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Scienmag

JULY 18, 2021

The models allow for virtual trials of drugs and vaccines, opening the possibility of pre-assessment for drug and vaccine efficacy against the virus. Researchers are using computer models to simulate COVID-19 infections on a cellular level – the basic structural level of the human body.

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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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NY Times

FEBRUARY 10, 2022

The panel debated whether overseas trials could be applied to a more diverse U.S. The decision may affect other Chinese drug trials, and spotlights the high cost of immunotherapy. population.

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pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

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pharmaphorum

AUGUST 25, 2022

At the Fatty Liver Foundation, we are formally opposed to that being the standard of care and we are working to make a difference by raising awareness, by advocating for simplification in clinical trial protocols to encourage more patient participation, and by setting up screenings for those at high-risk. Others are not so fortunate.

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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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pharmaphorum

FEBRUARY 4, 2022

Last year, Bayer launched a project to explore the use of artificial intelligence in clinical trials, working with Finland’s Aalto University to find ways to use the technology to support decentralised trials and streamline the testing process.

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Scienmag

JULY 8, 2021

Researchers, including academics from the University of York, analysed systematic reviews of 1,200 Randomised Controlled Trials (RCTs) to assess whether reporting had improved over time.

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pharmaphorum

SEPTEMBER 27, 2021

As people have become more conscious and vocal about diversity and inclusion, Page & Page’s Lisa Lishman says pharma should reassess how it conducts clinical trials. The pharmaceutical industry is one of the most important industries in the world, providing lifesaving drugs and treatment to people who need it the most.

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pharmaphorum

JANUARY 19, 2021

A survey by rare disease patient network Raremark found that 86% of the community members asked were interested in taking part in clinical trials. CEO Jeremy Edwards looks at how decentralised trial models can solve some of the challenges for clinical trial recruitment in rare disease.

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