Scienmag

JANUARY 19, 2022

New research suggests manufacturers of newly developed antidepressant drugs have become more forthcoming about clinical trials that don’t pan out.

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BioSpace

FEBRUARY 15, 2021

According to a statement made by Cortexyme, the partial hold was placed on the development program for atuzaginstat after an FDA review of the trial data identified hepatic adverse events.

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Drug Trials Trials Drugs Development 88

BioPharma Reporter

OCTOBER 4, 2022

Kibow Biotech is celebrating its 25th anniversary as the company pivots toward developing a drug based on its proprietary probiotic strains that benefit kidney disease suffers.

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pharmaphorum

FEBRUARY 19, 2021

million, which uses artificial intelligence (AI) technology to speed up drug development. With the acquisition MindMed gains access to HealthMode’s intellectual property, platforms for clinical drug trials, and its entire 24-strong digital medicine team.

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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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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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Drug Trials Trials Clinical Trials Clinical Trials 98

STAT News

MARCH 27, 2023

Food and Drug Administration proposed cancer drug developers in most cases conduct more rigorous trials to seek accelerated approval for their candidates , Reuters tells us. Continue to STAT+ to read the full story…

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Velocity Clinical Research

OCTOBER 21, 2024

For a clinical trials organization to achieve this level of scale is notable. The clinical trials sector in the US is typically made up of small independent businesses that collectively play an important role in trialing new protocols and aiding drug development. Velocity is among the few exceptions.

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BioPharma Reporter

JULY 4, 2023

Sosei Heptares has dosed the first subject in a phase 1 trial evaluating HTLâ149, a first-in-class GPR52 agonist, which represents a novel mechanism of action for the treatment of schizophrenia and related neurological diseases.

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Delveinsight

AUGUST 13, 2021

Clinical trials are an essential part of the drug development process. Worldwide, more than 2 million clinical trials are registered and the number is steadily increasing over the past several years. The conduct of trials was not possible due to the risk of catching coronavirus. What are Virtual Clinical Trials?

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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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Drug Trials Trials Drugs Clinical Trials 59

XTalks

MAY 16, 2023

Clinical trials for pulmonary fibrosis are being conducted to evaluate the effectiveness of novel therapies and interventions, providing hope for improved outcomes in the future. Exposure to substances like asbestos, silica dust and certain chemicals has been linked to the development of pulmonary fibrosis.

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Clinical Trials Clinical Trials Trials Research 98

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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pharmaphorum

AUGUST 25, 2022

When cirrhosis complications develop, some will be lucky enough to be listed for a transplant. But herein lies the dichotomy that medicine has created: By failing to regularly screen to find the early-stage disease, the number of patients who could participate in drug trials is limited. Others are not so fortunate.

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Development Drugs Trials Medicine 98

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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Clinical Trials Clinical Trials Trials Drugs 98

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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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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Clinical Trials Clinical Trials Trials Research 98

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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pharmaphorum

OCTOBER 1, 2020

Researchers at the University of Oxford in the UK have started a trial of TNF inhibitor adalimumab for COVID-19 patients in care homes and other community settings. Sandoz is providing the adalimumab to be used in the trial, which will be carried out at care homes around the UK and is due to get underway later this month.

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Worldwide Clinical Trials

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. In turn, the FDA’s guidance recognized the difficulty in recruiting for rare diseases and encouraged sponsors to become more resourceful and intentional about trial enrollment.

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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. Clinical trial packaging and labelling solutions.

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Roots Analysis

FEBRUARY 29, 2024

Shares of Zealand Pharma experienced a significant surge, jumping 16% as the market opened on Monday, following the release of groundbreaking phase II trial results for an experimental obesity treatment being developed in collaboration with Boehringer Ingelheim. The trial, conducted by Boehringer Ingelheim, revealed that up to 83.0%

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XTalks

SEPTEMBER 13, 2024

Diverse clinical trials are a matter of equity and essential for the validity and reliability of research outcomes. Historically, racial and ethnically minoritized groups or populations have been excluded from clinical trials, leading to a lack of data on how different demographic subgroups respond to treatments.

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Trials Clinical Trials Clinical Trials Clinical Research 52

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

OCTOBER 27, 2020

Collecting and analysing anonymised patient data has the potential to generate valuable insights that can catalyse research, lead to improved patient care, and power the development of new treatments. In trials for cardiovascular, HIV, kidney disease and digestive diseases, women have especially been underrepresented.

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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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Clinical Trials Clinical Trials Trials Clinical Research 111

XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease. Malaria Vaccine Phase II Trial.

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XTalks

FEBRUARY 25, 2022

There has been increasing awareness around the need for improving inclusion and diversity in clinical trials. They are also at a high risk of developing heart disease and stroke. times greater risk of developing kidney disease and are 2.3 times greater risk of developing kidney disease and are 2.3

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Clinical Trials Clinical Trials Trials Research 52

Delveinsight

AUGUST 12, 2021

Through its development and use of different algorithms, Zebra Medical has been able to recognize visual symptoms for diseases such as breast cancer , osteoporosis , and fatty liver , as well as conditions such as aneurysms and brain bleeds. The original agreement had Finch responsible for early-stage development through phase 2 studies.

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Trials Clinical Trials Clinical Trials Development 97

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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Clinical Trials Clinical Trials Trials Clinical Research 52

Placebo Control

DECEMBER 4, 2013

Instead of looking at registered trials and following them through to publication, this study starts with a random sample of phase 3 and 4 drug trials that already had results posted on ClinicalTrials.gov - so in one, very obvious sense, none of the trials in this study went unpublished.

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Pharmaceutical Technology

SEPTEMBER 7, 2022

Before drugs are authorised, evidence of their safety and efficacy is limited to results from clinical trials, so it is essential that pharmacovigilance continues after a therapy has been approved. After AEs are recorded, they must be translated and put back out to doctors and scientists for processing. It has translated more than 6.3

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VirTrial

MAY 26, 2020

Scottsdale, AZ (May 26, 2020) – VirTrial today announced a new service designed to enable virtual site monitoring visits in the clinical trials industry. VirTrial is a bioscience technology company providing a stable, long-standing telemedicine platform to transform the clinical trial industry.

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pharmaphorum

AUGUST 4, 2020

Rare diseases drugs have always faced challenges when it comes to HTA approvals, even as governments bring in more regulatory policies that make their path through assessment easier. The authors also note that orphan drug trials with higher p values and surrogate endpoints are often accepted for assessment in the country.

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Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.

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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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Clinical Research Research Clinical Trials Clinical Trials 52

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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