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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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. Anti-fibrotic therapies: Anti-fibrotic drugs have shown promise in treating pulmonary fibrosis.

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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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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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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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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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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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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

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. Meanwhile, we have been busy foraging for items of interest, which we hope will ease your journey today. We appreciate insightful tips. … The U.S.

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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

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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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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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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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

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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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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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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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

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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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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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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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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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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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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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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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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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

OCTOBER 27, 2020

Women are likely to have different symptoms to men for the same illness and do not necessarily have the same reactions to certain drugs or respond to the same doses as a male counterpart. In trials for cardiovascular, HIV, kidney disease and digestive diseases, women have especially been underrepresented.

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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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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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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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Delveinsight

AUGUST 12, 2021

Beta-blockers, such as nadolol and propranolol, are the standard therapy and sometimes combine with heart rhythm drug mexiletine, made under various names by Teva, Lannett, Boehringer Ingelheim, and other biopharma. Takeda leads Finch-partnered Microbiome IBD drug. Nanox acquires Zebra Medical Vision for USD 200 Million.

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FDA Law Blog

MAY 3, 2021

On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a). 42 U.S.C. §

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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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Pharmaceutical Technology

SEPTEMBER 7, 2022

Pharmacovigilance refers to the practice of collecting, detecting, assessing, monitoring and preventing adverse effects (AEs) caused by new drug substances. To meet the challenges caused by the Covid-19 pandemic, RWS integrated machine translation (MT) technology into its workflow.

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XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. Given the success of Oxford’s Phase II trial, the study investigators are now gearing up for a Phase III licensure trial to assess large-scale safety and efficacy in 4,800 children aged 5 to 36 months across four countries in Africa.

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