pharmaphorum

AUGUST 25, 2022

When cirrhosis complications develop, some will be lucky enough to be listed for a transplant. Cirrhosis is not just an “old drunk guys” disease, a stigma which has long hampered interest and investment in research. Dozens of companies are working at various stages of drug development. Others are not so fortunate.

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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. Fortunately, there are a number of researchers working on this issue. Similarly, older Latino and Hispanic individuals are 1.5

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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

AUGUST 6, 2020

When Lundbeck began the trial at the beginning of last year, it said the drug could be a new approach to treating schizophrenia. The company hoped to tackle persistent symptoms by inhibiting the activity of the PDE10-enzyme in the brain with Lu AF11167, which was invented by Lundbeck’s in-house research operation.

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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. The post Scepticism in press over Kintor’s COVID-19 US drug trial appeared first on.

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Scienmag

JULY 18, 2021

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

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Trials Drug Trials Drugs Vaccine 63

pharmaphorum

OCTOBER 27, 2020

Analysing real-world health data could help overcome the bias towards men in traditional medical research, says Sensyne Health’s Dr Lucy Mackillop. Medical research has often focused on men, meaning that the insights gained have not always been reflective of how women would react to a treatment or disease.

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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. Furthermore, the list includes clinical supply packaging, as well as labelling, storage, and logistics service providers for drug trial projects.

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Packaging Packaging Marketing Clinical Trials 100

VirTrial

MAY 26, 2020

The solution enables pharmaceutical sponsors and CROs to evaluate, qualify and routinely monitor research sites for studies without physical travel. COVID-19 spurred a significant increase in Virtual Pre-Site inquiries to accommodate site monitoring for existing studies and to expedite study startups for COVID and other drug trials.

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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

Velocity Clinical Research

OCTOBER 21, 2024

At the beginning of September, Velocity Clinical Research topped Business North Carolina ’s 2024 Fast 40 list. For a clinical trials organization to achieve this level of scale is notable. This is vital if we’re to ensure that drug trials are inclusive and deliver results that are representative of the entire population.

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Clinical Trials Clinical Trials Trials Clinical Research 105

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. Looking to diversify the reach of your orphan drug trial?

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Clinical Trials Clinical Trials Trials Drugs 130

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

MAY 16, 2023

The exact cause of pulmonary fibrosis is often unknown, and in such cases, it is referred to as idiopathic pulmonary fibrosis (IPF); however, certain factors can contribute to the development of pulmonary fibrosis, including environmental and occupational exposures, certain medications, autoimmune diseases and genetic predisposition.

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Clinical Trials Clinical Trials Trials Research 98

pharmaphorum

DECEMBER 1, 2022

A recent survey of clinical trial professionals found that more than two-thirds of respondents (61%) believe giving patients choice will have a positive impact on clinical research, and well over half (58%) said that their organisations plan to give patients the option to choose how they participate in clinical trials moving forward.

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Clinical Trials Clinical Trials Trials Clinical Research 111

Delveinsight

AUGUST 12, 2021

The company’s founders have confirmed this role in recent research out of Beth Israel Deaconess Medical Center and Massachusetts General Hospital, LQTT said. The original agreement had Finch responsible for early-stage development through phase 2 studies. Anthony Rosenzweig, M.D., David Milan, M.D., and Saumya Das, M.D.,

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Trials Clinical Trials Clinical Trials Development 97

pharmaphorum

SEPTEMBER 27, 2021

As the vaccines were developed and rolled out, the disparity in their take up among different sections of the community highlighted how excluded some minority communities felt from areas of healthcare. In 2020, 53 novel medicines were approved by the FDA and of the patients who took part in trials, just 8% were black and 6% were Asian.

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Clinical Trials Clinical Trials Trials Vaccine 122

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

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. Why the Need?

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Clinical Trials Clinical Trials Trials Drugs 98

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.

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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. FDA Expedited Programs.

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pharmaphorum

AUGUST 4, 2020

New research looks at the factors that speed up and slow down HTA appraisals for rare disease medicines across Europe. 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.

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Pharmaceutical Technology

SEPTEMBER 7, 2022

Among the many effects the Covid-19 pandemic has had on the pharmaceutical industry is a substantial increase in the number of AEs being reported from drug trials, due to the fast-tracked development, approval and marketing of vaccines for the SARS-CoV-2 virus. It has translated more than 6.3

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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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Clinical Trials Clinical Trials Trials Drugs 98

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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Clinical Trials Clinical Trials Trials Antibody 52

XTalks

FEBRUARY 25, 2022

And Black people continue to face generational disenfranchisement in healthcare systems and medical research. They are also at a high risk of developing heart disease and stroke. times greater risk of developing kidney disease and are 2.3 They are also more likely to develop hypertension earlier in life than white individuals.

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Clinical Trials Clinical Trials Trials Research 52

Crucial Data Soutions

FEBRUARY 24, 2020

(CDS), a leading technology provider focused on data collection and clinical trial management, today announced several updates in celebration of its tenth anniversary, including the company’s latest technological development, TrialKit AI, a machine-learning API. 888) 753-4777 carley.nolan@crucialdatasolutions.com.

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XTalks

AUGUST 4, 2022

This started back in 1993 when the FDA established guidelines to increase diversity by gender and race/ethnicity of participants in clinical trials that were contributing to new drug approvals. In January 2015, the FDA implemented its Drug Trials Snapshots program to make clinical trial demographic data more transparent and available.

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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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Trials Clinical Trials Clinical Trials Containment 40

World of DTC Marketing

JULY 19, 2021

CDC and new drugs have fostered an era of mistrust with some people. DTC marketers need to be more forthcoming when it comes to drug trials and side effects. Besides the blatant misinformation, most issues revolve around long-term safety as people feel the vaccine was developed too quickly.

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Vaccine Vaccination Marketing Drugs 279

pharmaphorum

FEBRUARY 4, 2022

. “This way, the control group does not need to recruit patients, which also increases the cost-efficiency of drug development,” according to Aalto’s Prof Harri Lähdesmäki, who also works within the Finnish Center for Artificial Intelligence (FCAI).

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XTalks

OCTOBER 7, 2024

Takeda has forecasted continued financial pressure but is banking on new drug trials to stabilize its position​. The most recent layoff plan came after news in early August that Genentech was shuttering its cancer immunology group as the company reprioritized investments in cancer research.

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Production Marketing Manufacturing Clinical Trials 52

Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. These products will require clinical trial data to get to market, but with significantly fewer participants required as compared to a drug trial.

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Clinical Trials Clinical Trials Trials Production 52

ACRP blog

DECEMBER 18, 2024

Medical device trials, however, are typically smaller in scale and require fewer phases [than drug trials]. The information from this site goes on to describe how medical device studies are divided into three different classes, rather than into the familiar phases of drug studies. Other Medical Devices.

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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 ). China backs developing countries’ call to waive IP rights on COVID-19 vaccines ( Reuters ). Now they fear an increase.

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