Nxera and Cancer Research UK to present promising cancer drug trial at ESMO
Pharma Times
SEPTEMBER 13, 2024
Innovative immunotherapy drug HTL0039732 shows potential in trials
Clinical research is about trial and error
pharmaphorum
FEBRUARY 21, 2024
Clinical research involves trial and error as part of the drug development process. Learn more about how to optimise drug trials and the important role of participants in clinical research.
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New drug trial to investigate treatment for patients with bronchiectasis
Pharma Times
AUGUST 22, 2024
200,000 people in the UK have what is considered a ‘hidden’ lung condition
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McMaster drug trial receives more than $6m to test smallpox vaccine against mpox
Pharma Times
AUGUST 15, 2024
Children accounted for the majority of mpox cases and deaths in the DRC since June 2023
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Beckley adds digital element to its psychedelic drug trials
pharmaphorum
MAY 19, 2022
The alliance centres around Empatica’s EmbracePlus, a medical-grade smartwatch (pictured) and software combination that is used to collect physiological data and has been selected as the device used by NASA for its space health research programme. The post Beckley adds digital element to its psychedelic drug trials appeared first on.
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GSK suffers another R&D setback, axing ulcerative colitis drug trial
pharmaphorum
JANUARY 25, 2021
GlaxoSmithKline has suffered another research setback after it axed a phase 2 trial of an anti-LAG3 drug in patients with ulcerative colitis, following a major disappointment with a key lung cancer drug last week. The post GSK suffers another R&D setback, axing ulcerative colitis drug trial appeared first on.
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New lupus partnership with FDA aims to end drug trials’ history of failure
STAT News
MARCH 29, 2023
And hopeful patients, many of them young women of color, are waiting — just three lupus drugs have been approved by the Food and Drug Administration in six decades. On Wednesday, the nonprofit Lupus Research Alliance announced it was entering into a public-private partnership with the FDA.
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Small Pharma stock market launch funds DMT-based depression drug trial
pharmaphorum
MAY 7, 2021
Small Pharma is following the trend for development of psychedelic medicines, a field where research has been suppressed for years because of legal restrictions on use of these compounds in many countries. The post Small Pharma stock market launch funds DMT-based depression drug trial appeared first on.
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CytoDyn scores $12M in legal battle win: A huge breakthrough for its antibody drug trials
BioPharma Reporter
JULY 11, 2024
Amid a period of clinical holds and legal tangles, the US antibody specialist CytoDyn has reached a settlement to resolve legal disputes with its former contract research organization (CRO) Amarex Clinical Research.
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STAT+: Pfizer scraps half of participants in Lyme disease drug trial due to quality issues
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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Unlocking the potential in rare disease research with decentralised trials
pharmaphorum
JANUARY 19, 2021
Sites need to be close enough for travel, and the number of site visits and trial appointments must also be manageable for people living with the complications of having little-known and rarely-researched orphan diseases. In fact, how do rare disease patients even feel about clinical trials?
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Review reports improved transparency in antidepressant drug trials
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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Diversity in Clinical Trials: Tackling the Issues in Alzheimer’s Research at AAIC 2021
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
Study coordinator pleads guilty to trial data falsification
Outsourcing Pharma
NOVEMBER 1, 2021
A former employee of Tellus Clinical Research in Miami has admitted to charges related to a conspiracy to falsify data on a list of clinical drug trials.
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What to know about the new drug trial for Alzheimer's
Medical Xpress
DECEMBER 29, 2022
A new drug designed to ward off Alzheimer's is being tested at more than 100 sites around the world, including the University of Pennsylvania.
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Lundbeck gets cold feet, axes schizophrenia drug trial
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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Mathematical models and computer simulations are the new frontiers in COVID-19 drug trials
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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Reporting of adverse effects in drug trials has only improved slightly in 17 years, new study shows
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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HCPs sound off on pharma marketing
World of DTC Marketing
APRIL 20, 2022
The feedback suggests that pharma has significant opportunities to get closer to HCPs via more transparency about drug trials and data. The most likely reason to visit a pharma website for HCPs is to download the product label. Will they transform their HCP marketing or stick to dated models?
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Scepticism in press over Kintor’s COVID-19 US drug trial
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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VirTrial Announces Service for Virtual Site Monitoring Visits to Allow CRA’s Continued Access to Research Sites During COVID-19 Pandemic
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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71 #news #biotech Troubled Cytokinetics’ stock soars as gets much needed phase 2 heart drug trial win, plans late-stage effort by year’s end
BioTech 365
JULY 19, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Troubled Cytokinetics’ stock soars as gets much needed phase 2 heart drug trial win, plans late-stage effort by year’s end.Troubled Cytokinetics’ stock soars as gets much needed … Continue reading →
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Phases of Clinical Research: A Detailed Overview
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.
Do Therapies for Alzheimer’s & Parkinson’s that Clear Abnormal Brain Proteins Make the Diseases W.
BioSpace
APRIL 1, 2021
One of the common research approaches to treating brain diseases such as Parkinson’s disease (PD) and Alzheimer’s disease (AD) is using antibodies designed to clear the accumulated misfolded proteins implicated in the diseases. To date, these drug trials have not been particularly successful at i.
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LSD biotech MindMed buys digital trial firm HealthMode
pharmaphorum
FEBRUARY 19, 2021
With the acquisition MindMed gains access to HealthMode’s intellectual property, platforms for clinical drug trials, and its entire 24-strong digital medicine team. Karlin will serve as chief medical officer of MindMed after holding several leadership roles at Pfizer’s Neuroscience Research Unit.
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Leading clinical packaging companies in contract marketing
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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What can we learn from women’s health data?
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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STAT+: Pharmalittle: Private equity moving to buy clinical trials firms; data provider limits media access to drug prices
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.
Merck Drops Late-Stage Cancer Drug Trial Due to Disappointing Efficacy | 2021-01-20
The Pharma Data
JANUARY 20, 2021
Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.
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aTyr Pharma Finishes Enrollment of Respiratory Drug Trial for COVID-19 Patients | 2020-10-27
The Pharma Data
OCTOBER 26, 2020
based aTyr Pharma has finalized enrollment for a phase 2 trial to evaluate an investigational anti-inflammatory drug in COVID-19 patients with severe respiratory complications. San Diego, Calif.-based ATYR1923 is meant to reduce inflammation and restore the lung’s immune balance.
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What the FDA’s guidance on diversity means for rare disease sponsors
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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Are the benefits of new cancer drugs worth the cost?
Medical Xpress
DECEMBER 21, 2022
An international research group including scientists from Italy, the United States, Ireland, and Israel have published a three-year analysis of the Mesothelioma (Me) drug trial, Check-Mate 743 (CM-743).
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How using AI in clinical trials accelerates drug development
Pharmaceutical Technology
JUNE 15, 2023
The process of drug development typically starts with the identification of a potential target for a drug. Once the target is identified, researchers work to develop a compound that can interact with it. AI-based analysis can provide insight into participant behavior that informs how researchers design trials.
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Scaling With a Purpose: Championing the Clinical Trials Sector
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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Steps to building a more patient-centric industry
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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Bellicum’s Phase 1/2 Cancer Drug Trial Stopped Following Patient Death | 2020-12-08
The Pharma Data
DECEMBER 8, 2020
The FDA has issued a clinical hold on Bellicum Pharmaceuticals for its ongoing phase 1/2 trial evaluating CAR-T therapy BPX-601 in patients who received prior treatment for metastatic pancreatic or prostate cancer, following the death of a trial participant. The Houston, Tex.,
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Clinical Trials for Pulmonary Fibrosis: How Can Participation Be Improved?
XTalks
MAY 16, 2023
RELATED: New Report Highlights Major Barriers to IPF Disease Management Clinical trials for pulmonary fibrosis play a crucial role in advancing our understanding of the disease and developing new treatment options. Researchers continue to explore new anti-fibrotic agents and combinations to enhance treatment outcomes.
UK scientists trial Humira biosimilar for COVID-19 in care homes
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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How does HTA for orphan drugs differ across Europe?
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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Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy
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.
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Diseases Don’t Discriminate, So Why Aren’t Clinical Trials More Diverse?
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?
Reaction of Investigational Drugs to Acid-Reducing Agents Should Be Studied, Guidance Says | 2020-11-30
The Pharma Data
NOVEMBER 30, 2020
Sponsors of drug trials should determine what effect the use of acid-reducing agents (ARA), such as antacids, proton pump inhibitors and histamine blockers, could have on the solubility of an orally administered drug, according to a new FDA draft guidance released Monday.
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Treatment for all: the key steps to better representation in pharma
pharmaphorum
SEPTEMBER 27, 2021
In the UK, research found that even among people working within the healthcare sector, there was greater vaccine hesitancy among every minority of healthcare workers (HCW) than among white HCWs. 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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LQTT secures $19M; Nanox acquires Zebra Medical Vision; Takeda leads IBD drugVisus raises $20M
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. AbbVie reported the success of two phase 3 trials of its drug trial in October and filed for FDA approval in February. Anthony Rosenzweig, M.D.,
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