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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. MORE
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. MORE
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. MORE
Exploring the fact that drug trials predominantly involve white, male participants, and looking at how this may lead to inaccurate and harmful prescribing for other patients. Image copyright. Eva Larkai. Image caption. MORE
was convicted on 47 counts of fraud and drug related charges on Oct. A 41-year-old man from Richland, Wash. 1, according to the U.S. Justice Department’s Eastern District of Washington MORE
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. The double-blind, placebo-controlled trial, which has 32 participants across the U.S., MORE
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. MORE
Comparator Network" - which will perhaps streamline member companies' ability to obtain drugs from each other for clinical trials using active comparator arms - the CEO of the consortium, Dalvir Gill, drops a rather remarkable quote: "Locating and accessing these comparators at the right time, in the right quantities and with the accompanying drug stability and regulatory information we need, doesn't always happen efficiently. MORE
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. ADNI trial. MORE
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. MORE
Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “ fake fix ” that was being thoroughly “ignored” by the pharmaceutical industry. In it, the authors report even lower levels of FDAAA compliance – a mere 20% of randomized clinical trials met requirements of posting results on clinicaltrials.gov within one year. Results reporting requirements are pretty clear. MORE
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. The post UK scientists trial Humira biosimilar for COVID-19 in care homes appeared first on. MORE
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. MORE
US biotech BioSig Technologies has abandoned a phase 2 trial of its antiviral drug merimepodib with Gilead’s Veklury in severe COVID-19 patients, after concluding the safety of the combination was in doubt. MORE
Scottsdale, AZ (May 26, 2020) – VirTrial today announced a new service designed to enable virtual site monitoring visits in the clinical trials industry. With the current restriction on travel due to the COVID-19 pandemic, this option enables studies to proceed without delay and facilitates an expedited trial process for sponsors developing drugs to address the current global crisis.”. MORE
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. With more than 10,000 users conducting hundreds of clinical device and drug trials across all phases, CDS has been a quiet industry leader for many years,” said Jeff Rogers, President of Crucial Data Solutions. “As MORE
LYT-100 will be evaluated in patients with persistent symptoms caused by COVID-19 MORE
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. One potential concern is the search methodology used by the authors to match posted and published trials. MORE
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. MORE
Adam Feuerstein points out - and expresses considerable alarm over - an overlooked clause in the 21 st Century Cures Act: Waive informed consent requirement for clinical trials?!?! pic.twitter.com/dqmWPpxPdE — Adam Feuerstein (@adamfeuerstein) July 14, 2015 In another tweet, he suggests that the act will "decimate" informed consent in drug trials. A drug manufacturer wants to understand physicians’ rationales for performing a certain procedure. MORE
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. N above each bar equals the number of drugs reviewed by the respective HTA body. MORE
Food and Drug Administration halted a cancer drug trial due to safety concerns Shares of Poseida Therapeutics plunged more than 20% in premarket trading this morning after the company announced the U.S. MORE
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. MORE
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. MORE
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. MORE
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 MORE
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 MORE
Drug Trials Related Topics 
Pharma Phorum
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.
Pharma Times
DECEMBER 4, 2020
LYT-100 will be evaluated in patients with persistent symptoms caused by COVID-19
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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
Pharma Phorum
OCTOBER 27, 2020
US biotech BioSig Technologies has abandoned a phase 2 trial of its antiviral drug merimepodib with Gilead’s Veklury in severe COVID-19 patients, after concluding the safety of the combination was in doubt.
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
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.
Pharma Phorum
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.
BioSpace
OCTOBER 11, 2020
was convicted on 47 counts of fraud and drug related charges on Oct. A 41-year-old man from Richland, Wash. 1, according to the U.S. Justice Department’s Eastern District of Washington
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. The double-blind, placebo-controlled trial, which has 32 participants across the U.S.,
BioSpace
AUGUST 17, 2020
Food and Drug Administration halted a cancer drug trial due to safety concerns Shares of Poseida Therapeutics plunged more than 20% in premarket trading this morning after the company announced the U.S.
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.
Pharma Phorum
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.
Pharma Phorum
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.
Pharma Phorum
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. The post UK scientists trial Humira biosimilar for COVID-19 in care homes appeared first on.
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. With the current restriction on travel due to the COVID-19 pandemic, this option enables studies to proceed without delay and facilitates an expedited trial process for sponsors developing drugs to address the current global crisis.”.
The Pharma Data
NOVEMBER 10, 2020
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. ADNI trial.
Pharma Phorum
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.
Pharma Phorum
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.
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. With more than 10,000 users conducting hundreds of clinical device and drug trials across all phases, CDS has been a quiet industry leader for many years,” said Jeff Rogers, President of Crucial Data Solutions. “As
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.
The Pharma Data
AUGUST 16, 2020
Exploring the fact that drug trials predominantly involve white, male participants, and looking at how this may lead to inaccurate and harmful prescribing for other patients. Image copyright. Eva Larkai. Image caption.
Pharma Phorum
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. N above each bar equals the number of drugs reviewed by the respective HTA body.
Placebo Control
JULY 14, 2015
Adam Feuerstein points out - and expresses considerable alarm over - an overlooked clause in the 21 st Century Cures Act: Waive informed consent requirement for clinical trials?!?! pic.twitter.com/dqmWPpxPdE — Adam Feuerstein (@adamfeuerstein) July 14, 2015 In another tweet, he suggests that the act will "decimate" informed consent in drug trials. A drug manufacturer wants to understand physicians’ rationales for performing a certain procedure.
Placebo Control
AUGUST 7, 2013
Comparator Network" - which will perhaps streamline member companies' ability to obtain drugs from each other for clinical trials using active comparator arms - the CEO of the consortium, Dalvir Gill, drops a rather remarkable quote: "Locating and accessing these comparators at the right time, in the right quantities and with the accompanying drug stability and regulatory information we need, doesn't always happen efficiently.
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. One potential concern is the search methodology used by the authors to match posted and published trials.
Placebo Control
JULY 31, 2013
Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “ fake fix ” that was being thoroughly “ignored” by the pharmaceutical industry. In it, the authors report even lower levels of FDAAA compliance – a mere 20% of randomized clinical trials met requirements of posting results on clinicaltrials.gov within one year. Results reporting requirements are pretty clear.
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