GSK suffers another R&D setback, axing ulcerative colitis drug trial

Pharma Phorum

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.

PureTech launches phase II ‘long COVID’ drug trial

Pharma Times

LYT-100 will be evaluated in patients with persistent symptoms caused by COVID-19

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Vertex Moves Full Steam Ahead on Type 1 Diabetes Drug Trial With FDA’s OK

BioSpace

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

BioSig abandons COVID-19 drug trial on safety concerns

Pharma Phorum

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.

FDA Places Partial Clinical Hold on Cortexyme’s Alzheimer’s Drug Trial

BioSpace

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

Merck Drops Late-Stage Cancer Drug Trial Due to Disappointing Efficacy | 2021-01-20

The Pharma Data

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.

Lundbeck gets cold feet, axes schizophrenia drug trial

Pharma Phorum

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.

Washington Man Faces 28 Years in Prison for Fraudulent Drug Trial Scandal

BioSpace

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

aTyr Pharma Finishes Enrollment of Respiratory Drug Trial for COVID-19 Patients | 2020-10-27

The Pharma Data

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.,

FDA Halts Poseida’s CAR-T Trial for Prostate Cancer Following Patient Death

BioSpace

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.

Reaction of Investigational Drugs to Acid-Reducing Agents Should Be Studied, Guidance Says | 2020-11-30

The Pharma Data

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.

LSD biotech MindMed buys digital trial firm HealthMode

Pharma Phorum

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.

A collaborative approach to greater diversity in clinical trials

Pharma Phorum

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.

UK scientists trial Humira biosimilar for COVID-19 in care homes

Pharma Phorum

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 Announces Service for Virtual Site Monitoring Visits to Allow CRA’s Continued Access to Research Sites During COVID-19 Pandemic 

VirTrial

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.”.

Eli Lilly Designs P-Tau Biomarker Assay for Early Alzheimer’s Disease Diagnosis

The Pharma Data

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.

What can we learn from women’s health data?

Pharma Phorum

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.

Unlocking the potential in rare disease research with decentralised trials

Pharma Phorum

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.

Trials 101

Crucial Data Solutions Announces Updates to TrialKit AI, EHR to EDC API

Crucial Data Soutions

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

Diseases Don’t Discriminate, So Why Aren’t Clinical Trials More Diverse?

XTalks

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 medical school trying to become anti-racist

The Pharma Data

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.

How does HTA for orphan drugs differ across Europe?

Pharma Phorum

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.

Drugs 74

Waiver of Informed Consent - proposed changes in the 21st Century Cures Act

Placebo Control

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.

Counterfeit Drugs in Clinical Trials?

Placebo Control

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.

Half of All Trials Unpublished*

Placebo Control

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.

Brazen Scofflaws? Are Pharma Companies Really Completely Ignoring FDAAA?

Placebo Control

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.