Development, Drug Trials and Drugs - Clinical Research Informer

JPM23: Vaccine developers as dealmakers, Gilead’s trial tea leaves and building platform companies

Bio Pharma Dive

JANUARY 10, 2023

Moderna’s Stéphane Bancel and Pfizer’s Albert Bourla hinted Monday at greater dealmaking to come for their companies, while Gilead gave investors an update on an important cancer drug trial.

Trials

Trials Drug Trials Development Vaccination

Beckley adds digital element to its psychedelic drug trials

pharmaphorum

MAY 19, 2022

Phase 2 trials of Beckley Psytech’s psychedelic drug candidates will make use of digital technologies for patient monitoring, thanks to a new partnership with Empatica. Eventually, it intends to layer in digital monitoring as a fundamental component in the development of all its psychedelic-assisted psychotherapy programmes.

Drug Trials

Drug Trials Trials Drugs Development

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.

Drug Trials

Drug Trials Trials Drugs Licensing

How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

JUNE 15, 2023

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

BioSig abandons COVID-19 drug trial on safety concerns

pharmaphorum

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. Moreover, as an orally-active drug merimepodib could also have found a role outside the hospital setting.

Drug Trials

Drug Trials Trials Drugs Contract Manufacturing

Small Pharma stock market launch funds DMT-based depression drug trial

pharmaphorum

MAY 7, 2021

UK-based Small Pharma has launched on the Toronto’s TSX Venture Exchange, raising 58 million Canadian dollars (around £34m) to develop medicines based on N,N-dimethyltriptylene (DMT) to treat depression. The goal of the trial is for proof of concept of the drug as a wrap-around therapy for Major Depressive Disorder.

Drug Trials

Drug Trials Trials Marketing Drugs

Kibow Biotech celebrates 25th anniversary as drug trials commence

BioPharma Reporter

OCTOBER 4, 2022

Kibow Biotech is celebrating its 25th anniversary as the company pivots toward developing a drug based on its proprietary probiotic strains that benefit kidney disease suffers.

Drug Trials

Drug Trials Drugs Trials Development

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.

Clinical Research

Clinical Research Trials Research Drug Trials

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.

Trials

Trials Drug Trials Clinical Trials Clinical Trials

Fatty liver disease: With little early detection, more challenging drug development

pharmaphorum

AUGUST 25, 2022

When cirrhosis complications develop, some will be lucky enough to be listed for a transplant. But herein lies the dichotomy that medicine has created: By failing to regularly screen to find the early-stage disease, the number of patients who could participate in drug trials is limited. Others are not so fortunate.

Development

Development Drugs Trials Medicine

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

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.

Drug Trials

Drug Trials Trials Drugs Development

STAT+: Pharmalittle: FDA proposes more rigorous cancer drug trials for accelerated approval; insurers not covering obesity meds for kids

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.

Trials

Trials Drug Trials Drugs Clinical Trials

Avacta opens two US sites and doses first patient in sarcoma drug trial

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.

Trials

Trials Drug Trials Clinical Trials Clinical Trials

How does HTA for orphan drugs differ across Europe?

pharmaphorum

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. The results show that HTAs for orphan drugs can vary widely across Europe, causing inconsistencies in evidence requirements and recommendations.

Drugs

Drugs Manufacturing Marketing Regulation

New system that defines Huntington’s Disease will ‘revolutionise’ drug trials

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.

Drug Trials

Drug Trials Trials Drugs Clinical Trials

Sosei Heptares doses first patient in schizophrenia drug trial

BioPharma Reporter

JULY 4, 2023

Sosei Heptares has dosed the first subject in a phase 1 trial evaluating HTLâ149, a first-in-class GPR52 agonist, which represents a novel mechanism of action for the treatment of schizophrenia and related neurological diseases.

Drug Trials

Drug Trials Trials Drugs Development

Lundbeck gets cold feet, axes schizophrenia drug trial

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.

Drug Trials

Drug Trials Trials Drugs Development

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. Reuters quoted Kintor’s chief financial officer Lucy Lu, who said that Kayali was one of its trial investigators.

Drug Trials

Drug Trials Trials Drugs Dermatology

Mathematical models and computer simulations are the new frontiers in COVID-19 drug trials

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.

Trials

Trials Drug Trials Drugs Vaccination

LSD biotech MindMed buys digital trial firm HealthMode

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.

Trials

Trials Medicine Engineer Drug Trials

Zealand Pharma Stock Surge on Liver Disease Drug Trial Data

Roots Analysis

FEBRUARY 29, 2024

Shares of Zealand Pharma experienced a significant surge, jumping 16% as the market opened on Monday, following the release of groundbreaking phase II trial results for an experimental obesity treatment being developed in collaboration with Boehringer Ingelheim.

Drug Trials

Drug Trials Trials Drugs Marketing

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. Finding the best clinical trial packaging services providers.

Packaging

Packaging Packaging Marketing Clinical Trials

What can we learn from women’s health data?

pharmaphorum

OCTOBER 27, 2020

Collecting and analysing anonymised patient data has the potential to generate valuable insights that can catalyse research, lead to improved patient care, and power the development of new treatments. In trials for cardiovascular, HIV, kidney disease and digestive diseases, women have especially been underrepresented.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

Treatment for all: the key steps to better representation in pharma

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Vaccination

Scaling With a Purpose: Championing the Clinical Trials Sector

Velocity Clinical Research

OCTOBER 21, 2024

The clinical trials sector in the US is typically made up of small independent businesses that collectively play an important role in trialing new protocols and aiding drug development. This is vital if we’re to ensure that drug trials are inclusive and deliver results that are representative of the entire population.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

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

pharmaphorum

OCTOBER 1, 2020

While some drugs like dexamethasone have been shown to help patients within hospitals, so far no therapies have emerged that work in community care settings, and the Oxford trial aims to see whether adalimumab could fulfil that role.

Scientist

Scientist Trials Drugs Drug Trials

What the FDA’s guidance on diversity means for rare disease sponsors

Worldwide Clinical Trials

NOVEMBER 3, 2022

In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. But in rare disease trials, that can be challenging given the barriers inherent in U.S. Looking to diversify the reach of your orphan drug trial?

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

Reimagining Clinical Trials: Why are Virtual Clinical Trials Becoming the New Normal?

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?

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

LQTT secures $19M; Nanox acquires Zebra Medical Vision; Takeda leads IBD drugVisus raises $20M

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.

Trials

Trials Clinical Trials Clinical Trials Development

FDA Approvals for a Liquid Epilepsy Drug and Vitiligo Medication – Xtalks Life Science Podcast Ep. 71

XTalks

AUGUST 3, 2022

The drug is the first FDA approved oral suspension form of zonisamide. Hear about how the drug could help increase accessibility and flexibility for epilepsy patients and improve treatment adherence. Hear more about raising awareness about rare diseases like vitiligo and how it can help foster the development of new treatments.

Life Science

Life Science FDA Approval Drugs Development

Unlocking the potential in rare disease research with decentralised trials

pharmaphorum

JANUARY 19, 2021

A survey of members of the Raremark community found that 86% of respondents were interested in taking part in a clinical trial now or in the future. Research and development will always be important to rare disease patients. Progress in research and development for better treatments will always be a priority for rare disease patients.

Trials

Trials Research Clinical Trials Clinical Trials

Advancement through adversity: how Covid-driven innovations are becoming best practices for pharmacovigilance

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. RWS’ resource management team also had to develop new methods to ensure the availability of linguistic resources and ‘any language, anytime’ capabilities.

Engineer

Engineer Production Medicine Trials

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. Malaria Vaccine Phase II Trial.

Vaccination

Vaccination Vaccine Immune Response Trials

Clinical Trials for Pulmonary Fibrosis: How Can Participation Be Improved?

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

An Evolving Regulatory Environment for Rare and Orphan Diseases

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.

Clinical Trials

Clinical Trials Clinical Trials FDA Approval Drugs

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

XTalks

SEPTEMBER 11, 2020

Disease doesn’t discriminate, and researchers understand different populations react differently to drugs. Why, then, are clinical trials so stubbornly homogeneous? Clinical trials, however, don’t reflect that diversity. Why aren’t clinical trials more inclusive? Nearly all diseases have a genetic component.

Clinical Trials

Clinical Trials Clinical Trials Trials Drugs

Steps to building a more patient-centric industry

pharmaphorum

DECEMBER 1, 2022

According to the FDA’s 2020 Drug Trials Snapshot Report , only 8% of clinical trial participants are Black or African American, as compared to nearly 14% of the US population. The fact is, many minorities never learn about vital clinical trials in play, or that they’re eligible to participate. Keep it simple.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

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

“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.”.

Research

Research Clinical Trials Clinical Trials Clinical Research Coordinator

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.

Clinical Research

Clinical Research Research Clinical Trials Clinical Trials

Building Inclusive Trials: Insights from CTTI’s Diversity Initiatives

XTalks

SEPTEMBER 13, 2024

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. It also develops trust in clinical trials results and facilitates uptake if a medical product is approved,” Mervin-Blake noted.

Trials

Trials Clinical Trials Clinical Trials Clinical Research

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

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Antibody

Broadening Your Pharma Network on LinkedIn

Pharma Marketing Network

OCTOBER 23, 2024

Whether you’re looking to promote a new drug brand or stay updated on trending healthcare innovations , having a broad network is key. Incorporate SEO-friendly keywords like pharma marketing , drug commercialization , and healthcare innovations. Isn’t it just a platform for recruiters and job seekers? First impressions matter.

Branding

Branding Marketing Drugs FDA Approval

Years after Pfizer merger, ex-Medivation exec gets insider trading charge

pharmaphorum

AUGUST 17, 2021

A complaint filed by the US Securities and Exchange Commission (SEC) today accuses Matthew Panuwat, the then-head of business development at Medivation, of buying sizeable stock options in rival cancer-focused biotech InCyte Corp in the days before the merger went through in September 2016. Matthew Panuwat.

Business Development

Business Development Drug Trials Trials Development

Diversity in Clinical Trials: Tackling the Issues in Alzheimer’s Research at AAIC 2021

XTalks

JULY 29, 2021

times more likely than white Americans to suffer from dementia, less than one percent have participated in a National Institutes of Health (NIH) clinical trial. However, increasing diversity in Alzheimer’s trials is a multifactorial issue that requires understanding and solutions that address the many factors at play.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

JPM23: Vaccine developers as dealmakers, Gilead’s trial tea leaves and building platform companies

Beckley adds digital element to its psychedelic drug trials

Trending Sources

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

How using AI in clinical trials accelerates drug development

BioSig abandons COVID-19 drug trial on safety concerns

Small Pharma stock market launch funds DMT-based depression drug trial

Kibow Biotech celebrates 25th anniversary as drug trials commence

Clinical research is about trial and error

Review reports improved transparency in antidepressant drug trials

Fatty liver disease: With little early detection, more challenging drug development

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

STAT+: Pharmalittle: FDA proposes more rigorous cancer drug trials for accelerated approval; insurers not covering obesity meds for kids

Avacta opens two US sites and doses first patient in sarcoma drug trial

How does HTA for orphan drugs differ across Europe?

New system that defines Huntington’s Disease will ‘revolutionise’ drug trials

Sosei Heptares doses first patient in schizophrenia drug trial

Lundbeck gets cold feet, axes schizophrenia drug trial

Scepticism in press over Kintor’s COVID-19 US drug trial

Mathematical models and computer simulations are the new frontiers in COVID-19 drug trials

LSD biotech MindMed buys digital trial firm HealthMode

Zealand Pharma Stock Surge on Liver Disease Drug Trial Data

Leading clinical packaging companies in contract marketing

What can we learn from women’s health data?

Treatment for all: the key steps to better representation in pharma

Scaling With a Purpose: Championing the Clinical Trials Sector

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

What the FDA’s guidance on diversity means for rare disease sponsors

Reimagining Clinical Trials: Why are Virtual Clinical Trials Becoming the New Normal?

LQTT secures $19M; Nanox acquires Zebra Medical Vision; Takeda leads IBD drugVisus raises $20M

FDA Approvals for a Liquid Epilepsy Drug and Vitiligo Medication – Xtalks Life Science Podcast Ep. 71

Unlocking the potential in rare disease research with decentralised trials

Advancement through adversity: how Covid-driven innovations are becoming best practices for pharmacovigilance

Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy

Clinical Trials for Pulmonary Fibrosis: How Can Participation Be Improved?

An Evolving Regulatory Environment for Rare and Orphan Diseases

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

Steps to building a more patient-centric industry

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

Phases of Clinical Research: A Detailed Overview

Building Inclusive Trials: Insights from CTTI’s Diversity Initiatives

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

Broadening Your Pharma Network on LinkedIn

Years after Pfizer merger, ex-Medivation exec gets insider trading charge

Diversity in Clinical Trials: Tackling the Issues in Alzheimer’s Research at AAIC 2021

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