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.

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Drug Trials Trials Drugs Development 88

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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Trials Drug Trials Clinical Trials Clinical Trials 83

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.

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Drug Trials Trials Clinical Trials Clinical Trials 98

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.

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Trials Drug Trials Drugs Clinical Trials 98

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.

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Drug Trials Trials Drugs Development 78

pharmaphorum

AUGUST 6, 2020

.” Finding new medicines to treat schizophrenia has proved to be a tough task for Lundbeck – its share price cratered in late 2018 after another potential drug failed in a phase 3 trial. The post Lundbeck gets cold feet, axes schizophrenia drug trial appeared first on.

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Drug Trials Trials Drugs Development 52

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.

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Drug Trials Trials Drugs Clinical Trials 59

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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Trials Medicine Engineer Drug Trials 134

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.

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Drug Trials Trials Drugs Marketing 40

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.

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Packaging Packaging Marketing Clinical Trials 100

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.

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Clinical Trials Clinical Trials Trials Development 116

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.

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Trials Research Clinical Trials Clinical Trials 133

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

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. Looking to diversify the reach of your orphan drug trial? Reach out to learn how Worldwide Clinical Trials can help.

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Clinical Trials Clinical Trials Trials Drugs 130

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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Clinical Trials Clinical Trials FDA Approval Drugs 52

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.”.

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Research Clinical Trials Clinical Trials Clinical Research Coordinator 71

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.

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Trials Clinical Trials Clinical Trials Clinical Research 52

pharmaphorum

AUGUST 4, 2020

Germany had the highest approval rate of orphan drugs at 98% – however most of these recommendations (73%) were awarded a ‘non-quantifiable benefit’ rating, the automatic rating for an orphan drug, which shows the regulator did not see any benefit compared to comparator products (see graph 1).

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Drugs Manufacturing Marketing Regulation 122

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.

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Clinical Trials Clinical Trials Trials Research 98

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.

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Business Development Drug Trials Trials Development 52

XTalks

AUGUST 3, 2022

Hear more about raising awareness about rare diseases like vitiligo and how it can help foster the development of new treatments. The topical medication is the first approved treatment for repigmentation in vitiligo and also the first approved topical formulation of a JAK inhibitor in the US.

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Life Science FDA Approval Drugs Development 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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Clinical Trials Clinical Trials Branding Trials 40

FDA Law Blog

MAY 3, 2021

The “responsible party” is the sponsor or principal investigator of the trial. An “applicable clinical trial” is generally defined to mean any clinical trial (other than a device feasibility trial or a phase I drug trial) to collect data to support an FDA premarket submission, such as a New Drug Application or 510(k) premarket notification.

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Clinical Trials Clinical Trials Trials Regulation 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

Pharma Marketing Network

OCTOBER 23, 2024

You can find numerous pharma-specific groups dedicated to topics like drug development , market access , and pharmaceutical marketing. Sharing Branded Drug Updates and Innovations LinkedIn is a fantastic platform to share updates on branded drug innovations.

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Branding Marketing Drugs FDA Approval 52

XTalks

OCTOBER 7, 2024

Takeda has forecasted continued financial pressure but is banking on new drug trials to stabilize its position​. This includes 495 people at its Cambridge, Massachusetts headquarters and 146 at its Lexington campus in the same state. The restructuring could ultimately affect up to 8,000 of its 78,000 employees globally. ​At

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Production Marketing Manufacturing Clinical Trials 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

FDA Law Blog

MAY 3, 2021

The “responsible party” is the sponsor or principal investigator of the trial. An “applicable clinical trial” is generally defined to mean any clinical trial (other than a device feasibility trial or a phase I drug trial) to collect data to support an FDA premarket submission, such as a New Drug Application or 510(k) premarket notification.

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Clinical Trials Clinical Trials Trials Regulation 40

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.

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Development Drugs Trials Medicine 98

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

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.

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Trials Drug Trials Development Vaccination 292

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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Drug Trials Trials Drugs Dermatology 52

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.

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Clinical Trials Clinical Trials Trials Clinical Research 105

Delveinsight

AUGUST 12, 2021

Through its development and use of different algorithms, Zebra Medical has been able to recognize visual symptoms for diseases such as breast cancer , osteoporosis , and fatty liver , as well as conditions such as aneurysms and brain bleeds. The original agreement had Finch responsible for early-stage development through phase 2 studies.

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Trials Clinical Trials Clinical Trials Development 97

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

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.

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Clinical Trials Clinical Trials Trials Clinical Research 111

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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