April, 2024

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Women want to participate in clinical trials. Lack of flexibility is still a problem.

Bio Pharma Dive

Underrepresentation of women in clinical trials affects the resulting drugs that become available later. Even small changes could boost participation.

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Early Data Indicate Cell Therapies Could ‘Reset the Clock’ in Parkinson’s

BioSpace

A one-time treatment for Parkinson’s disease could be a ‘market changer,’ experts told BioSpace, adding that cell therapies could limit the adverse effects seen with current drugs.

Marketing 113
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Moderna banks on OpenAI to accelerate mRNA research 

pharmaphorum

In an ambitious move, Moderna has teamed up with OpenAI, the artificial intelligence company behind ChatGPT, to further integrate generative AI (GenAI) across its mRNA drug development and manufacturing operations.

Research 105
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Clinical trial recruitment tools for today’s patients

Antidote

Understanding how to recruit patients for clinical trials can be one of the most challenging aspects of performing medical research. Sponsors and sites have more tools at their disposal than ever before, but keeping track of how to use these various outreach methods can be time-consuming. Additionally, using a mix of outreach is typically the best strategy to reach the highest number of potentially qualified patients — meaning observing best practices across marketing disciplines is advised.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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“This Is The First Time”: Drug Shows Signs of Slowing Parkinson’s Disease

AuroBlog - Aurous Healthcare Clinical Trials blog

A drug used to treat diabetes slowed the progression of motor issues associated with Parkinson’s disease, a study published in the New England Journal of Medicine said Wednesday. Parkinson’s is a devastating nervous system disorder affecting 10 million people worldwide, with no current cure.

Drugs 181
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Optimizing Data Collection in Post-Surgical Pain Studies & The Role of Clinical Assessments

Worldwide Clinical Trials

Authors: Rolana Avrumson, MS, VP Clinical Projects, Clinical Assessment Technologies; Barry Dussault Executive Director, Project Management, Franchise Area Lead, Pain Upwards of 58% of patients experience moderate to severe post-surgical pain, while some research places that figure even higher at a staggering 80%. These data highlight both the prevalence of post-surgical pain and the critical need for comprehensive, non-opioid treatments aimed at alleviating it.

More Trending

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Clinical Trial Binders: Are You Doing it the Hard Way?

Imperical Blog

Clinical trials have become more and more complex over the last decade, largely due to the challenges driven by an increasingly global reach. As a sponsor, are you making it hard for clinical trial teams? Learn about a unique solution to managing clinical trial binders.… The post Clinical Trial Binders: Are You Doing it the Hard Way? appeared first on Imperial Clinical Research Services Blog.

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Clearmind licenses psychedelic compounds for mental disorders

Pharmaceutical Technology

Clearmind Medicine has entered into a licensing agreement with Yissum to develop Generation 3.0 psychedelic compounds for mental disorders.

Licensing 246
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Psychiatry drugs finally have pharma’s attention. Can they keep it?

Bio Pharma Dive

Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. But many development hurdles still stand in the way of new medicines for the brain.

Medicine 343
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Alzheimer’s Is More Common in Women, And This May Help Explain Why

AuroBlog - Aurous Healthcare Clinical Trials blog

In the US, roughly two out of every three people with Alzheimer’s is a woman, a statistic that could be partially explained by the fact women typically live longer than men. Yet researchers have suspected there could be more to the story.

Hormones 224
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Strategies for Successful Navigation of Complex Radiopharmaceutical Trials

Worldwide Clinical Trials

By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. As with other targeted therapies, radiopharmaceutical development requires unique and specialized strategies to ensure successful execution.

Trials 204
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April 3, 2024: In This Week’s PCT Grand Rounds, a New Look at P Values for Randomized Trials

Rethinking Clinical Trials

Dr. Erik van Zwet In this Friday’s PCT Grand Rounds, Erik van Zwet of Leiden University Medical Center will present “A New Look at P Values for Randomized Clinical Trials.” The Grand Rounds session will be held on Friday, April 5, 2024, at 1:00 pm eastern. Dr. van Zwet is an associate professor in the Department of Biomedical Data Sciences at Leiden University Medical Center in the Netherlands.

Trials 189
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Study suggests tumour microenvironments could predict cancer progression

Pharma Times

NSCLC is the most common type of lung cancer and is responsible for up to 85% of all cases

Research 160
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Pfizer and BioNTech commence legal action against Moderna in UK court

Pharmaceutical Technology

Pfizer and its Germany partner BioNTech have urged London’s High Court to invalidate competitor Moderna's patents over technology instrumental in the Covid-19 vaccines development as the latest phase of a global legal fight that started yesterday (23 April), reported Reuters.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Cerevel, in ‘major surprise,’ finds success in late-stage Parkinson’s study

Bio Pharma Dive

Analysts had low expectations for Cerevel’s drug tavapadon, which was something of an afterthought in AbbVie’s proposed buyout of the biotech.

Drugs 319
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Export of Ayush and herbal products registers 1.65% growth in first 10 months

AuroBlog - Aurous Healthcare Clinical Trials blog

Exports of Ayush (Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa-Rigpa and Homoeopathy) drugs and herbal products from the country have reported 1.65 per cent growth during the first ten months of the current fiscal year. The growth in the month of January stood at 14.

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Demystifying the ICH M10 Bioanalytical Method Validation Guidelines

Worldwide Clinical Trials

Developing pharmaceuticals is a complex process, requiring stringent bioanalytical method validation guidelines to ensure drug safety and efficacy. However, with varying national regulatory agencies each requiring their own unique specifications, this process can be remarkably perplexing. To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016.

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April 10, 2024: Primary Results of PRIM-ER Trial to Be Featured in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Corita Grudzen, principal investigator of PRIM-ER In this Friday’s PCT Grand Rounds, Corita Grudzen of the Memorial Sloan Kettering Cancer Center will present “Primary Palliative Care for Emergency Medicine, a Cluster Randomized Stepped-Wedge Trial Across 33 Emergency Departments,” including the results of the PRIM-ER trial. The Grand Rounds session will be held on Friday, April 12, 2024, at 1:00 pm eastern.

Trials 182
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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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ICR collaboration forms national NHS patient database registry for Lynch syndrome patients

Pharma Times

The genetic condition affects one in 279 people in England and significantly increases cancer risk

Genetics 160
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Outrun Therapeutics announces launch with $10m seed funding

Pharmaceutical Technology

Outrun Therapeutics announced its launch with $10m seed funding to advance a protein stabilisation pipeline focused on E3 ligase inhibitors.

Protein 323
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Metsera, a well-funded obesity drug startup, sees chance to challenge Lilly, Novo

Bio Pharma Dive

It’s “early innings” in the obesity drug race, said Metsera CEO Clive Meanwell, whose company has acquired a portfolio of medicines it aims to test in combination.

Drugs 319
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IPC’s Pharmacovigilance Programmes complements CDSCO & Pharmexcil initiatives to fortify patient safety

AuroBlog - Aurous Healthcare Clinical Trials blog

In a concerted effort to bolster patient safety measures within the healthcare landscape, the Indian Pharmacopoeia Commission (IPC) is set to roll out its Skill Development Programmes on Pharmacovigilance.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Enhancing Sponsor Outcomes: The Power of In-House Clinical Assessment Support

Worldwide Clinical Trials

By Rolana Avrumson, MS, Vice President of Clinical Projects, Clinical Assessment Technologies In the intricate world of clinical trials, the precision and reliability of clinical assessments stand as pivotal factors in determining a trial’s success. Expertly managed clinical assessments by a team with fastidious attention to detail optimizes precision and reliability and helps you successfully navigate the complex terrain of clinical research.

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April 17, 2024: In This Week’s PCT Grand Rounds, 10 Years of the YODA Project

Rethinking Clinical Trials

Dr. Joseph Ross In this Friday’s PCT Grand Rounds, Joseph Ross of Yale University will present “The Yale Open Data Access (YODA) Project: 10 Years of Clinical Trial Data Sharing.” The Grand Rounds session will be held on Friday, April 19, 2024, at 1:00 pm eastern. The YODA Project promotes open science, research transparency, and the sharing of clinical research data to support healthcare research.

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Researchers call to reduce repeat antibiotic prescriptions for respiratory tract infections

Pharma Times

RTIs account for around 60% of global antibiotic prescribing and are a key driver of AMR

Research 154
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ESCMID 2024: Using AI in infection prevention and control

Pharmaceutical Technology

Artificial intelligence tools can be used for infection control through facial recognition systems designed to identify proper face mask use within hospitals.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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New postpartum depression drugs are here. Diagnosis, treatment hurdles still stand in the way.

Bio Pharma Dive

The first medicine approved for PPD, Sage’s Zulresso, never gained traction. The company is in the midst of launching its second, but long-standing challenges could slow uptake.

Medicine 319
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DTAB recommends prohibiting pain relief combination S(+) etodolac+paracetamol

AuroBlog - Aurous Healthcare Clinical Trials blog

The Drugs Technical Advisory Board (DTAB) of the Union health ministry has once again recommended prohibiting the manufacture, sale and distribution of pain relief drug combination S(+) etodolac+paracetamol, after considering a sub-committee report.

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FDA settles ivermectin lawsuit, removes contentious COVID-19 posts

BioPharma Reporter

The FDA has agreed to permanently remove several social media posts urging people not to take ivermectin for the treatment of COVID-19, after a lawsuit brought by three doctors accused the regulatory body of interfering with their ability to practice medicine.

Doctors 145
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April 4, 2024: ICD-Pieces Trial Sees No Reduction in Hospitalization for Patients With Chronic Kidney Disease

Rethinking Clinical Trials

Dr. Miguel Vazquez, principal investigator for ICD-Pieces A primary care intervention for patients with coexisting chronic kidney disease, type 2 diabetes, and hypertension did not reduce the hospitalization rate for these patients when compared to usual care, according to the ICD-Pieces study. The results of the study were published this week in the New England Journal of Medicine.

Trials 173
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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g