November, 2023

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Harnessing Social Media for Clinical Trial Recruitment

BioSpace

Harnessing Social Media for Clinical Trial Recruitment - read this article along with other careers information, tips and advice on BioSpace

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Patient perspectives: Clinical trials and Diabetes Awareness Month

Antidote

Each November is designated as Diabetes Awareness Month , an event that highlights the importance of spreading awareness about diabetes and the health issues it can cause.

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Paper details Astellas gene therapy study that led to patient deaths

Bio Pharma Dive

The company, which is working with regulators to lift a clinical hold, said the treatment could still help people with X-linked myotubular myopathy.

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IO Biotech enrolls 380 Patients in phase 3 advanced melanoma trial

BioPharma Reporter

IO Biotech, a clinical-stage biopharma company developing therapeutic cancer vaccines, has completed enrollment in its phase 3 trial for IO102-IO103, in combination with KEYTRUDA (pembrolizumab), Merckâs anti-PD-1 therapy, in patients with advanced melanoma.

Trials 85
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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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Investigating Industry Involvement in Modern Clinical Trials

Pharmaceutical Commerce

Study aims to find ways industry gets involved in the most influential clinical trials, and how transparent these trials are.

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Not to be missed - our patient centricity in action webinar with three top speakers

BioPharma Reporter

Outsourcing Pharma is delighted to invite you to join our not-to-be-missed webinar on one of the most important areas of the industry â patient centricity â and its solutions.

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Exploring the impact of patient flow forecasting on the patient and the HCP

pharmaphorum

Exploring the impact of patient flow forecasting on the patient and the HCP Mike.

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Cultivating quality excellence in the clinical trials landscape

pharmaphorum

Cultivating quality excellence in the clinical trials landscape Mike.

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Texas AG sues Pfiz­er and Tris Phar­ma for adul­ter­at­ed ADHD drug

Pharmaceutical Technology

Texas AG has sued Pfizer and Tris Pharma for providing adulterated attention-deficit/hyperactivity disorder drug, Quillivant XR, to children.

Drugs 353
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Roche’s Genentech partners with Nvidia in AI drug deal

Bio Pharma Dive

The partnership is another investment by the biotech subsidiary in artificial intelligence for drug discovery and development, continuing an industry trend.

Drugs 328
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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There’s an Important Reason Disturbed Sleep Makes Everything Hurt More

AuroBlog - Aurous Healthcare Clinical Trials blog

Ever feel like everything hurts after not getting enough sleep? A new study reveals a neurotransmitter involved in the pain that sleep deprivation causes, indicating a potential new target for treatment. In sleep-deprived mouse models, the neurotransmitter N-arachidonoyl dopamine (NADA), an endocannabinoid, was reduced in one brain region linked to sensory processing and arousal.

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How Worldwide and Every Cure Are Using AI To Unlock New Rare Disease Treatments

Worldwide Clinical Trials

Since the advent of modern medicine, the scientific community has developed more than 3,000 drugs for thousands of diseases. Despite significant progress, there are more than 6,500 rare diseases without a single approved treatment. We recently partnered with Every Cure , a nonprofit organization, to help them advance their mission of unlocking the full potential of every existing medicine to treat as many diseases as possible — with a specific focus on rare diseases.

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November 29, 2023: Special Biostatistics Series Continues With Guidelines for Stepped-Wedge Trials

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Jim Hughes of the University of Washington will continue our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with his presentation, “Guidelines for Design and Analysis of Stepped-Wedge Trials.” The session will be held on Friday, December 1, at 1:00 pm eastern. Hughes is a professor emeritus of biostatistics at the University of Washington.

Trials 162
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Pfizer site in Connecticut in line for layoffs amid $3.5B cost-cutting campaign

Fierce Pharma

With layoffs hitting employees on both sides of the Atlantic, Pfizer’s $3.5 billion cost-cutting spree has kicked it into high gear this month. | The company's Groton, Connecticut, research site is the latest to fall victim to job cuts as part of Pfizer's massive $3.5 billion cost-cutting mission, following layoffs across the U.S. and the U.K.

Research 145
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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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Japan grants approval for CSL and Arcturus’ Covid-19 vaccine 

Pharmaceutical Technology

Japan’s MHLW has approved CSL and Arcturus Therapeutics’ self-amplifying mRNA (sa-mRNA) Covid-19 vaccine, ARCT-154.

Vaccine 312
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What if a CRISPR cure isn’t such an easy choice?

Bio Pharma Dive

A gene editing therapy developed by Vertex Pharmaceuticals and CRISPR Therapeutics can mute sickle cell disease’s most damaging symptoms. Yet treatment may not be as simple as its dramatic benefit makes it seem.

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FDA to Finally Outlaw Soda Ingredient Banned Around The World

AuroBlog - Aurous Healthcare Clinical Trials blog

An ingredient once commonly used in citrus-flavored sodas to keep the tangy taste mixed thoroughly through the beverage could finally be banned for good across the US.

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The Significance of the MHRA Approval and Upcoming FDA Review of the First Gene Editing Treatment

Worldwide Clinical Trials

By: Amy Raymond, PMP, PhD, Senior Director, Therapeutic Strategy Lead, Cellular & Genetic Medicines On November 16, the British regulatory body, Medicines and Healthcare products Regulatory Agency (MHRA) approved exagamglogene autotemcel (exa-cel) to treat severe sickle cell disease for patients ages 12 and up, becoming the first gene editing treatment to receive regulatory approval.

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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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November 28, 2023: Workshop Summary Now Available From ‘Getting the Right Evidence to Decision-Makers Faster’

Rethinking Clinical Trials

The workshop summary is now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Getting the Right Evidence to Decision-Makers Faster.” The 2-day workshop explored the critical cycle of evidence generation by researchers to decision-making by healthcare system leaders to implement the findings of pragmatic clinical trials conducted within healthcare systems.

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Moderna loses a COVID vaccine patent in Europe amid heated clash with BioNTech, Pfizer

Fierce Pharma

With litigation spanning many countries, the COVID-19 vaccine giants remain engaged in a heated patent war. | Moderna pledged to appeal after the European Patent Office ruled one of its patents invalid in the intellectual property battle that spans multiple countries.

Vaccine 145
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Eli Lilly supports Alto Neuroscience in $45m Series C round

Pharmaceutical Technology

The funding will go towards the development of the company's four CNS candidates, with Phase II study data readouts expected by early 2025.

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Pharma benefited from basing business overseas. An international tax effort could spur a rethink.

Bio Pharma Dive

U.S. tax law changes enacted six years ago slashed large pharma companies' rates and saved them billions. Now, a push for an international floor could disrupt their R&D accounting.

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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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Huge Study Implicates Salt in Type 2 Diabetes, But Let’s Look At The Facts

AuroBlog - Aurous Healthcare Clinical Trials blog

When people think of foods related to type 2 diabetes, they often think of sugar (even though the evidence for that is still not clear). Now, a new study from the US points the finger at salt.

Research 245
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3 Considerations of the Patient Perspective from the 2023 Pain Therapeutics Summit

Worldwide Clinical Trials

Pain for chronic patients is not merely a condition they must manage but a social dynamic with various feelings and opinions. Its psychological impact is often understated, though it carries the same weight as pain’s physical effects. At this year’s annual Pain Therapeutics Summit , which took place in San Diego, CA, October 19 to 20th, I heard brilliant presentations on novel pain medication development, targeted discoveries, pain classifications, the NIH HEAL Initiative , trial designs, biomar

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November 27, 2023: NIH Announces Funding Opportunity for Implementation Studies of Substance Use Treatment and Prevention in Populations That Experience Health Disparities

Rethinking Clinical Trials

The National Institutes of Health’s Office of Disease Prevention (ODP) issued a new funding opportunity to support implementation studies in treatment and prevention for alcohol, tobacco, and other drugs use and misuse in adult populations that experience health disparities. ODP and participating NIH Institutes and Centers are inviting applications for research projects that test innovative approaches to implementing screening, brief intervention, and referral to treatment or prevention fo

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FDA investigates 'serious risk' of secondary cancer following CAR-T treatment

Fierce Pharma

In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. | In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs.

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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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Cloud in pharma: Q&A with GlobalData thematic analyst

Pharmaceutical Technology

GlobalData analyst Jemima Walker discusses key topics around cloud computing for the pharmaceutical industry.

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World’s first CRISPR medicine approved in UK for sickle cell, beta thalassemia

Bio Pharma Dive

Clearance of Vertex Pharmaceuticals and CRISPR Therapeutics' Casgevy in the U.K. comes ahead of expected regulatory decisions in the U.S. and Europe.

Medicine 317
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Millions of Women Feel Severe Pain From This Condition. Why Don’t We Talk About It?

AuroBlog - Aurous Healthcare Clinical Trials blog

Endometriosis causes physical, sexual and emotional pain. About 190 million people around the globe have endometriosis, including one in 10 American women, but there has historically been a deafening silence about the disease and the pervasive impact it can have on a person’s life.

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The Role of Process and Technology Innovation in Advanced Biopharmaceutical Manufacturing

Pharma Mirror

By Alexei Voloshin, Global Head of Bioprocess Science, 3M Biopharmaceutical Purification Article Synopsis: Modern biotechnology has brought a revolution in improving the human condition around the world both in terms of quantity and quality. The rapid pace of innovation in biopharmaceutical treatments has enabled the treatment of life-threatening and life-changing conditions such as cancer, inflammation, and infectious disease.

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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