Sat.Mar 16, 2024 - Fri.Mar 22, 2024

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The unique clinical trial challenges faced by digital therapeutics

pharmaphorum

On today’s podcast, host Jonah Comstock is joined by Meri Beckwith, co-founder of Lindus Health, a next-gen CRO that includes digital therapeutics among its specialties. They talk a little bit about the often unseen difficulties of validating a digital therapeutic through a clinical trial.

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Employee experience in healthcare: The importance of EX for patient experience

pharmaphorum

Understanding the employee experience in healthcare is essential for improving the patient experience. Learn more about the importance of employee experience in healthcare and how it impacts patient care.

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Patient-centricity and HCP engagement: 7 Challenges in pharma and life sciences outreach

pharmaphorum

Discover the top 7 challenges faced by pharmaceutical and life sciences companies in achieving patient-centricity and engaging healthcare professionals (HCPs). Explore strategies to overcome these obstacles for successful outreach efforts.

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DoP releases new UCPMP for pharma and medical devices companies

AuroBlog - Aurous Healthcare Clinical Trials blog

The Department of Pharmaceuticals (DoP) has issued a new Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024, permitting pharma companies to provide brand reminders such as informational and education items and free samples to medical professionals with restrictions on sample packs and total value.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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myTomorrows collaborates with the ALS Association to give easy access to clinical trials for patients

Outsourcing Pharma

In a significant move aimed at supporting patients battling amyotrophic lateral sclerosis (ALS), myTomorrows has announced a strategic partnership with the ALS Association, a leading nonprofit organization dedicated to combating ALS.

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Improving patient engagement and drug development through AI and enhanced medical affairs roles

pharmaphorum

Learn how AI and enhanced medical affairs roles are transforming the landscape of drug development and patient engagement in the health industry. Explore the benefits and advancements in this exciting field.

More Trending

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Akums introduces Hydroxyurea oral suspension for sickle cell disease

Pharmaceutical Technology

Akums Drugs and Pharmaceuticals has introduced Hydroxyurea oral suspension, a room temperature-stable drug for treating sickle cell disease.

Drugs 306
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Scientists Discovered a ‘Fear Switch’ in The Brain, And How to Turn It Off

AuroBlog - Aurous Healthcare Clinical Trials blog

The hair rising on the back of your neck, the gelid pool in the pit of your stomach, the flutter in your heart when a shadow shifts. Fear can be devastating, sickening, and, strangely, a lot of fun.

Scientist 202
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March 21, 2024: NINR Announces Funding Opportunity to Improve Health and Advance Equity in Rural Populations

Rethinking Clinical Trials

The National Institute of Nursing Research (NINR) published a funding opportunity for research to improve health outcomes and advance health equity in rural populations. Rural populations experience high rates of many causes of morbidity and disability, and high and increasing rates of premature death. Meaningful and sustained improvements in the health of rural populations require effective solutions to address the underlying causes.

Nurses 161
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Clasp launches with $150M and a plan for precision cancer immunotherapies

Bio Pharma Dive

The company claims its approach could yield more effective and safer T-cell engagers, a type of cancer medicine that’s attracted significant interest from drugmakers in recent years.

Medicine 285
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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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Bionomics to advance non-SSRI PTSD candidate to Phase III

Pharmaceutical Technology

Bionomics plans to meet with the FDA following positive topline data from the Phase IIb ATTUNE trial of the post-traumatic stress disorder (PTSD) drug BNC210.

Trials 262
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Expert Reveals What Intermittent Fasting Could Be Doing to Your Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

Intermittent fasting has become a popular dietary approach to help people lose or manage their weight. It has also been promoted as a way to reset metabolism, control chronic disease, slow ageing and improve overall health.

Research 198
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March 20, 2024: Early Diagnosis and Assessment of Autism to Be Featured in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Warren Jones In this Friday’s PCT Grand Rounds, Warren Jones of Emory University will present “Early Diagnosis and Assessment of Autism via Objective Measurements of Social Visual Engagement.” The Grand Rounds session will be held on Friday, March 22, 2024, at 1:00 pm eastern. Jones is the director of research at the Marcus Autism Center and the Norman Nien Distinguished Chair in Autism and an associate professor of pediatrics at the Emory University School of Medicine.

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NextCure to lay off 37% of staff, dial back research plans

Bio Pharma Dive

The job cuts at the cancer drug developer will primarily impact manufacturing roles, but will touch on several other parts of the organization, the company said.

Research 286
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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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NVIDIA doubles down on AI in healthcare with drug discovery deals

Pharmaceutical Technology

In addition to drug discovery deals, NVIDIA also announced partnerships with J&J MedTech and GE Healthcare for genAI in MedTech.

Drugs 281
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Scientists Identify Speech Trait That Foreshadows Cognitive Decline

AuroBlog - Aurous Healthcare Clinical Trials blog

Can you pass me the whatchamacallit? It’s right over there next to the thingamajig. Many of us will experience “lethologica”, or difficulty finding words, in everyday life. And it usually becomes more prominent with age.

Scientist 190
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Bayer Eliminates Nearly Half of Its Executive Positions in Major Overhaul

BioSpace

As part of a sweeping reorganization, Bayer Pharmaceuticals on Wednesday shuffled its leadership roster, which included the creation of a new unit and role changes for its executives.

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The digital divide: Balancing automation and human interaction regardless of the patient support program model

Bio Pharma Dive

Balancing automated patient support with human touch is key in healthcare. Hybrid models offer a pragmatic path forward, prioritizing patient-centricity.

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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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Johnson & Johnson’s paediatric HIV-1 treatment secures FDA approval

Pharmaceutical Technology

Johnson & Johnson has received approval from the FDA for EDURANT PED to treat human immunodeficiency virus-1 (HIV-1) in children.

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Aging And Schizophrenia Share Striking Similarities in 2 Types of Brain Cells

AuroBlog - Aurous Healthcare Clinical Trials blog

Similar genetic changes in two different types of brain cells may contribute to cognitive impairment in schizophrenia and aging. US researchers examined gene expression in more than a million brain cells collected post-mortem from 191 donors.

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BioNTech's shares tumble—again—amid continued COVID vaccine sales slide

Fierce Pharma

Four months ago, when BioNTech slashed its 2023 revenue projection from 5 billi | When BioNTech reported its fourth-quarter earnings Wednesday, it was another harsh reminder of the plummeting demand for COVID-19 vaccines. Sales came to 1.5 billion euros ($1.6 billion) for the fourth quarter and 3.8 billion euros ($4.1 billion) for 2023, coming up short of expectations.

Sales 133
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Thermo Fisher, Bayer partner to develop companion diagnostics

Bio Pharma Dive

The companies aim to identify potential patients for Bayer’s precision cancer therapies and increase access to the treatments.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Merck to invest €300m in South Korean bioprocessing centre

Pharmaceutical Technology

Merck KGaA has announced an investment of over €300m ($326.1m) to establish a new bioprocessing production centre in Daejeon, South Korea.

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Breakthrough Therapy Obliterates Deadly Brain Tumor in Days

AuroBlog - Aurous Healthcare Clinical Trials blog

Brain scans of a 72-year-old man diagnosed with a highly aggressive form of cancer known as a glioblastoma have revealed a remarkable regression in his tumor’s size within days of receiving an infusion of an innovative new treatment.

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Merck’s Keytruda Continues NSCLC Losing Streak with Phase III Flop

BioSpace

Keytruda, when used with AstraZeneca’s Lynparza, did not significantly improve overall and progression-free survival in specific patients with metastatic non-squamous non-small cell lung cancer.

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Mirador debuts with $400M, picking up where immune drugmaker Prometheus left off

Bio Pharma Dive

The financing for the startup, which is led by former executives of a biotech Merck recently bought for nearly $11 billion, is the sector’s largest for a privately held company this year.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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EMA CHMP recommends Novo Nordisk’s weekly insulin for diabetes

Pharmaceutical Technology

The EMA CHMP has recommended marketing authorisation for Novo Nordisk's Awiqli for treating diabetes in adult patients.

Insulin 264
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Voice AI is reshaping the landscape of healthcare: Rustom Lawyer

AuroBlog - Aurous Healthcare Clinical Trials blog

Rustom Lawyer, co-founder & CEO of Augnito, a leading voice AI solutions provider, has unveiled profound insights into the potential of voice artificial intelligence (AI) in healthcare. Emphasizing its transformative role, Lawyer shed light on how voice AI is reshaping the landscape of healthcare, empowering a new generation of healthcare professionals – the ‘superclinicians.

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Orchard Sets $4.25M US Price for Gene Therapy Lenmeldy on Heels of Approval

BioSpace

Two days after winning FDA approval, Orchard Therapeutics on Wednesday provided its U.S. launch plans for metachromatic leukodystrophy gene therapy Lenmeldy, which has a wholesale acquisition cost of $4.25 million for the one-time treatment.

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Orchard sets out to sell world’s priciest gene therapy

Bio Pharma Dive

Orchard is counting on the long-term data it’s accrued to convince insurers to cover Lenmeldy’s $4.25 million list price, the highest of any genetic medicine to come to market.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.