Wed.Mar 19, 2025

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Grand Rounds March 14, 2025: Spillover Due to Constraints on Care Delivery: A Potential Source of Bias in Pragmatic Clinical Trials (Sean Mann)

Rethinking Clinical Trials

Speaker Sean Mann Senior Policy Analyst RAND Corporation Slides Keywords Development Economics; Spillover; Bias; Pragmatic Clinical Trials Key Points Individually randomized, parallel-group embedded pragmatic trials randomly assign patients to a new healthcare intervention or to a control group that receives some form of usual care.

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Do Ice Baths Really Work? Here’s What The Science Says

AuroBlog - Aurous Healthcare Clinical Trials blog

Do ice baths live up to the hype? (Diana Light/Unsplash) Ice baths have become increasingly popular over the past few years. Fitness enthusiasts and casual exercisers around the world are embracing this trend that was once reserved for elite athletes. Ice baths (also known as “cold water immersion“) are exactly what they sound like.

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Sarepta’s Gene Therapy Elevidys Under Scrutiny After Patient Death

XTalks

A 16-year-old patient died after treatment with Elevidys (delandistrogene moxeparvovec), Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy (DMD). The patient suffered acute liver failure several months after receiving the therapy in December. Liver injury is a known risk with Elevidys and other gene therapies that use adeno-associated viral (AAV) vectors.

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New Publication Shares Insights on Decentralized Clinical Trial Elements in Cancer Trials During the COVID-19 Pandemic

CTTI (Clinical Trials Transformation Initiative)

A new publication from the FDA Oncology Center of Excellence (OCE) and the Clinical Trials Transformation Initiative (CTTI), published in the Clinical Cancer Research journal, provides important insights into how decentralized clinical trial (DCT) elements were used in cancer trials leading to FDA approval during the COVID-19 pandemic. DCT elementssuch as remote monitoring, telemedicine, and home delivery of investigational products were widely used in cancer trials to maintain patient safety an

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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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Sacklers to pay up to $7bn in Purdue Pharma’s opioid settlement plan

Pharmaceutical Technology

Purdue Pharmas new bankruptcy plan outlines the payment structure of the largest opioid settlement to date.

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ICMR to establish Centre for Advanced Research in Aging to explore India-specific biomarkers

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Council of Medical Research (ICMR) is working to set up a Centre for Advanced Research in Aging, marking a significant move in India’s efforts to address the challenges of aging and age-related diseases.

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More Trending

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Allogeneic cell therapies “poised for prime time” says expert

Pharmaceutical Technology

While the allogeneic vs autologous debate continues in the cell therapy field, research on in vivo therapies is drawing interest.

In-Vivo 147
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Cargo shelves cell therapy research and lays off almost all staff

Bio Pharma Dive

CEO Gina Chapman is also departing the company, which plans to review options for pursuing a reverse merger or other business combination.

Research 154
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USPTO allows patents for Remedy’s large hemispheric infarction drug

Pharmaceutical Technology

The US Patent and Trademark Office (USPTO) has allowed two new patents for Remedy Pharmaceuticals Cirara, aimed at treating LHI.

Drugs 147
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Eneboparatide Advances in Hypoparathyroidism Trial: Key Phase III Update

XTalks

Eneboparatide (AZP-3601), an investigational parathyroid hormone 1 receptor (PTH1R) agonist, met its primary endpoint in the CALYPSO Phase III trial, offering new data for adults with chronic hypoparathyroidism. While detailed outcome data were not shared, suggested that the therapy significantly improved albumin-adjusted serum calcium levels and reduced reliance on active vitamin D and oral calcium therapies.

Trials 59
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Arbor to advance gene editing treatments with $73.9m funding

Pharmaceutical Technology

Arbor Biotechnologies has closed $73.9m for its gene editing therapeutic pipeline aimed at liver and central nervous system diseases.

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Optum Rx says it will eliminate some prior authorization requirements

Bio Pharma Dive

The PBM plans to stop requiring coverage reauthorization for about 80 drugs, including Vertex’s cystic fibrosis medicines and many MS treatments.

Medicine 130
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Insight and insitro partner on AI model to seek ocular biomarkers

Pharmaceutical Technology

Insight Health Data Research Hub and insitro have announced a partnership to develop an AI foundation model for ocular biomarkers.

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Innovating Treg Therapies for ALS and Alzheimer’s with Coya Therapeutics CEO Dr. Arun Swaminathan — Episode 200

XTalks

Join us as we celebrate a major milestone the 200th episode of the Xtalks Life Science Podcast! From groundbreaking biotech innovations to exclusive interviews with life science industry innovators and leaders, we’ve covered it all. Thank you for tuning in each week! We look forward to continuing to bring the latest and greatest across the pharma, biotech and medical industries!

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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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Drug Patent Expirations: Unlocking Strategic Investment Opportunities

Drug Patent Watch

Unlocking Strategic Investment Opportunities in the Pharmaceutical Industry As we navigate the ever-evolving landscape of the pharmaceutical industry, one thing remains constant: the expiration of patents on blockbuster medications. These expirations can have a significant impact on the market, creating opportunities for strategic investment and growth.

Drugs 52
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Charles Eger, MD, Authors New Article in Nature Medicine

Velocity Clinical Research

Charles Eger, MD, contributed to new research on a combination vaccine intended to provide protection against both seasonal flu and COVID-19 in a single shot. Early results from the Phase 1/2 trial show that the vaccine is well-tolerated and induces strong immune responses, potentially paving the way for a more convenient approach to respiratory virus prevention.

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Xtalks Life Science Podcast: Celebrating 200 Episodes of Industry Innovation

XTalks

This week, were celebrating a significant milestone: the release of our 200th episode of the Xtalks Life Science Podcast ! Over the years, Xtalks has built the industrys preeminent life science podcast, helping brands in pharma, biotech, healthcare and medical devices showcase their expertise to key decision-makers through valuable, industry-leading content.

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Orca Bio’s T-cell therapy shows promise in haematological malignancies

Pharma Times

The company is preparing to submit the results to the FDA this year

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Developing a Comprehensive Drug Patent Strategy

Drug Patent Watch

Navigating the Complex World of Drug Patents: A Comprehensive Strategy is Key As a pharmaceutical professional, you know that developing new medications is a costly and time-consuming process. But what happens when your product's patent is about to expire, or you're facing competition from generic manufacturers? A well-crafted drug patent strategy can make all the difference in protecting your intellectual property and maintaining market share.

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Initial leap of faith inspires today’s fast-growing digital clinical trial movement

pharmaphorum

Explore how Tufts Center for the Study of Drug Development (CSDD) has spearheaded the growth of digital clinical trials through an initial leap of faith. Learn more about todays fast-growing movement in the field.

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Access USA 2025: Spreading Awareness of Medicare Part D Reforms

Pharmaceutical Commerce

The conferences first panel offers insight on the current state of awareness among beneficiaries of the Part D cap and Medicare Prescription Payment Plan via the PAN Foundations latest research.

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Sarepta slumps on Elevidys patient death

pharmaphorum

The death of a patient treated with Sarepta's Duchenne muscular dystrophy gene therapy Elevidys has hit its share price

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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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PAP 2025: How Charitable Programs Are Evolving to Improve Patient Access to Life-Saving Medications

Pharmaceutical Commerce

Jonathan James, CEO, Hope Charities, discusses reimbursement challenges and barriers to care in patients requiring life-saving medications.

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Google promises new AI models for drug discovery

pharmaphorum

Google has said it will release new open-source AI models for drug discovery, TxGemma, through a developers' programme later this month

Drugs 72
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Access USA 2025: Uncovering Patient Access Complexities

Pharmaceutical Commerce

A roundtable explores how patient access needs are being measured, while also discussing the value of affordability in decision-making.

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Novartis sheds staff as Entresto patent expiry looms

pharmaphorum

Novartis will cut 427 jobs this year in the US as it prepares for the loss of market exclusivity for its blockbuster heart failure therapy Entresto

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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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Access USA 2025: How Charitable Programs Are Evolving to Improve Patient Access to Life-Saving Medications

Pharmaceutical Commerce

Jonathan James, CEO, Hope Charities, discusses reimbursement challenges and barriers to care in patients requiring life-saving medications.

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Roche taps Oxford BioTherapeutics for cancer drug discovery

pharmaphorum

Oxford BioTherapeutics has lined up another big pharma partner for its drug discovery platform, signing a $1bn deal with oncology giant Roche

Drugs 59
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Pharma Pulse 3/19/25: Strategies to Close Women’s Health Innovation Gap, Enhancing Patient Care in Heart Failure–Related Anemia & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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2nd GLP-1-Based Therapeutics Summit

pharmaphorum

2nd GLP-1-Based Therapeutics Summit Sara.

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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.