Sat.Mar 23, 2024 - Fri.Mar 29, 2024

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Oncology in 2024: The clinical trial trends reshaping the role of CROs

Pharmaceutical Technology

CROs are fundamental to the development of cancer treatments but face multiple challenges. We analyze the biggest trends in oncology and the technological solutions available to CROs to optimize efficiencies.

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Epigenetic Editing Explodes on the Heels of Gene Editing Success

BioSpace

Ubiquitous potential, possible safety advantages and the recent growth of cell and gene therapy are driving investment in a different type of genetic editing.

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How Latinas are Shaping Clinical Research

WCG Clinical

This content is password protected. To view it please enter your password below: Password: The post How Latinas are Shaping Clinical Research appeared first on WCG.

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March 28, 2024: Health Equity Core Provides Reference for Equitable Language in Pragmatic Trials

Rethinking Clinical Trials

Dr. Rosa Gonzalez-Guarda The NIH Pragmatic Trials Collaboratory’s Health Equity Core developed a written aid to offer guidance on inclusive language and terms to use when referring to specific people, groups, and communities. The Equitable Language Cheat Sheet is available on the Health Equity Core webpage and will be updated as terminology and guidance evolves.

Trials 219
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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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Exploring the Power of Scale in Patient Recruitment: A Recap of the Velocity and HealthMatch Presentation at SCOPE

Velocity Clinical Research

Last month, Nick Spittal , Velocity’s chief operating officer announced the company’s latest partnership with HealthMatch and results from an unprecedented patient recruitment pilot at the SCOPE conference in Orland, Florida. He was joined by HealthMatch CEO, Manuri Gunawardena, on stage for a joint presentation, as Clinical Trials Report journalist Michael Causey reports: Velocity announced its partnership with HealthMatch on an innovative patient-centric recruitment pilot during the session, “

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Antidote joins forces with Melanoma Research Alliance to enhance clinical trial search for people impacted by melanoma

Antidote

We’re thrilled to announce a collaboration with our partners at Melanoma Research Alliance to bring a curated experience to patients and caregivers impacted by melanoma. In the United States, melanoma is one of the most common types of cancer , and its prevalence has tripled in recent decades. It is estimated that 100,000 people will be diagnosed with invasive melanoma each year , and more than 1.4 million people currently live with the condition.

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Improving clinical trial design with real-world data

Bio Pharma Dive

Leveraging real-world data (RWD) transforms global clinical trials, enhancing patient engagement and improving regulatory decision-making.

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Women in Science: Follow your passion and you’ll get to where you’re meant to be - Jennifer Visser-Rogers

BioPharma Reporter

From math hater to a leader in clinical data, itâs been a long journey for Jennifer Visser-Rogers, vice president for statistical research and consultancy at Phastar.

Research 104
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Best Airlines For Clinical Research Travel

ECRG Media's Clinical Research Podcast

Best Airlines of 2023 Don't forget to Subscribe for new content! Merch: [link] Subscribe: / eliteclinicalresearch Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Elite Clinical Re

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Measles cases continue to rise in US amid lagging vaccination rates

Pharmaceutical Technology

According to the CDC, over 64 cases of measles have been documented in the US in 2024, already exceeding 2023's total of 58.

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

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Bristol Myers says KRAS drug succeeds in key trial

Bio Pharma Dive

Confirmatory results for Krazati, which Bristol Myers acquired via its buyout of Mirati, could help the drug win full approval while Amgen has been set back.

Drugs 305
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March 27, 2024: A Cluster Randomized Trial to Improve Kidney Transplant Access, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Drs. Amit Garg and Stephanie Dixon In this Friday’s PCT Grand Rounds, Amit Garg and Stephanie Dixon of Western University’s Schulich School of Medicine and Dentistry will present “Effect of a Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: A Pragmatic, Cluster-Randomized Trial.” The Grand Rounds session will be held on Friday, March 27, 2024, at 1:00 pm eastern.

Trials 173
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BioNTech Hit with NIH Notice of Default over COVID-19 Vaccine Royalties

BioSpace

The National Institutes of Health claims BioNTech is in default regarding alleged royalty payments the agency contends it is owed in connection with the company’s COVID-19 vaccine Comirnaty.

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US FDA grants approval for Alexion’s NMOSD treatment

Pharmaceutical Technology

The US FDA has approved Alexion’s Ultomiris to treat adults with AQP4 Ab+ neuromyelitis optica spectrum disorder (NMOSD).

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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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Viking stays in obesity drug race with early data for weight loss pill

Bio Pharma Dive

The results are from a small Phase 1 study, but suggest Viking’s oral GLP-1 drug may not come with high rates of gastrointestinal side effects.

Drugs 304
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March 25, 2024: PCORI Announces Foundational Expectations for Partnerships in Research

Rethinking Clinical Trials

The Patient-Centered Outcomes Research Institute (PCORI) announced the release of its new Foundational Expectations for Partnerships in Research. The resource is an update of the 2014 PCORI Engagement Rubric. It builds on a growing body of evidence about engaging patients and other partners in patient-centered comparative effectiveness research. A webinar on April 4 will explore the foundational expectations, which PCORI describes as “building blocks for meaningful, effective, and sustaina

Research 150
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In banner year, Lilly rewards CEO David Ricks with 24% boost in total pay to $26.6M

Fierce Pharma

In 2023, Eli Lilly CEO David Ricks received a 24% boost in pay from $21.4 million to $26.6 million. The increase coincides with the company's booming sales.

Sales 143
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Nanoscope Therapeutics exhibits positive top-line Phase IIb results for MCO-010

Pharmaceutical Technology

Nanoscope Therapeutics released promising top-line results for its RESTORE trial, which is studying the gene therapy MCO-010 in patients with retinitis pigmentosa (RP).

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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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Gilead bets on Xilio cancer drug as biotech restructures

Bio Pharma Dive

Xilio will get just over $40 million from Gilead in return for a license to its experimental IL-12 immunotherapy. The biotech is also discontinuing other work and laying off staff.

Licensing 298
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Opinion: ALS Is Not a Singular Disease. Stop Treating It Like One

BioSpace

Imagine testing a really good drug for HER2+ breast cancer in someone with liver cancer. Would it be any surprise when that drug fails?

Drugs 139
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BioNTech hit with 'notice of default' from NIH in COVID-19 vaccine royalty dispute

Fierce Pharma

Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. | Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. officials are pressing the company to pay royalties linked to the commercialization of its lucrative Pfizer-partnered COVID-19 vaccine.

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Astellas secures approval for gastric cancer antibody in Japan

Pharmaceutical Technology

The approval from Japan’s Ministry of Health, Labour, and Welfare (MHLW) is based on positive results from two studies.

Antibody 246
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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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FDA rejects Regeneron lymphoma drug, setting back company’s oncology push

Bio Pharma Dive

The agency wants Regeneron to make more progress with a confirmatory trial before clearing odronextamab, a “bispecific” antibody being developed for multiple blood cancers.

Antibody 299
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PMLiVE’s T40 – open for submissions!

Pharma Times

Healthcare agencies can submit their entries free of charge with a deadline of 30 April

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Intelligence officials warned lawmakers WuXi AppTec furnished China with client's intellectual property: Reuters

Fierce Pharma

An alleged development in the national security crackdown against WuXi AppTec and a handful of other Chinese companies in the U.S. | An alleged development in the national security crackdown against WuXi AppTec and a handful of other Chinese companies in the U.S. suggests intelligence officials and lawmakers may have good reason to be concerned about the CDMO’s potential political ties to its home country.

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Cancer Research UK and CRIS fund lung cancer vaccine research

Pharmaceutical Technology

Cancer Research UK and the CRIS Cancer Foundation have awarded a £1.7m ($2.1m) grant for developing the lung cancer vaccine LungVax.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA approves Merck lung disease drug acquired in $11B deal

Bio Pharma Dive

Merck is couting on Winrevair, which it acquired by buying Acceleron Pharma, to help soften the blow when Keytruda loses patent protection later this decade.

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Strand Therapeutics develops new class of mRNA molecules for cancer

Pharma Times

The self-replicating mRNA molecule could be used in cancer and potentially a broad range of other diseases

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Nanoscope preps filing for retinitis pigmentosa gene therapy

pharmaphorum

Nanoscope Therapeutics is on the brink of filing for FDA approval of what could be the first gene therapy for incurable eye disease retinitis pigmentosa (RP) that can be used regardless of underlying genetic mutations.

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FDA approves J&J’s OPSYNVI for pulmonary arterial hypertension

Pharmaceutical Technology

The US FDA approved Johnson & Johnson's (J&J) OPSYNVI for chronic treatment in adult patients with pulmonary arterial hypertension.

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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.