December, 2024

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Lilly’s Zepbound beats Novo’s Wegovy in high-stakes obesity drug trial

Bio Pharma Dive

Results from the head-to-head study showed treatment with Zepbound resulted in 47% greater relative weight loss than Wegovy, a finding that could advantage Lilly in the companies’ market competition.

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Reprieve for Chinese biotechs as BIOSECURE Act left out of key bill

Pharmaceutical Technology

Shares in WuXi AppTec, one of those implicated in the Chinese biotech blacklisting legislation, surged following the omission.

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Scientists Finally Identified Where Gluten Reactions Begin

AuroBlog - Aurous Healthcare Clinical Trials blog

(uzhursky/Getty Images) For roughly one in every hundred people, food containing even the smallest amounts of gluten can deliver a gutful of hurt.

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December 5, 2024: Nudge Pragmatic Trial Finds No Improvement in Adherence to Cardiovascular Medications

Rethinking Clinical Trials

Dr. Michael Ho and Dr. Sheana Bull, principal investigators for Nudge Text message–based reminders to patients who delayed refilling their cardiovascular medications did not improve medication adherence compared with usual care in the recently completed Nudge trial. The results of the study were published online ahead of print in JAMA. Nudge, an NIH Collaboratory Trial, was a randomized, pragmatic clinical trial embedded in 3 healthcare systems testing a variety of text messaging strategies to

Trials 162
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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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World Orphan Drug Congresses Europe vs. The US: Global Perspectives on Genetic Testing

Worldwide Clinical Trials

At the recent World Orphan Drug Congresses (WODC) in Europe and the United States, Worldwide Clinical Trials Derek Ansel , Vice President, Therapeutic Strategy Lead, Rare Disease, facilitated roundtable discussions to explore the operational challenges and ethical barriers surrounding genetic testing. While the agenda remained the same across both events, the conversations revealed key regional distinctions and global perspectives on how genetic testing, ethics, and operational challenges are ad

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RFK Jr. could 'cost lives in this country' if he pursues changes to US vaccine policy, Gottlieb says

Fierce Pharma

Robert F. Kennedy Jr.’s appointment last month to lead the U.S. Department of Health and Human Services immediately sent waves of speculation swirling throughout the biopharma industry. | The former FDA Commissioner pointed to the threat of measles if vaccination rates were to decline by 5%.

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Citryll gains Series B funds to develop NET-targeting antibody

Pharmaceutical Technology

Citryll has secured an oversubscribed Series B funding round, raising 85m ($89.8m) to advance the clinical development of CIT-013.

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Protecting Your Muscle Mass Is Vital For Healthy Aging – Here’s Why

AuroBlog - Aurous Healthcare Clinical Trials blog

Skeletal muscle fibers (multinucleated cells) with their nerve connections. (Ed Reschke/Stone/Getty Images) We’d all like to live longer; at least, I would. But what about enjoying the time we have while we’re here and living healthier? Over the past century, human life expectancy has dramatically increased for a variety of reasons.

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December 3, 2024: Sharing Results With Research Participants Raises Special Considerations in Pragmatic Trials

Rethinking Clinical Trials

In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists explores the ethical obligation to share aggregate results from pragmatic clinical trials with research participants. They conclude with recommendations for how to meet this obligation. The article was published online ahead of print in Clinical Trials. There is growing appreciation of the importance of sharing aggregate results of clinical trials with research participants.

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Pharma prepares for CDMO growth in 2025 as CPHI Milan reports record attendance

Pharma Mirror

CPHI Milan the worlds largest pharma event hosted last month in Milan saw a new record attendance of 59,000 pharma executives buoyed by returning confidence and increased deal-making on site. The post Pharma prepares for CDMO growth in 2025 as CPHI Milan reports record attendance appeared first on Pharma Mirror Magazine.

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

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Eli Lilly's Zepbound defeats Novo Nordisk's Wegovy in head-to-head weight loss trial

Fierce Pharma

Over the last two-plus years, as Eli Lilly and Novo Nordisk have battled for their share of the massive weight loss market and patients wondered which company’s products were more effective, there | Eli Lilly revealed results from a study that showed its obesity drug Zepbound was 47% more effective than Novo’s Wegovy in helping patients lose weight.

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Janux impresses Wall Street with new prostate cancer drug results

Bio Pharma Dive

While early and from a small trial, the findings suggest Janux’s method of “masking” T cell engagers could lead to differentiated results, some analysts said.

Drugs 297
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Nobel laureates ‘strongly urge’ Senate to oppose confirmation of RFK Jr

Pharmaceutical Technology

In the letter, 77 Nobel Prize winners argue that appointing RFK as Secretary of HHS would put the US publics health in jeopardy.

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Scientists Predict 80% of American Adults Will Be Overweight or Obese by 2050

AuroBlog - Aurous Healthcare Clinical Trials blog

(Ivan Rodriguez Alba/E+/Getty Images) Nearly half of adolescents and three-quarters of adults in the US were classified as being clinically overweight or obese in 2021. The rates have more than doubled compared with 1990.

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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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December 11, 2024: Home Blood Pressure Telemonitoring in Black and Hispanic Patients With Stroke, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Gbenga Ogedegbe In this Friday’s PCT Grand Rounds, Gbenga Ogedegbe of the NYU Grossman School of Medicine will present “Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, December 13, 2024, at 1:00 pm eastern.

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FDA Refines Accelerated Approval Pathway with New Draft Guidance

XTalks

The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions. This guidance focuses on improved accountability, earlier confirmatory studies and greater clarity on novel endpoints.

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FDA considers 'regulatory action' for bluebird's Skysona after blood cancer reports

Fierce Pharma

The FDA is investigating reports of patients develo | The FDA is investigating reports of patients developing blood cancer after receiving bluebird bio’s gene therapy Skysona and is evaluating the need for “further regulatory action,” the U.S. agency said last week. The FDA notification came seven weeks after the New England Journal of Medicine (NEJM) published a report that seven of 67 children who received Skysona during clinical trials had developed blood cancer.

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Antag, a startup backed by Versant and Novo, joins hunt for obesity drug alternatives

Bio Pharma Dive

The company, which raised $84 million, sees validation of its GIP-blocking approach to weight loss in Amgen's recent MariTide drug data.

Drugs 290
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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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PrEP therapies utter new hope in HIV preventive landscape as vaccine failures amass

Pharmaceutical Technology

The HIV vaccine space has seen dwindling research activity as drug manufacturers turn to PrEP therapies for preventive treatment.

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India takes centre-stage in clinical trials for HIV/AIDS drug

AuroBlog - Aurous Healthcare Clinical Trials blog

India has taken centre-stage in clinical trials for HIV/AIDS drug as there are several ongoing clinical trials in India focused on advancing HIV treatment. These trials are investigating new drug candidates, therapies, and approaches to manage HIV more effectively and potentially cure it.

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December 2, 2024: NCI-Supported LungSMART Trial Joins the NIH Pragmatic Trials Collaboratory

Rethinking Clinical Trials

From left to right: Drs. David Wetter, Guilherme Del Fiol, and Ken Kawamoto, principal investigators for LungSMART The NIH Pragmatic Trials Collaboratory is pleased to welcome LungSMART (Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers) to its portfolio of innovative NIH Collaboratory Trials. Lung cancer is the leading cause of cancer-related deaths in the United States, but only 6.5% of eligible individuals were screened for lung cancer in 20

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Leriglitazone meets endpoint in trial for cerebral adrenoleukodystrophy

Pharma Times

Promising results set stage for European marketing authorization

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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 J&J's subcutaneous Rybrevant filing and AZ's full approval bid for Andexxa

Fierce Pharma

Johnson & Johnson has received coal in its stocking from the FDA as manufacturing issues have tripped up the companys attempt to gain approval of its subcutaneous version of lung cancer drug R | The FDA has sent complete response letters to Johnson & Johnson and AstraZeneca, rejecting J&J's application for subcutaneous Rybrevant and AZ's bid for a full approval of Andexxa.

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Novartis wagers billions of dollars on PTC Huntington’s drug

Bio Pharma Dive

At the center of a new licensing deal is an experimental medicine, PTC518, which is currently being tested in a roughly 250-person study that should produce results next year.

Licensing 290
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Sanofi’s combo vaccines gain FDA fast track designation

Pharmaceutical Technology

Sanofi has announced that its two combination vaccine candidates have received fast track status from the US FDA.

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Clinical Trials For Drug That Replaces Missing Teeth Finally Underway

AuroBlog - Aurous Healthcare Clinical Trials blog

People with missing teeth may be able to grow new ones, say Japanese dentists testing a pioneering drug they hope will offer an alternative to dentures and implants.

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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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Grand Rounds December 13, 2024: Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial (Gbenga Ogedegbe, MD, MPH, FACP)

Rethinking Clinical Trials

Speaker Gbenga Ogedegbe, MD, MPH, FACP Dr. Adolph & Margaret Berger Professor of Population Health NYU Grossman School of Medicine Director, Institute for Excellence in Health Equity (IEHE) NYU Langone Health Slides Keywords Hypertension; Racial Disparities; Case Management; Telemonitoring Key Points There are significant racial disparities when it comes to stroke outcomes in the U.S., with Black and Hispanic populations experiencing poorer outcomes than Caucasian

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Genmab expands its pipeline with $630m Scancell deal

pharmaphorum

Genmab has licensed another anti-glycan antibody for cancer from UK biotech Scancell as it continues to expand its in-house pipeline.

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Commercial tea bags release millions of microplastics, entering human intestinal cells

Medical Xpress

UAB research has characterized in detail how polymer-based commercial tea bags release millions of nanoplastics and microplastics when infused. The study shows for the first time the capacity of these particles to be absorbed by human intestinal cells, and are thus able to reach the bloodstream and spread throughout the body.

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Atea plans Phase 3 study for hepatitis C drug after mid-stage results

Bio Pharma Dive

The struggling biotech company is looking to break into the lucrative hepatitis C market with the promise of an easier treatment regimen.

Drugs 261
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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