Sat.Nov 30, 2024 - Fri.Dec 06, 2024

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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.

Scientist 182
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CEO of UnitedHealthcare, Brian Thompson, shot dead in New York City

Pharmaceutical Technology

US police have confirmed that Brian Thompson was fatally shot outside an investor conference by a masked assailant.

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Are You Using Next-Gen Sequencing to inform AAV product and process quality? Here are 4 reasons you should

Bio Pharma Dive

Next-generation sequencing allows for critical insights into gene therapy products, which can help streamline and accelerate everything from process development and production to regulatory approval.

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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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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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Deadline looms for post-Brexit label changes for UK meds

pharmaphorum

The MHRA has reminded pharma companies that from 1st January all medicines sold in the UK will have to comply with new labelling requirements

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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.

More Trending

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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 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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Novartis and Olema expand alliance with $250m to boost breast cancer trials

Pharmaceutical Technology

Olema Oncology and Novartis have signed a clinical trial collaboration and supply agreement for a Phase III trial in metastatic breast cancer.

Trials 246
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Diabetes advocacy group discourages use of compounded GLP-1 drugs

Bio Pharma Dive

The ADA recommended doctors avoid prescribing unapproved, off-brand versions of drugs like Wegovy, wading into a dispute that has gripped the FDA and compounding pharmacies over the past few months.

Pharmacy 301
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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.

Scientist 176
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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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All-in-one milling platforms: How to reduce your machinery footprint  

Pharmaceutical Technology

Many machines are required for pharmaceutical milling processes. Can you reduce that number, streamline operations and improve efficiency?

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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 292
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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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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

Trials 147
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Eli Lilly to invest $3bn in Wisconsin facility expansion

Pharmaceutical Technology

Eli has announced a $3bn investment to expand its newly acquired manufacturing facility in Kenosha County, Wisconsin, in the US.

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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 284
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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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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.

Licensing 129
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December 4, 2024: In This Week’s PCT Grand Rounds, Large Language Models for Postmarketing Surveillance of Medical Products

Rethinking Clinical Trials

Dr. Michael Matheny In this Friday’s PCT Grand Rounds, Michael Matheny of Vanderbilt University will present “Opportunities and Challenges in the Use of Large Language Models for Postmarketing Surveillance of Medical Products.” The Grand Rounds session will be held on Friday, December 6, 2024, at 1:00 pm eastern. Matheny is a professor of biomedical informatics, biostatistics, and medicine and the director of the Center for Improving the Public’s Health Through Informatic

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FDA shares new draft guidance for accelerated approval

Pharmaceutical Technology

The new FDA guidance outlines how surrogate or intermediate clinical endpoints can support accelerated approval.

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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 284
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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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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.

Trials 117
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NICE endorses Neuraxpharm’s ublituximab for treating MS

Pharma Times

New antibody therapy shows promise in managing condition

Antibody 126
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Nature study finds obesity costs US industry $347bn a year

Pharmaceutical Technology

A study published in Nature estimates the economic burden associated with obesity on major US industries to be in excess of $347bn in 2023.

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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 258
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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A New Alzheimer’s Drug Shrinks The Brain. Scientists Say That’s The Point.

AuroBlog - Aurous Healthcare Clinical Trials blog

MRI scans of the human brain. (corelens/Canva) Decreases in brain volume are used as an indicator of Alzheimer’s disease, yet the latest class of Alzheimer’s treatments cause the brain to shrink even further. A new study now suggests this might paradoxically be a good thing.

Scientist 130
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Everest therapy shows promise in nephropathy trial

Pharma Times

Data highlights effectiveness of EVER001 in treating pMN

Trials 124
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Cell and gene therapy companies must demonstrate strong value proposition for investment          

Pharmaceutical Technology

Investment for companies developing cell and gene therapies (CGTs) was discussed during the GenScript Biotech Global Forum London 2024 conference held on 20 November 2024.

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With conflicts of interest in focus, Trump’s pick to run FDA could face scrutiny of his own industry ties

Bio Pharma Dive

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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.