Trending Articles

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Sanofi, Teva say study results show gut disease drug could be ‘best in class’

Bio Pharma Dive

Phase 2 results in inflammatory bowel disease hinted the therapy could be more potent than similar medicines from Merck and Roche, each of which were acquired in multibillion-dollar deals.

Medicine 232
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Abera and Orexo partner for vaccine powder formulations

Pharmaceutical Technology

Abera and Orexo have entered a partnership to develop and test the powder formulations of the formers vaccine candidates.

Vaccine 165
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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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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

Genetics 130
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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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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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Merck targets 2025 RSV season with antibody now under FDA review

Bio Pharma Dive

An FDA approval of Merck’s drug clesrovimab by June would give physicians another option for protecting newborns from respiratory syncytial virus.

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Study Reveals Major Drawback to The Health Benefits of Fasting

AuroBlog - Aurous Healthcare Clinical Trials blog

The human body can survive without food for some time before starvation risks causing significant harm to the body.

Research 146
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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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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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Novo’s next-gen obesity drug misses expectations in closely watched trial

Bio Pharma Dive

Novo shares lost nearly a quarter of their value after an experimental combination treatment called cagrisema fell short of the bar set by executives.

Trials 179
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Novo Nordisk takes a hit as CagriSema underperforms in weight loss

Pharmaceutical Technology

Novo Nordisk has announced positive results from its Phase III trial of CagriSema but fell short of a previously promised 25% weight loss.

Trials 162
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Abnormal Patterns in Brain Waves May Indicate ADHD, Expert Says

AuroBlog - Aurous Healthcare Clinical Trials blog

Children with attention deficit hyperactivity disorder ( ADHD) do not have a behavioural disorder, nor are they lazy, or lacking in manners and boundaries. Their brains mature in a different way, with different patterns of neurological activity and a number of neurochemical differences. For this reason, ADHD is considered to be a neurodevelopmental disorder.

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Dissemination and Implementation in Embedded Pragmatic Trials: Getting the Timing Right in Real-World Research: AcademyHealth (December 2024)

Rethinking Clinical Trials

December 8, 2024 : The NIH Pragmatic Trials Collaboratory hosted a workshop at AcademyHealth's 17th Annual Conference on the Science of Dissemination and Implementation in Health. The workshop introduced concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a focus on methods relevant to health services researchers.

Trials 130
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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.

Research 109
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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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Zepbound, Mounjaro shortages are resolved, FDA confirms

Bio Pharma Dive

The FDA’s decision will close a lucrative market opportunity for compounding pharmacies, although the agency will give a limited grace period before taking any enforcement actions.

Pharmacy 179
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FDA confirms end of Eli Lilly’s tirzepatide shortage after re-evaluation

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has stood by an earlier decision confirming that the tirzepatide shortage is over.

Drugs 162
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Unloxcyt Wins FDA Approval for Advanced Skin Cancer, Set to Compete with Keytruda

XTalks

The US Food and Drug Administration (FDA) has granted approval to Checkpoint Therapeutics PD-L1 inhibitor Unloxcyt (cosibelimab-ipdl) for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in patients who cannot be cured with surgery or radiation therapy. The approval marks the first product approval for the Massachusetts-based biotech and the first approved anti-programmed death-ligand 1 (PD-L1) treatment for advanced cSCC. cSCC is the second most common fo

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December 16, 2024: Study Snapshot and Updated Ethics Documentation Available for I CAN DO Surgical ACP

Rethinking Clinical Trials

A new study snapshot and updated ethics and regulatory documentation are now available for the I CAN DO Surgical ACP trial. As part of the study’s transition from the planning phase to the implementation phase this fall, the investigators reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. Read the updated ethics and regulatory documentation See the study snapshot I CAN DO Surgical ACP, an NIH Collaboratory Trial, is testing a system-based ap

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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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Checkpoint Therapeutics takes on Merck's mighty Keytruda with FDA approval for Unloxcyt in skin cancer

Fierce Pharma

Another checkpoint inhibitor has entered the fray, as Checkpoint Therapeutics has passed the FDAs checkpoint with its PD-L1 inhibitor cosibelimab. | Another checkpoint inhibitor has entered the fray, as Checkpoint Therapeutics has passed the FDAs checkpoint with its PD-L1 inhibitor cosibelimab.

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Merck calls quits on two immunotherapies for cancer

Bio Pharma Dive

The company is scrapping two drugs aimed at targets called TIGIT and LAG-3, both of which were in the middle of Phase 3 testing.

Drugs 173
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Astellas and Sangamo sign capsid deal for neurological diseases

Pharmaceutical Technology

Astellas Pharma and Sangamo have signed a licence agreement for neurotropic adeno-associated virus (AAV) capsid, STAC-BBB.

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Mesoblast finally pushes GvHD cell therapy over finish line

pharmaphorum

At its third attempt, Mesoblast has secured FDA approval for the first-ever mesenchymal stem cell (MSC) therapy, Ryoncil for acute GvHD in children.

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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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Hypersensitive strain sensor enables real-time stroke monitoring

Medical Xpress

A research team led by Prof. Seung-Kyun Kang from the Department of Materials Science and Engineering at Seoul National University has developed a strain sensor with record-breaking sensitivity in collaboration with researchers from Dankook University, Ajou University, and Purdue University.

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After studies flag possible link between Novo's Ozempic and rare eye disorder, Danish agency calls for probe

Fierce Pharma

Its not a new question, but it is one that is gaining increased traction: Is there a link between Novo Nordisks diabetes superstar Ozempic and blindness? | After the recent release of two independent studies from the University of Southern Denmark suggested the use of Ozempic increases patients' chances of developing a rare eye disorder, the Danish Medicines Agency has asked European officials to investigate.

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Merck moves into obesity with deal for Hansoh’s GLP-1 pill

Bio Pharma Dive

News of Merck’s licensing of Hansoh’s preclinical medicine pressured shares in Viking and other obesity drug developers seen as likely buyout targets.

Licensing 162
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CTO Europe 2024: keep the burden of trials away from patients, say experts

Pharmaceutical Technology

The two-day event included talks on subjects ranging from how to best utilise AI to how to build a stable CRO.

Trials 162
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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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MSD eyes June verdict for paediatric RSV antibody

pharmaphorum

The FDA has started a review of MSD's RSV antibody clesrovimab, a potential rival to Beyfortus, with a verdict due in the middle of next year

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Discovery of norovirus replication hubs offers new antiviral targets

Medical Xpress

Human norovirus, a positive-strand RNA virus that is the leading cause of viral gastroenteritis accounting for an estimated 685 million cases and approximately 212,000 deaths globally per year, has no approved vaccines or antivirals.

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India needs new drugs, improve infection control practices to thwart AMR: Dr Prabhu Vinayagam

AuroBlog - Aurous Healthcare Clinical Trials blog

India needs new drugs, vaccines, and improve infection control practices to thwart antimicrobial resistance (AMR). From an India and global perspective, the recent advances in AMR treatment are bacteriophage therapy, nanotechnology, immunotherapies, among others. According to Dr Prabhu Vinayagam, medical advisor, Orchid AMS, a division of Orchid Pharma, the latest developments are novel antimicrobial agents.

Drugs 103
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A venture firm breathes new life into an old NGM drug

Bio Pharma Dive

An startup formed by KdT Ventures intends to test the drug, which was once licensed to Merck and evaluated in multiple metabolic disorders, for an unspecified rare conditon.

Licensing 147
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time