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FDA approves Lilly’s obesity med Zepbound to treat obstructive sleep apnoea

Pharmaceutical Technology

Lillys Zepbound has become the first prescription medicine approved to treat adults with moderate to severe obstructive sleep apnoea (OSA) and obesity.

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Surprise Hair Loss Breakthrough: A Sugar Gel Triggers Robust Regrowth

AuroBlog - Aurous Healthcare Clinical Trials blog

Earlier this year, scientists stumbled upon a potential new treatment for hereditary-patterned baldness, the most common cause of hair loss in both men and women worldwide. It all started with research on a sugar that naturally occurs in the body and helps form DNA: the ‘deoxyribose‘ part of deoxyribonucleic acid.

DNA 161
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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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Top 5 Things to Know Before Joining a Clinical Trial

Pharma Mirror

Have you ever wondered how life-saving treatments for cancer, Alzheimers, or chronic diseases come to life? Clinical trials are the foundation of medical innovation, paving the way for groundbreaking therapies. Yet for many, the idea of joining a trial can feel intimidating or unclear. Experts are here to demystify the clinical trial process, with Dr.

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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

Genetics 130
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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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Your Sniffles Could Be a Sign of The Fungi Hidden in Your Nose

AuroBlog - Aurous Healthcare Clinical Trials blog

(Runstudio/Photodisc/Getty Images) If you find yourself sniffling at the merest hint of an irritant, you likely have a different set of microbes calling your nostrils home than everyone else. An international team of researchers has found a unique assortment of fungi up the noses of people who suffer from hayfever and asthma.

Research 161
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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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Fierce Pharma - Untitled Article

Fierce Pharma

The company already moved to cut its entire commercial sales force following several FDA setbacks in its efforts to introduce sotagliflozin in diabetes.

Sales 97
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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Pfizer’s colorectal cancer combo therapy gains accelerated approval from FDA

Pharmaceutical Technology

Pfizer has gained accelerated approval from the US FDA for BRAFTOVI in conjunction with cetuximab and mFOLFOX6 for treating mCRC.

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The Risk of Cancer Fades as We Get Older, And We May Finally Know Wh

AuroBlog - Aurous Healthcare Clinical Trials blog

Researchers studied cancer growth in mice. (Zhuang et al., Nature, 2024) Aging brings two opposing trends in cancer risk: first, the risk climbs in our 60s and 70s, as decades of genetic mutations build up in our bodies.

Genetics 130
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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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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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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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Regeneron says study data support big bet on new blood thinners

Bio Pharma Dive

The company is planning a “broad Phase 3 program” for two anticoagulants after they outperformed marketed medicines in a pair of mid-stage trials.

Medicine 147
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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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Playing catch-up with Pfizer and Roche, China-made ALK drug clears FDA in lung cancer

Fierce Pharma

Following in the footsteps of several Big Pharma companies, another ALK inhibitor has made its entry into the U.S. | Following in the footsteps of Pfizer, Roche and Takeda, another ALK inhibitor has made its belated entry into the U.S. The FDA nod comes four years after its initial approval in China.

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Sanofi takes SK Bio-partnered pneumococcal shot into phase 3

pharmaphorum

Sanofi has moved ahead with plans to challenge Pfizer and MSD for a piece of the market for pneumococcal vaccines.

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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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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.

RNA 86
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Novartis shutters MorphoSys sites, lays off staff

Bio Pharma Dive

While the pharma is still developing a MorphoSys drug acquired in its $2.9 billion deal for the biotech, it is closing down sites in the U.S. and Germany.

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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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Fierce Pharma - Untitled Article

Fierce Pharma

Perhaps PD-1 inhibitors just arent for ovarian cancer after all. | Merck's and GSK's similar overall survival setbacks suggest that PD-1 inhibitors may not be for ovarian cancer after all.

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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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AZ gets EU okay for Tagrisso in early-stage lung cancer

pharmaphorum

AstraZeneca's EGFR inhibitor Tagrisso has become the first drug in the class to be approved in the EU for a form of early-stage lung cancer.

Drugs 84
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Study reveals brain's role in starting meals through GABA, dopamine

Medical Xpress

When you are feeling hungry, the brain takes the necessary steps toward consuming a meal. Many of these steps are not well known, but a new study published in the journal Metabolism by researchers at Baylor College of Medicine and the University of Texas Health Science Center at Houston reveals brain circuits and chemical messengers that contribute to the regulation of meal initiation and food intake.

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Vertex ‘ends the year in pain’ as latest non-opioid drug data disappoint

Bio Pharma Dive

Mixed results from a study focused on lower back pain left analysts wanting as well as confused about Vertex's plans to forge ahead in the indication.

Drugs 147
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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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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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Fierce Pharma - Untitled Article

Fierce Pharma

Merck in-licensed a preclinical oral GLP-1 candidate from China's Hansoh Pharma. Astellas doubled down in gene therapy with a viral capsid deal with Sangamo Therapeutics. Betta Pharma's Ensacove became the first innovative targeted lung cancer med developed by a Chinese company to win FDA approval. And more.

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Novo completes $16.5bn takeover of Catalent

pharmaphorum

Novo Holdings' $16.

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International study reveals COVID-19 pandemic's impact on other causes of death

Medical Xpress

Researchers have analyzed cause-of-death data for 24 countries before and during the COVID-19 pandemic. The researchers found that life expectancy declined in 2020 for all but four of the 24 included countries, with the US experiencing the largest decline of 2.1 years for males. In 2021, most countries experienced further declines in life expectancy, with females in Bulgaria and males in Latvia experiencing the largest losses of over two years.

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Ionis gets a milestone approval; Another top FDA official to step down

Bio Pharma Dive

The clearance of Tryngolza gives Ionis its first wholly-owned, marketed medicine. Elsewhere, Robert Temple became the latest FDA leader to leave the agency, and two biotechs cut research deals.

Medicine 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time