Sat.Oct 12, 2024 - Fri.Oct 18, 2024

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Imitation Ozempic Is Flooding The Market: Here’s What You Need to Know

AuroBlog - Aurous Healthcare Clinical Trials blog

(Abdullah Durmaz/Getty Images) In just a few years, brand-name injectable drugs such as Ozempic, Wegovy, Mounjaro and Zepbound have rocketed to fame as billion-dollar annual sellers for weight loss as well as to control blood sugar levels and reduce the risk of heart disease.

Marketing 246
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The growing role of CDMOs in the circular economy

Pharmaceutical Technology

Pharmaceutical giants cannot work in a silo to reach net zero. Pharma contract manufactures have a duty to engage with the science-based climate targets, says ACG.

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Innovation in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

Worldwide Clinical Trials

Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.

Research 147
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Wave sees RNA editing validation in early trial results

Bio Pharma Dive

The results provide the first clinical evidence of RNA editing, a burgeoning field that's drawn interest from biotechs and pharmaceutical companies alike.

RNA 358
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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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Women in STEM: Gitte Barknowitz’s journey to leading global initiatives

BioPharma Reporter

From exploring the wonders of plants as a curious teen to leading global initiatives at SCIEX, Gitte Barknowitz has carved out an exciting and unconventional career in science.

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October 16, 2024: Testing of Behavior Change Interventions, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Alexander Fanaroff In this Friday’s PCT Grand Rounds, Alexander Fanaroff of the University of Pennsylvania will present “Rigorous Testing of Behavior Change Interventions: Lessons From the BE ACTIVE Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, October 18, 2024, at 1:00 pm eastern. Fanaroff is an assistant professor of medicine at the University of Pennsylvania.

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After rejections, AbbVie secures approval for Parkinson’s drug

Bio Pharma Dive

Vyalev’s clearance is the second victory for AbbVie in Parkinson’s this year, following an April readout for a drug acquired through its Cerevel buyout.

Drugs 340
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mRNA licensing agreements surge 800% amid GSK lawsuits

Pharmaceutical Technology

An 800% increase in licensing deal values indicates growing confidence in mRNA technology, but some vaccine producers are facing lawsuits.

Licensing 278
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SPECTRALIS Flex Module Add-On Gets FDA Clearance, Aims to Improve Access to Ophthalmic Imaging

XTalks

The US Food and Drug Administration (FDA) has granted clearance to imaging and healthcare IT company Heidelberg Engineering’s Flex Module, a multimodal, diagnostic imaging-only platform designed for imaging the posterior segment of pediatric and adult patients in a supine (face up) position. Being able to image macular and optic nerve pathologies in the supine position ensures that vulnerable individuals can receive timely and sight-saving diagnoses and treatments.

Engineer 104
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Does Stress Really Turn Your Hair Gray?

AuroBlog - Aurous Healthcare Clinical Trials blog

(juanma hache/Getty Images) When we start to go gray depends a lot on genetics. Your first gray hairs usually appear anywhere between your twenties and fifties. For men, gray hairs normally start at the temples and sideburns. Women tend to start graying on the hairline, especially at the front.

Genetics 246
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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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Lundbeck to buy brain drug developer Longboard for $2.6B

Bio Pharma Dive

The deal would hand Lundbeck a treatment for a series of rare brain disorders that could, by the company's estimates, become a blockbuster product.

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Cell and gene therapy approvals drive paradigm change in manufacturing

Pharmaceutical Technology

Trends in gene therapy approvals in recent years are rapidly shaping the future of manufacturing capabilities in the pharmaceutical industry.

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Lundbeck drops in on epilepsy drug with $2.6bn Longboard bid

pharmaphorum

Neuroscience specialist Lundbeck has agreed to buy Longboard Pharmaceuticals for $2.6 billion, expanding its pipeline with an epilepsy drug tipped as a future blockbuster.The Danish drugmaker has offered $60 per share for California biotech Longboard, with the main asset in the deal bexicaserin, an oral, centrally acting serotonin 5-HT 2C receptor super-agonist in late-stage testing for seizures associated with rare forms of epilepsy.

Drugs 105
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Isometric Exercise: Why This Workout Regime Is So Good For You

AuroBlog - Aurous Healthcare Clinical Trials blog

(Valerii Apetroaiei/Getty Images) Exercise is great for improving heart health. But the thought of hitting the gym or going for a jog might put some people off from doing it. And, if you have a heart condition already, such dynamic exercises may not be safe to do.

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

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Sage to cut one-third of workforce, streamline drug pipeline

Bio Pharma Dive

The restructuring, which follows clinical setbacks in Alzheimer’s, Parkinson’s and tremor, will also involve the departure of five senior executives.

Drugs 286
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Opioid addiction market to reach $2.4 billion across 8MM by 2033

Pharmaceutical Technology

Late-stage pipeline products could drive combined sales of approximately $171.4 million by 2033 in the 8MM.

Sales 269
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Recent CTTI Publication Reviews Current Applications and Future Opportunities for Disease Progression Modeling

CTTI (Clinical Trials Transformation Initiative)

A new CTTI publication , published in Clinical Pharmacology & Therapeutics , reviews current applications of disease progression modeling (DPM) and opportunities to advance the awareness and value of DPM in clinical trials. Use of modeling and simulation during drug development, otherwise known as model-informed drug development (MIDD), can help researchers make informed decisions when planning and executing clinical trials.

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Can a Supplement Really Help Control Your Pesky Eye Floaters?

AuroBlog - Aurous Healthcare Clinical Trials blog

(Filipp Romanovski/Unsplash) If you look up at the sky on a clear day, you might notice little cobweb-like structures drifting across your field of vision.

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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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FDA, facing pressure, to review position on Zepbound, Mounjaro shortage

Bio Pharma Dive

The agency agreed in court to allow compounding companies to continue producing copycat versions of Lilly’s fast-selling medicines while it reevaluates its recent decision to declare the drugs back in supply.

Medicine 287
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Glaukos eyes FDA approval for ocular therapy after Phase III win

Pharmaceutical Technology

The company’s keratoconus medication, Epioxa, was effective in a Phase III trial, with plans to file for submission with the US Food and Drug Administration (FDA).

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Celltrion unveils promising dose escalation results for subcutaneous infliximab

Pharma Times

Study reveals potential new strategy for managing inflammatory bowel disease

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Lilly pledges £279m to UK for biotech hub and obesity plan

pharmaphorum

Eli Lilly may invest $364m in the UK and work with the government to tackle serious public health challenges including obesity.

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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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Sanofi, expanding in radiopharma, strikes a joint venture deal

Bio Pharma Dive

The French drugmaker will invest 300 million euros into a new entity that will develop lead isotope-based therapies for cancer under the Orano Med brand.

Branding 285
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Intercept’s liver disease drug Ocaliva faces FDA approval delay

Pharmaceutical Technology

An FDA AdCom in September recommended against full approval for Ocaliva by a 13-1 vote for the treatment of primary biliary cholangitis.

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HBC Immunology shares promising results for prostate cancer co-therapy

Pharma Times

There are around 55,100 new prostate cancer cases in the UK every year

Hormones 146
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3rd time's the charm: AbbVie scores FDA nod for continuous Parkinson's disease therapy Vyalev

Fierce Pharma

AbbVie made history in 2015 with its Parkinson’s disease infusion pump therapy Duopa, kicking off a trend of delivery system innovation in the space as drugmakers sought to avoid the common pitfall | The 24-hour Parkinson's disease therapy crossed the FDA finish line after an initial manufacturing-related rejection last year and another snub in June.

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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 puts Novavax flu vaccine trials on hold

Bio Pharma Dive

The hold, which was made in response to a serious adverse event report, could impact the company’s plans to start a Phase 3 trial of a combination shot for COVID-19 and influenza.

Trials 284
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Sanofi in talks to sell stake in consumer healthcare unit to CD&R

Pharmaceutical Technology

Sanofi has announced negotiations with Clayton Dubilier & Rice (CD&R), regarding the potential sale of a 50% controlling stake in Opella.

Sales 246
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Lundbeck to acquire Longboard Pharmaceuticals in strategic deal

Pharma Times

Acquisition to enhance Lundbeck’s neuroscience pipeline

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GSK turns its guns on Moderna in mRNA jab patent dispute

pharmaphorum

GSK has filed lawsuits against Moderna, claiming infringement of patents covering mRNA vaccines for COVID-19 and RSV

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time