Sat.May 11, 2024 - Fri.May 17, 2024

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Elite Runners Live Years Longer Than The Average Person, Scientists Find

AuroBlog - Aurous Healthcare Clinical Trials blog

Running 10 hours a week for more than 120 km (75 miles) is extreme exercise, to be sure. Yet far from pushing the body beyond its limits, a new study suggests some professional athletes are adding years to their lives with such brutal routines.

Scientist 212
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Tracking the opioid lawsuit settlements amidst calls for oversight

Pharmaceutical Technology

The US National Opioid Settlement is distributing more than $54 billion to communities grappling with the opioid crisis.

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Ajax, aiming for a better JAK drug, raises $95M to begin first tests

Bio Pharma Dive

Goldman Sachs and Eli Lilly are among those backing the startup, which claims its prospect could be more potent than the myelofibrosis therapies that have come to market in recent years.

Drugs 325
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6 Principles of Our Rare Disease Methodology That Drive Success for Our Sponsors

Worldwide Clinical Trials

By: Amy Raymond, Derek Ansel, Nathan Chadwick, & Juliane Mills When choosing a CRO for a rare disease study, what truly sets them apart is their methodology: the CRO’s mindset, their approach to each unique study, and their agility in navigating the inherent complexities of rare disease research. The team’s ability to apply insights and proven strategies from their experience in rare disease research brings concepts to reality, getting medications to patients faster.

Trials 204
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Takeda wagers up to $2.2bn on AC Immune Alzheimer’s shot

pharmaphorum

Takeda has made a strong play for a stake in the Alzheimer’s disease market, paying $100 million upfront for an option on AC Immune’s amyloid-targeting immunotherapy. The option fee could be followed by another up to $2.1 billion in potential milestones if Takeda takes global rights to the programme, currently headed by ACI-24.060 which is in a phase 1b/2 trial with new data due in the next few weeks.

Trials 132
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Sanders issues warning to Novo Nordisk amid GLP-1 drug price investigation

Pharmaceutical Technology

The US Senator took another swipe at the US prices of Novo Nordisk’s blockbuster GLP-1 receptor agonist drugs Ozempic and Wegovy.

Drugs 290

More Trending

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Scientists Reveal Just How Far Plastic Can Reach Into Your Lungs

AuroBlog - Aurous Healthcare Clinical Trials blog

Miniscule fragments of plastic pollution invade the human body every day without our knowing it, not just from eating and drinking but from simply breathing. By some estimates, the average person inhales a credit card’s worth of plastic every week with unknown health effects.

Scientist 200
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May 16, 2024: Journal Peer Reviewers Are Familiar With Pragmatic Trials, Want More on Implementation

Rethinking Clinical Trials

According to a report from the NIH Pragmatic Trials Collaboratory Coordinating Center, journal editors and peer reviewers were familiar with pragmatic clinical trials and their designs and analytic approaches, but they often asked for more information about intervention implementation. The report was published this week in the Living Textbook of Pragmatic Clinical Trials.

Trials 147
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Docetaxel albumin bound by CSPC Pharmaceutical Group for Hypopharyngeal Cancer: Likelihood of Approval

Pharmaceutical Technology

Docetaxel albumin bound is under clinical development by CSPC Pharmaceutical Group and currently in Phase II for Hypopharyngeal Cancer.

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Biogen, Ionis shelve ALS drug following study failure

Bio Pharma Dive

While results indicated the drug works as intended, it didn’t have enough of an effect on a protein that’s become integral to many ALS research programs.

Drugs 312
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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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SEC recommends permission to SII for Omicron XBB 1.5 variant Covid-19 vaccine

AuroBlog - Aurous Healthcare Clinical Trials blog

A Subject Expert Committee (SEC), which advices the national drug regulator on approvals and clinical trials related to Covid-19 vaccines, has recommended grant of permission to Serum Institute of India (SII) for Omicron XBB 1.5 variant Covid-19 vaccine with local clinical trial waiver, for restricted use in emergency situation subject to conditions.

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Could Cancer Vaccines Be the Next Big Breakthrough in Immunotherapy?

BioSpace

The race is on to develop therapeutic cancer vaccines that could give immunotherapies an edge, and late-stage trials could soon provide more-robust data about candidates’ efficacy and safety.

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Dementia Action Week 2024: the future of Alzheimer’s diagnostics  

Pharmaceutical Technology

As the debate over using tau levels to guide patient treatment persists, the landscape for Alzheimer’s diagnostics continues to move ahead.

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Lilly’s once-weekly insulin matches daily shots in late-stage tests

Bio Pharma Dive

The results, which showed Lilly’s drug was as effective at controlling blood sugar as standard injections, come as Novo Nordisk seeks approval for a competing once-weekly insulin.

Insulin 294
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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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PCI issues guidelines for institutions prior to commencement of inspection process

AuroBlog - Aurous Healthcare Clinical Trials blog

The Pharmacy Council of India (PCI) has issued guidelines for the institutions related to the inspection process for the academic year 2024-25, mandating that the students and the faculties should have their smart cards and the infrastructure of the institutions should have mandatory active Quick Response (QR) code at the time of inspection.

Pharmacy 174
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Amgen Wins FDA Approval for Difficult-to-Treat Lung Cancer

BioSpace

Bolstered by promising response data from its Phase II study, Amgen announced Thursday it got the FDA’s green light for its first-in-class bi-specific T-cell engager Imdelltra for extensive-stage small lung cancer.

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Docetaxel albumin bound by CSPC Pharmaceutical Group for Oropharyngeal Cancer: Likelihood of Approval

Pharmaceutical Technology

Docetaxel albumin bound is under clinical development by CSPC Pharmaceutical Group and currently in Phase II for Oropharyngeal Cancer.

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Eisai sets new revenue target for Alzheimer’s drug Leqembi

Bio Pharma Dive

The annual forecast, which comes as Eisai and Biogen have begun submitting a more convenient form of Leqembi for approval, looks “more realistic” than previous guidance, according to Jefferies analysts.

Drugs 293
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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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Top 10 countries accounted for India’s 63% of Ayush and herbal products export in 2023-24

AuroBlog - Aurous Healthcare Clinical Trials blog

The top 10 destinations led by USA, Germany and Italy accounted for almost 63.3 per cent of India’s Ayush and herbal products during the fiscal year 2023-24. Exports to these 10 countries together stood at $412 million, with a growth of 5.

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ICER raps conduct of Lykos’ psychedelic trial for PTSD

pharmaphorum

The Institute for Clinical and Economic Review (ICER) typically focuses on the cost-effectiveness of new therapies, but in an unusual move has sharply criticised the design and conduct of clinical trials of Lykos Therapeutics psychedelic therapy for post-traumatic stress disorder (PTSD).

Trials 119
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FDA rejects label expansion for Dynavax’s hepatitis B vaccine

Pharmaceutical Technology

The US agency rejected the expanded use of Dynavax’s vaccine for adults on haemodialysis, citing insufficient efficacy and safety data.

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Detailed trial data show Bayer drug alleviates menopause symptoms

Bio Pharma Dive

Full study results disclosed ahead of a medical meeting showed elinzanetant consistently reduced the frequency and severity of hot flashes.

Trials 294
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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A Neuroscientist Explains How Your Brain Actually Thinks

AuroBlog - Aurous Healthcare Clinical Trials blog

Have you ever wondered how your brain creates thoughts or why something randomly popped into your head? It may seem like magic – but actually the brain is like a supercomputer inside your head that helps you think, learn and make decisions. Imagine your brain as a busy city with lots of streets and buildings.

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With 4-year data, Novo bolsters star power of obesity blockbuster Wegovy

Fierce Pharma

With new four-year data in hand, Novo Nordisk can make a case for its popular obesity med Wegovy to be used as a long-term treatment. | An analysis unveiled at the European Congress on Obesity showed that Wegovy patients lost 10% of their weight, on average, over a 4-year span.

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Docetaxel albumin bound by CSPC Pharmaceutical Group for Laryngeal Cancer: Likelihood of Approval

Pharmaceutical Technology

Docetaxel albumin bound is under clinical development by CSPC Pharmaceutical Group and currently in Phase II for Laryngeal Cancer.

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Takeda nabs option to license Alzheimer’s immunotherapies from AC Immune

Bio Pharma Dive

The deal — worth $100 million up front and potentially billions more later on — gives Takeda an exclusive option to license an Alzheimer’s vaccine and other “active immunotherapies.

Licensing 195
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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.

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PCI issues guidelines for institutions prior to commencement of inspection process

AuroBlog - Aurous Healthcare Clinical Trials blog

The Pharmacy Council of India (PCI) has issued guidelines for the institutions related to the inspection process for the academic year 2024-25, mandating that the students and the faculties should have their smart cards and the infrastructure of the institutions should have mandatory active Quick Response (QR) code at the time of inspection.

Pharmacy 156
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Bayer’s 1,500 Layoffs Are Latest Salvo in CEO Bill Anderson’s Company Overhaul

BioSpace

Since taking the helm in 2023, Anderson has embarked on a radical departure from the traditional structure of large pharma companies. Will getting rid of management layers fix Bayer?

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FDA clears IND for Verismo Therapeutics’ CAR-T therapy 

Pharmaceutical Technology

Verismo Therapeutics announced FDA clearance for a Phase I trial of its CAR-T therapy to treat non-Hodgkin lymphoma.

Trials 263
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FogPharma, Artbio join forces to design a different radiopharma drug

Bio Pharma Dive

The biotechs aim to marry FogPharma’s polypeptide science with Artbio’s lead-based radiopharmaceutical technology in one of the industry’s hottest fields.

Drugs 195
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.