Trending Articles

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March 18, 2025: ABATE Infection Analysis Explores Cost-Effectiveness of Strategies to Prevent Hospital-Acquired Infections

Rethinking Clinical Trials

In a cost-effectiveness analysis using data from the ABATE Infection trial, a strategy of chlorhexidine bathing and nasal decolonization targeted to hospitalized adults with medical devices in nonintensive care unit (ICU) settings was cost-effective in reducing hospital-acquired infections. The study results were published this month in JAMA Network Open.

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AstraZeneca and Alteogen agree on ALT-B4 platform tech

Pharmaceutical Technology

AstraZeneca has entered an exclusive licence agreement with Alteogen involving the latters ALT-B4 platform technology.

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March 12, 2025: In This Week’s PCT Grand Rounds, Spillover as a Potential Source of Bias in Pragmatic Trials

Rethinking Clinical Trials

Sean Mann In this Friday’s PCT Grand Rounds, Sean Mann of RAND will present “Spillover Due to Constraints on Care Delivery: A Potential Source of Bias in Pragmatic Clinical Trials.” The Grand Rounds session will be held on Friday, March 14, 2025, at 1:00 pm eastern. Mann is a senior policy analyst at RAND. Join the online meeting. The post March 12, 2025: In This Week’s PCT Grand Rounds, Spillover as a Potential Source of Bias in Pragmatic Trials appeared first on Rethink

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MeiraGTx spins Parkinson’s, obesity gene therapies into AI startup

Bio Pharma Dive

The joint venture with generative AI firm Hologen hands MeiraGTx $200 million up front as well as other financial perks — a “transformative” deal, according to the company’s CEO.

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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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CagriSema, Novo Nordisk’s Latest Obesity Drug Offering, Disappoints Investors with Trial Results

XTalks

Novo Nordisks investigational obesity combination drug, CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg), underperformed in its latest clinical trial, leading to a dip in the companys share price. In response to the trial outcomes, Novos shares declined by approximately 8% this week. Novo shared the latest data from the Phase III REDEFINE 2 trial evaluating the drug in overweight or obese patients with type 2 diabetes.

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Wholemeal or Wholegrain? An Expert Explains How to Choose Your Bread.

AuroBlog - Aurous Healthcare Clinical Trials blog

(Laura Leyshon/Getty Images) If you head to the shops to buy bread, you’ll face a variety of different options. But it can be hard to work out the difference between all the types on sale. For instance, you might have a vague idea that wholemeal or wholegrain bread is healthy. But what’s the difference?

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AstraZeneca director says AI must be a “thought partner” in drug discovery

Pharmaceutical Technology

AstraZenecas senior director in oncology data science outlined how the company uses AI for drug discovery at a recent talk.

Drugs 262
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Advanced Biomed IPO Raises $6.56M Towards Liquid Biopsy Testing

XTalks

On March 7, 2025, Advanced Biomed Inc. raised $6.56 million in its IPO and began trading on Nasdaq under the ticker ADVB. The biotech firm, which develops semiconductor-based microfluidic technology for early cancer detection, issued 1.64 million shares at $4 each, with an option to purchase an additional 246,000 shares within 45 days. Current Share Price: Established in 2014, Advanced Biomed has developed a proprietary microfluidic platform that functions as a compact laboratory on a chip.

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Overlooked Financial and Operational Costs of Diversity and Inclusion

ACRP blog

The benefits of diversity and inclusion in clinical research are widely recognized, yet the financial and operational costs of these efforts are often overlooked. Practical strategies are needed to identify and mitigate these hidden costs, helping organizations create effective and sustainable strategies. These will be more important than ever if current U.S.

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Grand Rounds March 7, 2025: A Trial of a “Kidney Action Team” for Hospitalized Patients with Acute Kidney Injury (F. Perry Wilson, MD MSCE)

Rethinking Clinical Trials

Speaker F. Perry Wilson, MD MSCE Associate Professor of Medicine and Public Health Director, Clinical and Translational Research Accelerator Yale University New Haven, CT Slides Keywords Electronic Alerts; Acute Kidney Injury; Action Team Key Points Acute Kidney Injury (AKI), or abrupt decline in kidney function, is common, affecting about 15% of hospitalized patients.

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

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Stoke CEO exits; Medicare drug price talks advance

Bio Pharma Dive

Ed Kaye, Stoke’s longtime leader, will be replaced by former Vertex executive Ian Smith. Elsewhere, all 12 drugmakers targeted for second round of Medicare price talks agreed to participate.

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MeiraGTx and Hologen launch AI-backed gene therapy venture

Pharmaceutical Technology

The venture aims to advance MeiraGTxs Parkinsons gene therapy through Phase III trials with up to $430m in funding from Hologen.

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Povorcitinib Phase III Results Stir Mixed Signals for Incyte and Investors

XTalks

Incytes recent announcement on the topline results from two Phase III clinical trials of povorcitinib in patients with hidradenitis suppurativa has stirred both hope and caution in the market. Hidradenitis suppurativa affecting roughly 1% of the population is a chronic skin condition marked by painful boils and abscesses that can significantly disrupt daily life.

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Open-source AI matches top proprietary model in solving tough medical cases

Medical Xpress

Artificial intelligence can transform medicine in a myriad of ways, including its promise to act as a trusted diagnostic aide to busy clinicians.

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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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Budgeting and Contracting Best Practices for Research Sites

ACRP blog

This is a sponsored message. To grow your business, negotiate and collect fair payment for your work by understanding its true costs before budget discussions. This includes all direct and indirect costs, and typically covers: Personnel costs: salaries, overtime, training, and additional staffing if needed. Facility costs: not only facility space, maintenance, utilities, and equipment, but also any additional space or modifications needed for the study.

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Orca Bio to seek approval of T cell transplant after positive trial data

Bio Pharma Dive

Study results showed Orca’s treatment, a purified mix of donor-derived T cells and stem cells, was safer than standard transplant in treating certain blood cancers.

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Ono earmarks $940m to gain rare blood cancer therapy from Ionis

Pharmaceutical Technology

Ono Pharmaceuticals has secured the global rights to sapablursen, an RNA-targeting therapy by Ionis to treat polycythemia vera (PV).

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Medical Device & MedTech Layoffs in 2025: A Roundup

XTalks

In 2025, as market pressures intensify and companies refocus on core strategic priorities, medical device and medtech companies have been forced to make tough decisions regarding their workforces. These developments come amid a broader nationwide trend of workforce realignment, with both private and public entities, including the FDA’s recent rehires amid mass layoffs, adapting to ongoing pressures.

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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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Ebola-infected monkeys cured with a pill, sparking human treatment hopes

Medical Xpress

Monkeys infected with Ebola can be cured with a pill, according to a new study out Friday that could pave the way for more practical, affordable treatments in humans.

Research 135
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Drug Patent Expirations: Unlocking Strategic Investment Opportunities

Drug Patent Watch

Unlocking Strategic Investment Opportunities in the Pharmaceutical Industry As we navigate the ever-evolving landscape of the pharmaceutical industry, one thing remains constant: the expiration of patents on blockbuster medications. These expirations can have a significant impact on the market, creating opportunities for strategic investment and growth.

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NGS is changing GxP compliance. Will you adapt?

Bio Pharma Dive

Discover NGS for GxP compliance with full audit trails, operational control and robust data security.

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Health Canada approves Biogen’s Skyclarys for Friedreich’s ataxia

Pharmaceutical Technology

Health Canada has granted approval for Biogens Skyclarys to treat Friedreichs ataxia (FA) in individuals aged 16 years and above.

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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 Cautions Hemodialysis Tubing Shortage Could Persist into Fall

XTalks

The FDA has issued a letter addressed to healthcare providers warning that the ongoing shortage of hemodialysis bloodlines may extend into the autumn months. Also referred to as dialysis catheters, hemodialysis bloodlines are sets of tubes inserted into a vein during dialysis treatment. They connect the patients bloodstream to the dialysis machine, which filters the blood to remove waste and excess fluid in patients with impaired kidney function.

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Ready or Not, it’s Time to Take AI in Clinical Research Seriously

ACRP blog

Consumers of popular culture in the 1960s and 1970s preferred their artificial intelligence (AI) to come with overtones of danger, if not outright world domination, judging by small- and large-screen science fiction artifacts ranging from episodes of the original Star Trek series to movies like 2001: A Space Odyssey and Colossus: The Forbin Project.

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Looking at Images of Nature Does Something Powerful in The Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

(Ippei Naoi/Getty Images) Simply looking at nature or even just digital pictures of it can relieve pain, according to new research which scanned the brains of people receiving electrical shocks. Nature’s many health benefits have been documented by decades of research.

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How biotech and pharma teams are reaching LPI ahead of schedule

Bio Pharma Dive

With the right strategy, reaching LPI ahead of schedule isn’t a myth. Learn how some biotech and pharma teams are achieving the impossible.

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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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Big tech meets biotech: Recursion and the AI gold rush in pharma 

Pharmaceutical Technology

The use of AI in drug discovery and development has been recognised, explored, and implemented throughout the last decade, with a notable acceleration in recent years.

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Roche Invests $5.3B in Zealand’s Petrelintide, an Obesity Drug Candidate

XTalks

Roche, a global leader in biotechnology and diagnostics, has entered into an exclusive collaboration and licensing agreement with Zealand Pharma, a specialist in innovative therapeutics, to co-develop and co-commercialize petrelintide as a potential foundational therapy for people with overweight and obesity. Under the deal, Zealand Pharma will receive an upfront cash payment of $1.65 billion $1.4 billion at closing and an additional $250 million over the first two anniversaries.

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The Issue with Reissue: PTE Edition

FDA Law Blog

By Sara W. Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. Even though the PTE provisions established in the Drug Price Competition and Patent Restoration Act are forty-plus years old, courts are still grappling with questions about how to best implement the Patent Term Extension.

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Charles Eger, MD, Authors New Article in Nature Medicine

Velocity Clinical Research

Charles Eger, MD, contributed to new research on a combination vaccine intended to provide protection against both seasonal flu and COVID-19 in a single shot. Early results from the Phase 1/2 trial show that the vaccine is well-tolerated and induces strong immune responses, potentially paving the way for a more convenient approach to respiratory virus prevention.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time