Bio Pharma Dive

MARCH 24, 2025

Speed vs. success in oncology trials: Discover data-driven strategies to accelerate drug development.

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Development Drugs Trials 245

Rethinking Clinical Trials

MARCH 20, 2025

Dr. Sara Singer, principal investigator for iPATH Researchers from iPATH, an NIH Collaboratory Trial, described key considerations for integrating artificial intelligence tools into analyses of qualitative data. The report was posted this month on the AcademyHealth Blog. The iPATH trial, led by principal investigator Sara Singer at Stanford University, will test the implementation of a practice transformation strategy for type 2 diabetes in federally qualified health centers in California, Massa

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Clinical Trials Clinical Trials Trials Research 146

Rethinking Clinical Trials

MARCH 18, 2025

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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Allergies Trials Clinical Trials Clinical Trials 146

Bio Pharma Dive

MARCH 18, 2025

A young man treated with Elevidys died of acute liver failure. The case may give doctors pause before prescribing the treatment in the future, some analysts wrote.

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Gene Therapy Gene Doctors Doctor 357

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

Medicine

Pharmaceutical Technology

MARCH 18, 2025

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

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 20, 2025

A Parliamentary Panel has recommended implementation of a comprehensive, nationwide and phased Medicines Regulatory Maturity Enhancement Programme on the lines of World Health Organisation’s (WHO) vaccine benchmarking process to ensure a consistently high standard of drug regulation across the country.

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Regulation Drugs Vaccine Vaccination 113

Bio Pharma Dive

MARCH 20, 2025

Amvuttra’s clearance in a rare form of cardiomyopathy could help Alnylam turn a regular profit — if it can wrest control of a competitive and fast-changing market.

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FDA Approval Drugs Marketing 285

Pharmaceutical Technology

MARCH 20, 2025

OBT has entered a multi-year partnership with Roche to discover antibody-based therapeutics for cancer treatment.

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Antibody 238

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 19, 2025

Do ice baths live up to the hype? (Diana Light/Unsplash) Ice baths have become increasingly popular over the past few years. Fitness enthusiasts and casual exercisers around the world are embracing this trend that was once reserved for elite athletes. Ice baths (also known as “cold water immersion“) are exactly what they sound like.

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Clinical Trials Clinical Trials Trials 244

Drug Patent Watch

MARCH 19, 2025

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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Rethinking Clinical Trials

MARCH 19, 2025

Speaker Sean Mann Senior Policy Analyst RAND Corporation Slides Keywords Development Economics; Spillover; Bias; Pragmatic Clinical Trials Key Points Individually randomized, parallel-group embedded pragmatic trials randomly assign patients to a new healthcare intervention or to a control group that receives some form of usual care.

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Clinical Trials Clinical Trials Trials Development 100

Bio Pharma Dive

MARCH 18, 2025

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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Drugs 274

Pharmaceutical Technology

MARCH 24, 2025

AstraZeneca has announced a $2.5bn investment to establish the companys sixth worldwide strategic R&D centre in China.

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XTalks

MARCH 19, 2025

A 16-year-old patient died after treatment with Elevidys (delandistrogene moxeparvovec), Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy (DMD). The patient suffered acute liver failure several months after receiving the therapy in December. Liver injury is a known risk with Elevidys and other gene therapies that use adeno-associated viral (AAV) vectors.

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Gene Therapy Gene Genetics Clinical Trials 80

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

CTTI (Clinical Trials Transformation Initiative)

MARCH 19, 2025

A new publication from the FDA Oncology Center of Excellence (OCE) and the Clinical Trials Transformation Initiative (CTTI), published in the Clinical Cancer Research journal, provides important insights into how decentralized clinical trial (DCT) elements were used in cancer trials leading to FDA approval during the COVID-19 pandemic. DCT elementssuch as remote monitoring, telemedicine, and home delivery of investigational products were widely used in cancer trials to maintain patient safety an

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Clinical Trials Clinical Trials Trials FDA Approval 72

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 20, 2025

After a long, stressful day at work, or when pressed for time, the temptation to have a quick, satisfying snack like crisps or a chocolate bar can be strong.

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Bio Pharma Dive

MARCH 17, 2025

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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Trials 273

Pharmaceutical Technology

MARCH 18, 2025

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

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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.

Clinical Trials

ACRP blog

MARCH 18, 2025

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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Clinical Research Research Compliance Clinical Trials 69

Drug Channels

MARCH 21, 2025

Todays guest post comes from Greg Skalicky, President of EVERSANA. Greg discusses some of the challenges manufacturers face with product commercialization, patient access and adherence, and negotiating partnerships with pharmacy benefit managers (PBMs). He introduces us to EVERSANA DIRECT Commercialization, a direct-to-patient change/model. To learn more about EVERSANA DIRECT Commercialization and how the direct-to-patient model can help you, meet with EVERSANA at the Asembia Summit in Las Vegas

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Pharmacy Manufacturing Production Drugs 98

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 19, 2025

The Indian Council of Medical Research (ICMR) is working to set up a Centre for Advanced Research in Aging, marking a significant move in India’s efforts to address the challenges of aging and age-related diseases.

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Pharmaceutical Technology

MARCH 18, 2025

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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Development Drugs 207

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.

Clinical Research

XTalks

MARCH 17, 2025

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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Production Manufacturing DNA Genetics 71

FDA Law Blog

MARCH 18, 2025

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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Production Drugs Regulation 59

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 18, 2025

(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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Research Clinical Trials Clinical Trials Trials 147

Bio Pharma Dive

MARCH 21, 2025

A panel of CDC advisers, who had been set to meet in February, will discuss the current measles outbreak as well as guidelines for several types of shots.

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Vaccination Vaccine 263

Advertiser: FourKites

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.

Research

Pharmaceutical Technology

MARCH 21, 2025

J&J is the latest pharma company to announce a major US investment, committing to a $55bn influx in the next four years.

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Pharma Companies 191

XTalks

MARCH 18, 2025

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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Manufacturing Marketing Production Life Science 59

Intouch Solutions

MARCH 18, 2025

In our latest POV by Roberto Ascione, President of EVERSANA INTOUCHs Health Innovation, and Ferdinando Scala, Director of Strategic Planning, the evolving landscape of digital health and its implications for the life sciences industry are explored with an emphasis on the importance of understanding digital determinants of health, which include factors such as internet access, digital literacy, and the availability of digital devices.

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Life Science Genetics Development Marketing 59

ACRP blog

MARCH 17, 2025

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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Research Compliance Radiology Trials 59

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