Worldwide Clinical Trials

JANUARY 21, 2025

Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. What is one contributing factor that sets the 20% that do apart from the rest? Rigorous procedures to ensure that drugs are effective and safe.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 1, 2025

The Central Drugs Standard Control Organisation (CDSCO) has sought the industry to start submitting the applications for clinical trial site addition and change of principal investigator through online mode, as part of streamlining the regulatory submission procedure.

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Rethinking Clinical Trials

JANUARY 9, 2025

The NIH Pragmatic Trials Collaboratory will hold a virtual workshop on February 5 and 6, 2025, on Digging Into Dilemmas of Pragmatic Clinical Trials. A keynote presentation will address the state of healthcare delivery in the United States and the constraints on healthcare systems that are important for researchers to understand. Day 1 of the workshop will develop participants understanding of the landscape for pragmatic research, including stressors on the healthcare system and barriers and opp

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Bio Pharma Dive

JANUARY 30, 2025

Despite high demand for an option like Journavx, doctors fear the drug’s price could be a major hangup for insurers, potentially limiting patients’ ability to access it.

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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

JANUARY 21, 2025

Innophore will launch the CavitOmiX AI tool to screen for new drugs, predict side effects, and repurpose existing molecules.

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Drugs 345

Medical Xpress

JANUARY 24, 2025

Researchers from Mass General Brigham and collaborating institutions have developed a non-invasive approach to manipulate cardiac tissue activity by using light to stimulate an innovative ink incorporated into bioprinted tissue. Their goal is to develop a technique that can be used to repair the heart. Their findings in preclinical models, published in Science Advances, show the transformative potential of non-invasive therapeutic methods to control electrically active tissues.

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FDA Law Blog

JANUARY 30, 2025

By Mark A. Tobolowsky & Charles G. Raver & James E. Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). That post largely focused on endpoints as well as the broader context for when accelerated approval is appropriate. However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated

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Rethinking Clinical Trials

JANUARY 6, 2025

In an upcoming session of the VA Spotlight on Pain Management Cyberseminars series curated by the Pain Management Collaboratory (PMC), Julie Fritz and Dan Rhon will present “Supporting Whole Person Pain Management in the Military Health System.” The session will be held on Tuesday, January 7, from 11:00 am to 12:00 pm eastern. Improving care for persons with chronic musculoskeletal pain is a priority in the Military Health System.

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Bio Pharma Dive

JANUARY 16, 2025

Pharma dealmaking for drugs invented in China is putting pressure on U.S. biotechs to compete harder, according to investors and executives interviewed by BioPharma Dive at the J.P. Morgan Healthcare Conference.

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Drugs 361

Pharmaceutical Technology

JANUARY 21, 2025

With increasing demand for cell and gene therapies, mesenchymal stem cells (MSCs) have gained attention for their versatility and potential.

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Clinical Supply

XTalks

JANUARY 2, 2025

Anteris Technologies Global Corp. (ATGC) has gone public with its initial public offering (IPO), marking a significant milestone in its journey to transform the heart valve market. The company offered 14.8 million shares of its common stock at an initial price of $6.00 per share. Trading began on the Nasdaq Global Market on December 13, 2024, under the ticker symbol “AVR,” with the offering closed on December 16, 2024.

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Antidote

JANUARY 16, 2025

When preparing for flu season, those with asthma may have concerns about how the virus can affect their respiratory health and breathing. While asthma is a manageable condition, it does require extra care when dealing with seasonal illnesses like the flu. In this blog, we'll explore how asthma and the flu interact, provide tips for managing both, and offer resources to help you stay informed and prepared.

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Drug Patent Watch

JANUARY 23, 2025

Designing the Future of Biosimilars: Strategies for Success As the biosimilar market continues to grow, pharmaceutical companies are facing increasing pressure to develop high-quality, cost-effective treatments that meet the evolving needs of patients and healthcare systems. One key aspect of this journey is the clinical trial design and execution process a critical step that can make or break the success of a biosimilar product.

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Rethinking Clinical Trials

JANUARY 21, 2025

Dr. Corita Grudzen and Dr. Keith Goldfeld, principal investigators for PRIM-ER An evidence-based training program to improve the capacity of emergency department care teams to communicate with seriously ill older patients about palliative care did not lead to lower rates of hospital admission, according to the results of the PRIM-ER trial. The results were published online ahead of print in JAMA.

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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

Bio Pharma Dive

JANUARY 23, 2025

In an interview, the CEO discussed trying to gain support from investors hyper-focused on M&A, and competing with Pfizer and Alnylam in a closely watched commercial battle.

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Pharmaceutical Technology

JANUARY 24, 2025

The settlement ends the Sackler familys ownership of the Oxycontin developer Purdue Pharma.

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Development 278

XTalks

JANUARY 7, 2025

In a major leap forward for trauma care, Humacyte has received full approval from the US Food and Drug Administration (FDA) for Symvess, a first-of-its-kind bioengineered human tissue designed to repair extremity arterial injuries. Dr. Rishi Kundi, a clinical investigator at the University of Maryland Medical System, believes Symvess holds the potential to transform vascular trauma care by overcoming longstanding challenges like infection control and graft failure that have plagued traditional r

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 7, 2025

Still from Breath of the Wild. (Nintendo) Many modern video games fall into the open-world category, giving players vast, detailed worlds to explore and a new study shows these expansive digital playgrounds have benefits for our mental health.

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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

Drug Patent Watch

JANUARY 23, 2025

The Future of Generic Drug Development: Opportunities and Challenges for Emerging Markets As the global healthcare landscape continues to evolve, emerging markets are playing an increasingly important role in shaping the future of generic drug development. With the rise of affordable healthcare initiatives and growing demand for quality medicines, emerging markets present a significant opportunity for generic drug manufacturers to expand their reach and improve access to life-saving treatments.

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Rethinking Clinical Trials

JANUARY 29, 2025

In this Friday’s PCT Grand Rounds, Richard Skolasky and Kevin McLaughlin of Johns Hopkins University will present “Advancing Rural Back Pain Outcomes Using Rehabilitation Telehealth (ARBOR-Telehealth): Early Progress and Lessons Learned.” The Grand Rounds session will be held on Friday, January 31, 2025, at 1:00 pm eastern. ARBOR-Telehealth, an NIH Collaboratory Trial, is evaluating the use of a telehealth physical therapy strategy for patients who present to primary care clini

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Bio Pharma Dive

JANUARY 8, 2025

The regulator is requiring labeling that warns of Guillan-Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.

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Regulation 354

Pharmaceutical Technology

JANUARY 10, 2025

Following a string of FDA resignations, Patrizia Cavazzoni has announced that her last day will be 18 January.

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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

JANUARY 16, 2025

BlueRock Therapeutics, a subsidiary of Bayer AG, is making waves in the treatment of Parkinsons disease by advancing its investigational cell therapy, bemdaneprocel, to a Phase III clinical trial. Called exPDite-2, the registrational trial meaning a trial designed to gather the necessary data for potential regulatory approval is slated to begin in the first half of 2025.

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Trials Clinical Trials Clinical Trials Gene Therapy 104

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 6, 2025

Artificial intelligence (AI) and machine learning (ML) are poised to redefine the landscape of critical care medicine, offering innovative solutions to the challenges faced in intensive care units (ICUs). ICUs are high-stakes environments where every decision can mean the difference between life and death.

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Drug Channels

JANUARY 22, 2025

For 2025, the three largest pharmacy benefit managers (PBMs)Caremark (CVS Health), Express Scripts (Cigna), and Optum Rx (United Health Group)have again each excluded hundreds of drugs from their standard formularies. You can find our updated counting below. As youll see below, the combination of formulary exclusion and private labels is creating an increasingly confusing and crowded biosimilar marketplace.

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Rethinking Clinical Trials

JANUARY 13, 2025

From left to right: Dr. Rachel Winer, Dr. Amanda Petrik, and Dr. Jasmin Tiro, principal investigators of the STEP-2 trial The NIH Pragmatic Trials Collaboratory is pleased to welcome the STEP-2 trial (Self-Testing for Cervical Cancer in Priority Populations) to its portfolio of innovative NIH Collaboratory Trials. Only half of eligible patients in US federally qualified health centers were screened for cervical cancer in 2021.

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Trials Clinical Trials Clinical Trials Research 130

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

Bio Pharma Dive

JANUARY 28, 2025

The startup says its specially constructed RNAi therapies can get deep into brain tissue, yielding new ways to treat neurological conditions like Huntington’s.

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Drugs 334

Pharmaceutical Technology

JANUARY 13, 2025

NVIDIA starts 2025 by announcing a trio of partnerships and a research collaboration to boost healthcare sector presence.

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Research 277

XTalks

JANUARY 15, 2025

Known for its AI-driven diagnostic tools, IMVARIA, a Berkeley-based health tech company, recently earned the FDAs 510(k) clearance of ScreenDx, a first-of-its-kind algorithm designed to identify potential interstitial lung disease (ILD) cases. This follows their earlier success with Fibresolve , a tool for idiopathic pulmonary fibrosis (IPF) that became the first FDA Breakthrough-designated AI diagnostic for lung fibrosis.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 8, 2025

(SDI Productions/E+/Getty Images) The right therapy can dramatically boost the self-healing capabilities of the human heart after heart failure, a new study has found giving the vital organ regenerative powers even beyond those of a healthy heart.

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Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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