Advarra

JANUARY 18, 2024

Sponsor and contract research organization (CRO) team members such as clinical research associates (CRAs), study managers, and startup specialists collaborate with research site teams to activate and execute clinical trials. Despite each stakeholders’ best efforts, there are persistent challenges regularly throwing studies off track and resulting in costly workarounds: Failure to achieve recruitment goals : About 20 to 50% of clinical trials will require “rescue”, where new sites are added

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Clinical Trials Clinical Trials Trials Compliance 52

XTalks

JANUARY 15, 2024

The field of clinical research will witness significant advancements in 2024. From the continuing trend of the rapid adoption of AI tools to the growing use of real-world evidence (RWE) in regulatory decision-making and a focus on enhancing data integrity, find out how clinical trials will evolve in 2024 to shape the future of medical research. Read on to learn about the top 10 clinical trial trends for 2024, and be sure to explore and join upcoming webinars about clinical trials at Xtalks. 1.

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Clinical Trials Clinical Trials Trials Clinical Research 105

Rethinking Clinical Trials

JANUARY 17, 2024

Dr. Pamela Douglas (Photo: Erin Roth, Duke Health) In this Friday's PCT Grand Rounds, Pamela Douglas of Duke University will present "Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials." The Grand Rounds session will be held on Friday, January 19, 2024, at 1:00 pm eastern. Douglas is the Ursula Geller Professor of Research in Cardiovascular Diseases at Duke University and a past president of both the American College of Cardiology and the American Society of Echocardiograp

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Trials Cardiology Clinical Trials Clinical Trials 141

Drug Discovery World

JANUARY 16, 2024

A new study will compare whether giving tuberculosis vaccine by inhalation is better at protecting against tuberculosis (TB) than injection into the skin. The Jenner Institute at the University of Oxford is conducting the study using Bacille Calmette-Guérin (BCG), the current licensed vaccine against TB. As the natural route of infection with TB is through inhalation of droplets into the lungs, it is hoped that delivering BCG by the same route will be more effective at stimulating the immune sys

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Clinical Trials Clinical Trials Vaccination Vaccine 59

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Clinical Supply

XTalks

JANUARY 17, 2024

Oncology is recognized as having the largest drug pipeline of any therapeutic area. Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. There are many aspects of oncology drug development that are driven by the unique nature of the treatments being developed and the needs of the patients, their

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BioPharma Reporter

JANUARY 18, 2024

The Cell and Gene Therapy Catapult (CGT Catapult), an independent organization specialising in the advancement of cell and gene therapies, has revealed that the UK has remained an attractive destination for commercial trials, with this type of clinical trial accounting for 81% of trials in 2023 and 80% in 2022.

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Clinical Trials Clinical Trials Gene Therapy Trials 105

Rethinking Clinical Trials

JANUARY 16, 2024

Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory's newest trials is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the AIM-CP trial and the MOMs Chat & Care Study. The consultations took place by video conference and included representation from the studies' principal investigators, members of the NIH Collaboratory's Ethics and Regulat

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Trials Clinical Trials Clinical Trials 141

Bio Pharma Dive

JANUARY 17, 2024

The offering is the fifth outlined by a biotech startup this month, suggesting companies are becoming more willing to gauge investors’ appetite for new stock offerings.

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Marketing 303

Pharmaceutical Technology

JANUARY 17, 2024

Coya plans to file investigational new drug applications for COYA 302 in amyotrophic lateral sclerosis and frontotemporal dementia later this year.

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Development Drugs 246

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 16, 2024

A feral kitten in Omaha, Nebraska, tested positive for rabies in November 2023. It died of the raccoon variant of the virus, which is typically found only in the Appalachian Mountains.

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Clinical Trials Clinical Trials Clinical Research Trials 193

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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

Pharma Mirror

JANUARY 19, 2024

As we step into 2024, the global life science industry finds itself at a crossroads, facing plenty of challenges alongside an abundance of exciting opportunities. The pharmaceutical and contract outsourcing space has shifted, with new trends emerging that will shape the future of this rapidly changing industry. The global stage has witnessed significant upheavals throughout 2023, with wars impacting everything from oil prices to work locations.

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Life Science Vaccination Vaccine Research 130

Bio Pharma Dive

JANUARY 19, 2024

Phase 3 trial results showed Lutathera cut the risk of disease progression or death by 72% as initial treatment for gastroenteropancreatic neuroendocrine tumors, or GEP-NETs.

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Drugs Trials 290

Pharmaceutical Technology

JANUARY 16, 2024

XNK Therapeutics has received scientific recommendation from the EMA's Committee for Advanced Therapies (CAT) for its product evencaleucel.

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Production 246

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 18, 2024

Conventional wisdom would have us believe the journey to a long and healthy life begins with 10,000 steps. Each and every day. For those living a more sedentary lifestyle, it’s a goal that can take some effort to maintain. We’ve also known for some time it’s also almost certainly wrong.

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Scientist Clinical Trials Clinical Trials Trials 182

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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

Fierce Pharma

JANUARY 19, 2024

A jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in federal court in the Southern District of New York. | A federal jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in Manhattan. The jury convicted Amit Dagar, 44, of Hillsborough, N.J., of using advance information on successful trial results for Pfizer’s COVID-19 treatment Paxlovid to make more than $270,000 in stock trades.

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Trials 139

Bio Pharma Dive

JANUARY 17, 2024

The startup is focusing on immune cells called Tr1 cells, which it claims could be important in treating autoimmune conditions like graft-versus-host disease.

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Pharmaceutical Technology

JANUARY 17, 2024

Takeda has gained approval from the US Food and Drug Administration for HYQVIA to treat chronic inflammatory demyelinating polyneuropathy.

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FDA Approval Drugs 246

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 18, 2024

Even as the central government is expected to present its interim budget for 2024-25 in less than three weeks, the Medical Technology Association of India (MTaI) has urged the Union Finance Ministry to reduce the customs duty on certain devices. “India’s current tariff duty structure on medical device imports is very high.

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Clinical Trials Clinical Trials Clinical Research Trials 159

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

Drug Discovery World

JANUARY 19, 2024

The DDW Winter issue asks whether AI can deliver better immunotherapies for cancer and includes expert predictions on what to expect from the sector in 2024, alongside a supplement looking at SLAS2024 and an exclusive guide exploring therapeutic antibodies. DDW Winter 2023/2024 The post DDW Winter 2023/2024 appeared first on Drug Discovery World (DDW).

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Antibody Drugs 124

Bio Pharma Dive

JANUARY 16, 2024

The agency’s decision to expand use of Casgey, which won a landmark OK for sickle cell disease in December, comes more than two months ahead of schedule.

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Medicine 300

Pharmaceutical Technology

JANUARY 19, 2024

BridgeBio Pharma has secured strategic financing of $1.25bn from Blue Owl Capital and CPP Investments for genetic therapies.

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Genetics Development 246

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 17, 2024

The Union Ministry of Ayush (MoA) is taking steps to amend the Drugs and Cosmetics Act, 1940 to add the French Homoeopathic Pharmacopoeia and the European Pharmacopoeia under the standards on which the imports and manufacturing of homoeopathic drugs will be allowed in the country.

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Cosmetics Manufacturing Drugs Clinical Trials 147

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Clinical Research

XTalks

JANUARY 18, 2024

Affecting millions of people worldwide, autoimmune diseases present a complex and often debilitating set of challenges for patients. To that end, the quest for innovative treatments has led to the convergence of technology, research and patient-centric care. Over 80 distinct autoimmune disorders exist, with the most prevalent ones being multiple sclerosis, irritable bowel syndrome (IBS), lupus, type 1 diabetes, psoriasis and rheumatoid arthritis.

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Clinical Trials Clinical Trials Trials Life Science 124

Bio Pharma Dive

JANUARY 18, 2024

The company said it has secured agreement from labor representatives in Germany for job cuts that will shed “many managerial employees.

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Pharmaceutical Technology

JANUARY 17, 2024

The US FDA has approved Vertex's CASGEVY, a gene-edited cell therapy, to treat transfusion-dependent beta thalassemia.

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Gene Editing Gene FDA Approval 245

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 16, 2024

Parexel, one of the world’s largest clinical research organizations (CROs) providing the full range of Phase I to IV clinical development services, and the Japanese Foundation for Cancer Research (JFCR), the first and leading non-profit cancer research organization in Japan, has announced a strategic alliance to accelerate access to oncology clinical trials in Japan.

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Clinical Trials Clinical Trials Trials Clinical Research 146

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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.

Clinical Trials

XTalks

JANUARY 16, 2024

To date, the lack of objective longitudinal measures in central nervous system (CNS) clinical studies has resulted in less than 6 percent of drugs in this space making it to market. Many of the validated cognitive assessments today are paper based, introducing the potential for bias and limiting ethnic and geographic diversity in clinical studies. Additionally, blood biomarkers only provide a snapshot in time and do not provide insight into cognitive function.

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Development Drugs Clinical Trials Clinical Trials 122

Bio Pharma Dive

JANUARY 18, 2024

Called Advanced Medicine Partners, the new company will offer specialized cell and gene therapy manufacturing services to biotech and pharma clients.

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Gene Therapy Manufacturing Gene Medicine 273

Pharmaceutical Technology

JANUARY 18, 2024

The endocannabinoid inhibitor SYT-510 will be investigated in healthy patients to assess its safety, tolerability, and pharmacokinetics.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 17, 2024

A new drug called kush is wreaking havoc in west Africa, particularly in Sierra Leone where it is estimated to kill around a dozen people each week and hospitalise thousands.

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Containment Drugs Clinical Trials Clinical Trials 130

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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.

Clinical Trials