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Even in minimal-risk studies that do not use the standard consent process, there may be value in informing participants about the research. Such notifications should be considered the default for clinical trials conducted under a waiver of informed consent, argue the authors of a new report from the NIH Pragmatic Trials Collaboratory. The open-access article was published online ahead of print this week in Learning Health Systems.
A spokesperson confirmed the Danish drugmaker has asked U.S. regulators to clear an oral version of its weight loss drug Wegovy two years after reporting initial Phase 3 results.
Early Phase Unit, Worldwide Clinical Trials Neurodegenerative diseases represent a diverse group of progressive disorders characterized by the loss of structure and function of neurons. Despite their clinical heterogeneity, these diseases often share overlapping pathological mechanisms, including protein misfolding and aggregation, synaptic dysfunction, neuroinflammation, and axonal degeneration.
Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
The FDA has approved Blujepa (gepotidacin) for the treatment of uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients aged 12 and older. GSKs Blujepa represents the first new oral antibiotic in almost 30 years to address the growing challenge of antibiotic resistance in UTIs. uUTIs are the most common type of bacterial infection, affecting up to 16 million women in the US each year.
Researchers applied the “target trial emulation framework” to highlight important design considerations for observational studies that use real-world data to emulate randomized clinical trials. The work, which was supported by the NIH Pragmatic Trials Collaboratory’s Distributed Research Network and by a grant from the National Institute on Aging, was published this week in Alzheimer’s & Dementia: Translational Research & Clinical Interventions.
By John W.M. Claud & Michelle L. Butler Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functionsand as the administration plans a broader reorganization, the impact will likely grow. One area drawing increasing attention is how these changes will affect the drug development and review process. As reported by the Wall Street Journal last week , reviews of both innovative and follow-on drugs have been caught in a traffic jam, largely due to a
This World Hemophilia Day 2025, the bleeding disorders community comes together under the theme Access for all: Women and girls bleed too, spotlighting the long-overlooked experiences of women and girls with inherited bleeding disorders. Hemophilia occurs when a clotting protein is missing or deficient, causing prolonged bleeding that can lead to joint damage and chronic pain.
Dr. Sanjit Jolly In this Friday’s PCT Grand Rounds, Sanjit Jolly of McMaster University will present “Colchicine and Spironolactone Post-MI: A Review of the Late-Breaking Results of the CLEAR OASIS 9 Trial.” The Grand Rounds session will be held on Friday, April 18, 2025, at 1:00 pm eastern. Jolly is an interventional cardiologist at Hamilton Health Sciences and the Stuart Connolly Chair in Cardiology and a professor of medicine at McMaster University.
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
The advisory committee, which met Tuesday for the first time since Robert F. Kennedy Jr. was sworn in as health secretary, also discussed the Texas measles outbreak.
This is a sponsored message. Helen Keller once wrote: True happiness is not attained through self-gratification, but through fidelity to a worthy purpose. Nothing could be truer for the millions of clinical research professionals steadfastly committed to helping advance treatments that transform lives. These everyday unsung heroes occupy every corner of our industry from small clinician-run sites to large academic medical centers; from global pharmaceutical companies to nimble biotech startups
Soleno Therapeutics has announced the FDA approval of Vykat XR (diazoxide choline extended-release tablets) for the treatment of hyperphagia an intense, persistent hunger in patients with Prader-Willi syndrome (PWS). The approval marks the first FDA-approved therapy specifically targeting hyperphagia in this rare genetic disorder. After a series of failures in the indication, Soleno has achieved a breakthrough with the approval.
The TAICHIKNEE study randomized its first cohort of participants this month, and the intervention group began tai chi classes this week. Congratulations to the TAICHIKNEE team for reaching this important milestone! TAICHIKNEE will compare the effects of web-based tai chi interventions versus routine care for individuals experiencing knee pain due to osteoarthritis.
"Patent Expiration: The Secret to Unlocking $100 Billion in Pharmaceutical Value Did you know that patent expirations in the pharmaceutical industry are projected to unlock over $100 billion in new business opportunities? At Drug Patent Watch, we've analyzed the latest data to reveal the top 5 therapeutic areas poised for disruption. From oncology to cardiovascular disease, we've identified the key trends and insights you need to know to make informed investment decisions.
The postpandemic era has accelerated demand across healthcare and life sciences, rewarding companies that address emerging patient and provider needs. In 2024, Canadian health spending climbed 5.7% to approximately $268billion, driven by aging demographics and new provider agreements. Across the US, healthcare is poised to deliver 45% of all job gains through2032, reflecting sustained sector momentum.
Northeastern University scientists have discovered that a protein in the human brain could potentially be used to grow new neurons in the lab and enhance brain processes affected by aging or neurodegenerative diseases.
Two studies published in Nature found stem cell-derived products can not only be safely transplanted into the brain, but also show promising — albeit unproven — signs of efficacy.
"Game Changer Alert: Are You Leaving Millions on the Table? As a pharmaceutical executive, you know the importance of staying ahead of the competition. But are you overlooking a crucial aspect of your generic launch strategy? I recently came across a fascinating article from @DrugPatentWatch that highlights the untapped potential of integrating clinical trials and the 505(b)(2) pathway into your pharmaceutical portfolio management.
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.
The FDA has authorized the marketing of CT-132, a prescription digital therapeutic (DTx) developed by Click Therapeutics for the preventive treatment of episodic migraine in adults. CT132 is the first FDA-cleared digital therapeutic for migraine prevention, expanding treatment options beyond conventional medications. It also aligns with the growing interest in software-based interventions.
Henry Gosebruch is now chief executive of the spinout, which has roughly $2.5 billion and plans to use dealmaking to build a research pipeline targeting cancer, viruses and the immune system.
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.
What do you do when the traditional pillars of your marketing strategy start to crumble? For many pharmaceutical companies in 2025, the answer is clear: pivot aggressively toward digital. With geopolitical volatility sparking new tariff threats and mounting legislative scrutiny over pharmaceutical television ads, pharma digital ad spend is experiencing a noticeable surge.
As the prevalence of metabolic diseases such as diabetes, obesity and prediabetes continues to rise globally, there is an urgent need for innovative therapies that move beyond traditional hormone replacement strategies. Steffen-Sebastian Bolz, MD, PhD Executive Board Member, Chief Scientific Officer Aphaia Pharma Aphaia Pharma is redefining the landscape of metabolic disorder treatment by leveraging the bodys inherent biological processes.
"The Russian Pharmaceutical Industry: A Strategic Evolution Unfolding As the global pharmaceutical landscape continues to shift, one country is making a bold move: Russia. With a growing focus on domestic production and technological innovation, the Russian pharmaceutical industry is poised for significant growth. In this in-depth report, we dive into the key players, strategic evolution, and technological advancements driving the industry forward.
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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