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The study design paper for IMPACt-LBP has been published online in BMJ Open. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials! IMPACt-LBP is evaluating the effect of first-contact patient referral to physical therapists and doctors of chiropractic for low back pain. The study team is seeking to determine if initial contact with these “primary spine practitioners” will improve physical function and pain, decrease opioid prescripti
HELP committee chair Bill Cassidy, R-La., had invited Kennedy to testify April 10 on the sweeping layoffs of federal health workers Kennedy ordered last month. A hearing could still take place later.
Solid tumors present a significant challenge to clinical research due to their complex and heterogeneous nature. However, the emergence of precision medicine is revolutionizing the way we approach these tumors, offering new hope and innovative solutions. Have you optimized your trial designs to employ precision medicine approaches for your novel solid tumor intervention?
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!
There are over 10,000 rare diseases affecting an estimated 300 million people worldwide where 80% are genetic , 95% lack approved treatments and nearly half begin in childhood. Global rare disease clinical trials face unique challenges due to small patient populations, complex logistics, diverse regulatory environments and cultural differences. Reflecting on these challenges, Michelle Petersen, MS, Vice-President of Clinical Trial Management at Medpace, noted, When its rare, its personal every
In this Friday’s PCT Grand Rounds, Bill Heerman of Vanderbilt University will present “A Digital Health Behavior Intervention to Prevent Childhood Obesity: The Greenlight Plus Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, April 4, 2025, at 1:00 pm eastern. Heerman is an associate professor of internal medicine and pediatrics, the William K.
The Swiss drugmaker, which holds European rights to Elevidys, suspended three trials while researchers investigate the death of a young man who died following treatment.
The Swiss drugmaker, which holds European rights to Elevidys, suspended three trials while researchers investigate the death of a young man who died following treatment.
In a recent webinar, Challenges of Drug Development in Early Parkinsons Disease , Tom Babic, MD, PhD , our Vice President of Scientific Solutions in Neuroscience, uses his 40+ years of experience to share invaluable insights into the current state and future directions of early Parkinsons disease (PD) research. Although clinical research in PD began more than 25 years ago, there have been no significant updates in the last decade.
European AI med tech company AZmed received two new FDA clearances for its AI-powered chest X-ray tool, AZchest. The FDA approved AZchest applications to detect lung nodules and triage cases involving pneumothorax and pleural effusion. The applications offer radiologists improved interpretation and detection of these chest X-ray abnormalities. AZchest, a clinically validated AI radiology solution, automatically identifies, classifies and generates reports on key cardiac and pulmonary abnormaliti
By Kurt R. Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd. As the dust begins to settle and we all assess what this means for the future of FDA and the public health, generally, this blogger wanted to call out one particular division in the Office of Generic Drugs (OGD), funded by user fees under the Generic Drug User Fee Amendments (GDUFA), that was eradicated and what t
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 sweeping workforce reduction that began Tuesday was made worse by mistakes and poor communication, including directions for some CMS employees to contact a director who died last year.
The Kerala based Ayurveda Medicine Manufacturers Organisation of India (AMMOI) has got a chair in the administrative committee of the Ayush Export Promotion Council (Ayushexcil ) with the election of its general secretary Dr. D Ramanathan as one of the board of directors.
Cancer continues to be one of the most significant health challenges globally, prompting an ongoing pursuit of innovation in detection, treatment and patient care. Projections from the American Cancer Society indicate that in 2025 the US will see more than 2 million new cases of cancer , not counting nonmelanoma skin cancers, and over 618,000 people will die from the disease.
University of New Mexico researchers studying the health risks posed by gadolinium, a toxic rare earth metal used in MRI scans, have found that oxalic acid, a molecule found in many foods, can generate nanoparticles of the metal in human tissues.
Sarepta and Roche will share the monitors' findings with EMA to resolve a temporary hold. Elsewhere, Allakos agreed to a buyout and high-dose Ocrevus missed a study goal.
"5 Key Considerations for Valuing Pharma Companies As the pharmaceutical industry continues to evolve, accurately valuing pharma companies has become increasingly complex. At DrugPatentWatch, we've identified 5 key considerations that can help you make informed investment decisions. Patent Portfolio Strength : A strong patent portfolio can significantly impact a company's valuation.
According to the American Veterinary Medical Association (AVMA), as reported by Reuters , the FDA layoffs initiated last week included personnel directly involved in avian influenza monitoring and response efforts. Many employees found out about the layoffs after trying to enter office buildings on Tuesday, April 1, and being denied access. A Center for Veterinary Medicine (CVM) employee said the FDA let go almost all of the administrative staff.
In this Friday’s PCT Grand Rounds, Jeremy Shefner of theBarrow Neurological Institute will present “A Phase 2 Trial of Pridopidine in ALS, Studied as a Regimen With the Healey Platform Trial.” The Grand Rounds session will be held on Friday, April 11, 2025, at 1:00 pm eastern. Shefner is a professor of neurology at the Barrow Neurological Institute in Phoenix, Arizona.
Patient Safety in the Era of Generic Drugs: A Call to Action As the pharmaceutical industry continues to evolve, one thing remains constant: the need for patient safety. With the rise of generic drugs, it's more important than ever to ensure that these alternatives meet the same high standards as their brand-name counterparts. At DrugPatentWatch, we've seen firsthand the impact that generic drugs can have on patients.
In 2024, the healthcare industry made significant waves TIME spotlighted Laguna Health for its AI-powered patient-care platform, while The Healthcare Technology Report recognized 50 trailblazing women leading progress in digital health, AI and medical devices. AI also gained traction across the sector, with UK-based home healthcare company Cera earning a Health Tech Digital Award for its advanced AI tools that support clinical decision-making and enhance home care efficiency.
New research from The University of Manchester may reshape our understanding of what happens to the immune system when we fast. The study on mice shows that the brain's hypothalamus controls how the immune system adapts during fasting, through a handful of highly specialized neurons responsible for making animals hungry.
“There will be a ChatGPT moment for biotechnology,” a bipartisan commission wrote in the new report, which calls for the U.S. to invest at least $15 billion into the sector over the next five years.
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.
The Game-Changing Potential of Biosimilars in Population Health Management As healthcare professionals, we're constantly looking for innovative ways to improve patient outcomes and reduce costs. One area that's gaining significant attention is the use of biosimilars in population health management initiatives. But what exactly are biosimilars, and how can they make a meaningful impact on population health?
Eli Lilly shared new Phase II trial data showing that its experimental siRNA therapy, lepodisiran, leads to reductions in levels of lipoprotein(a) (Lp(a)) a genetically inherited risk factor for heart disease in adults with elevated levels of the marker. In the Phase II ALPACA trial, a single 400 mg dose of lepodisiran led to an average decrease of 93.9% in Lp(a) levels over the 60- to 180-day period after treatment compared to placebo, meeting the trials primary endpoint.
In today's interconnected world, infectious diseases pose an escalating threat, as demonstrated by the coronavirus pandemic and outbreaks of H1N1, SARS, Ebola, Zika, and H5N1 (bird flu) virusesall of which have had significant global health and economic impacts.
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
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