Bio Pharma Dive
MARCH 15, 2023
Novartis joined venture investor Sofinnova in leading an $85 million investment in the startup that also involved Pfizer, Eli Lilly and Bristol Myers Squibb.
Rethinking Clinical Trials
MARCH 15, 2023
IMPACt-LBP, an NIH Pragmatic Trials Collaboratory Demonstration Project, enrolled its first study participant this week. Congratulations to the IMPACt-LBP study team for reaching this important project milestone! Dr. Christine Goertz, Dr. Adam Goode, Dr. Jon Lurie, and Dr. Rishi Chakraborty Co-led by investigators at Duke University and Dartmouth University, IMPACt-LBP is a cluster randomized trial of a multidisciplinary collaborative team approach for low back pain versus usual care.
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Bio Pharma Dive
MARCH 15, 2023
Tang Capital’s Concentra Biosciences is offering Jounce investors a competing bid to the biotech’s planned reverse merger with Redx Pharma.
Pharmaceutical Technology
MARCH 15, 2023
Novo Nordisk has announced plans to reduce the US wholesale acquisition cost (WAC), also known as the list price, of several pre-filled insulin pens and vials by up to 75% for people living with type 1 and type 2 diabetes. Set to come into effect from 1 January 2024, these changes will be applicable for products including pre-filled pens and vials of basal (long-acting), bolus (short-acting) and pre-mix insulins, Levemir, Novolin, NovoLog and NovoLog Mix 70/30 in specific.
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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
Bio Pharma Dive
MARCH 15, 2023
Under the Inflation Reduction Act, pharma companies owe rebates to Medicare for price increases that exceed inflation. But they won’t need to pay until 2025.
Rethinking Clinical Trials
MARCH 15, 2023
In this Friday’s PCT Grand Rounds, Ethan Basch of the University of North Carolina at Chapel Hill will present “Patient-Reported Outcomes for Symptom and Adverse Event Monitoring in Oncology.” The Grand Rounds session will be held on Friday, March 17, 2023, at 1:00 pm eastern. Basch is the Richard M. Goldberg Distinguished Professor of Medical Oncology in the UNC School of Medicine and professor of health policy and management in the UNC Gillings School of Global Public Health.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
MARCH 15, 2023
SVB’s unraveling created a hole in life sciences financing that could be filled by bigger banks, but might hamper access to quick, short-term cash for startups.
NPR Health - Shots
MARCH 15, 2023
After years of high rates, the country hit a new high during the pandemic, far exceeding rates in other developed nations. Black women are at especially high risk.
STAT News
MARCH 15, 2023
In the summer and fall of 2021, West Nile virus spread rapidly through Arizona’s Maricopa County and other areas of the state. The outbreak, with more than 1,700 cases reported and 127 deaths. was the largest in the United States since the mosquito-borne virus first emerged in this country in 1999. But with the nation facing a far larger public health crisis with the Covid-19 pandemic, it went almost unnoticed.
NPR Health - Shots
MARCH 15, 2023
If the case succeeds, it could have sweeping repercussions — for abortion clinics and patients across the nation, as well as for the FDA's drug-approval process.
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 15, 2023
Technology adoptions like artificial intelligence and machine learning are bringing in major transformation in the way a primary physician will extend treatment protocols. Technology helps to better under the complex symptoms, stated medical experts.
Rethinking Clinical Trials
MARCH 15, 2023
Speaker Brennan Kahan, PhD MRC Clinical Trials Unit University College London (UCL) Slides Keywords Cluster-Randomized Trial, Estimands, Cluster-Average Treatment Effect, Participant-Average Cluster Size Key Points The TRIGGER trial inspired statistician Brennan Kahan to ask in the questions, “But what if we’d chosen a different analysis?
NPR Health - Shots
MARCH 15, 2023
Many of Ricardo Nuila's patients at Houston's Ben Taub Hospital are dealing with serious illnesses as a result of not being able to access basic preventive care. His new book is The People's Hospital.
STAT News
MARCH 15, 2023
Chatbots like OpenAI’s ChatGPT can hold fun conversations across many topics. But when it comes to providing people with accurate health information, they need help from humans. As tech enthusiasts who research and develop AI-driven chatbots in health care, we are optimistic about the role these agents will play in providing consumer-centered health information.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
NPR Health - Shots
MARCH 15, 2023
The rates of premature birth in the U.S. are high, especially in certain states. Experts worry that states restricting abortion have fewer maternal care providers than those with abortion access.
STAT News
MARCH 15, 2023
WASHINGTON — The Biden administration will fine drugmakers who hiked prices faster than the rate of inflation on 27 medications administered in physicians’ offices, the agency said Wednesday. Pfizer had the most drugs on the list of any manufacturer, with five. Seagen’s bladder cancer drug Padcev, which also garnered penalties, will likely soon be in Pfizer’s portfolio, too, after the pharma giant completes its $43 billion acquisition of the Washington state company.
Medical Xpress
MARCH 15, 2023
Sleeping less than five hours a night is associated with a 74% raised likelihood of developing peripheral artery disease (PAD) compared with seven to eight hours. That's the finding of a study published today in European Heart Journal—Open.
Antidote
MARCH 15, 2023
Idiopathic pulmonary fibrosis , or IPF, can be a frightening diagnosis. IPF is a rare, progressive lung disease that develops differently for everyone, and managing its development can be difficult. However, some individuals are able to live with the disease and stay active for many years.
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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.
STAT News
MARCH 15, 2023
As hospitals and companies continue t o leverage artificial intelligence in medicine, researchers are also grappling with how to check the AI systems to protect patient safety. “Risk management is a tricky business,” said Gyorgy Simon, scientific co-director for the University of Minnesota’s clinical AI program. “Treatment models are changing, the population is changing.
XTalks
MARCH 15, 2023
Attention-deficit/hyperactivity disorder (ADHD) is among the most common childhood neurobehavioral mental health disorders. Characterized by persistent problems that can include difficulty paying attention, hyperactivity and impulsive behavior, the disorder affects about five percent of adults and 11 percent of children in the US. Symptoms of ADHD begin in early childhood, but many individuals may not be diagnosed until adulthood.
STAT News
MARCH 15, 2023
STAT’s Matthew Herper struck an industry nerve when he wrote that the drug development industry is “not prepared for the next wave of biotech innovation.” His report ends on a somewhat dismal note: the industry is long on diagnosis (clinical development is too expensive) and short on cures.
Medical Xpress
MARCH 15, 2023
Researchers at ETH Zurich, Empa and EPFL are developing a 3D-printed insole with integrated sensors that allows the pressure of the sole to be measured in the shoe and thus during any activity. This helps athletes or patients to determine performance and therapy progress.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
STAT News
MARCH 15, 2023
AMARILLO, Texas — A conservative judge in Texas raised questions Wednesday about a Christian group’s effort to overturn federal regulators’ decades-old approval of a leading abortion drug , in a case that could threaten the country’s most common method to end pregnancies. Judge Matthew Kacsmaryk heard more than four hours of debate over the Alliance Defending Freedom’s request to revoke or suspend the Food and Drug Administration’s approval of mifepristo
Medical Xpress
MARCH 15, 2023
An artificial pancreas originally developed at the University of Virginia Center for Diabetes Technology improves blood sugar control in children ages 2 to 6 with type 1 diabetes, according to a new study. Details of the clinical study and its findings have been published in the New England Journal of Medicine.
STAT News
MARCH 15, 2023
WASHINGTON — After years of struggling to regulate the drug middlemen that create pharmacy networks, the federal government could lean on states to rein them in — even, potentially, in Medicare. The Department of Justice has until next month to tell a federal appeals court where the administration stands on the issue. Insurers determine what drugs are covered, where their customers can obtain these drugs, and how much drug costs their customers must pay for.
Medical Xpress
MARCH 15, 2023
New research by the Human Brain Project has found that in the brains of patients with epilepsy, changes in large scale neuronal activations can be detected in the brain's resting state activity, even when no seizure is ongoing. The non-invasive approach could lead to a new method to aid epilepsy diagnostics.
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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.
STAT News
MARCH 15, 2023
After two years as host of the “First Opinion Podcast” and many more as the founding editor of STAT’s expansive, authoritative First Opinion platform, Pat Skerrett put down his editing pen and microphone to start a new chapter — retirement. Pat bade us farewell with a favorite quote from Maurice Sendak’s “Where the Wild Things Are”: “Let the wild rumpus start!
Medical Xpress
MARCH 15, 2023
Two phase 3 trials suggest that a 16 week treatment with a drug called lebrikizumab was effective in adults and adolescents with moderate to severe dermatitis, according to a paper published in the New England Journal of Medicine.
Pharma Times
MARCH 15, 2023
Lyophilized PCR reaction bead reduces the cost of transport and extends shelf life for the test
Medical Xpress
MARCH 15, 2023
A new study of the aggressive brain cancer glioblastoma suggests that two specific cancer cell mutations may work together to help hide tumors from the immune system, offering a possible way to predict whether the tumors would respond to an emerging class of immunotherapy drugs. The research appears in Cell Reports.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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