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Consolidation has brought together large, economically significant insurer/PBM/specialty pharmacy/provider organizations within U.S. drug channels. At least half of all U.S. healthcare spending flows through these seven familiar entities: Blue Cross Blue Shield, Centene, Cigna, CVS Health, Elevance Health, Humana, and United Health Group. In the brief video clip below, I review these businesses and offer some thoughts on their positioning for 2023.
National Glaucoma Awareness Month is a campaign aimed at increasing awareness around glaucoma, a leading cause of vision loss and blindness with no early warning signs.
This chart shows the drugs with the most patents in Poland. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Poland? appeared first on DrugPatentWatch - Make Better Decisions.
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!
Each year Eye on FDA provides a look-back to see what the agency was talking about and what has changed over time. This year is a telling one and FDA may be changing the nature of the way they are communicating with the public. Moreover, this year is marked by the fact that the agency appeared to have less to say than in most recent years – perhaps taking a breather after the frenzy of the COVID-19 pandemic years.
By Holly N. Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC). The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide infor
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Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
By Holly N. Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC). The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide infor
Asthma affects more than 235 million people worldwide, and due to lacking effective implementation of clinical guidelines, there continue to be high rates of uncontrolled asthma. In order to evaluate differences in healthcare resource utilization and cost among patients with controlled and uncontrolled asthma in Germany, Cytel experts applied a unique approach: a linked data study comparing insurance claims data with primary data.
Today’s guest post comes from Clay Courville, Chief Product Officer at CoverMyMeds. Clay discusses the ongoing problem of medication errors. He describes CoverMyMeds’ provider alerts solution, which is designed to minimize medication errors. Click here to learn more about CoverMyMeds’ Provider Medication Alerts solution. Read on for Clay’s insights.
Alzheimer’s disease is the most common type of dementia in the United States, impacting around 6.2 million people above the age of 65. Since it was first observed in the early 1900s, a lot of information has been uncovered through medical research.
This chart shows the pharmaceutical companies with the most patents in Israel. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Israel? appeared first on DrugPatentWatch - Make Better Decisions.
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
On November 1, 2022, the U.S. Food and Drug Administration (FDA) adopted an addendum to the guidance titled “ S1B(R1) Testing for Carcinogenicity of Pharmaceuticals ,” which had previously been finalized by the International Council for Harmonization (ICH). The guidance document and integrated addendum detail an integrative, weight-of-evidence (WoE) method of determining whether carcinogenicity testing in rats will be informative in human risk assessments for drug approvals.
Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing an essential working knowledge of core FDA concepts, and real-world examples that will help you to excel in your everyday practices. This year’s conference co-chairs include Stacy Cline Amin (Partner, Morrison Forester) and Kurt R.
Fresh human tissue residual to surgical and diagnostic procedures is often discarded as waste or processed and prepared in a fixed or frozen state for long-term storage as part of a biobank collection. Some stored tissue may be compatible with, and distributed for use in, future investigations and studies, but for many, the donated tissue can remain in storage unused for years.
For 2023, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again increased the number of drugs they exclude from their standard formularies. Each exclusion list now contains about 600 products. Growth in the number of excluded drugs slowed for the second year, due partly to the fact that so many drugs have already been dropped from PBMs’ formularies.
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.
Hemophilia is a disease in which the blood does not clot properly. It is rare and typically hereditary, often leading to spontaneous or excessive bleeding, especially following injuries or surgery, and internal bleeding can be a major risk factor. Below, we’re exploring a few hemophilia facts many people may not know.
Annual Drug Patent Expirations for TOVIAZ Toviaz is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are four patents protecting…. The post New patent expiration for Pfizer drug TOVIAZ appeared first on DrugPatentWatch - Make Better Decisions.
Bringing new medicines and hope to patients faster all starts with preclinical research. But on average, a staggering 98 percent of all pharmaceutical research investment fails to reach patients. There’s a reason for this: biology is incredibly complex. Choosing the right targets, designing successful experiments, and identifying safety and efficacy risks, as just a few examples, involve hundreds or even thousands of trial-error processes and require scientists to work with a seemingly endless n
For me, the most enjoyable aspect of discovery research is exploring the unknown. It is about having a big idea; believing in that big idea based on a scientific belief framework ; coming to a crossroads in the validity of the big idea, which is usually marked by deep uncertainty and skepticism; making a data-driven scientific decision to proceed (or not) to the next inflection point of testing the big idea; and ultimately arriving at a conclusion of whether the big idea is true.
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.
Should your clinical trial be adaptive? Trials that include a prospectively planned modification based on an interim analysis, otherwise known as adaptive trials , are often associated with greater efficiency and better prospects for patients without compromising statistical rigor. And new holistic approaches to creating these designs are making room for transformative, even revolutionary, changes to strategic drug development.
Time for the Drug Channels annual reality check on drug pricing. The data once again tell a different story than you might read in your favorite politician’s Twitter feed or misleading news reports. For 2022, brand-name drugs’ net prices dropped for an unprecedented fifth consecutive year. What’s more, after adjusting for overall inflation, brand-name drug net prices plunged by almost 9%.
Before becoming available to patients, every medication, therapy, and intervention must undergo a rigorous approval process: the clinical trial. Clinical trials are divided into phases that are aimed at testing the safety and efficacy of every potential new treatment before it is able to enter the market.
Annual Drug Patent Expirations for JANUMET Janumet is a drug marketed by Merck Sharp Dohme and is included in two NDAs. It is available from two suppliers. There are four… The post New patent expiration for Merck Sharp drug JANUMET appeared first on DrugPatentWatch - Make Better Decisions.
Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
With the launch of ASCEND™ by BenchSci, we wanted to take the time to dive deeper into the story of how it came to be and the instrumental role one of our top customers played to help shape this revolutionary new technology platform for preclinical pharmaceutical research.
Metabolism of 2022 FDA approved small molecule drugs – Part 1 Does CYP3A4 still rule? By Julia Shanu-Wilson It won’t come as much surprise to learn that of the 17 small molecules* approved by the FDA in 2022, CYP3A4 was the major player in drug metabolism. Nonetheless, there are some interesting facets to discover, a selection of which we take a look at in a two-part blog on “Metabolism of 2022 FDA approved small molecule drugs.” Analysis of the 100 most commonly prescribed dr
Laboratory professionals in all areas of science have experienced significant changes in recent years, and 2022 was no exception. As steady progress continues in returning to normalcy as we’ve learned how to manage COVID-19, the emergence of mpox last year brought a new set of challenges for healthcare professionals, laboratories and diagnostics developers to navigate.
Today’s guest post comes from Saket Patel, Consultant, Advisory Services at MMIT. Saket discusses market access and contracting strategies for medical benefit products when pharmacy benefit biosimilar therapies launch. He then describes how to automate formulary and medical policies to protect manufacturers from overpayment. Click here to learn about MMIT’s Contract Validation solution.
Osteoporosis, translated directly to “porous bone,” is a condition that impacts approximately 10 million Americans. The human body is constantly producing bone cells, but they are constantly being lost as well — and when the cells are being dissolved faster than they are being produced, weakness can result. Below, we’ll be taking a closer look at what osteoporosis is, what causes it, and how people can reduce the likelihood of developing the condition in their lifetime.
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