January, 2023

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Clarivate Identifies Fifteen Potential Blockbuster Drugs in Annual Drugs to Watch Report

Drug Discovery Today

Report highlights personalized medicines ensuring greater efficacy for rare diseases and previously untreatable conditions.

Disease 113
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The history of Alzheimer’s disease

Antidote

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.

Disease 98
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Vertical Integration in Healthcare: 2023 Outlook for the Seven Major Players (Video)

Drug Channels

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.

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Which pharmaceutical companies have the most drug patents in Israel?

Drug Patent Watch

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.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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What They Said – Looking Back at FDA Press Releases During 2022

Eye on FDA

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.

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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog: Drug Discovery

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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5 hemophilia facts you might not know

Antidote

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.

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Brand-Name Drug Prices Fell for the Fifth Consecutive Year—And Plummeted After Adjusting for Inflation

Drug Channels

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%.

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Which pharmaceutical drugs have the most drug patents in Poland?

Drug Patent Watch

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.

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Linked Data Studies: Improving the Way We Do Observational Research in Germany

Cytel

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.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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ACI’s 40th FDA Boot Camp – March 22-23, 2023 (Virtual)

FDA Law Blog: Drug Discovery

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.

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Make a Difference with Fresh Residual Human Tissue Donation for Research – How to Get Involved!

Reprocell

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.

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What are clinical trial phases?

Antidote

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.

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The Big Three PBMs’ 2023 Formulary Exclusions: Observations on Insulin, Humira, and Biosimilars

Drug Channels

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.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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New patent expiration for Pfizer drug TOVIAZ

Drug Patent Watch

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.

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Introducing ASCEND™ by BenchSci, our innovative new AI platform with the power to transform preclinical pharmaceutical research

BenchSci

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

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Discovery moments: TYK2 pseudokinase inhibitor

Plenge Gen

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.

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To Adapt or Not to Adapt? A Decision Framework

Cytel

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.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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What causes osteoporosis?

Antidote

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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A New Point-of-Prescribing Solution to Help Increase Prescribing Accuracy, Speed to Therapy and Patient Adherence

Drug Channels

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.

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Which pharmaceutical drugs have the most drug patents in Malaysia?

Drug Patent Watch

This chart shows the drugs with the most patents in Malaysia. 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 Malaysia? appeared first on DrugPatentWatch - Make Better Decisions.

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From Coffee to Collaboration: Bringing ASCEND to Life with AMGEN

BenchSci

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.

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Metabolism of 2022 FDA approved small molecule drugs PART 1

Metabolite Tales Blog

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

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Amcenestrant (SAR 439859)

New Drug Approvals

Amcenestrant (SAR 439859) アムセネストラント Molecular Weight 554.48 Formula C 31 H 30 Cl 2 FNO 3 CAS No. 2114339-57-8 6-(2,4-dichlorophenyl)-5-[4-[(3 S )-1-(3-fluoropropyl)pyrrolidin-3-yl]oxyphenyl]-8,9-dihydro-7 H -benzo[7]annulene-2-carboxylic acid Amcenestrant 8-(2,4-dichlorophenyl)-9-(4-{[(3 S )-1-(3-fluoropropyl)pyrrolidin-3-yl]oxy}phenyl)-6,7-dihydro – 5H- Benzo[7]annulene-3-carboxylic acid 8-(2,4-Dichlorophenyl)-9-(4-{[(3 S )-1-(3-fluoropropyl)pyrrolidin-3-yl]oxy}phenyl)-6,7-dihydro-5 H -be

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National Glaucoma Awareness Month: A Q&A with BrightFocus

Antidote

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.

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The Evolution of Medical Benefit Contracting: How Pharma Can Prepare

Drug Channels

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.

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New patent expiration for Merck Sharp drug JANUMET

Drug Patent Watch

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.

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The Year Ahead: 2023 Trends Shaping Diagnostics & Life Sciences

PerkinElmer

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.

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Bayesian Approach in Oncology Trials

Cytel

People think in Bayesian terms all the time: we use prior information and the evidence at hand to make decisions in our day-to-day lives. And it is this adaptive thinking that can be so useful in clinical trials, for example, in oncology trials where the standard of care might evolve during the course of the trial. In his recent webinar, “Novel Methods of Trial Design,” Prof.

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Data-Centric AI is Making Waves

DrugBank

The world of artificial intelligence (AI) is rapidly changing, and one of the shifts we’re most excited about is a refocusing on data. As a bit of background, AI is made up of two major components, the model and the data. The models are essentially the tools or algorithms that enable computers to analyze data. The data is what the models are using to make decisions from.

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Antidote is attending SCOPE 2023

Antidote

We’re always excited to get a chance to connect with people in the clinical trial industry, and this year, we’re thrilled to share that we’ll be attending SCOPE 2023 from February 6 to 9 in Orlando, Florida.

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Informa Connect’s PAP – Patient Assistance & Access Programs | Part of Access USA

Drug Channels

Informa Connect’s PAP – Patient Assistance & Access Programs | Part of Access USA Hybrid Event | March 20-22, 2023, Philadelphia Marriott Downtown www.informaconnect/pap Exclusive Offer – Be sure to use your exclusive promocode 23DCPAP10 to save 10% off* your registration. The last thing a patient should worry about is access to care. With growing demand for patient assistance, accelerating prescription access and affordability is as crucial as ever.

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New patent expiration for Merck Sharp drug JANUVIA

Drug Patent Watch

Annual Drug Patent Expirations for JANUVIA Januvia is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from three suppliers. There are three… The post New patent expiration for Merck Sharp drug JANUVIA appeared first on DrugPatentWatch - Make Better Decisions.

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