December, 2022

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Conformation and energy investigation of microtubule longitudinal dynamic instability induced by natural products

Chemical Biology and Drug Design

The microtubule targeting agents plinabulin, docetaxel, and vinblastine interrupt MT polymerization by altering both MT conformation and binding free energy of the neighboring tubulin subunits. Abstract The natural products plinabulin, docetaxel, and vinblastine are microtubule targeting agents (MTAs). They have been used alone or in combination in cancer treatment.

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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

By Mark A. Tobolowsky & James E. Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies 119
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Medical terms A to Z: Common and confusing terms used in the doctor’s office

Antidote

Generally, a doctor’s visit is intended to provide clarity and insight into a patient’s concerns — but many people are all too familiar with the feeling of walking out of a clinic more confused than when they arrived. In fact, many Americans find themselves searching for health literacy tips after becoming confused by a doctor’s instructions or the directions on a prescription label.

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USA Clinical Trial Market Size and Opportunities

ProRelix Research

Clinical trials form the crux of all regulatory decisions regarding any new health intervention such as drugs and medical devices and thus require to be performed with the utmost care […]. The post USA Clinical Trial Market Size and Opportunities appeared first on ProRelix Research.

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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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The Inflation Reduction Act: Three Unintended Consequences for Biosimilars, Health Plans, Providers, and Pharmacies (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Outlook 2023. Click here to see the original post and comments from September 2022. During Friday’s webinar, I’ll be sharing my updated thoughts about the IRA’s impact on manufacturers, Part D plans, and patient behavior. By now, you have already read innumerable articles explaining what’s in the new Inflation Reduction Act of 2022 (IRA; P.L. 117-169).

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Which pharmaceutical companies have the most drug patents in Croatia?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Croatia. 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 Croatia? appeared first on DrugPatentWatch - Make Better Decisions.

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Nirsevimab

New Drug Approvals

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What is patient centricity in clinical trials?

Antidote

At Antidote, we consider the patient voice in how we think about the entire clinical trial process. From recruitment to randomization, the patient journey is a driving force in all that we do — and we think this strategy is helpful for clinical trial sponsors, as well. Designing treatments, clinical trials, and health solutions around patients practicing patient centricity, and it can have key benefits for everyone involved.

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Sygnature Discovery partners the Oncology Development Programme (ODP2) to find UK-based breakthroughs in Oncology

Sygnature Discovery

Sygnature Discovery joins four of the top ten global pharma companies, Cancer Research Horizons , Manchester Cancer Research Centre (MCRC) and over 20 Contract Research Organisations (CROs) to support innovation in oncology through the second Oncology Development Programme (ODP2). The initiative aims to accelerate development of high impact novel cancer innovations with delivery of the programme overseen by Lean Life Science.

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Small Pharmacies Walk Away from Medicare Part D’s 2023 Preferred Networks

Drug Channels

In yesterday’s post , I highlighted the largest pharmacy chains that will participate in the 2023 Medicare Part D prescription drug plans (PDP). Today, I update our annual analyses of how smaller pharmacies will participate as preferred cost sharing pharmacies via the pharmacy services administrative organizations (PSAOs) that represent them in negotiations with plans.

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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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Which pharmaceutical drugs have the most drug patents in Sweden?

Drug Patent Watch

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

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Top Bayesian Topics of 2022

Cytel

Bayesian methods have been playing a key role in transforming clinical research, providing a variety of new opportunities for efficient and flexible clinical trials. Bayesian topics are frequently explored in Perspectives on Enquiry and Evidence. Here are some of our most-read articles on Bayesian methods in 2022.

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Keypoint Newsletter: Nobel Laureate Svante Pääbo to Give Keynote Address at Meeting in Germany

keypoint

The Keystone Symposia "New Frontiers in Reconstructing Human Evolution History," will feature the newly minted 2022 Nobel Laureate Svante Pääbo as the Keynote Speaker, in May of 2023!

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The value of Match data of partners

Antidote

Antidote’s robust partner network, consisting of over 300 organizations , is made up of patient advocacy groups, point-of-care-companies, health influencers, and more. Though each organization we partner with is unique and multi-faceted, they all share similar goals, one of which is: connecting their communities with resources and research opportunities that can drive medical progress or improve an individual’s quality of life.

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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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Sygnature Discovery partners the Oncology Development Programme (ODP2) to find UK-based breakthroughs in Oncology

Sygnature Discovery

Sygnature Discovery joins four of the top ten global pharma companies, Cancer Research Horizons , Manchester Cancer Research Centre (MCRC) and over 20 Contract Research Organisations (CROs) to support innovation in oncology through the second Oncology Development Programme (ODP2). The initiative aims to accelerate development of high impact novel cancer innovations with delivery of the programme overseen by Lean Life Science.

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CVS, Walgreens, and Walmart Keep Position in 2023 Part D Preferred Networks—While Kroger Bails Over its Express Scripts Blowup

Drug Channels

In Preferred Pharmacy Networks in 2023’s Medicare Part D Plans: Cigna, CVS Health, Humana, UnitedHealthcare, WellCare, and More , I highlighted how those networks have taken over the world of stand-alone Medicare Part D prescription drug plans (PDP) and become a major presence in Medicare Advantage prescription drug (MA-PD) plans. Today, I examine the seven largest retail chains’ 2023 participation in the 22 major 2023 Part D preferred networks that the eight largest plan sponsors will offer.

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New patent expiration for Novo Nordisk drug VICTOZA

Drug Patent Watch

Annual Drug Patent Expirations for VICTOZA Victoza is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from two suppliers. There are seven…. The post New patent expiration for Novo Nordisk drug VICTOZA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 81
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Top Interviews of 2022: Industry Voices and Career Perspectives

Cytel

Perspectives on Enquiry and Evidence features two recurring interview series: Our new Industry Voices series, in which we interview Cytel’s thought leaders and experts on cutting-edge topics in their respective fields, and our Career Perspectives series, which highlights the career journey and insights into roles integral to Cytel. Here are some of our most-read interviews of 2022.

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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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Olutasidenib

New Drug Approvals

Olutasidenib FT-2102 FT2102 C 18 H 15 ClN 4 O 2 354.79 CAS1887014-12-1 Rezlidhia (Forma Therapeutics) SYN Caravella JA, et al. Structure-Based Design and Identification of FT-2102 (Olutasidenib), a Potent Mutant-Selective IDH1 Inhibitor. J Med Chem. 2020 Feb 27;63(4):1612-1623. doi: 10.1021/acs.jmedchem.9b01423. Epub 2020 Feb 12. FDA 12/1/2022, To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, Rezlidhia Olutasidenib

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What are the best ways to participate in research studies?

Antidote

Participating in a clinical research study can have many benefits. From offering specialized care to providing participants with potential new treatment options, finding the right clinical trial can lead to positive outcomes for today’s patients and unlock breakthroughs for those diagnosed in the future.

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Top 5 Challenges and Opportunities Drug Developers Face in Executing Clinical Trials

PPD

PPD, Thermo Fisher Scientific ’s clinical research business, surveyed more than 150 decision-making leaders at pharmaceutical and biotech companies around the globe to collect key insights on the state of the evolving drug development industry. Drug developers shared the disruptive impact of the COVID-19 pandemic and ever-changing industry landscape, which resulted in increased challenges in clinical trial execution.

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Five Surprising Facts About GoodRx and the Discount Card Market (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for tomorrow’s live video webinar: Drug Channels Outlook 2023. Click here to see the original post and comments from October 2022. Last month, IQVIA quietly released a fascinating new report on discount cards. (Link below.) The research was sponsored by the Association for Accessible Medicines (AAM).

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New patent expiration for Sanofi Aventis drug OFORTA

Drug Patent Watch

Annual Drug Patent Expirations for OFORTA Oforta is a drug marketed by Sanofi Aventis Us and is included in one NDA. There is one patent protecting this drug. This drug…. The post New patent expiration for Sanofi Aventis drug OFORTA appeared first on DrugPatentWatch - Make Better Decisions.

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Top Adaptive Clinical Trial Topics of 2022

Cytel

Adaptive trial designs – that is, trials that include a prospectively planned modification based on an interim analysis – have been traditionally 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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ChEMBL wishes you a Merry Christmas: A look back and a glimpse into 2023!

The ChEMBL-og

The ChEMBL Team heads off soon on their Christmas holidays! Before we leave, we would like to remember some highlights of 2022 and share some outlook for the next year! 2022 was an extraordinary year for the UK and also for the ChEMBL Team! It was a year of celebrations, farewells, and new beginnings. The ChEMBL team underwent major personnel changes in 2022 , with Anna and Patricia leaving the team, and Barbara, Eloy and Fiona taking on new roles within the ChEMBL leadership team. 2022 was a ye

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The difference between CKD, Stage 3 Kidney Disease, and C3G

Antidote

Though kidney disease is estimated to affect 31 million people across the U.S., the different terms surrounding this common condition still remain a source of confusion. Chronic kidney disease (CKD), Stage 3 kidney disease, and C3G all share similarities, both in name and impact, but understanding how they relate to one another can help to make things more clear.

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Exploring the Dynamic Landscape of Digital Medicines and Digital Therapeutics

The Premier Consulting Blog

Digital health products are widely used for the prevention, diagnosis, treatment, and management of health and disease. The introduction of digital medicines—and, more recently, digital therapeutics (DTx)—has begun to influence the treatment and management of certain diseases, both by consumers and by clinicians. Driven by advances in technology and increased acceptance of telehealth, digital medicines and DTx are poised to become an integral part of the healthcare model.

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Health Insurance Startup CEOs’ Sky-High Compensation Figures Are Deceiving

Drug Channels

Today’s guest post comes from Leslie Small, Managing Editor, and Jinghong Chen, Reporter, at Health Plan Weekly , published by AIS Health, the journalism division of Managed Markets Insight & Technology, LLC. (MMIT). Leslie and Jinghong discuss the terms of health insurance startups CEOs’ compensation packages. They explain why the reported CEO total compensation numbers are deceiving.

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Which pharmaceutical drugs have the most drug patents in Czech Republic?

Drug Patent Watch

This chart shows the drugs with the most patents in Czech Republic. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical drugs have the most drug patents in Czech Republic? appeared first on DrugPatentWatch - Make Better Decisions.

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Topics in Bayesian Statistical Methods

Cytel

Bayesian methods have been playing a key role in transforming clinical research, and Bayesian topics are frequently featured in Cytel’s Perspectives on Enquiry and Evidence. Our new ebook features a set of articles exploring various topics related to Bayesian statistical methods.

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Transforming Drug Discovery with 3D Adult Stem Cell Organoids and High Content Imaging

Crown Bioscience

3D adult stem cell (ASC)-derived tumor organoids can enhance the translatability of drug discovery data, especially in combination with high content imaging (HCI). In this blog post, we explore how the pairing of these two technologies allows researchers to develop highly comprehensive and predictive data that can enable better decisions earlier in drug discovery, while improving the translatability of the most promising lead compounds.

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What is the difference between nephropathy and neuropathy?

Antidote

Though nephropathy and neuropathy are two medical terms that sound similar, they refer to conditions that are very different. Nephropathy is a term related to disease or damage of the kidneys , while neuropathy is a term related to damage of the nervous system.

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NIH Invests in a New Harm Reduction Research Network

National Institute on Drug Abuse: Nora's Blog

NIH Invests in a New Harm Reduction Research Network mfleming Wed, 12/14/2022 - 19:34 Nora's Blog December 16, 2022 Image ©Getty Images/ Maskot The need to save lives and reduce negative health outcomes from drug use is unprecedented. In 2021 alone, the overdose epidemic took the lives of more than 107,000 people in the U.S., according to provisional data from the Centers for Disease Control and Prevention.