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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.
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.
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.
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.
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!
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).
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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Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
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.
Perspectives on Enquiry and Evidence explores a wide variety of topics within clinical trial design and data science in the form of expert articles, interviews, ebooks, and more. Here are some of our most read posts of 2022.
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.
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.
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
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).
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.
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.
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!
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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.
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.
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.
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
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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