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JOURNAL ARTICLE
Anton Berns
Discovery research is the starting point for the development of more effective anti-cancer treatments. It requires an interdisciplinary research environment with first-class infrastructural support in which curiosity-driven research can lead to new concepts for treating cancer. Translating such research findings to clinical practice requires complementary skills and infrastructures, including high-quality clinical facilities, access to patient cohorts and participation of pharma. This complex ecosystem has yielded many new but also "me too" treatment regimens, especially in immuno-oncology resulting in an extremely high pricing of anti-cancer agents...
April 18, 2024: Molecular Oncology
#2
JOURNAL ARTICLE
Julie K Wisch, Nicole S McKay, Anna H Boerwinkle, James Kennedy, Shaney Flores, Benjamin L Handen, Bradley T Christian, Elizabeth Head, Mark Mapstone, Michael S Rafii, Sid E O'Bryant, Julie C Price, Charles M Laymon, Sharon J Krinsky-McHale, Florence Lai, H Diana Rosas, Sigan L Hartley, Shahid Zaman, Ira T Lott, Dana Tudorascu, Matthew Zammit, Adam M Brickman, Joseph H Lee, Thomas D Bird, Annie Cohen, Patricio Chrem, Alisha Daniels, Jasmeer P Chhatwal, Carlos Cruchaga, Laura Ibanez, Mathias Jucker, Celeste M Karch, Gregory S Day, Jae-Hong Lee, Johannes Levin, Jorge Llibre-Guerra, Yan Li, Francisco Lopera, Jee Hoon Roh, John M Ringman, Charlene Supnet-Bell, Christopher H van Dyck, Chengjie Xiong, Guoqiao Wang, John C Morris, Eric McDade, Randall J Bateman, Tammie L S Benzinger, Brian A Gordon, Beau M Ances
BACKGROUND: In people with genetic forms of Alzheimer's disease, such as in Down syndrome and autosomal-dominant Alzheimer's disease, pathological changes specific to Alzheimer's disease (ie, accumulation of amyloid and tau) occur in the brain at a young age, when comorbidities related to ageing are not present. Studies including these cohorts could, therefore, improve our understanding of the early pathogenesis of Alzheimer's disease and be useful when designing preventive interventions targeted at disease pathology or when planning clinical trials...
May 2024: Lancet Neurology
#3
REVIEW
Morgan R Price, Kaelyn E Mead, Diana M Cowell, Alyssa M Troutner, Tyler E Barton, Sheryl A Walters, Clinton J Daniels
OBJECTIVE: The purpose of this systematic review was to ascertain guideline-recommended pharmaceutical approaches to lumbosacral radicular symptoms, assess the quality of the clinical practice guidelines (CPGs) with the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool, and qualitatively synthesize the guideline recommendations. LITERATURE SURVEY: Literature searches were performed in PubMed, Cochrane Database of Systematic Reviews, Index to Chiropractic Literature, Allied and Complementary Medicine Database (AMED), Cumulative Index for Nursing and Allied Health Literature (CINAHL), and Physiotherapy Evidence Database (PEDro)...
April 17, 2024: PM & R: the Journal of Injury, Function, and Rehabilitation
#4
JOURNAL ARTICLE
Shrutangi Vaidya, Shubham Atal, Rajnish Joshi
Introduction Type 2 diabetes mellitus (T2DM) poses a substantial burden globally and particularly in India, affecting health, finances, and overall quality of life. The management of this condition relies on lifestyle modifications and advanced pharmacological interventions, with emerging drugs showing promise in areas such as administration, side effects, efficacy, and cardiovascular benefits. However, their market penetration is hindered by high costs. Understanding the target population's expectations and willingness to pay (WTP) for these drugs is crucial...
March 2024: Curēus
#5
JOURNAL ARTICLE
Gastrointestinal Acute Radiation Syndrome: Mechanisms, Models, Markers, and Medical Countermeasures.
Thomas A Winters, Libero Marzella, Olivia Molinar-Inglis, Paul W Price, Nyun Calvin Han, Jonathan E Cohen, Sue-Jane Wang, Anthony F Fotenos, Julie M Sullivan, John Esker, Paula J Lapinskas, Andrea L DiCarlo
There have been a number of reported human exposures to high dose radiation, resulting from accidents at nuclear power plants (e.g., Chernobyl), atomic bombings (Hiroshima and Nagasaki), and mishaps in industrial and medical settings. If absorbed radiation doses are high enough, evolution of acute radiation syndromes (ARS) will likely impact both the bone marrow as well as the gastrointestinal (GI) tract. Damage incurred in the latter can lead to nutrient malabsorption, dehydration, electrolyte imbalance, altered microbiome and metabolites, and impaired barrier function, which can lead to septicemia and death...
April 15, 2024: Radiation Research
#6
JOURNAL ARTICLE
Rebecca G Kim, Claire McDonell, Jeff McKinney, Lisa Catalli, Jennifer C Price, Meghan D Morris
BACKGROUND: Telemedicine offers the opportunity to provide clinical services remotely, thereby bridging geographic distances for people engaged in the medical system. Following the COVID-19 pandemic, the widespread adoption of telemedicine in clinical practices has persisted, highlighting its continued relevance for post-pandemic healthcare. Little is known about telemedicine use among people from socially marginalized groups. METHODS: The No One Waits (NOW) Study is a single-arm clinical trial measuring the acceptability, feasibility, and safety of an urban point-of-diagnosis hepatitis C (HCV) treatment initiation model delivered in a non-clinical community setting...
March 25, 2024: Healthcare (Basel, Switzerland)
#7
JOURNAL ARTICLE
Iris An der Heiden, Guido Schiffhorst, Laura Müller, Martin Albrecht, Arne Bartol, Stefanie Wiberny
BACKGROUND: Based on the legal framework laid down in section 130b (9) of Book V of the German Social Code, various criteria are relevant for the negotiated price for new patented drugs in Germany. European reference prices (ERPs) are one criterion. The ERP is based on the ex-factory prices (EFPs) of the countries included in the European country basket. However, in some of these countries, the EFP is not published due to confidential wholesale margins. Wholesale margins must therefore be estimated and deducted from purchase prices...
April 12, 2024: Health Economics Review
#8
JOURNAL ARTICLE
Jason B Gibbons, Charles L Bennett, Kenneth R Carson, Gerard F Anderson
The Inflation Reduction Act of 2022 (IRA) allows the Medicare program to negotiate drug prices beginning in 2024. Based on the guidance in the statute, CMS has selected specific data items to use to adjust initial price offers for 10 drugs in the decision-making process. Although much of the data are publicly available, some of these data items will need to be collected directly from drug companies. A 2019 US House of Representatives Committee on Oversight and Accountability investigative report collected a wide range of data from manufacturers of 12 high-revenue drugs that show what is available from the drug companies, including development costs, marketing, pricing, competition, and patent status...
April 2024: American Journal of Managed Care
#9
JOURNAL ARTICLE
Anil Kumar Kalia, Corinna Rösseler, Rafael Granja-Vazquez, Ayesha Ahmad, Joseph J Pancrazio, Anika Neureiter, Mei Zhang, Daniel Sauter, Irina Vetter, Asa Andersson, Gregory Dussor, Theodore J Price, Benedict J Kolber, Vincent Truong, Patrick Walsh, Angelika Lampert
BACKGROUND: Human induced pluripotent stem cell (iPSC)-derived peripheral sensory neurons present a valuable tool to model human diseases and are a source for applications in drug discovery and regenerative medicine. Clinically, peripheral sensory neuropathies can result in maladies ranging from a complete loss of pain to severe painful neuropathic disorders. Sensory neurons are located in the dorsal root ganglion and are comprised of functionally diverse neuronal types. Low efficiency, reproducibility concerns, variations arising due to genetic factors and time needed to generate functionally mature neuronal populations from iPSCs remain key challenges to study human nociception in vitro...
April 5, 2024: Stem Cell Research & Therapy
#10
JOURNAL ARTICLE
Hasana Baber, Arega Aghajani, B Harold Gallimore, Cassandra Bethel, James G Hyatt, Elizabeth F B King, Helen P Price, Marissa L Maciej-Hulme, Suat Sari, Anja Winter
Leishmaniasis is a spectrum of conditions caused by infection with the protozoan Leishmania spp. parasites. Leishmaniasis is endemic in 98 countries around the world, and resistance to current anti-leishmanial drugs is rising. Our work has identified and characterised a previously unstudied galactokinase-like protein (GalK) in Leishmania donovani, which catalyses the MgATP-dependent phosphorylation of the C-1 hydroxyl group of d-galactose to galactose-1-phosphate. Here, we report the production of the catalytically active recombinant protein in E...
April 3, 2024: Biochimie
#11
JOURNAL ARTICLE
Youwen Zhu, Yinxin Lin, Kun Liu, Hong Zhu
OBJECTIVE: Mirvetuximab soravtansine (MIRV), a new antibody-drug conjugate, versus the investigator's choice of chemotherapy (IC) was the first treatment to demonstrate benefits for progression-free and overall survival in platinum-resistant recurrent ovarian cancer (PROC) with high folate receptor-alpha (high-FRα) expression. Efficacy, safety, and economic effectiveness make MIRV the new standard of care for these patients. METHODS: Based on patients and clinical parameters from MIRASOL (GOG 3045/ENGOT-ov55) phase III randomized controlled trials, the Markov model with a 20-year time horizon was established to evaluate the cost and efficacy of MIRV and IC for PROC with high-FRα expression, considering the bevacizumab-pretreated situation from the American healthcare system...
March 21, 2024: Journal of Gynecologic Oncology
#12
JOURNAL ARTICLE
Narcyz Ghinea
Most new medicines entering the market are high-cost speciality drugs. These drugs can cost tens to hundreds of thousands of dollars per course of treatment and in some cases millions of dollars per dose. Approximately half of all spending on medicines is projected to target only 2-3% of patients, raising important questions about resource allocation. While there is no doubt that breakthrough innovations have transformed clinical care in some disciplines, it is also true that cost is becoming one of the primary barriers to treatment access and that many new medicines do not provide value commensurate with their prices...
April 4, 2024: Internal Medicine Journal
#13
JOURNAL ARTICLE
Victoria Vincent
Sensorineural hearing loss and chronic rhinosinusitis with nasal polyps affect a large proportion of the UK population. However, treatment with high efficacy to manage these pathologies remains to be found. With the development of biologic drug treatments, there is hope that this will improve quality of life for patients affected by these conditions. A literature review was carried out using PubMed. Studies that investigated the use of biologic drug treatment in chronic rhinosinusitis with nasal polyps, head and neck squamous cell carcinoma and sensorineural hearing loss were included in this paper...
April 2024: Indian Journal of Otolaryngology and Head and Neck Surgery
#14
JOURNAL ARTICLE
Zhao Li, Wanzhi Shen, Tao Zhang
Focusing on the research scenario that integrates value-based healthcare objectives with the pharmaceutical group purchasing model, this study delineates value-based healthcare objectives in pharmaceutical group purchasing from three perspectives: drug sales price, drug quality, and service level. We construct a three-level pharmaceutical group purchasing supply chain consisting of drug manufacturers, medical institutions, and non-profit drug group purchasing organisations. Under centralised and decentralised decision-making, we introduce cost-sharing contracts and "cost-sharing-quantity-discount" contracts to analyse the impact of factors such as drug sales price, quality, and sensitivity of the service level...
April 15, 2024: Heliyon
#15
JOURNAL ARTICLE
Jonathan Guo, Ibukunoluwa King, Andrew Hill
BACKGROUND: Elexacaftor/tezacaftor/ivacaftor (ETI) has revolutionized cystic fibrosis (CF) treatment. However, previous research has demonstrated profound global disparities in diagnosis and treatment access. If unaddressed, these threaten to widen existing health inequities. Therefore, in this analysis we aimed to reappraise gaps and evaluate progress in diagnosis and treatment equity in high-income (HIC) versus low- and middle-income countries (LMICs). METHODS: Estimates of the global CF population were made in 158 countries using patient registries, systematic literature searches, and an international survey of 14 CF experts...
April 1, 2024: Pediatric Pulmonology
#16
JOURNAL ARTICLE
Sara Abudahab, Mohamad M Kronfol, Mikhail G Dozmorov, Thomas Campbell, Fay M Jahr, Jasmine Nguyen, Ola AlAzzeh, Dalia Y Al Saeedy, Ashley Victor, Sera Lee, Shravani Malay, Dana M Lapato, Matthew S Halquist, MaryPeace McRae, Laxmikant S Deshpande, Patricia W Slattum, Elvin T Price, Joseph L McClay
Hepatic xenobiotic metabolism and transport decline with age, while intact xenobiotic metabolism is associated with longevity. However, few studies have examined the genome-wide impact of epigenetic aging on these processes. We used reduced representation bisulfite sequencing (RRBS) to map DNA methylation changes in liver DNA from mice ages 4 and 24 months. We identified several thousand age-associated differentially methylated sites (a-DMS), many of which overlapped genes encoding Phase I and Phase II drug metabolizing enzymes, in addition to ABC and SLC classes of transporters...
April 1, 2024: GeroScience
#17
REVIEW
S Demuth, N Collongues
Neuromyelitis optica spectrum disorder (NMOSD) is a rare but debilitating autoimmune disease of the central nervous system (CNS) for which several biotherapies have recently been approved on the market. Historically, NMOSD disease-modifying treatments relied on wide-spectrum off-label immunosuppressants, such as azathioprine, mycophenolate mofetil, and cyclophosphamide. Since 2015, evidence has accumulated to support off-label biotherapies (rituximab and tocilizumab) and to approve satralizumab, inebilizumab, eculizumab, and ravulizumab...
March 28, 2024: Revue Neurologique
#18
JOURNAL ARTICLE
Joseph C Del Paggio, Rohini Naipaul, Scott Gavura, Rebecca E Mercer, Rachel Koven, Bishal Gyawali, Brooke E Wilson, Christopher M Booth
BACKGROUND: The financial impact of cancer medicines on health systems is not well known. We describe temporal trends in expenditure on cancer medicines within the single-payer health system of Ontario, Canada, and the extent of clinical benefit these treatments offer. METHODS: In this cross-sectional study, we identified cancer medicines and expenditures from formularies and costing databases (the New Drug Funding Program, Ontario Drug Benefit Program, and The High-Cost Therapy Funding Program) during 10 consecutive years (April 1, 2012, to March 31, 2022) in Ontario, Canada...
April 2024: Lancet Oncology
#19
JOURNAL ARTICLE
Anne M Sydor, Emily Bergin, Jonathan Kay, Erik Stone, Robert Popovian
Background: Medication formularies, initially designed to promote the use of cost-effective generic drugs, are now designed to maximize financial benefits for the pharmacy benefit management companies that negotiate purchase prices. In the second-largest pharmacy benefit management formulary that is publicly available, 55% of mandated substitutions are not for generic or biosimilar versions of the same active ingredient and/or formulation and may not be medically or financially beneficial to patients. Methods: We modeled the effect of excluding novel agents for atrial fibrillation/venous thromboembolism, migraine prevention, and psoriasis, which all would require substitution with a different active ingredient...
2024: Journal of health economics and outcomes research
#20
JOURNAL ARTICLE
Margarida Miranda, Zoe Volmer, Alicia Cornick, Aidan Goody, Catarina Cardoso, Alberto A C C Pais, Marc Brown, Carla Vitorino
Over the past decade, topically applied drug products have experienced extraordinary price increases, due to the shortage of multisource generic drug products. This occurrence is mainly related to the underlying challenges evolved in topical bioequivalence documentation. Although there has been continuing regulatory efforts to present surrogate in vitro methods to clinical endpoint studies, there is still a continued need for cost- and time-efficient alternatives that account for product specificities. Hence, this work intended to expose bioequivalence assessment issues for complex topical formulations, and more specifically those related with product efficacy guidance...
March 25, 2024: International Journal of Pharmaceutics
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