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https://www.readbyqxmd.com/read/27911360/development-of-a-more-sensitive-and-specific-chromogenic-agar-medium-for-the-detection-of-vibrio-parahaemolyticus-and-other-vibrio-species
#1
Marie Yeung, Trevor Thorsen
Foodborne infections in the US caused by Vibrio species have shown an upward trend. In the genus Vibrio, V. parahaemolyticus is responsible for the majority of Vibrio-associated infections. Thus, accurate differentiation among Vibrio spp. and detection of V. parahaemolyticus is critically important to ensure the safety of our food supply. Although molecular techniques are increasingly common, culture-depending methods are still routinely done and they are considered standard methods in certain circumstances...
November 8, 2016: Journal of Visualized Experiments: JoVE
https://www.readbyqxmd.com/read/27911112/treatment-of-alpha-and-beta-herpesvirus-infections-in-solid-organ-transplant-recipients
#2
C L Abad, R R Razonable
Human herpesviruses frequently cause infections in solid organ transplant (SOT) recipients. Areas covered: We provide an overview of the clinical impact of alpha and beta herpesviruses and highlight the mechanisms of action, pharmacokinetics, clinical indications, and adverse effects of antiviral drugs for the management of herpes simplex virus, varicella zoster virus and cytomegalovirus. We comprehensively evaluated key clinical trials that led to drug approval, and served as the foundation for management guidelines...
December 2, 2016: Expert Review of Anti-infective Therapy
https://www.readbyqxmd.com/read/27910962/baricitinib-jak-inhibition-for-rheumatoid-arthritis
#3
J Gras
Rheumatoid arthritis (RA), a chronic autoimmune inflammatory disease characterized by inflammation and joint destruction, is associated with pain, progressive disability, systemic comorbidities and early death. Conventional disease-modifying antirheumatic drugs (DMARDs) and biological DMARDs (bDMARDs) have been able to achieve remission or a very low disease activity status for RA. Nevertheless, since many patients do not reach a sufficient response with DMARDs or present with unacceptable side effects, new therapies are needed...
October 2016: Drugs of Today
https://www.readbyqxmd.com/read/27910765/gene-therapy-for-rheumatoid-arthritis
#4
Shuang Liu, Kazutaka Maeyama
With the aim of controlling disease relapse and bone deformation of individual joints, the application of gene therapy in rheumatoid arthritis (RA) has slowly progressed on a trial-and-error basis. Several new therapeutic targets have been identified in preclinical studies in animal models, although a limited number of gene-based clinical trials have been conducted. In this article, we summarize the status of gene therapy for RA by addressing issues related to innovating drug development. More disease- and target-specific preclinical tests are required to overcome the insufficient information regarding pharmacokinetics and toxicokinetics, which are related to safety issues in the field of RA gene therapy...
2016: Critical Reviews in Immunology
https://www.readbyqxmd.com/read/27908281/health-technology-assessment-of-drugs-for-rare-diseases-insights-trends-and-reasons-for-negative-recommendations-from-the-cadth-common-drug-review
#5
REVIEW
Ghayath Janoudi, William Amegatse, Brendan McIntosh, Chander Sehgal, Trevor Richter
BACKGROUND: A shift in biochemical research towards drugs for rare diseases has created new challenges for the pharmaceutical industry, government regulators, health technology assessment agencies, and public and private payers. In this article, we aim to comprehensively review, characterize, identify possible trends, and explore reasons for negative reimbursement recommendations in submissions made to the Common Drug Review (CDR) for drugs for rare diseases (DRD) at the Canadian Agency for Drugs and Technologies in Health (CADTH), a publicly funded pan-Canadian health technology assessment agency...
December 1, 2016: Orphanet Journal of Rare Diseases
https://www.readbyqxmd.com/read/27908220/pluripotent-stem-cells-the-last-10-years
#6
Erin A Kimbrel, Robert Lanza
Pluripotent stem cells (PSCs) can differentiate into virtually any cell type in the body, making them attractive for both regenerative medicine and drug discovery. Over the past 10 years, technological advances and innovative platforms have yielded first-in-man PSC-based clinical trials and opened up new approaches for disease modeling and drug development. Induced PSCs have become the foremost alternative to embryonic stem cells and accelerated the development of disease-in-a-dish models. Over the years and with each new discovery, PSCs have proven to be extremely versatile...
December 2, 2016: Regenerative Medicine
https://www.readbyqxmd.com/read/27907972/-tenofovir-alafenamide-fumarate-a-new-generation-of-tenofovir
#7
Svatava Snopková, Kateřina Havlíčková, Petr Husa
Antiretroviral therapy as a life-long treatment has to meet the criteria of maximum efficiency while maintaining the highest possible level of safety and tolerance. Tenofovir disoproxil fumarate (TDF) is an antiretroviral drug with an excellent effect of virological suppression. However, some patients can over time develop clinically significant nephrotoxicity or bone loss. Tenofovir alafenamide fumarate (TAF) is a novel prodrug of tenofovir (TFV) that is more stable in human plasma and more efficiently penetrates into target cells than TFV...
September 2016: Klinická Mikrobiologie a Infekc̆ní Lékar̆ství
https://www.readbyqxmd.com/read/27906472/long-term-clinical-impact-and-cost-effectiveness-of-obeticholic-acid-for-the-treatment-of-primary-biliary-cholangitis
#8
Sumeyye Samur, Matthew Klebanoff, Reiner Banken, Daniel S Pratt, Rick Chapman, Daniel A Ollendorf, Anne M Loos, Kathleen Corey, Chin Hur, Jagpreet Chhatwal
: Primary biliary cholangitis (PBC) is a chronic, progressive autoimmune liver disease that mainly affects middle-aged women. Obeticholic acid (OCA), which was recently approved by the Food and Drug Administration for PBC treatment, has demonstrated positive effects on biochemical markers of liver function. Our objective was to evaluate the long-term clinical impact and cost-effectiveness of OCA as a second-line treatment for PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA...
November 7, 2016: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/27905916/study-protocol-a-dose-escalating-phase-2-study-of-oral-lisdexamfetamine-in-adults-with-methamphetamine-dependence
#9
Nadine Ezard, Adrian Dunlop, Brendan Clifford, Raimondo Bruno, Andrew Carr, Alexandra Bissaker, Nicholas Lintzeris
BACKGROUND: The treatment of methamphetamine dependence is a continuing global health problem. Agonist type pharmacotherapies have been used successfully to treat opioid and nicotine dependence and are being studied for the treatment of methamphetamine dependence. One potential candidate is lisdexamfetamine, a pro-drug for dexamphetamine, which has a longer lasting therapeutic action with a lowered abuse potential. The purpose of this study is to determine the safety of lisdexamfetamine in this population at doses higher than those currently approved for attention deficit hyperactivity disorder or binge eating disorder...
December 1, 2016: BMC Psychiatry
https://www.readbyqxmd.com/read/27904819/an-overview-of-compassionate-use-programs-in-the-european-union-member-states
#10
REVIEW
Gayathri Balasubramanian, Suman Morampudi, Pankdeep Chhabra, Arun Gowda, Behsad Zomorodi
The past decade witnessed rapid development of novel drugs and therapeutic biological agents. The marketing authorization for novel therapies is often time consuming and distressing for patients. Earlier clinical trials were the only way to access new drugs under development. However, not every patient meets the enrolment criteria, and participation is difficult for patients with life-threatening, long-lasting or seriously debilitating diseases like rare diseases. Early access programs like "Compassionate Use Program (CUP)" have generated alternative channels for such patients...
November 2016: Intractable & Rare Diseases Research
https://www.readbyqxmd.com/read/27903216/treatment-and-response-to-statins-gender-related-differences
#11
Raparelli Valeria, Pannitteri Gaetano, Todisco Tommaso, Toriello Filippo, Napoleone Laura, Manfredini Roberto, Basili Stefania
Response to drug administration is a primary determinant for treatment success. Sex and gender disparities play a role in determining the efficacy and safety of the most common used medications suggesting the need for a sex-tailored approach in prescription. Statins are a cost-effective strategy for cardiovascular disease (CVD) prevention. While statins are similarly effective in secondary CVD prevention, some concerns raised by conflicting data reported in primary CVD prevention clinical trials. The small representation of women in clinical trials and the fewer rates of events due to the lower female baseline CVD risk may have conditioned contradictory meta-analysis findings...
November 17, 2016: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/27903029/-lupus-erythematosus-update-2016
#12
Martin Aringer, Reinhard Edmund Voll
Meanwhile, five years have passed since the approval of the anti-BAFF antibody belimumab as a first biological for SLE, but no further SLE drug candidate is even close to approval. There are still no clinical trial data available for the use of new oral anticoagulants in antiphospholipid syndrome. In spite of convincing evidence for the use of mycophenolate mofetil (MMF) in lupus nephritis, the German "Gemeinsame Bundesausschuss" (GBA) has not yet decided on its reimbursement. However, several of the ongoing clinical trials have potential to lead to important advances in SLE treatment in the future...
November 2016: Deutsche Medizinische Wochenschrift
https://www.readbyqxmd.com/read/27902417/lantibiotics-produced-by-actinobacteria-and-their-potential-applications-a-review
#13
Karen Gomes, Rafael Silva Duarte, Maria do Carmo de Freire Bastos
The phylum Actinobacteria, which comprises a great variety of Gram-positive bacteria with a high G+C content in their genomes, is known for its large production of bioactive compounds, including those with antimicrobial activity. Among the antimicrobials, bacteriocins, ribosomally-synthesized peptides, represent an important arsenal of potential new drugs to face the increasing prevalence of resistance to antibiotics among microbial pathogens. The actinobacterial bacteriocins form a heterogeneous group of substances that is difficult to adapt to most proposed classification schemes...
November 22, 2016: Microbiology
https://www.readbyqxmd.com/read/27900832/bromodomain-and-extraterminal-protein-inhibitors-in-pediatrics-a-review-of-the-literature
#14
REVIEW
Irene Jiménez, André Baruchel, François Doz, Johannes Schulte
The last few years have seen the identification of pharmacologic approaches to target bromodomain and extraterminal (BET) proteins for cancer treatment. These proteins have an essential role in gene transcription regulation by binding acetylated lysine residues on histone tails, activating gene transcription. BET inhibitors have been tested in preclinical models including pediatric malignancies and several adult clinical trials are ongoing. Since the development of new drugs in pediatric cancer has long lagged behind programs for adults, the aim of this review is to show the importance of these therapies in pediatric malignancies to support their development in pediatric oncology/hematology...
November 30, 2016: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/27900615/good-manufacturing-practice-requirements-for-the-production-of-tissue-vitrification-and-warming-and-recovery-kits-for-clinical-research
#15
Monica M Laronda, Kelly E McKinnon, Alison Y Ting, Ann V Le Fever, Mary B Zelinski, Teresa K Woodruff
Products that are manufactured for use in a clinical trial, with the intent of gaining US Food and Drug Administration (FDA) approval for clinical use, must be produced under an FDA approved investigational new drug (IND) application. We describe work done toward generating reliable methodology and materials for preserving ovarian cortical tissue through a vitrification kit and reviving this tissue through a warming and recovery kit. We have described the critical steps, procedures, and environments for manufacturing products with the intent of submitting an IND...
November 30, 2016: Journal of Assisted Reproduction and Genetics
https://www.readbyqxmd.com/read/27899962/new-emerging-therapies-in-the-management-of-chronic-lymphocytic-leukemia
#16
Xiao-Lin Li, Ci-Xian Zhang
Chronic lymphocytic leukemia (CLL) is considered incurable despite advances in management strategies. New drugs targeting cell pathways are currently being developed for the efficient management of CLL. Various strategies involving different targets have been developed, or are currently in the developing stage. A search was conducted in the electronic database PubMed, for pre-clinical as well as clinically controlled trials reporting various strategies against CLL currently under investigation. Novel strategies included use of antibodies, small cell inhibitors, such as spleen tyrosine kinase, LYN, cyclin-dependent kinase, and histone deacetylase inhibitors...
November 2016: Oncology Letters
https://www.readbyqxmd.com/read/27898364/liquid-chromatography-tandem-mass-spectrometry-assay-for-the-quantification-of-niraparib-and-its-metabolite-m1-in-human-plasma-and-urine
#17
L van Andel, Z Zhang, S Lu, V Kansra, S Agarwal, L Hughes, M M Tibben, A Gebretensae, H Rosing, J H M Schellens, J H Beijnen
Niraparib (MK-4827) is a novel poly(ADP-Ribose) polymerase (PARP) inhibitor currently investigated in phase III clinical trials to treat cancers. The development of a new drug includes the characterisation of absorption, metabolism and excretion (AME) of the compound. AME studies are a requirement of regulatory agencies and for this purpose bioanalytical assays are essential. This article describes the development and validation of a bioanalytical assay for niraparib and its carboxylic acid metabolite M1 in human plasma and urine using liquid chromatography-tandem mass spectrometry (LC-MS/MS)...
November 19, 2016: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/27897119/glaucoma-hot-topics-in-pharmacology
#18
Shiama I Balendra, Parth Arvind Shah, Mishank Jain, Andrzej Grzybowski, Francesca M Cordeiro
BACKGROUND: Glaucoma comprises a group of neurodegenerative diseases resulting in retinal ganglion cell death within the optic nerve head. It is projected to affect almost 80 million people worldwide by 2020. The condition's asymptomatic nature translates to over half of glaucoma sufferers being unaware of their condition. By the time of diagnosis, irreversible blindness is likely to have occurred. Prime areas of glaucoma research therefore include identification and optimization of risk factors for the disease, accurate and early diagnostic tools and novel therapeutic methods...
November 29, 2016: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/27896681/financial-impact-of-direct-acting-oral-anticoagulants-in-medicaid-budgetary-assessment-based-on-number-needed-to-treat
#19
Kathleen A Fairman, Lindsay E Davis, Courtney R Kruse, David A Sclar
BACKGROUND: Faced with rising healthcare costs, state Medicaid programs need short-term, easily calculated budgetary estimates for new drugs, accounting for medical cost offsets due to clinical advantages. OBJECTIVE: To estimate the budgetary impact of direct-acting oral anticoagulants (DOACs) compared with warfarin, an older, lower-cost vitamin K antagonist, on 12-month Medicaid expenditures for nonvalvular atrial fibrillation (NVAF) using number needed to treat (NNT)...
November 28, 2016: Applied Health Economics and Health Policy
https://www.readbyqxmd.com/read/27896268/challenges-for-relative-effectiveness-assessment-and-early-access-of-cancer-immunotherapies-in-europe
#20
Mira Pavlovic
Clinical endpoints relevant for relative effectiveness assessment (REA) reflect how patients feel, function, or survive. Outcome data requested by health technology assessment (HTA) bodies in Europe to support reimbursement of an anticancer drug are based on final endpoints coming from completed comparative phase 3 trials; overall survival improvement is the preferred criterion for the demonstration of the patient benefit in this field. Recent arrival of new treatments that target identified functional genetic mutations ("targeted therapies") or PD-1/PD-L1,2 axis ("immunotherapies") and their combinations have profoundly changed treatment strategies in cancers as they considerably improve patient survival, but also raise new challenges in REA and decision-making process in Europe as compared to the REA of "classical" chemotherapies...
2016: Frontiers in Medicine
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