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https://www.readbyqxmd.com/read/28432048/solithromycin-a-novel-ketolide-antibiotic
#1
Michael J Buege, Jack E Brown, Samuel L Aitken
PURPOSE: The pharmacology, pharmacokinetics, pharmacodynamics, antimicrobial activity, clinical safety, and current regulatory status of solithromycin are reviewed. SUMMARY: Solithromycin is a novel ketolide antibiotic developed for the treatment of community-acquired bacterial pneumonia (CABP). Its pharmacologic, pharmacokinetic, and pharmacodynamic properties provide activity against a broad range of intracellular organisms, including retained activity against pathogens displaying various mechanisms of macrolide resistance...
April 21, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28431767/the-new-drug-conditional-approval-process-in-china-challenges-and-opportunities
#2
REVIEW
Xuefang Yao, Jinxi Ding, Yingfang Liu, Penghui Li
PURPOSE: Our aim was to characterize the newly established new drug conditional approval process in China and discuss the challenges and opportunities with respect to new drug research and development and registration. METHODS: We examined the new approval program through literature review, law analysis, and data analysis. Data were derived from published materials, such as journal articles, government publications, press releases, and news articles, along with statistical data from INSIGHT-China Pharma Databases, the China Food and Drug Administration website, the Center for Drug Evaluation website, the US Food and Drug Administration website, and search results published by Google...
April 18, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28431671/where-are-we-now-a-clinicians-guide-to-the-use-of-follow-on-insulin-for-patients-with-diabetes
#3
Steven V Edelman, Priscilla A Hollander, Eugene E Wright
Insulin has been used as a standard treatment for patients with diabetes for almost 100 years. Over time, advances in insulin development have improved its pharmacologic properties. (Online access: http://courses.elseviercme.com/t2dm/666). Most recently, the US Food and Drug Administration approved a novel, follow-on basal insulin agent, with more expected to be commercially available in the near future. With the imminent availability of follow-on basal insulin agents, clinicians need to be aware of the potential benefits and concerns in order to facilitate informed decision making and to provide the best possible advice and guidance to their patients with diabetes...
May 2017: American Journal of Medicine
https://www.readbyqxmd.com/read/28431262/immunologic-approaches-for-the-treatment-of-multiple-myeloma
#4
REVIEW
Leo Rasche, Niels Weinhold, Gareth J Morgan, Frits van Rhee, Faith E Davies
The FDA approval of two monoclonal antibodies in 2015has heralded a new era of targeted immunotherapies for multiple myeloma (MM). In this review we discuss the recent approaches using different immunological components to treat MM. In particular, we review current monoclonal antibody based therapies, engineered T- and NK cell products, 'off-target' immunomodulation, and strategies utilizing allogeneic cell transplantation in MM. We discuss how an immunologic approach offers promise for the treatment of this genetically heterogeneous disease, and how patients with acquired drug resistance may particularly benefit from these therapies...
April 6, 2017: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/28428790/nanoparticle-interactions-with-the-immune-system-clinical-implications-for-liposome-based-cancer-chemotherapy
#5
Ninh M La-Beck, Alberto A Gabizon
The development of stable and long-circulating liposomes provides protection of the drug cargo from degradation and increases tumor drug delivery, leading to the design of liposome formulations with great potential in cancer therapy. However, despite the sound pharmacologic basis, many liposomal as well as other nanoparticle-based drug formulations have failed to meet regulatory criteria for approval. The question that arises is whether we have missed key liposome-host interactions that can account for the gap between the major pharmacologic advantages in preclinical studies and the modest impact of the clinical effects in humans...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/28428506/-a-new-therapeutic-approach-for-cancer-related-breakthrough-pain-focused-on-oral-transmucosal-fentanyl
#6
Kinomi Yomiya, Masayuki Kaneshima, Beni Kyosaka, Etsuko Warita, Rie Hosonuma, Shinnosuke Osato
In 2013, oral transmucosal fentanyl was first approved in Japan for reducing breakthrough pain(BTP). The development of BTP may contribute to less-effective analgesia, a reduced satisfaction with analgesia therapy, obstacles in daily life, mood disorders, and an increased use of healthcare resources. In most BTP, both the duration from BTP onset to its maximum intensity and the overall duration of BTP episodes are relatively short. The need for improved rapid pain relief for BTP in this setting has led to the development of rapid-onset opioids(ROOs), including oral transmucosal fentanyl citrate(OTFC)...
April 2017: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28428191/the-role-of-minimal-residual-disease-testing-in-myeloma-treatment-selection-and-drug-development-current-value-and-future-applications
#7
Kenneth C Anderson, Daniel Auclair, Gary J Kelloff, Caroline C Sigman, Herve Avet-Loiseau, Ann T Farrell, Nicole J Gormley, Shaji K Kumar, Ola Landgren, Nikhil C Munshi, Michele Cavo, Faith E Davies, Alessandra Di Bacco, Jennifer S Dickey, Steven I Gutman, Howard R Higley, Mohamad A Hussein, J Milburn Jessup, Ilan R Kirsch, Richard F Little, Robert D Loberg, Jens G Lohr, Lata Mukundan, James L Omel, Trevor J Pugh, Gregory H Reaman, Michael D Robbins, A Kate Sasser, Nancy Valente, Elena Zamagni
Treatment of myeloma has benefited from the introduction of more effective and better tolerated agents, improvements in supportive care, better understanding of disease biology, revision of diagnostic criteria, and new sensitive and specific tools for disease prognostication and management. Assessment of minimal residual disease (MRD) in response to therapy is one of these tools, as longer progression-free survival (PFS) is seen consistently among patients who have achieved MRD negativity. Current therapies lead to unprecedented frequency and depth of response, and next generation flow and sequencing methods to measure MRD in bone marrow are in use and being developed with sensitivities in the range of 10(-5)‒10(-6) cells...
April 20, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28427072/anti-vascular-endothelial-growth-factor-injections-the-new-standard-of-care-in-proliferative-diabetic-retinopathy
#8
Xintong Li, Marco A Zarbin, Neelakshi Bhagat
For decades, panretinal photocoagulation (PRP) has been the standard of care for the treatment of proliferative diabetic retinopathy (PDR). The relatively recent advent of anti-vascular endothelial growth factor (VEGF) formulations for intravitreal injection has provided a fresh perspective on PDR treatment, especially in eyes with concurrent diabetic macular edema (DME). The anti-VEGF agent ranibizumab has demonstrated a potentially protective effect on eyes with DME in terms of progression to PDR in the RIDE/RISE trials, as has aflibercept in the VIVID/VISTA trials...
2017: Developments in Ophthalmology
https://www.readbyqxmd.com/read/28426220/fluorescent-neuraminidase-assay-based-on-supramolecular-dye-capture-after-enzymatic-cleavage
#9
Wenqi Liu, César F A Gómez-Durán, Bradley D Smith
A conceptually new type of enzymatic cleavage assay is reported that utilizes in-situ supramolecular capture of the fluorescent product. A squaraine-derived substrate with large blocking groups at each end of its structure cannot be threaded by a tetralactam macrocycle until the blocking groups are removed by enzyme cleavage. A prototype design responds to viral neuraminidase, an indicator of influenza infection, and also measures susceptibility of the sample to neuraminidase inhibitor drugs. The substrate structure incorporates three key features; (a) a bis(4-amino-3-hydroxyphenyl)squaraine core with bright deep-red fluorescence and excellent photostability, (b) an N-methyl group at each end of the squaraine core that ensures fast macrocycle threading kinetics, and (c) sialic acid blocking groups that prevent macrocycle threading until they are removed by viral neuraminidase...
April 20, 2017: Journal of the American Chemical Society
https://www.readbyqxmd.com/read/28424703/immune-responses-to-bacillus-calmette-gu%C3%A3-rin-vaccination-why-do-they-fail-to-protect-against-mycobacterium-tuberculosis
#10
REVIEW
Juan I Moliva, Joanne Turner, Jordi B Torrelles
Mycobacterium tuberculosis (M.tb), the causative agent of tuberculosis (TB), is the current leading cause of death due to a single infectious organism. Although curable, the broad emergence of multi-, extensive-, extreme-, and total-drug resistant strains of M.tb has hindered eradication efforts of this pathogen. Furthermore, computational models predict a quarter of the world's population is infected with M.tb in a latent state, effectively serving as the largest reservoir for any human pathogen with the ability to cause significant morbidity and mortality...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/28424538/metal-complexes-in-cancer-therapy-an-update-from-drug-design-perspective
#11
REVIEW
Umar Ndagi, Ndumiso Mhlongo, Mahmoud E Soliman
In the past, metal-based compounds were widely used in the treatment of disease conditions, but the lack of clear distinction between the therapeutic and toxic doses was a major challenge. With the discovery of cisplatin by Barnett Rosenberg in 1960, a milestone in the history of metal-based compounds used in the treatment of cancers was witnessed. This forms the foundation for the modern era of the metal-based anticancer drugs. Platinum drugs, such as cisplatin, carboplatin and oxaliplatin, are the mainstay of the metal-based compounds in the treatment of cancer, but the delay in the therapeutic accomplishment of other metal-based compounds hampered the progress of research in this field...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28423702/experience-with-precision-genomics-and-tumor-board-indicates-frequent-target-identification-but-barriers-to-delivery
#12
Alan H Bryce, Jan B Egan, Mitesh J Borad, A Keith Stewart, Grzegorz S Nowakowski, Asher Chanan-Khan, Mrinal M Patnaik, Stephen M Ansell, Michaela S Banck, Steven I Robinson, Aaron S Mansfield, Eric W Klee, Gavin R Oliver, Jennifer B McCormick, Norine E Huneke, Colleen M Tagtow, Robert B Jenkins, Kandelaria M Rumilla, Sarah E Kerr, Jean-Pierre A Kocher, Scott A Beck, Martin E Fernandez-Zapico, Gianrico Farrugia, Konstantinos N Lazaridis, Robert R McWilliams
BACKGROUND: The ability to analyze the genomics of malignancies has opened up new possibilities for off-label targeted therapy in cancers that are refractory to standard therapy. At Mayo Clinic these efforts are organized through the Center for Individualized Medicine (CIM). RESULTS: Prior to GTB, datasets were analyzed and integrated by a team of bioinformaticians and cancer biologists. Therapeutically actionable mutations were identified in 65% (92/141) of the patients tested with 32% (29/92) receiving genomically targeted therapy with FDA approved drugs or in an independent clinical trial with 45% (13/29) responding...
March 9, 2017: Oncotarget
https://www.readbyqxmd.com/read/28421763/synthetic-approaches-to-new-drugs-approved-during-2015
#13
Andrew C Flick, Hong Xia Ding, Carolyn A Leverett, Robert E Kyne, Kevin K-C Liu, Sarah J Fink, Christopher J O'Donnell
New drugs introduced to the market every year represent privileged structures for particular biological targets. These new chemical entities (NCEs) provide insight into molecular recognition while serving as leads for designing future new drugs. This annual review describes the most likely process-scale synthetic approaches to twenty nine new chemical entities (NCEs) that were approved for the first time in 2015.
April 19, 2017: Journal of Medicinal Chemistry
https://www.readbyqxmd.com/read/28421338/tailoring-pharmacotherapy-to-specific-eating-behaviours-in-obesity-can-recommendations-for-personalised-therapy-be-made-from-the-current-data
#14
Carl A Roberts, Paul Christiansen, Jason C G Halford
Pharmacotherapy provides an adjunct to behaviour modification in the management of obesity. There are a number of new drug therapies purportedly targeting appetite; liraglutide, and bupropion/naltrexone, which are European Medicines Agency and US Food and Drug Administration (FDA) approved, and lorcaserin and phentermine/topiramate, which have FDA approval only. Each of the six drugs, used singly or in combination, has distinct pharmacological, and presumably distinct behavioural, mechanisms of action, thus the potential to provide defined therapeutic options to personalise the management of obesity...
April 19, 2017: Acta Diabetologica
https://www.readbyqxmd.com/read/28420994/scaffold-diversity-of-fungal-metabolites
#15
Mariana González-Medina, John R Owen, Tamam El-Elimat, Cedric J Pearce, Nicholas H Oberlies, Mario Figueroa, José L Medina-Franco
Many drug discovery projects rely on commercial compounds to discover active leads. However, current commercial libraries, with mostly synthetic compounds, access a small fraction of the possible chemical diversity. Natural products, in contrast, possess a vast structural diversity and have proven to be an outstanding source of new drugs. Several chemoinformatic analyses of natural products have demonstrated their diversity and structural complexity. However, to our knowledge, the scaffold content and structural diversity of fungal secondary metabolites have never been studied...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28420989/fda-facilitated-regulatory-pathways-visualizing-their-characteristics-development-and-authorization-timelines
#16
Lawrence Liberti, Magda Bujar, Alasdair Breckenridge, Jarno Hoekman, Neil McAuslane, Pieter Stolk, Hubert Leufkens
The US Food and Drug Administration (FDA) has four facilitated regulatory pathways (FRPs): Fast Track (FT), Breakthrough Therapy (BTD), Priority Review (PR), and Accelerated Approval (AA). Only PR specifies an expedited review timeline (6 months). We sought to determine to what extent the combination of two or more FRPs influenced development and approval times. We developed a "metro map" to illustrate FRP elements and their influence on review times. We assessed 125 new active substances (approved January 2013 to December 2015) 74 of which used one or more FRPs...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28420366/pirfenidone-attenuates-bleomycin-induced-pulmonary-fibrosis-in-mice-by-regulating-nrf2-bach1-equilibrium
#17
Yuan Liu, Fuai Lu, Lirong Kang, Zhihua Wang, Yongfu Wang
BACKGROUND: Oxidative stress is one of the important factors involved in the pathogenesis of idiopathic pulmonary fibrosis (IPF). The equilibrium of Nuclear factor-erythroid-related factor 2 (Nrf2)/[BTB (broad-complex, tramtrack and bric-a-brac) and CNC (cap'n'collar protein) homology 1, Bach1] determines the expression level of antioxidant factors, further regulating the function of oxidation/antioxidation capacity. Pirfenidone (PFD) is one of two currently for IPF therapy approved drugs...
April 18, 2017: BMC Pulmonary Medicine
https://www.readbyqxmd.com/read/28419972/neprilysin-inhibitors-a-new-hope-to-halt-the-diabetic-cardiovascular-and-renal-complications
#18
REVIEW
Vajir Malek, Anil Bhanudas Gaikwad
Diabetes is an enormous and ever-growing calamity and a global public health threat of the 21st century. Besides insulin and oral hypoglycaemic drugs, blockage of the renin-angiotensin system (RAS) denotes a key pharmacotherapy for the management of cardiovascular (CVD) and chronic kidney diseases (CKD), which are the leading causes of disability and death among diabetic patients. Neprilysin (NEP) inhibition, auxiliary to RAS blockage increases the bioavailability of natriuretic peptides and benefits the cardio-renal system...
April 15, 2017: Biomedicine & Pharmacotherapy, Biomédecine & Pharmacothérapie
https://www.readbyqxmd.com/read/28419437/a-new-paradigm-learn-learn-more-dose-exposure-response-at-the-centre-of-drug-development-and-regulatory-approval
#19
REVIEW
Alan Maloney
No abstract text is available yet for this article.
April 17, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28418652/design-and-development-of-highly-potent-hiv-1-protease-inhibitors-with-a-crown-like-oxotricyclic-core-as-the-p2-ligand-to-combat-multidrug-resistant-hiv-variants
#20
Arun K Ghosh, Kalapala Venkateswara Rao, Prasanth R Nyalapatla, Heather L Osswald, Cuthbert D Martyr, Manabu Aoki, Hironori Hayashi, Johnson Agniswamy, Yuan-Fang Wang, Haydar Bulut, Debananda Das, Irene T Weber, Hiroaki Mitsuya
Design, synthesis, and evaluation of a new class of exceptionally potent HIV-1 protease inhibitors are reported. Inhibitor 5 displayed superior antiviral activity and drug-resistance profiles. In fact, this inhibitor showed several orders of magnitude improved antiviral activity over the FDA approved drug darunavir. This inhibitor incorporates an unprecedented 6-5-5 ring-fused crown-like tetrahydropyranofuran as the P2 ligand and an aminobenzothiazole as the P2' ligand with the (R)-hydroxyethylsulfonamide isostere...
April 18, 2017: Journal of Medicinal Chemistry
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