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https://www.readbyqxmd.com/read/28448778/economic-impact-of-above-label-dosing-with-etanercept-adalimumab-or-ustekinumab-in-patients-with-psoriasis
#1
Steven R Feldman, Yang Zhao, Huanxue Zhou, Vivian Herrera, Haijun Tian, Yunfeng Li
BACKGROUND: Patients with moderate-to-severe psoriasis may be treated with above-label doses of biologics in an attempt to optimize outcomes. Dose escalation will have an effect on the cost of treatment. OBJECTIVE: To examine costs related to above-label use of etanercept, adalimumab, and ustekinumab among patients with moderate-to-severe psoriasis. METHODS: A retrospective study was performed using a large U.S. claims database. Patients were included in the study if they were aged ≥ 18 years with a diagnosis of psoriasis (excluding psoriatic arthritis) and had at least 1 medication fill for etanercept, adalimumab, or ustekinumab between January 1, 2011, and June 30, 2012...
May 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28447077/evidence-europe-2017-london-uk-february-22-23-2017
#2
A Kibble
As the political backdrop changes in both the U.S. and Europe, volatility in the pharma industry is beginning to be felt as the sector becomes sensitive to the uncertainty. U.S. President Trump has stated he will pursue an agenda against high U.S. drug prices and is expected to seek to repeal the Affordable Care Act, while in Europe, Brexit casts further unknowns in regulatory authorization procedures, trade and external reference pricing. With these factors in mind, Terrapin's Evidence Europe meeting provided for a very topical discussion on the use of evidence to define and communicate value in healthcare...
March 2017: Drugs of Today
https://www.readbyqxmd.com/read/28444354/easy-assessment-of-levofloxacin-and-minocycline-in-relevant-biomimetic-media-by-hplc-uv-analysis
#3
Ana C Matos, Rosana V Pinto, Ana F Bettencourt
Simple, economic and environmental friendly high-performance liquid chromatography methods for levofloxacin and minocycline quantification in biomimetic media were developed and validate including their stability at body temperature, an often neglected evaluation parameter. Both methods are similar only differing in the wavelength setting, i.e., for levofloxacin and minocycline quantification the UV detection was set at 284 and at 273 nm, respectively. The separation of both antibiotics was achieved using a reversed-phase column and a mobile phase consisting of acetonitrile and water (15:85) with 0...
April 24, 2017: Journal of Chromatographic Science
https://www.readbyqxmd.com/read/28440707/recent-developments-in-nanocarrier-aided-mucosal-vaccination
#4
Olga Kammona, Vassilis Bourganis, Theodora Karamanidou, Costas Kiparissides
To date, most of the licensed vaccines for mucosal delivery are based on live-attenuated viruses which carry the risk of regaining their pathogenicity. Therefore, the development of efficient nonviral vectors allowing the induction of potent humoral and cell-mediated immunity is regarded as an imperative scientific challenge as well as a commercial breakthrough for the pharma industries. For a successful translation to the clinic, such nanocarriers should protect the antigens from mucosal enzymes, facilitate antigen uptake by microfold cells and allow the copresentation of robust, safe for human use, mucosal adjuvants to antigen-presenting cells...
April 25, 2017: Nanomedicine
https://www.readbyqxmd.com/read/28435690/the-complex-legal-and-ethical-issues-related-to-generic-medications-viral-hepatitis-a-case-study
#5
EDITORIAL
M Danta, N Ghinea
The economic impact of medications is significant, with many countries unable to afford the essential medicines listed by the WHO. Generic medications are one strategy to address this issue. Generic medications are similar to but not the same as originator medications. They have a significant cost advantage because they do not require the background research and development studies to support registration. Consequently, they are gaining increased market share in both the developed and developing world. Many new medications are now licensed to generic manufacturers in the developing world...
April 1, 2017: Journal of Virus Eradication
https://www.readbyqxmd.com/read/28433436/subharmonic-aided-pressure-estimation-for-monitoring-interstitial-fluid-pressure-in-tumors-calibration-and-treatment-with-paclitaxel-in-breast-cancer-xenografts
#6
Valgerdur G Halldorsdottir, Jaydev K Dave, Andrew Marshall, Anya I Forsberg, Traci B Fox, John R Eisenbrey, Priscilla Machado, Ji-Bin Liu, Daniel A Merton, Flemming Forsberg
Interstitial fluid pressure (IFP) in rats with breast cancer xenografts was non-invasively estimated using subharmonic-aided pressure estimation (SHAPE) versus an invasive pressure monitor. Moreover, monitoring of IFP changes after chemotherapy was assessed. Eighty-nine rats (calibration n = 25, treatment n = 64) were injected with 5 × 10(6) breast cancer cells (MDA-MB-231). Radiofrequency signals were acquired (39 rats successfully imaged) with a Sonix RP scanner (BK Ultrasound, Richmond, BC, Canada) using a linear array (L9-4, transmit/receive: 8/4 MHz) after administration of Definity (Lantheus Medical Imaging, North Billerica, MA, USA; 180 μL/kg) and compared with readings from an invasive pressure monitor (Stryker, Berkshire, UK)...
April 19, 2017: Ultrasound in Medicine & Biology
https://www.readbyqxmd.com/read/28432054/arkansas-execution-proceeds-as-pharma-companies-lose-battle-to-stop-use-of-their-drugs
#7
Owen Dyer
No abstract text is available yet for this article.
April 21, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28431767/the-new-drug-conditional-approval-process-in-china-challenges-and-opportunities
#8
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/28430363/cerebrolysin-for-acute-ischaemic-stroke
#9
REVIEW
Liliya Eugenevna Ziganshina, Tatyana Abakumova, Ludivine Vernay
BACKGROUND: Cerebrolysin is a mixture of low-molecular-weight peptides and amino acids derived from pigs' brain tissue, which has potential neuroprotective and neurotrophic properties. It is widely used in the treatment of acute ischaemic stroke in Russia, Eastern Europe, China, and other Asian and post-Soviet countries. OBJECTIVES: To assess the benefits and risks of cerebrolysin for treating acute ischaemic stroke. SEARCH METHODS: In May 2016 we searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE, Embase, Web of Science Core Collection, with Science Citation Index, LILACS, OpenGrey, and a number of Russian Databases...
April 21, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28429340/controlled-prospective-observational-study-on-the-efficiency-and-tolerability-of-a-combination-of-potential-nrf2-inducing-antioxidants-and-micronutrients-as-pre-treatment-for-icsi-in-dyspermic-patients-with-previous-failure
#10
R Rago, M Gallo, A Dal Lago, E Licata, G Paciotti, M Amodei, C Meneghini, C Fabiani, G Dani, C Liberanome, D Antonaci, R Corno, D Miriello, G Giuffrida, B Giammusso
OBJECTIVE: To evaluate the efficiency of pre-treatment in dyspermic males in IVF couples with a combination of micronutrients, for the purpose of improving the fertilization rate, the implantation rate and the outcome of the pregnancy. PATIENTS AND METHODS: This controlled prospective clinical study was performed in two medically assisted reproduction centers. 59 males with mild oligo-astheno-teratospermia (OAT) were admitted to the study. All of them had a history of previous in vitro fertilization (IVF) attempts with female partners aged < 40 diagnosed having tubal or idiopathic infertility...
April 2017: European Review for Medical and Pharmacological Sciences
https://www.readbyqxmd.com/read/28419094/an-open-source-pharma-roadmap
#11
Manica Balasegaram, Peter Kolb, John McKew, Jaykumar Menon, Piero Olliaro, Tomasz Sablinski, Zakir Thomas, Matthew H Todd, Els Torreele, John Wilbanks
In an Essay, Matthew Todd and colleagues discuss an open source approach to drug development.
April 2017: PLoS Medicine
https://www.readbyqxmd.com/read/28402142/development-of-separation-technology-for-the-removal-of-radium-223-from-targeted-thorium-conjugate-formulations-part-ii-purification-of-targeted-thorium-conjugates-on-cation-exchange-columns
#12
Janne Olsen Frenvik, Knut Dyrstad, Solveig Kristensen, Olav B Ryan
Tumour targeting pharmaceuticals will play a crucial role in future pharma pipelines. The Targeted Thorium Conjugate (TTC) therapeutic platform could provide real benefit to patients, whereby targeting moieties like monoclonal antibodies are radiolabelled with the alpha-emitting radionuclide thorium-227 ((227)Th, t1/2=18.7 days). A potential problem could be the accumulation of the long-lived daughter nuclide radium-223 ((223)Ra, t1/2=11.4 days) in the drug product during manufacture and distribution. Therefore, the level of (223)Ra must be standardised before administration to the patient...
April 12, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28401466/antibacterial-effects-of-lactobacillus-isolates-of-curd-and-human-milk-origin-against-food-borne-and-human-pathogens
#13
Chetan Sharma, Brij Pal Singh, Nishchal Thakur, Sachin Gulati, Sanjolly Gupta, Santosh Kumar Mishra, Harsh Panwar
This study was undertaken to assess the antibacterial efficacy of lactobacilli isolated from curd and human milk samples. Identities of thirty-one different lactobacilli (20 from curd and 11 from human milk) were confirmed by genus-specific PCR and 16S rRNA-based sequencing. These strains belonged to five species, Lactobacillus casei, L. delbrueckii, L. fermentum, L. plantarum, and L. pentosus. Antibacterial activities of cell-free supernatants (CFSs) of all the Lactobacillus isolates were estimated through standard agar-well diffusion assay, against commonly occurring food-borne and clinically important human pathogens...
May 2017: 3 Biotech
https://www.readbyqxmd.com/read/28397452/investigation-and-optimization-of-the-effect-of-polymers-on-drug-release-of-norfloxacin-from-floating-tablets
#14
Dipak D Gadade, Kalpana Sarda, Sadhana R Shahi
BACKGROUND: Norfloxacin is fluoroquinolone anti-infective used in the treatment of urinary tract infections, prostatitis, gonorrhea and genital tract infections. It has plasma half life of 3 to 4 h requiring multiple dosing in the treatment. Releaseretarding polymers can be used to modulate the drug release of norfloxacin. OBJECTIVES: The objective of this study was to investigate the effect of release-retarding polymers on the drug release of norfloxacin from floating tablets...
July 2016: Polimery W Medycynie
https://www.readbyqxmd.com/read/28394189/academia-pharma-partnerships-for-novel-drug-discovery-essential-or-nice-to-have
#15
Michelle Palmer, Rathnam Chaguturu
No abstract text is available yet for this article.
April 10, 2017: Expert Opinion on Drug Discovery
https://www.readbyqxmd.com/read/28387385/the-year-s-new-drugs-biologics-2016-part-i
#16
A I Graul, P Pina, E Cruces, M Stringer
Nearly 90 new drugs and biologics, including important new line extensions, were approved or launched for the first time globally in 2016, a comparatively lower number with respect to previous years. Forty-four new drugs and biologics reached their first markets worldwide in 2016, nearly 10% fewer than the previous year. Seven of the new launches were first-in-class agents, meaning the first drug with a novel mechanism of action to be approved and launched anywhere in the world. In addition, 23 novel line extensions (i...
January 2017: Drugs of Today
https://www.readbyqxmd.com/read/28379794/clinical-trials-series-%C3%A2-large-pharma
#17
LETTER
Michael Rosenblatt
No abstract text is available yet for this article.
April 6, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28376614/benchmarking-a-fast-proton-titration-scheme-in-implicit-solvent-for-biomolecular-simulations
#18
Fernando Luis Barroso da Silva, Donal MacKernan
pH is a key parameter for technological and biological processes, intimately related with biomolecular charge. As such, it controls biomolecular conformation and inter molecular interactions, for example protein/RNA stability and folding, enzyme activity, regulation through conformational switches,protein-polyelectrolyte association, and protein-RNA interactions. pH also plays an important role in technological systems in food, brewing, pharma, bioseparations and biomaterials in general. Predicting the structure of large proteins and complexes remains a great challenge, experimentally; industrially; and theoretically, despite the variety of numerical schemes available ranging from Poisson-Boltzmann approaches to explicit solvent based methods...
April 4, 2017: Journal of Chemical Theory and Computation
https://www.readbyqxmd.com/read/28369768/pharma-perspective-on-drug-repurposing
#19
REVIEW
Y Cha, T Erez, I J Reynolds, D Kumar, J Ross, G Koytiger, R Kusko, B Zeskind, S Risso, E Kagan, S Papapetropoulos, I Grossman, D Laifenfeld
Drug repurposing holds the potential to bring medications with known safety profiles to new patient populations. Numerous examples exist for the identification of new indications for existing molecules, most stemming from serendipitous findings or focused recent efforts specifically limited to the mode of action of a specific drug. In recent years, the need for new approaches to drug R&D, combined with the advent of big-data repositories and associated analytics has generated interest in developing systematic approaches to drug repurposing...
March 29, 2017: British Journal of Pharmacology
https://www.readbyqxmd.com/read/28363098/brand-to-generic-levetiracetam-switch-in-patients-with-epilepsy-in-a-routine-clinical-setting
#20
Sofia Markoula, Dimitrios Chatzistefanidis, Stylianos Gatzonis, Anna Siatouni, Eleftheria Siarava, Anastasia Verentzioti, Athanassios P Kyritsis, Philip N Patsalos
PURPOSE: The therapeutic equivalence of generic and brand antiepileptic drugs, based on studies performed on healthy volunteers, has been questioned. We compare, in a routine clinical setting, brand versus generic levetiracetam (LEV) bioequivalence in patients with epilepsy and also the clinical efficacy and tolerability of the substitution. METHODS: A prospective, open-label, non-randomized, steady-state, multiple-dose, bioequivalence study was conducted in 12 patients with epilepsy (5 females), with a mean age of 38...
March 19, 2017: Seizure: the Journal of the British Epilepsy Association
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