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https://www.readbyqxmd.com/read/28635655/from-farm-to-pharma-an-overview-of-industrial-heparin-manufacturing-methods
#1
REVIEW
Jan-Ytzen van der Meer, Edwin Kellenbach, Leendert J van den Bos
The purification of heparin from offal is an old industrial process for which commercial recipes date back to 1922. Although chemical, chemoenzymatic, and biotechnological alternatives for this production method have been published in the academic literature, animal-tissue is still the sole source for commercial heparin production in industry. Heparin purification methods are closely guarded industrial secrets which are not available to the general (scientific) public. However by reviewing the academic and patent literature, we aim to provide a comprehensive overview of the general methods used in industry for the extraction of heparin from animal tissue...
June 21, 2017: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
https://www.readbyqxmd.com/read/28631242/relationship-between-duration-of-type-2-diabetes-and-effectiveness-of-dpp-4-inhibitor-versus-sulfonylurea-as-add-on-therapy-a-post-hoc-analysis
#2
Helmut Brath, Päivi M Paldánius, Giovanni Bader, Chantal Mathieu
INTRODUCTION: To assess the impact of duration of type 2 diabetes on glucose-lowering effectiveness of the dipeptidyl peptidase-4 (DPP-4) inhibitor vildagliptin versus sulfonylureas (SUs) in a real-life setting. METHODS: Data were extracted from the large 1-year, observational EDGE study (N = 45,868). Patients receiving either DPP-4 inhibitor or any SU as add-on to monotherapy were selected (N = 36,164). Impact of the disease duration on change in glycated hemoglobin (HbA1c) levels was evaluated by using a linear multiple regression model...
June 19, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28631217/24-month-open-label-teriparatide-once-weekly-efficacy-research-trial-examining-bone-mineral-density-in-subjects-with-primary-osteoporosis-and-high-fracture-risk
#3
Toshitsugu Sugimoto, Masataka Shiraki, Masao Fukunaga, Hiroshi Hagino, Teruki Sone, Tetsuo Nakano, Hideaki Kishimoto, Masako Ito, Hideki Yoshikawa, Mitsukazu Kishida, Chika Irie, Toshitaka Nakamura
INTRODUCTION: To clarify the additional efficacy and safety benefits of 24 months' treatment with the once-weekly formulation of teriparatide, which is currently used for 72 weeks. METHODS: This was a multicenter, open-label, single-arm study conducted in Japan. Subjects who were 65 years or older with prevalent vertebral fractures received once-weekly subcutaneous injection of 56.5 μg teriparatide for 24 months. The main outcome measure was percentage change from baseline in lumbar (L2-L4) BMD measured by dual-energy X-ray absorptiometry...
June 19, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28631216/safety-and-tolerability-of-empagliflozin-in-patients-with-type-2-diabetes-pooled-analysis-of-phase-i-iii-clinical-trials
#4
Sven Kohler, Cordula Zeller, Hristo Iliev, Stefan Kaspers
INTRODUCTION: We characterized the safety and tolerability of empagliflozin in patients with type 2 diabetes (T2DM) randomized 1:1:1 to placebo, empagliflozin 10 mg, or empagliflozin 25 mg in clinical trials. METHODS: Pooled data were analyzed from patients with T2DM treated with placebo (N = 4203), empagliflozin 10 mg (N = 4221), or empagliflozin 25 mg (N = 4196) in 15 randomized phase I-III trials plus four extension studies. Adverse events (AEs) were assessed descriptively in participants who took at least one dose of study drug...
June 19, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28630367/health-canada-wants-more-funds-from-pharma
#5
Lauren Vogel
No abstract text is available yet for this article.
June 19, 2017: CMAJ: Canadian Medical Association Journal, Journal de L'Association Medicale Canadienne
https://www.readbyqxmd.com/read/28626119/eco-pharma-of-approved-drug-focused-on-mitochondria-fission
#6
Tsukasa Shimauchi, Akiyuki Nishimura, Tatsuya Ishikawa, Motohiro Nishida
No abstract text is available yet for this article.
2017: Nihon Yakurigaku Zasshi. Folia Pharmacologica Japonica
https://www.readbyqxmd.com/read/28625625/economic-burden-of-clinical-trials-in-lung-cancer-in-a-german-comprehensive-cancer-center
#7
F Kron, A Kostenko, M Scheffler, D Müller, J-P Glossmann, R Fischer, S Michels, L Nogova, M Hallek, T Zander, J Wolf
OBJECTIVES: The recent success of individualized lung cancer therapy has triggered fundamental changes in clinical research strategies. To date there is a strong focus on early proof of concept trials in genetically preselected small patient subgroups. This analysis focuses on the economic burden caused by such trials for advanced lung cancer patients in a German Comprehensive Cancer Center (CCC). METHODS: The profit margins between recruiting groups with ≤3 and >3 patients were compared...
June 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28624633/from-flamingo-dance-to-desirable-drug-discovery-a-nature-inspired-approach
#8
REVIEW
Aminael Sánchez-Rodríguez, Yunierkis Pérez-Castillo, Stephan C Schürer, Orazio Nicolotti, Giuseppe Felice Mangiatordi, Fernanda Borges, M Natalia D S Cordeiro, Eduardo Tejera, José L Medina-Franco, Maykel Cruz-Monteagudo
The therapeutic effects of drugs are well known to result from their interaction with multiple intracellular targets. Accordingly, the pharma industry is currently moving from a reductionist approach based on a 'one-target fixation' to a holistic multitarget approach. However, many drug discovery practices are still procedural abstractions resulting from the attempt to understand and address the action of biologically active compounds while preventing adverse effects. Here, we discuss how drug discovery can benefit from the principles of evolutionary biology and report two real-life case studies...
June 14, 2017: Drug Discovery Today
https://www.readbyqxmd.com/read/28623625/switching-between-reference-biologics-and-biosimilars-for-the-treatment-of-rheumatology-gastroenterology-and-dermatology-inflammatory-conditions-considerations-for-the-clinician
#9
REVIEW
Robert Moots, Valderilio Azevedo, Javier L Coindreau, Thomas Dörner, Ehab Mahgoub, Eduardo Mysler, Morton Scheinberg, Lisa Marshall
PURPOSE OF REVIEW: Biosimilars of the reference biologic therapeutics infliximab, etanercept, adalimumab, and rituximab are entering the market. Clinical and real-world data on the effects of reference → biosimilar switching are limited. This review was carried out to assess the current body of switching data. RECENT FINDINGS: Fifty-three switching studies were identified. Infliximab publications covered CT-P13 (25 studies), SB2 (1), infliximab NK (1), and unspecified infliximab biosimilars (2)...
June 2017: Current Rheumatology Reports
https://www.readbyqxmd.com/read/28616853/comparison-of-the-simple-patient-centric-atopic-dermatitis-scoring-system-pest-with-scorad-in-young-children-using-a-ceramide-dominant-therapeutic-moisturizer
#10
Mark Jean-Ann Koh, Yoke Chin Giam, Hui Min Liew, Alice Yee-Wah Foong, Chong Jin Ho, Sharon Mun Yee Wong, Mark Boon Yang Tang, Madeline Sheun Ling Ho, Lucinda Siyun Tan, James M Mason, Michael J Cork
INTRODUCTION: Patient eczema severity time (PEST) is a new atopic dermatitis (AD) scoring system based on patients' own perception of their disease. Conventional scales such as SCORing of atopic dermatitis (SCORAD) reflect the clinician's observations during the clinic visit. Instead, the PEST score captures eczema severity, relapse and recovery as experienced by the patient or caregiver on a daily basis, promoting patient engagement, compliance with treatment and improved outcomes. This study aims to determine the correlation between carer-assessed PEST and clinician-assessed SCORAD in paediatric AD patients after 12 weeks of treatment using a ceramide-dominant therapeutic moisturizer...
June 14, 2017: Dermatology and Therapy
https://www.readbyqxmd.com/read/28616806/ipragliflozin-reduces-epicardial-fat-accumulation-in-non-obese-type-2-diabetic-patients-with-visceral-obesity-a-pilot-study
#11
Tatsuya Fukuda, Ryotaro Bouchi, Masahiro Terashima, Yuriko Sasahara, Masahiro Asakawa, Takato Takeuchi, Yujiro Nakano, Masanori Murakami, Isao Minami, Hajime Izumiyama, Koshi Hashimoto, Takanobu Yoshimoto, Yoshihiro Ogawa
INTRODUCTION: Epicardial fat (EF) was reported to be independently associated with cardiovascular disease regardless of obesity. We have previously reported that a sodium-glucose co-transporter-2 (SGLT2) inhibitor, luseogliflozin, reduces the EF volume (EFV) in parallel with the reduction of body weight in obese patients (BMI ≥25 kg/m(2)) with type 2 diabetes. However, it is unknown whether SGLT2 inhibitors could reduce EFV in non-obese patients (BMI <25 kg/m(2)) with type 2 diabetes...
June 14, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28603465/spinal-cord-as-an-adjunct-to-brain-magnetic-resonance-imaging-in-defining-no-evidence-of-disease-activity-in-multiple-sclerosis
#12
Subhash Tummala, Tarun Singhal, Vinit V Oommen, Gloria Kim, Fariha Khalid, Brian C Healy, Rohit Bakshi
ACTIVITY AVAILABLE ONLINE: To access the article, post-test, and evaluation online, go to http://www.cmscscholar.org. TARGET AUDIENCE: The target audience for this activity is physicians, physician assistants, nursing professionals, and other health-care providers involved in the management of patients with multiple sclerosis (MS). LEARNING OBJECTIVES: 1) Describe the concept of "no evidence of disease activity" in MS.2) Recognize the role of spinal cord imaging in routine monitoring of MS disease activity...
May 2017: International Journal of MS Care
https://www.readbyqxmd.com/read/28602331/ocular-tolerance-in-rabbits-after-intracameral-administration-of-a-fixed-combination-of-tropicamide-phenylephrine-and-lidocaine-with-and-without-rinsing
#13
Rudy M M A Nuijts, Rita Mencucci, Karen Viaud-Quentric, Pierre-Paul Elena, Céline Olmière, Anders Behndig
PURPOSE: To evaluate the safety and tolerability of a single intracameral administration of a combined mydriatic (tropicamide and phenylephrine) and anesthetic (lidocaine) formulation (Mydrane) with or without rinsing. SETTING: Iris Pharma, La Gaude, France. DESIGN: Experimental study. METHODS: Sixty pigmented rabbits received 100 μL or 200 μL of the combination product or a placebo (sodium chloride 0.9%) by intracameral injection...
May 2017: Journal of Cataract and Refractive Surgery
https://www.readbyqxmd.com/read/28601342/organ-preservation-for-rectal-cancer-greccar-2-a-prospective-randomised-open-label-multicentre-phase-3-trial
#14
Eric Rullier, Philippe Rouanet, Jean-Jacques Tuech, Alain Valverde, Bernard Lelong, Michel Rivoire, Jean-Luc Faucheron, Mehrdad Jafari, Guillaume Portier, Bernard Meunier, Igor Sileznieff, Michel Prudhomme, Frédéric Marchal, Marc Pocard, Denis Pezet, Anne Rullier, Véronique Vendrely, Quentin Denost, Julien Asselineau, Adélaïde Doussau
BACKGROUND: Organ preservation is a concept proposed for patients with rectal cancer after a good clinical response to neoadjuvant chemotherapy, to potentially avoid morbidity and side-effects of rectal excision. The objective of this study was to compare local excision and total mesorectal excision in patients with a good response after chemoradiotherapy for lower rectal cancer. METHODS: We did a prospective, randomised, open-label, multicentre, phase 3 trial at 15 tertiary centres in France that were experts in the treatment of rectal cancer...
June 7, 2017: Lancet
https://www.readbyqxmd.com/read/28595756/impact-of-generic-substitution-on-levetiracetam-serum-concentration-a-prospective-study-in-an-outpatient-setting
#15
Arne Reimers, Patrik Olsson, Johanna Nilsson, Elin Hoff, Margareta Reis, Maria Strandberg, Anders Lundgren, Kristina Källén
BACKGROUND: Switching patients from a branded antiepileptic drug (AED) to a generic is often challenging. Several studies have shown that considerable proportions of patients report deteriorated seizure control or increased adverse effects, enforcing a switchback to the original drug. Since tolerability and seizure control usually correlate with AED serum concentrations, we examined the fluctuation of levetiracetam (LEV) serum concentrations in patients with epilepsy before and after generic substitution...
August 2017: Epilepsy Research
https://www.readbyqxmd.com/read/28583429/towards-the-virtual-human-patient-quantitative-systems-pharmacology-in-alzheimer-s-disease
#16
Hugo Geerts, Athan Spiros, Patrick Roberts, Robert Carr
Development of successful therapeutic interventions in Central Nervous Systems (CNS) disorders is a daunting challenge with a low success rate. Probable reasons include the lack of translation from preclinical animal models, the individual variability of many pathological processes converging upon the same clinical phenotype, the pharmacodynamical interaction of various comedications and last but not least the complexity of the human brain. This paper argues for a re-engineering of the pharmaceutical CNS Research & Development strategy using ideas focused on advanced computer modeling and simulation from adjacent engineering-based industries...
June 2, 2017: European Journal of Pharmacology
https://www.readbyqxmd.com/read/28580435/the-national-heart-lung-and-blood-institute-small-business-program-a-comprehensive-ecosystem-for-biomedical-product-development
#17
Kurt W Marek
Small companies working to develop products in the cardiovascular space face numerous challenges, from regulatory, intellectual property, and reimbursement barriers to securing funds to keep the lights on and reach the next development milestone. Most small companies that spin out from universities have the scientific knowledge, but product development expertise and business acumen are also needed to be successful. Other challenges include reduced interest in early stage technologies (Pharma & Biotech 2015 in Review, EP Vantage) and limited deal flow for cardiovascular products (Gormley B...
December 2016: JACC. Basic to Translational Science
https://www.readbyqxmd.com/read/28550997/prescription-errors-related-to-the-use-of-computerized-provider-order-entry-system-for-pediatric-patients
#18
Kamel Alhanout, Sok-Siya Bun, Karine Retornaz, Laurent Chiche, Nathalie Colombini
OBJECTIVES: To evaluate the nature and frequency of medication errors resulting from the use of a computerized provider order-entry (CPOE) system in a pediatric department. METHODS: We conducted a retrospective study to examine errors related to computerized orders using the software Pharma(®) (Computer Engineering, France) in pediatric department between 31/05/2015 to 01/12/2015. These errors were signaled by pharmacists who examine CPOEs daily. RESULTS: A total of 302 pharmacist interventions (PharmInt) were carried out by clinical pharmacists during the study period...
July 2017: International Journal of Medical Informatics
https://www.readbyqxmd.com/read/28550592/certolizumab-pegol-for-treating-rheumatoid-arthritis-following-inadequate-response-to-a-tnf-%C3%AE-inhibitor-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#19
REVIEW
Iñigo Bermejo, Matt Stevenson, Rachel Archer, John W Stevens, Edward Goka, Mark Clowes, David L Scott, Adam Young
As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer (UCB Pharma) of certolizumab pegol (CZP; Cimzia(®)) to submit evidence of its clinical and cost effectiveness for the treatment of rheumatoid arthritis (RA) following inadequate response to a tumour necrosis factor-α inhibitor (TNFi). The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG)...
May 26, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28541926/addition-of-omega-3-fatty-acid-and-coenzyme-q10-to-statin-therapy-in-patients-with-combined-dyslipidemia
#20
Štefan Tóth, Matej Šajty, Tímea Pekárová, Adil Mughees, Peter Štefanič, Matan Katz, Katarína Spišáková, Jozef Pella, Daniel Pella
BACKGROUND: Statins represent a group of drugs that are currently indicated in the primary and secondary prevention of cardiovascular events. Their administration can be associated with side effects and the insufficient reduction of triacylglyceride (TAG) levels. This study aimed to assess the effect of the triple combination of statins with omega-3 fatty acids and coenzyme Q10 (CoQ10) on parameters associated with atherogenesis and statin side effects. MATERIALS AND METHODS: In this pilot randomized double-blind trial, 105 subjects who met the criteria of combined dislipidemia and elevated TAG levels were randomly divided into three groups...
May 23, 2017: Journal of Basic and Clinical Physiology and Pharmacology
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