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Mohammad Reza Bagherinejad, Hamid Mir-Mohammad Sadeghi, Daryoush Abedi, Fateme Moazen, Mohammad Rabbani
Background: Twine-arginine translocation (TAT) system is one of the exporting systems in Escherichia coli which could transport fully/semi-correctly folded proteins outside the reductive cytoplasmic space. In combination with co-expression with a chaperone system, the correctly folded proteins could be transported to oxidative periplasmic space and culture media to pass the main limitations in E. coli expression system such as misfolding and inclusion body formation. Materials and Methods: To study the effectiveness of signaling sequences and chaperone co-expression on the translocation of expressed protein, somatropin was selected as the target...
2018: Advanced Biomedical Research
Fadi Farhat, Alfredo Torres, Wungki Park, Gilberto de Lima Lopes, Raja Mudad, Chukwuemeka Ikpeazu, Simon Abi Aad
Biologic agents are currently the fastest emerging segment of drug expenditure. Unlike chemically synthesized small-molecule drugs, biologics are more complex, medicinal products produced by a living organism. They have become part of the standard of care in the treatment of a large variety of diseases, such as growth disorders, autoimmune diseases, cancer, cardiovascular illnesses, hemophilia, and rare genetic conditions, to name a few. Biosimilars, which are copies of biologics that are highly similar, were introduced in the market with an aim to offer efficacy that is not clinically different from the originator or reference product, at lower prices...
December 28, 2017: Oncologist
Heike Hoyer-Kuhn, Jeremy Franklin, Christine Jones, Werner F Blum, Eckhard Schoenau
Background Growth hormone (GH) treatment in children with short stature homeobox-containing gene (SHOX) deficiency is recognized to increase height velocity (HV) and adult height. Prediction of growth response continues to be a challenge. A comparatively accurate method is the Cologne prediction model developed in children with GH deficiency. The aim was to investigate whether this model also applies to patients with SHOX deficiency. Methods Included were 48 patients with SHOX deficiency confirmed by DNA analysis and treated with 0...
January 26, 2018: Journal of Pediatric Endocrinology & Metabolism: JPEM
Sreedhar Sagi, Hillel P Cohen, Gillian R Woollett
It is important that systems are in place to ensure that appropriate and comprehensive records are kept for use of all medications. It is fundamental to an effective pharmacovigilance system that patient medical records contain sufficient information to identify which medication has been prescribed, when it was administered, and at what dose. The availability of biologics from multiple sponsors has raised questions by some health care providers about the ability of current pharmacovigilance systems to trace specific biologics...
December 2017: Journal of Managed Care & Specialty Pharmacy
Ch O Jacke, F Wild
Personalized medicines such as biologics and their generic equivalents, biosimilars, are pouring onto the pharmaceutical markets. Data of 16 private health insurance companies were used to describe the market shares of selected biosimilars available in 2014 and 2015. The purpose of this study focuses on the question of whether market access of biosimilars will lead to a price competition of the expense of innovation competition. The results show that prescriptions of biosimilars made up 37% of total prescriptions in 2015 compared to 35% in 2014, and that their share of prescription costs went up from 21% to 23% in the same period...
December 15, 2016: Versicherungsmedizin
Keiichi Ozono, Tsutomu Ogata, Reiko Horikawa, Yoichi Matsubara, Yoshihisa Ogawa, Keiji Nishijima, Susumu Yokoya
This randomized double-blind multicenter trial (NCT01927861) evaluated the growth-promoting effect and safety of Norditropin(®) (NN220; somatropin) in Japanese children with short stature due to Noonan syndrome. Prepubertal children aged 3-<11 years (boys) or 3-<10 years (girls) with Noonan syndrome were randomized to receive GH 0.033 mg/kg/day (n = 25, mean age 6.57 years, 11 females) or 0.066 mg/kg/day (n = 26, mean age 6.06 years, eight females) for 104 weeks. Change in height standard deviation score (HSDS) from baseline was analyzed based on an ANCOVA model...
November 7, 2017: Endocrine Journal
Régis Coutant, Clémentine Dupuis, Patricia Pigeon, Phillipe Rebaud
BACKGROUND: A questionnaire-based survey was conducted to evaluate attitudes towards a reusable self-injection system, SurePal™, among paediatric patients with growth disturbances who were prescribed treatment with somatropin (Omnitrope(®)) as part of routine clinical practice. METHODS: This cross-sectional survey was incorporated into the multinational, multi-centre, noninterventional PAtients TReated with Omnitrope(®) (PATRO) Children study. Questions were mainly focused on five areas: the attractiveness of SurePal™; training received; use of the device; opinion of the low-drug wastage system; experience compared with previous devices used (among pretreated patients)...
September 2017: Therapeutic Advances in Endocrinology and Metabolism
Poupak Rahimzadeh, Farnad Imani, Seyed-Hamid-Reza Faiz, Mahmoud-Reza Alebouyeh, Damoon Azad-Ehyaei, Leila Bahari, Arash Memarian, Kyung-Hoon Kim
INTRODUCTION: Intra-articular injections of platelet rich plasma (PRP) for the treatment of knee osteoarthritis have been shown to reduce pain and improve joint function. The aim of this study is to examine the joint function by adding intra-articular growth hormone to platelet rich plasma. This study was performed on the individuals with knee osteoarthritis and under ultrasound guidance. METHODS: Fifty four patients who were scheduled for ultra-sound guided intra-articular injection were enrolled in the study...
December 2016: Anesthesiology and Pain Medicine
F Y Tian, B Wu, T Xu, X H Jiang
Objective: To systcmatically evaluate the effectiveness and safety of recombinant human growth hormone (rhGH) in treating adults with severe burn. Methods: Databases including PubMed, Cochrane Library, and Embase were searched using key words " burns, thermal, human growth hormone, growth hormone, hGH, and somatropin (human)" , and China Biology Medicine disc, Chinese Journals Full-text Database, VIP Database, and Wanfang Database were searched using key words in Chinese version "," to obtain the randomized controlled trials about rhGH in the treatment of adults with severe burn from the establishment of each database to December 2016...
September 20, 2017: Zhonghua Shao Shang za Zhi, Zhonghua Shaoshang Zazhi, Chinese Journal of Burns
Hitoshi Ishii, Akira Shimatsu, Hiromi Nishinaga, Osamu Murai, Kazuo Chihara
OBJECTIVE: Improvement of quality of life (QOL) by growth hormone (GH) therapy was not demonstrated in Japanese adult growth hormone deficiency (AGHD) patients by either the QOL Assessment of Growth Hormone Deficiency in Adults or the Questions on Life Satisfaction-Hypopituitarism, which are widely used to evaluate QOL in Western AGHD patients. We therefore evaluated QOL in Japanese AGHD patients receiving recombinant GH, Norditropin® (Novo Nordisk A/S, Denmark), using the newly developed Adult Hypopituitarism Questionnaire (AHQ)...
September 1, 2017: Growth Hormone & IGF Research
Saja Alnahar, Rachel A Elliott, Murray D Smith
Background Biological medicines are starting to lose their patent protection, so similar, inexact copies (biosimilars) are being developed and licensed. The high acquisition costs of biologics for healthcare providers could be reduced by switching to biosimilars, thus alleviating budgetary pressures and increasing patient access. Therefore, the acceptance of biosimilars by prescribers in Great Britain (GB; England, Scotland, Wales) needs to be described and understood. Objective To determine uptake of the first wave of biosimilars (somatropin, epoetin, filgrastim) by local formularies (lists of preferred medicines for prescribing in local healthcare settings)...
October 2017: International Journal of Clinical Pharmacy
Michel Polak, Jo Blair, Primoz Kotnik, Effie Pournara, Birgitte Tønnes Pedersen, Tilman R Rohrer
OBJECTIVE: To investigate the effect of age at growth hormone (GH) treatment start on near adult height (NAH) in children with isolated GH deficiency (GHD). DESIGN: NordiNet® International Outcome Study (IOS) (Nbib960128), a non-interventional, multicentre study, evaluates the long-term effectiveness and safety of Norditropin® (somatropin) (Novo Nordisk A/S) in the real-life clinical setting. METHODS: Patients (n = 172) treated to NAH (height at ≥18 years, or height velocity <2 cm/year at ≥16 (boys) or ≥15 (girls) years) were grouped by age (years) at treatment start (early (girls, <8; boys, <9), intermediate (girls, 8-10; boys, 9-11) or late (girls, >10; boys, >11)) and GHD severity (<3 ng/mL or 3 to ≤10 ng/mL)...
November 2017: European Journal of Endocrinology
Mamdouh R Rezk, Marwa F Mohamed, Faten Abdelaziz Fathalla, Mostafa A Shehata
A rapid and sensitive HPLC method was developed and validated for selective determination of the human growth hormone (hGH) somatropin in the presence of its deamidated and oxidized degradation products. Reversed-phase chromatography with an acetonitrile and ammonium bicarbonate mobile phase in gradient elution mode was used. A short run time of 15 min allowed rapid and cost-effective analysis, with an average retention time of 7.4 min for native hGH, 6.2 min for its deamidated form, and 4.3 and 6 min for its oxidized variants...
July 1, 2017: Journal of AOAC International
Paweł Kawalec, Ewa Stawowczyk, Tomas Tesar, Jana Skoupa, Adina Turcu-Stiolica, Maria Dimitrova, Guenka I Petrova, Zinta Rugaja, Agnes Männik, Andras Harsanyi, Pero Draganic
Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries. Methods: A questionnaire-based survey was conducted between November 2016 and January 2017 among experts from the following CEE countries: Bulgaria, Czech Republic, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. The requirements for the pricing and reimbursement of biosimilars were reviewed for each country...
2017: Frontiers in Pharmacology
Hossam Murad, Jana Mir Assaad, Rasha Al-Shemali, Abdul Qader Abbady
BACKGROUND: Monitoring blood levels of human growth hormone (hGH) in most children with short stature deficiencies is crucial for taking a decision of treatment with extended course of daily and expensive doses of recombinant hGH (rhGH or Somatropin(®)). Besides, misusing of rhGH by sportsmen is banned by the World Anti-Doping Agency and thus sensitive GH-detecting methods are highly welcome in this field. Nanobodies are the tiniest antigen-binding entity derived from camel heavy chain antibodies...
2017: Frontiers in Endocrinology
Nathalie Bracke, Han Yao, Evelien Wynendaele, Frederick Verbeke, Xiaolong Xu, Bert Gevaert, Alex Maes, Christophe Van de Wiele, Mike Sathekge, Sarah De Saeger, Bart De Spiegeleer
Chemical modifications on protein biopharmaceuticals introduce extra variability in addition to their inherent complexity, hence require more comprehensive analytical and functional characterization during their discovery, development, and manufacturing. Somatropin (i.e., recombinant human growth hormone, rhGH) modified with the chelating agent S-2-(4-isothiocyanatobenzyl)-1,4,7-triazacyclononane-1,4,7-triacetic acid (p-SCN-Bn-NOTA) allows the incorporation of radiometals for research and possible theranostic purposes...
February 16, 2017: Analytical Chemistry
Kira Philipsen Prahm, Ulla Feldt-Rasmussen, John Vissing
The aim was to investigate if daily low-dose treatment with recombinant human growth hormone (somatropine) can stabilize or improve muscle strength and walking capability in a patient with dominantly inherited calpainopathy. The patient was treated with daily injections of somatropine, except for a 6-month pause, over a period of 4.5 years. Efficacy was assessed by repeated muscle dynamometry tests and 6-minute walk tests (6MWT). Strength improved in most muscle groups on treatment, deteriorated in the 6-month off treatment, and improved again when treatment was resumed...
January 23, 2017: Neuromuscular Disorders: NMD
D Ferone, E Profka, V Gasco, M R Ambrosio, A Colao, C Di Somma, E Puxeddu, G Arnaldi, C Pagano, E Zecchi, A Pietropoli, P Beck-Peccoz
PURPOSE: To report the long-term effectiveness and safety of the recombinant human growth hormone Omnitrope(®), a somatropin biosimilar to Genotropin(®), in Italian patients with growth hormone deficiency (GHD) enrolled in the PATRO Adults study. METHODS: The PATRO Adults study is an ongoing observational, longitudinal, non-interventional global post-marketing surveillance study, conducted in several European countries. The primary endpoint is long-term safety; secondary endpoints include the effectiveness of Omnitrope(®), which was assessed using serum insulin-like growth factor-1 levels, body composition, bone mineral density and lipid levels...
June 2017: Journal of Endocrinological Investigation
Mamdouh R Rezk, Marwa F Mohamed, Faten Abdelaziz Fathalla, Mostafa A Shehata
A rapid and sensitive HPLC method was developedand validated for selective determination of thehuman growth hormone (hGH) somatropin in thepresence of its deamidated and oxidized degradationproducts. Reversed-phase chromatographywith an acetonitrile and ammonium bicarbonatemobile phase in gradient elution mode was used.A short run time of 15 min allowed rapid andcost-effective analysis, with an average retentiontime of 7.4 min for native hGH, 6.2 min for itsdeamidated form, and 4.3 and 6 min for its oxidizedvariants...
January 19, 2017: Journal of AOAC International
Mohammad Reza Bagherinejad, Hamid Mir-Mohammad Sadeghi, Daryoush Abedi, C Perry Chou, Fatemeh Moazen, Mohammad Rabbani
Recombinant protein production in E. coli has several advantages over other expression systems. Misfolding, inclusion body formation, and lack of eukaryotic post translational modification are the most disadvantages of this system. Exporting of correctly folded proteins to the outside of reductive cytoplasmic environment through twin-arginine system could help to pass these limiting steps. Two signal sequences, TorA and SufI are used at N-terminal of human growth hormone (hGH) bearing DsbA gene sequence at C-terminal to enhance folding...
December 2016: Research in Pharmaceutical Sciences
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