Networking Breakfast with ASBMR Leaders, NIH Representatives And
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Enzymatic Assay of L-METHIONINE GAMMA-LYASE (EC 4.4.1.11)
Enzymatic Assay of L-METHIONINE GAMMA-LYASE (EC 4.4.1.11) PRINCIPLE: L-Methionine Gamma-Lyase L-Methionine > Methanethiol + 2-Ketobutyrate + NH3 2-Ketobutyrate + MBTH > Azine Derivative Abbreviation used: MBTH = 3-Methyl-2-Benzothiazolinone CONDITIONS: T = 37°C, pH = 8.0, A320nm, Light path = 1 cm METHOD: Stopped Spectrophotometric Rate Determination REAGENTS: A. 100 mM Potassium Phosphate Buffer with 25 mM L-Methionine and 0.01 mM Pyridoxal 5-Phosphate, pH 8.0 at 37°C1 (Prepare 100 ml in deionized water using Potassium Phosphate, Monobasic, Anhydrous, Sigma Prod. No. P-5379, L-Methionine, Sigma Prod. No. M-9625, and Pyridoxal 5-Phosphate, Sigma Prod. No. P-9255. Adjust to pH 8.0 at 37°C with 5 M KOH.) B. 50% (w/v) Trichloroacetic Acid Solution (TCA) (Prepare 5 ml in deionized water using Trichloroacetic Acid, 6.1 N Solution, approximately 100% (w/v), Sigma Stock No. 490-10.) C. 1 M Sodium Acetate Buffer, pH 5.0 at 37°C (NaOAC) (Prepare 100 ml in deionized water using Sodium Acetate, Trihydrate, Sigma Prod. No. S-8625. Adjust to pH 5.0 at 37°C with 5 M HCl.) D. 0.1% (w/v) 3-Methyl-2-Benzothiazolinone Hydrazone (MBTH) (Prepare 10 ml in deionized water using 3-Methyl-2-Benzothiazolinone Hydrazone, Hydrochloride Hydrate, Sigma Prod. No. M-8006.) SSMETH01 Page 1 of 4 07/29/98 Enzymatic Assay of L-METHIONINE GAMMA-LYASE (EC 4.4.1.11) REAGENTS: E. 100 mM Potassium Phosphate Buffer with 1 mM Ethylenediaminetetraacetic Acid, 0.01% (v/v) 2-Mercaptoethanol and 0.02 mM Pyridoxal 5-Phosphate, pH 7.2 at 37°C (Enzyme Diluent)1 (Prepare 10 ml in deionized water using Potassium Phosphate, Monobasic, Anhydrous, Sigma Prod. -
![Lyxumia Subcutaneous Injection 300 Μg [Non-Proprietary Name] Lixisenatide (JAN*) [Name of Applicant] Sanofi K.K](https://docslib.b-cdn.net/cover/4198/lyxumia-subcutaneous-injection-300-g-non-proprietary-name-lixisenatide-jan-name-of-applicant-sanofi-k-k-324198.webp)
Lyxumia Subcutaneous Injection 300 Μg [Non-Proprietary Name] Lixisenatide (JAN*) [Name of Applicant] Sanofi K.K
Report on the Deliberation Results May 31, 2013 Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare [Brand name] Lyxumia Subcutaneous Injection 300 μg [Non-proprietary name] Lixisenatide (JAN*) [Name of applicant] Sanofi K.K. [Date of application] June 11, 2012 [Results of deliberation] In the meeting held on May 24, 2013, the First Committee on New Drugs concluded that the product may be approved and that this result should be reported to the Pharmaceutical Affairs Department of the Pharmaceutical Affairs and Food Sanitation Council. The re-examination period for the product is 8 years, and the drug substance and the drug product are both classified as powerful drugs and the product is not classified as a biological product or a specified biological product. The proposed Japanese brand name should be changed for ensuring medical safety. *Japanese Accepted Name (modified INN) This English version of the Japanese review report is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. The PMDA will not be responsible for any consequence resulting from the use of this English version. Review Report May 7, 2013 Pharmaceuticals and Medical Devices Agency The results of a regulatory review conducted by the Pharmaceuticals and Medical Devices Agency on the following pharmaceutical product submitted for registration are as follows. [Brand name] Lyxumia Subcutaneous -
Classification Decisions Taken by the Harmonized System Committee from the 47Th to 60Th Sessions (2011
CLASSIFICATION DECISIONS TAKEN BY THE HARMONIZED SYSTEM COMMITTEE FROM THE 47TH TO 60TH SESSIONS (2011 - 2018) WORLD CUSTOMS ORGANIZATION Rue du Marché 30 B-1210 Brussels Belgium November 2011 Copyright © 2011 World Customs Organization. All rights reserved. Requests and inquiries concerning translation, reproduction and adaptation rights should be addressed to [email protected]. D/2011/0448/25 The following list contains the classification decisions (other than those subject to a reservation) taken by the Harmonized System Committee ( 47th Session – March 2011) on specific products, together with their related Harmonized System code numbers and, in certain cases, the classification rationale. Advice Parties seeking to import or export merchandise covered by a decision are advised to verify the implementation of the decision by the importing or exporting country, as the case may be. HS codes Classification No Product description Classification considered rationale 1. Preparation, in the form of a powder, consisting of 92 % sugar, 6 % 2106.90 GRIs 1 and 6 black currant powder, anticaking agent, citric acid and black currant flavouring, put up for retail sale in 32-gram sachets, intended to be consumed as a beverage after mixing with hot water. 2. Vanutide cridificar (INN List 100). 3002.20 3. Certain INN products. Chapters 28, 29 (See “INN List 101” at the end of this publication.) and 30 4. Certain INN products. Chapters 13, 29 (See “INN List 102” at the end of this publication.) and 30 5. Certain INN products. Chapters 28, 29, (See “INN List 103” at the end of this publication.) 30, 35 and 39 6. Re-classification of INN products. -
The Un-Design and Design of Insulin: Structural Evolution
THE UN-DESIGN AND DESIGN OF INSULIN: STRUCTURAL EVOLUTION WITH APPLICATION TO THERAPEUTIC DESIGN By NISCHAY K. REGE Submitted in partial fulfillment of the requirements for the degree of Doctor of Philosophy Department of Biochemistry Dissertation Advisor: Dr. Michael A. Weiss CASE WESTERN RESERVE UNIVERSITY August, 2018 CASE WESTERN RESERVE UNIVERSITY SCHOOL OF GRADUATE STUDIES We hereby approve the thesis/dissertation of Nischay K. Rege candidate for the degree of Doctor of Philosophy*. Committee Chair Paul Carey Committee Member Michael Weiss Committee Member Faramarz Ismail-Beigi Committee Member George Dubyak Date of Defense: June 26th, 2018 *We also certify that written approval has been obtained for any proprietary material contained therein. Dedication This thesis is dedicated to my mother, Dipti, whose constant love and faith have never failed, to my father, Kiran, who taught me of the virtue of curiosity, and to my wife, Shipra, whose kindness and companionship have given me enough strength for eight lifetimes. i Table of Contents Dedication ..................................................................................................................................... i Table of Contents ......................................................................................................................... ii List of Tables ............................................................................................................................... v List of Figures ........................................................................................................................... -
February 2021 EPS Pipeline Report
Pipeline Report February 2021 Pipeline Report February 2021 © 2021 Envolve. All rights reserved. Page 1 This quarterly at-a-glance publication is developed by our Clinical Pharmacy Drug Information team to increase your understanding of the drug pipeline, Table of Contents ensuring you’re equipped with insights to prepare for shifts in pharmacy benefit management. In this issue, you’ll learn more about key themes and notable drugs referenced in the following points. COVID-19 1 > Veklury is currently the only agent that is FDA-approved for the treatment of COVID-19. Three additional therapeutics and two vaccines have been granted Emergency Use Authorization (EUA), and at least three more vaccines are Recent Specialty Drug Approvals1 4 expected to receive an EUA in the relatively near future. > The previous quarter noted the approval of several breakthrough therapies for rare or ultra-rare conditions, which previously had no available FDA-approved Recent Non-Specialty Drug Approvals 9 treatments — Zokinvy for Hutchinson-Gilford progeria syndrome and progeroid laminopathies, Oxlumo for primary hyperoxaluria type 1, and Imcivree for genetically mediated obesity. Upcoming Specialty Products 10 > Other notable approvals include: Lupkynis — the first oral therapy approved for lupus nephritis; Orladeyo — the first oral therapy approved as prophylaxis of hereditary angioedema attacks;Cabenuva – the first long-acting injectable antiretroviral therapy intended as maintenance treatment of HIV; and Breyanzi — Upcoming Non-Specialty Products 18 the -
CHMP Agenda of the 19-22 April 2021 Meeting
28 July 2021 EMA/CHMP/220334/2021 Corr.11 Human Medicines Division Committee for medicinal products for human use (CHMP) Agenda for the meeting on 19-22 April 2021 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes 19 April 2021, 09:00 – 19:30, virtual meeting/ room 1C 20 April 2021, 08:30 – 19:30, virtual meeting/ room 1C 21 April 2021, 08:30 – 19:30, virtual meeting/ room 1D 22 April 2021, 08:30 – 19:00, virtual meeting/ room 1C Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). 1 Correction in section 8.1.1 Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2021. -
Genetic Studies of Leptin Concentrations Implicate Leptin in the Regulation of Early
Page 1 of 93 Diabetes Genetic studies of leptin concentrations implicate leptin in the regulation of early adiposity Hanieh Yaghootkar1,2,3*&, Yiying Zhang4&, Cassandra N Spracklen5, Tugce Karaderi6,7,8,9, Lam Opal Huang10, Jonathan Bradfield11,12, Claudia Schurmann13, Rebecca S Fine14,15,16, Michael H Preuss13, Zoltan Kutalik1,17,18, Laura BL Wittemans6,19, Yingchang Lu13,20, Sophia Metz10, Sara M Willems19, Ruifang Li-Gao21, Niels Grarup10, Shuai Wang22, Sophie Molnos23,24, América A Sandoval-Zárate25, Mike A Nalls26,27, Leslie A Lange28, Jeffrey Haesser29, Xiuqing Guo30, Leo-Pekka Lyytikäinen31,32, Mary F Feitosa33, Colleen M Sitlani34, Cristina Venturini35, Anubha Mahajan6,36, Tim Kacprowski37,38, Carol A Wang22, Daniel I Chasman39,40, Najaf Amin41, Linda Broer42, Neil Robertson6,36, Kristin L Young43, Matthew Allison44, Paul L Auer45, Matthias Blüher46, Judith B Borja47,48, Jette Bork-Jensen10, Germán D Carrasquilla10, Paraskevi Christofidou35, Ayse Demirkan41, Claudia A Doege49, Melissa E Garcia50, Mariaelisa Graff43,51, Kaiying Guo4, Hakon Hakonarson11,52, Jaeyoung Hong22, Yii-Der Ida Chen30, Rebecca Jackson53, Hermina Jakupović10, Pekka Jousilahti54, Anne E Justice55, Mika Kähönen56,57, Jorge R Kizer58,59, Jennifer Kriebel23,24, Charles A LeDuc4, Jin Li60, Lars Lind61, Jian’an Luan19, David Mackey62, Massimo Mangino35,63, Satu Männistö54, Jayne F Martin Carli4, Carolina Medina-Gomez41,42, Dennis O Mook-Kanamori21,64, Andrew P Morris65,6,66, Renée de Mutsert21, Matthias Nauck67,38, Ivana Nedeljkovic41, Craig E Pennell22, Arund D Pradhan39,40, Bruce M Psaty68,69, Olli T Raitakari70,71,72, Robert A Scott19, Tea Skaaby73, Konstantin Strauch74,75, Kent D Taylor30, Alexander Teumer76,38, Andre G Uitterlinden41,42, Ying Wu5, Jie Yao30, Mark Walker77, Kari E North43, Peter Kovacs46, M. -
OBSERVATIONS Sured, As Indicated in Fig
LETTERS blood glucose concentrations were mea- lispro at 40 Ϯ 3 min and aspart at 49 Ϯ 3 OBSERVATIONS sured, as indicated in Fig. 1. If blood glu- min after injection, respectively (P ϭ cose was 3.5 mmol/l or lower, 20 ml 0.01). The maximum insulin concentra- glucose 30% was injected. One patient tion was 316 Ϯ 31 pmol/l on insulin lis- Direct Comparison of was excluded from the analysis because, pro and 295 Ϯ 27 pmol/l on insulin by mistake, he took a large extra dose of aspart (NS) (Fig. 1). The increase from 0 Insulin Lispro and insulin the night before the study. to 15 min after injection was 109 Ϯ 17 Aspart Shows Small Free insulin was measured after poly- pmol/l after injection of insulin lispro and Differences in ethylene glycol precipitation by Mercodia 53 Ϯ 11 pmol/l after injection of insulin Iso-Insulin (ELISA; Mercodia AB, Uppsala, Plasma Insulin aspart (P ϭ 0.02). Fasting insulin lispro Sweden), a two-site enzyme immunoassay levels reached 50% of peak concentration Profiles After containing two monoclonal antibodies at 20 Ϯ 1 min and aspart at 30 Ϯ 3 min against insulin. Identical results were ob- (P ϭ 0.02) (Fig. 2). The decrease of free Subcutaneous tained when equimolar concentrations of Injection in Type 1 insulin concentration from peak concen- human insulin, insulin lispro, and insulin tration to 50% of the maximum concen- aspart were tested, indicating 100% Diabetes tration was found at 113 Ϯ 10 min during cross-reactivity between lispro, aspart, insulin lispro and 154 Ϯ 14 min during and human insulin in this assay. -
INN-Nimet 1 1.4.2019 a Abacavir Abacavirum Abakaviiri Abagovomab Abagovomabum Abagovomabi Abaloparatide Abaloparatidum Abalopara
INN-nimet Lääkealan turvallisuus- ja kehittämiskeskus Säkerhets- och utvecklingscentret för läkemedelsområdet Finnish Medicines Agency 1.4. -
Thionein Can Serve As a Reducing Agent for the Methionine Sulfoxide Reductases
Thionein can serve as a reducing agent for the methionine sulfoxide reductases Daphna Sagher*†, David Brunell*†, J. Fielding Hejtmancik‡, Marc Kantorow*, Nathan Brot§, and Herbert Weissbach*¶ *Center for Molecular Biology and Biotechnology, Florida Atlantic University, Boca Raton, FL 33431; ‡Ophthalmic Genetic and Visual Function Branch, National Eye Institute, National Institutes of Health, Bethesda, MD 20892; and §Department of Microbiology and Immunology, Hospital for Special Surgery, Cornell University Medical Center, New York, NY 10021 Contributed by Herbert Weissbach, April 7, 2006 It has been generally accepted, primarily from studies on methio- not been reported. Most in vitro studies have used DTT as the nine sulfoxide reductase (Msr) A, that the biological reducing agent reducing agent for both MsrA and MsrB, because this agent for the members of the Msr family is reduced thioredoxin (Trx), works very well with the Msr family of proteins. although high levels of DTT can be used as the reductant in vitro. Recently, the human MsrB genes have been of interest to us as Preliminary experiments using both human recombinant MsrB2 part of our studies on the role of the Msr system in protecting lens (hMsrB2) and MsrB3 (hMsrB3) showed that although DTT can and retinal cells against oxidative damage (18–20). Using a color- function in vitro as the reducing agent, Trx works very poorly, imetric assay for Msr activity, based on the reduction of the prompting a more careful comparison of the ability of DTT and Trx individual epimers of 4-N,N-dimethylaminoazobenzene-4-sulfonyl to function as reducing agents with the various members of the (DABS)-Met(o), we were surprised to find that Trx serves very Msr family. -
![Newborn Screening ACT Sheet [Increased Methionine] Homocystinuria (CBS Deficiency)](https://docslib.b-cdn.net/cover/6249/newborn-screening-act-sheet-increased-methionine-homocystinuria-cbs-deficiency-2586249.webp)
Newborn Screening ACT Sheet [Increased Methionine] Homocystinuria (CBS Deficiency)
American College of Medical Genetics ACT SHEET Newborn Screening ACT Sheet [Increased Methionine] Homocystinuria (CBS Deficiency) Differential Diagnosis: Classical homocystinuria (cystathionine ß-synthase (CBS) deficiency); hypermethioninemia due to methionine adenosyltransferase I/III (MAT I/III) deficiency; glycine n-methyltransferase (GNMT) deficiency; adenosylhomocysteine hydrolase deficiency; liver disease; hyperalimentation. Condition Description: Methionine from ingested protein is normally converted to homocysteine. In classical homocystinuria due to CBS deficiency, homocysteine cannot be converted to cystathionine. As a result, the concentration of homocysteine and its precursor, methionine, will become elevated. In MAT I/III deficiency and the other hypermethioninemias, methionine is increased in the absence of or only with a slightly increased level of homocysteine. YOU SHOULD TAKE THE FOLLOWING ACTIONS: . Contact family to inform them of the newborn screening result and ascertain clinical status. Consult with pediatric metabolic specialist. Evaluate the newborn with attention to liver disease and refer as appropriate. Initiate confirmatory/diagnostic tests in consultation with metabolic specialist. Educate family about homocystinuria and its management, as appropriate. Report findings to newborn screening program. Diagnostic Evaluation: Quantitative plasma amino acids will show increased homocystine and methionine in classical homocystinuria but only increased methionine in the other disorders. Plasma homocysteine analysis will show markedly increased homocysteine in classical homocystinuria and normal or only slightly increased homocysteine in the other disorders. Urine homocysteine is markedly increased in classical homocystinuria. Clinical Considerations: Homocystinuria is usually asymptomatic in the neonate. If untreated, these children eventually develop mental retardation, ectopia lentis, a marfanoid appearance including arachnodactyly, osteoporosis, other skeletal deformities and thromboembolism. MAT I/III deficiency may be benign. -
Transfer of Β-Hydroxy-Β-Methylbutyrate from Sows to Their
Wan et al. Journal of Animal Science and Biotechnology (2017) 8:2 DOI 10.1186/s40104-016-0132-6 RESEARCH Open Access Transfer of β-hydroxy-β-methylbutyrate from sows to their offspring and its impact on muscle fiber type transformation and performance in pigs Haifeng Wan†, Jiatao Zhu†, Caimei Wu†, Pan Zhou, Yong Shen, Yan Lin, Shengyu Xu, Lianqiang Che, Bin Feng, Jian Li, Zhengfeng Fang and De Wu* Abstract Background: Previous studies suggested that supplementation of lactating sows with β-hydroxy-β-methylbutyrate (HMB) could improve the performance of weaning pigs, but there were little information in the muscle fiber type transformation of the offspring and the subsequent performance in pigs from weaning through finishing in response to maternal HMB consumption. The purpose of this study was to determine the effect of supplementing lactating sows with HMB on skeletal muscle fiber type transformation and growth of the offspring during d 28 and 180 after birth. A total of 20 sows according to their body weight were divided into the control (CON, n = 10) or HMB groups (HMB, n = 10). Sows in the HMB group were supplemented with β-hydroxy-β-methylbutyrate calcium (HMB-Ca) 2 g /kg feed during d 1 to 27 of lactation. After weaning, 48 mixed sex piglets were blocked by sow treatment and fed standard diets for post-weaning, growing, finishing periods. Growth performance was recorded during d 28 to 180 after birth. Pigs were slaughtered on d 28 (n = 6/treatment) and 180 (n = 6/treatment) postnatal, and the longissimus dorsi (LD) was collected, respectively.