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The Activation of the Glucagon-Like Peptide-1 (GLP-1) Receptor by Peptide and Non-Peptide Ligands
The Activation of the Glucagon-Like Peptide-1 (GLP-1) Receptor by Peptide and Non-Peptide Ligands Clare Louise Wishart Submitted in accordance with the requirements for the degree of Doctor of Philosophy of Science University of Leeds School of Biomedical Sciences Faculty of Biological Sciences September 2013 I Intellectual Property and Publication Statements The candidate confirms that the work submitted is her own and that appropriate credit has been given where reference has been made to the work of others. This copy has been supplied on the understanding that it is copyright material and that no quotation from the thesis may be published without proper acknowledgement. The right of Clare Louise Wishart to be identified as Author of this work has been asserted by her in accordance with the Copyright, Designs and Patents Act 1988. © 2013 The University of Leeds and Clare Louise Wishart. II Acknowledgments Firstly I would like to offer my sincerest thanks and gratitude to my supervisor, Dr. Dan Donnelly, who has been nothing but encouraging and engaging from day one. I have thoroughly enjoyed every moment of working alongside him and learning from his guidance and wisdom. My thanks go to my academic assessor Professor Paul Milner whom I have known for several years, and during my time at the University of Leeds he has offered me invaluable advice and inspiration. Additionally I would like to thank my academic project advisor Dr. Michael Harrison for his friendship, help and advice. I would like to thank Dr. Rosalind Mann and Dr. Elsayed Nasr for welcoming me into the lab as a new PhD student and sharing their experimental techniques with me, these techniques have helped me no end in my time as a research student. -
The National Drugs List
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List of Approved Ndas for Biological Products That Were Deemed to Be Blas on March 23, 2020
List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020 On March 23, 2020, an approved application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) was deemed to be a license for the biological product under section 351 of the Public Health Service Act (PHS Act) (see section 7002(e)(4)(A) of the Biologics Price Competition and Innovation Act of 2009). To enhance transparency and facilitate planning for the March 23, 2020, transition date, FDA compiled a preliminary list of approved applications for biological products under the FD&C Act that were listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) and that would be affected by this transition provision. FDA posted this list on the FDA website in December 2018, and periodically updated this list before the March 23, 2020, transition date. The September 2019 update to this preliminary list added certain administratively closed applications related to approved applications for biological products that were on the December 2018 version of this list. The January 2020 update to the preliminary list reflected a change to the definition of “biological product” made by the Further Consolidated Appropriations Act, 2020, which was enacted on December 20, 2019. Section 605 of this Act further amended the definition of a “biological product” in section 351(i) of the PHS Act to remove the parenthetical “(except any chemically synthesized polypeptide)” from the statutory category of “protein.” FDA has provided below a list of each approved application for a biological product under the FD&C Act that was deemed to be a license (i.e., an approved biologics license application (BLA)) for the biological product on March 23, 2020. -
Corticorelin Acetate, a Synthetic Corticotropin-Releasing Factor with Preclinical Antitumor Activity, Alone and with Bevacizumab, Against Human Brain Tumor Models
ANTICANCER RESEARCH 30: 5037-5042 (2010) Corticorelin Acetate, a Synthetic Corticotropin-releasing Factor with Preclinical Antitumor Activity, alone and with Bevacizumab, against Human Brain Tumor Models IDOIA GAMEZ1, ROBERT P. RYAN1 and STEPHEN T. KEIR2 1Celtic Pharmaceutical Development Services America, Inc., New York, NY 10022, U.S.A.; 2The Preston Robert Tisch Brain Tumor Center, Duke University, Durham, NC 27710, U.S.A. Abstract. Background: Corticorelin acetate (CrA) is a brain tumors. The cause of PBE is believed to result in part synthetic form of corticotropin-releasing factor that is from the leakage of edematous brain tumor fluid from currently undergoing clinical trials in the treatment of abnormal tumor vasculature into the surrounding tissue (1, peritumoral brain edema (PBE). This study preclinically 2). The mechanism(s) of action by which CrA exerts its investigated its potential as an antitumor agent against beneficial effect in the therapy of PBE has not been human brain tumor xenografts. Materials and Methods: The elucidated, but two factors appear to be relevant: decreased in vivo efficacy of CrA as a single agent and in combination vascular leakage and preserved integrity of the endothelial with the antiangiogenic agent, bevacizumab, was examined cells, which ultimately helps to maintain the blood-brain in three different patient-derived human brain tumor barrier (3, 4). xenografts implanted orthotopically (intracranially) or CrA appears to mediate its activity through two subtypes subcutaneously in athymic mice. Results: CrA significantly of G-protein coupled receptors: CRF receptor-1 (CRFR1) increased the lifespan of mice implanted orthotopically with and CRF receptor-2 (CRFR2) (5). These CRFRs are widely two different pediatric brain tumor xenograft models. -
(Pram) and Insulin A21G Improves Post-Prandial Glucose Vs Novolog
ADO09, A Co-Formulation Of Pramlintide (Pram) and Insulin A21G improves Post-Prandial Glucose Vs Novolog® in Type 1 Diabetes (T1DM) G.Meiffren¹, G.Andersen², R.Eloy¹, C.Seroussi¹, C.Mégret¹, S.Famulla², Y.-P Chan¹, M.Gaudier¹, O.Soula¹, J.H. DeVries²,T.Heise² (1 Adocia, Lyon, France ; 2 Profil, Neuss, Germany) Introduction & Background Overall safety Outpatient period results - CGM metrics o ADO09 (M1Pram) is a co-formulation of pramlintide and insulin A21G o Both treatments were well tolerated without any treatment-related serious adverse events o Most of the CGM metrics (TiR [70-180], TiR [80-140], mean blood glucose per day), were significantly improved developed to leverage the beneficial effects of pramlintide on post-prandial (Table 2). As expected M1Pram had numerically more, mostly gastrointestinal adverse events with M1Pram (Table 4). Postprandial and mean 24-hour glucose profiles were improved with M1Pram (Fig. 3) glucose without additional injections than insulin aspart Table 4: CGM metrics, all days. Significant differences are marked in bold Objective and design o No severe hypoglycemia were seen, slightly more hypoglycemic events occurred with M1Pram Ratio of LSMean* o To compare the effect of M1Pram and insulin aspart (Novolog®, Novo than with aspart (Table 3) Difference Parameter Treatment LS Mean M1Pram / Aspart P-value Nordisk) on post-prandial glucose control, glycemic control assessed by Table 2: Incidence of adverse events throughout the trial (M1Pram-Aspart) (95% CI) CGM and safety/tolerability M1Pram Aspart M1Pram -
1. Two Components, Two Sets of Lecturers
Conditions 1. Two components, two sets of lecturers. 2. Lectures 1-5 Prof. F. Hudecz Lectures 6-9 Dr. Gy. Domány Lectures 10-12 Dr. P. Buzder-Lantos 3. Examination: two parts determined by the lecturers and one mark. - option A: written test - option B: presentation based on literature - option C: oral examination 4. Participation at lectures > 70 % [email protected] Some Approved Peptide Pharmaceuticals and their Methods of Manufacture First generatioin Second generation New generation Oxytocin (L) Carbetocin (S) Abarelix (GnRH) (L) ACTH (1-24) & (1-39) (L,S) Terlipressin (L,S) Cetrorelix (GnRH) (L) Vasopressin (L,S) Felypressin (L,S) Ganirelix (GnRH) (L) Insulin (E,SS, R) Buserelin (L,S) Eptifibatide Glucagon (E,S,R) Deslorelin (L,S) Bivalirudin (L) Calcitonins (L,S,R) Goserelin (L) Copaxone (L) TRH (L) Histrelin (L) Techtide P-289(S) Gonadorelin (L,S) Leuprolide (L,S) Cubicin (F) Somatostatin (L,S) Nafarelin (S) Fuzeon (antiHIV (H) GHRH (1-29) & (1-44) (S) Tryptorelin (L,S) Ziconotide (pain) (S) CRF (Human & Ovine) (S) Lecirelin (S) Pramlintide (diabetes) (S) Cyclosporin (F) Lanreotide (S) Exenatide (diabetes) (S) Thymopentin (L) Octreotide (L,S) Icatibant (brady-rec) Thymosin Alpha-1 (S) Atosiban (L) Romiplostim (hormon) Secretins (Human & Porcine) (E,S) Desmopressin (L,S) Degarelix (GnRH) Parathyroid Hormone (1-34) & (1-84)(S) Lypressin (L) Mifamurtide (rák, adj.) Vasoactive Intestinal Polypeptide (S) Ornipressin Ecallantide (ödéma) Brain Natriuretic Peptide (R) Pitressin (L) Liraglutide (diabetes) Cholecystokinin (L) ACE Inhibitors (Enalapril, Lisinopril) (L) Tesamorelin Tetragastrin (L) HIV Protease Inhibitors (L) Surfaxin Pentagastrin (L) Peginesatide Eledoisin (L) Carfilzomib Linaclotide (enz.inh) L = in solution; S = on solid phase; E = extraction; F = fermentation; H = hybrid synthesis; R = recombinant; SS = semi-synthesis. -
Report Name:Ukraine's Mrls for Veterinary Drugs
Voluntary Report – Voluntary - Public Distribution Date: November 05,2020 Report Number: UP2020-0051 Report Name: Ukraine's MRLs for Veterinary Drugs Country: Ukraine Post: Kyiv Report Category: FAIRS Subject Report Prepared By: Oleksandr Tarassevych Approved By: Robin Gray Report Highlights: Ukraine adopted several maximum residue levels (MRLs) for veterinary drugs, coccidiostats and histomonostats in food products of animal origin. Ukraine also adopted a list of drugs residues that are not allowed in food products. THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY The Office of Agricultural Affairs of USDA/Foreign Agricultural Service in Kyiv, Ukraine prepared this report for U.S. exporters of domestic food and agricultural products. While every possible care was taken in the preparation of this report, information provided may not be completely accurate either because policies have changed since the time this report was written, or because clear and consistent information about these policies was not available. It is highly recommended U.S. exporters verify the full set of import requirements with their foreign customers, who are normally best equipped to research such matters with local authorities, before any goods are shipped. This FAIRS Subject Report accompanies other reports on Maximum, Residue Limits established by Ukraine in 2020. Related reports could be found under the following links: 1.) Ukraine's MRLs for Microbiological Contaminants_Kyiv_Ukraine_04-27-2020 2.) Ukraine's MRLs for Certain Contaminants_Kyiv_Ukraine_03-06-2020 Food Products of animal origin and/or ingredients of animal origin are not permitted in the Ukrainian market if they contain certain veterinary drugs residues in excess of the maximum residue levels established in Tables 1 and 2. -
Download PDF (Inglês)
Braz. J. vet. Res. anim. Sci., São Paulo, v. 38, n. 3, p. 142-145, 2001. CORRESPONDENCE TO: Lecirelin and Buserelin (Gonadotrophin Pietro Sampaio Baruselli Departamento de Reprodução Animal da Faculdade de Medicina releasing hormone agonists) are equally effective Veterinária e Zootecnia da USP Av. Prof. Dr. Orlando Marques de for fixed time insemination in buffalo Paiva, 87 Cidade Universitária Armando de Salles Oliveira 05508-000 – São Paulo – SP A Lecirelina apresenta eficiência similar à da Buserelina e-mail: [email protected] 1- Departamento de Reprodução (agonistas do hormônio liberador de Gonadotrofinas) Animal da Faculdade de Medicina Veterinária e Zootecnia da USP – SP para inseminação artificial em tempo fixo em bubalinos 2- Médico Veterinário Autônomo Pietro Sampaio BARUSELLI1; Renato AMARAL2; Francisco Bonomi BARUFI1; Renato VALENTIM1; Marcio de Oliveira MARQUES1 SUMMARY Buffalo has peculiar reproductive patterns, which make artificial insemination programs a hard and expensive task. Artificial insemination in fixed time is advantaged because females show low incidence of homosexual behaviour and strong dominance relationships, which leads to a poor accuracy in estrus detection. The aim of this experiment was to compare the efficiency of two different GnRH agonists in the GnRH/PGF2α/GnRH protocol (Buserelin vs Lecirelin). Two hundred and seventy buffaloes with 45 to 60 days postpartum were synchronized and fixed-time inseminated. The animals were kept on pasture in two farms at São Paulo and Mato Grosso do Sul (Brazil). Cows in Group 1 (n = 132) received, intramuscularly, 20 µg of Buserelin at a random day of the estrous cycle and, seven days later, 15 mg of prostaglandin F2α. -
Fully Automated Dried Blood Spot Sample Preparation Enables the Detection of Lower Molecular Mass Peptide and Non-Peptide Doping Agents by Means of LC-HRMS
Analytical and Bioanalytical Chemistry (2020) 412:3765–3777 https://doi.org/10.1007/s00216-020-02634-4 RESEARCH PAPER Fully automated dried blood spot sample preparation enables the detection of lower molecular mass peptide and non-peptide doping agents by means of LC-HRMS Tobias Lange1 & Andreas Thomas1 & Katja Walpurgis1 & Mario Thevis1,2 Received: 10 December 2019 /Revised: 26 March 2020 /Accepted: 31 March 2020 # The Author(s) 2020 Abstract The added value of dried blood spot (DBS) samples complementing the information obtained from commonly routine doping control matrices is continuously increasing in sports drug testing. In this project, a robotic-assisted non-destructive hematocrit measurement from dried blood spots by near-infrared spectroscopy followed by a fully automated sample preparation including strong cation exchange solid-phase extraction and evaporation enabled the detection of 46 lower molecular mass (< 2 kDa) peptide and non-peptide drugs and drug candidates by means of LC-HRMS. The target analytes included, amongst others, agonists of the gonadotropin-releasing hormone receptor, the ghrelin receptor, the human growth hormone receptor, and the antidiuretic hormone receptor. Furthermore, several glycine derivatives of growth hormone–releasing peptides (GHRPs), argu- ably designed to undermine current anti-doping testing approaches, were implemented to the presented detection method. The initial testing assay was validated according to the World Anti-Doping Agency guidelines with estimated LODs between 0.5 and 20 ng/mL. As a proof of concept, authentic post-administration specimens containing GHRP-2 and GHRP-6 were successfully analyzed. Furthermore, DBS obtained from a sampling device operating with microneedles for blood collection from the upper arm were analyzed and the matrix was cross-validated for selected parameters. -
20201127-Brochure-Dalmarelin.Pdf
The new-generation GnRH super-agonist ® LECIRELIN RESEARCH FOR REPRODUCTION Lecirelin GnRH GnRH (Gonadotropin-Releasing A breakthrough Hormone), a decapeptide produced by neurons in the in Pharmaceutical Design basal hypothalamus, is the master hormone controlling and Engineering reproductive physiology. Gly NH2 It stimulates the synthesis Dalmarelin contains Lecirelin, a new-generation Pro and secretion of FSH GnRH (Follicle-Stimulating Hormone) GnRH super-agonist, which elicits a strong LH surge Arg and of LH (Luteinizing and a sustained FSH release from the Leu Hormone) from the anterior anterior pituitary gland. pituitary gland. LH and FSH Gly finally acts on the gonads to Tyr stimulate gametogenesis and Ser steroidogenesis and to regulate the estrous cycle. Trp R His ES EA pGlu R C H NEt Lecirelin D-tert Leu State-of-the-art research and technology have Lecirelin is a nonapeptide modeled after the natural GnRH decapeptide. The design of this GnRH agonist has been directed toward stabilization of the molecule and allowed to synthesize increasing its affinity for the GnRH receptor. a drug which shows Substitution of glycin at position 6 with D-tert-leucin has conferred greater stability against maximal potency, still enzymatic degradation and increased receptor binding affinity. Replacement of glycine by preserving a physiological ethylamide at position 10 has enhanced biological potency and conveyed further resistance to response proteolysis. ® Potent action, high efficacy For any of the clinical or management uses, the key biological response to evaluate efficacy of GnRH products is an adequate LH surge. AUCLH 20 Gonadorelin 100 µg 60 Lecirelin 25 µg 18 50 Lecirelin 50 µg LH (ng/ml) 16 Buserelin 10 µg 40 30 14 ng.h/ml 20 12 10 10 0 8 Gonadorelin Buserelin Lecirelin 25 Lecirelin 50 6 Time course of plasma LH Area under the LH concentrations (ng/mL) concentration curve 4 after administration of after administration gonadorelin, lecirelin and of gonadorelin, lecirelin 2 buserelin. -
Gastric Secretory and Plasma Hormonal Responses to Sham-Feeding of Varying Duration in Patients with Duodenal Ulcer
Gut: first published as 10.1136/gut.22.12.1003 on 1 December 1981. Downloaded from Gut, 1981, 22,1003-1010 Gastric secretory and plasma hormonal responses to sham-feeding of varying duration in patients with duodenal ulcer S J KONTUREK,* J SWIERCZEK, N KWIECIEN, W OBTUTOWICZ, M DOBRZANSKA, B KOPP, AND J OLEKSY From the Institute ofPhysiology, Medica, Academy, Krakow, and District Hospital, Krakow, Poland SUMMARY Gastric acid and serum gastrin, pancreatic polypeptide, and insulin responses to cephalic vagal stimulation were studied in eight patients with duodenal ulcer using modified sham- feeding for periods varying from four to 30 minutes. In addition, the maximal acid response to sham-feeding was compared with that induced by pentagastrin in 10 healthy subjects and 14 patients with duodenal ulcer. It was found that the gastric acid response to modified sham-feeding reached the maximal value after 15 minutes of sham-feeding and amounted to about 68% of the pentagastrin maximum. The serum pancreatic polypeptide response was also increased after modified sham-feeding and depended on the duration of this procedure, whereas gastrin and insulin responses were not significantly affected by modified sham-feeding. When the peak acid output induced by modified sham-feeding was normalised as percentage of the peak response to pentagastrin, it was similar in healthy subjects and in patients with duodenal ulcer; this indicates that the increased peak acid response to modified sham-feeding observed in patients with duodenal ulcer corresponded with -
BCBSVT Specialty Drug List Effective 2021.07.01.Xlsx
Effective Date: 07/01/2021 SPECIALTY DRUG LIST Revised Date: 05/07/2021 DOSAGE EXCLUDED ON NATIONAL DRUG CLASS DRUG NAME GENERIC NAME FORM PERFORMANCE FORMULARY ANEMIA ARANESP SOLN DARBEPOETIN ALFA SOLN INJ ANEMIA ARANESP SOSY DARBEPOETIN ALFA SOLN PREFILLED SYRINGE ANEMIA EPOGEN SOLN EPOETIN ALFA INJ X ANEMIA PROCRIT SOLN EPOETIN ALFA INJ X ANEMIA REBLOZYL SOLR LUSPATERCEPT-AAMT FOR SUBCUTANEOUS INJ ANEMIA RETACRIT SOLN EPOETIN ALFA-EPBX INJ ANTI-GOUT AGENT KRYSTEXXA SOLN PEGLOTICASE INJ (FOR IV INFUSION) ANTI-INFECTIVE PREVYMIS SOLN LETERMOVIR IV SOLN ANTI-INFECTIVE PREVYMIS TABS LETERMOVIR TAB ASTHMA CINQAIR SOLN RESLIZUMAB IV INFUSION SOLN ASTHMA FASENRA SOSY BENRALIZUMAB SUBCUTANEOUS SOLN PREFILLED SYRINGE ASTHMA FASENRA PEN SOAJ BENRALIZUMAB SUBCUTANEOUS SOLN AUTO-INJECTOR ASTHMA NUCALA SOAJ MEPOLIZUMAB SUBCUTANEOUS SOLUTION AUTO-INJECTOR ASTHMA NUCALA SOLR MEPOLIZUMAB FOR INJ ASTHMA NUCALA SOSY MEPOLIZUMAB SUBCUTANEOUS SOLUTION PREF SYRINGE ASTHMA XOLAIR SOLR OMALIZUMAB FOR INJ ASTHMA XOLAIR SOSY OMALIZUMAB SUBCUTANEOUS SOLN PREFILLED SYRINGE CARDIOVASCULAR VYNDAMAX CAPS TAFAMIDIS CAP CARDIOVASCULAR VYNDAQEL CAPS TAFAMIDIS MEGLUMINE (CARDIAC) CAP CENTRAL NERVOUS SYSTEM AGENTS AUSTEDO TABS DEUTETRABENAZINE TAB CENTRAL NERVOUS SYSTEM AGENTS ENSPRYNG SOSY SATRALIZUMAB-MWGE SUBCUTANEOUS SOLN PREF SYRINGE CENTRAL NERVOUS SYSTEM AGENTS HETLIOZ CAPS TASIMELTEON CAPSULE CENTRAL NERVOUS SYSTEM AGENTS HETLIOZ LQ SUSP TASIMELTEON ORAL SUSP CHEMOTHERAPY PROTECTANT AMIFOSTINE SOLR AMIFOSTINE CRYSTALLINE FOR INJ CHEMOTHERAPY PROTECTANT ELITEK