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  • (12) United States Patent (10) Patent No.: US 9,498,481 B2 Rao Et Al
    USOO9498481 B2 (12) United States Patent (10) Patent No.: US 9,498,481 B2 Rao et al. (45) Date of Patent: *Nov. 22, 2016 (54) CYCLOPROPYL MODULATORS OF P2Y12 WO WO95/26325 10, 1995 RECEPTOR WO WO99/O5142 2, 1999 WO WOOO/34283 6, 2000 WO WO O1/92262 12/2001 (71) Applicant: Apharaceuticals. Inc., La WO WO O1/922.63 12/2001 olla, CA (US) WO WO 2011/O17108 2, 2011 (72) Inventors: Tadimeti Rao, San Diego, CA (US); Chengzhi Zhang, San Diego, CA (US) OTHER PUBLICATIONS Drugs of the Future 32(10), 845-853 (2007).* (73) Assignee: Auspex Pharmaceuticals, Inc., LaJolla, Tantry et al. in Expert Opin. Invest. Drugs (2007) 16(2):225-229.* CA (US) Wallentin et al. in the New England Journal of Medicine, 361 (11), 1045-1057 (2009).* (*) Notice: Subject to any disclaimer, the term of this Husted et al. in The European Heart Journal 27, 1038-1047 (2006).* patent is extended or adjusted under 35 Auspex in www.businesswire.com/news/home/20081023005201/ U.S.C. 154(b) by Od en/Auspex-Pharmaceuticals-Announces-Positive-Results-Clinical M YW- (b) by ayS. Study (published: Oct. 23, 2008).* This patent is Subject to a terminal dis- Concert In www.concertpharma. com/news/ claimer ConcertPresentsPreclinicalResultsNAMS.htm (published: Sep. 25. 2008).* Concert2 in Expert Rev. Anti Infect. Ther. 6(6), 782 (2008).* (21) Appl. No.: 14/977,056 Springthorpe et al. in Bioorganic & Medicinal Chemistry Letters 17. 6013-6018 (2007).* (22) Filed: Dec. 21, 2015 Leis et al. in Current Organic Chemistry 2, 131-144 (1998).* Angiolillo et al., Pharmacology of emerging novel platelet inhibi (65) Prior Publication Data tors, American Heart Journal, 2008, 156(2) Supp.
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  • Download Resume
    Curriculum Vitae Full Name: David M. Marks, M.D. Contact: [email protected] Mobile (619) 822-7117 Credentials: Diplomate, American Board of Psychiatry and Neurology (Psychiatry) Subspecialty Certification in Psychosomatic Medicine Diplomate, American Board of Pain Medicine Position Title: Associate Professor Department of Psychiatry and Behavioral Sciences Department of Community and Family Medicine Duke University Medical Center Duke Clinical Research Institute Duke Pain and Palliative Care Clinic Education: Institution & Location Degree Year Conferred Field of Study University of California at San Diego Fellowship 1999 - 2000 Consultation and San Diego, CA Liaison Psychiatry Medical College of Pennsylvania / Senior 1998 - 1999 Psychiatry Clinical Neuroscience Research Unit Resident Philadelphia, PA University of California at San Diego Resident 1995 - 1998 Psychiatry San Diego, CA University of Texas Medical Branch M.D. 1995 Galveston, TX Rice University B.A. 1991 Psychology Houston, TX Research and Professional Experience: Position Institution/Employer & Location Dates of Employment Attending Faculty Physician Duke Pain and Palliative Care Clinic 09/08-present (Chronic Pain Management) Attending Faculty Physician Duke University Medical Center, 07/06-present Inpatient Psychiatric Service, Emergency Service, Consultation/Liaison Service Attending Faculty Physician Durham Regional Hospital, 09/08-07/11 Consultation/Liaison Service Medical Director, Inpatient and Duke University Medical Center 07/06 – 02/07 Emergency Psychiatry Services Medical Director, CNS Division EStudy Site 05/05 -- 07/06 La Mesa, Oceanside, National City CA Chief Executive Officer/Medical Optimum Health Services 01/02 – 05/05 Director La Mesa, Oceanside CA Chief of Staff Alvarado Parkway Institute 01/04 – 01/05 1 La Mesa, CA Page _____________________________________________________________________ David M.
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  • Ontario Drug Benefit Formulary Edition 43
    Ministry of Health and Long-Term Care Ontario Drug Benefit Formulary/Comparative Drug Index Edition 43 Drug Programs Policy and Strategy Branch Ontario Public Drug Programs Ministry of Health and Long-Term Care Effective February 28, 2018 Visit Formulary Downloads: Edition 43 Table of Contents Part I Introduction ....................................................................................................... I.1 Part II Preamble .......................................................................................................... II.1 Part III-A Benefits List ........................................................................................... III-A.1 Part III-B Off-Formulary Interchangeable Drugs (OFI) ........................................ III-B.1 Part IV Section Currently Not In Use ......................................................................... IV Part V Index of Pharmacologic-Therapeutic Classification .................................... V.1 Part VI-A Facilitated Access - HIV/AIDS .............................................................. VI-A.1 Part VI-B Facilitated Access - Palliative Care ..................................................... VI-B.1 Part VI-C Temporary Facilitated Access - Rheumatology ................................. VI-C.1 Part VII Trillium Drug Program ................................................................................ VII.1 Part VIII Exceptional Access Program (EAP) ........................................................ VIII.1 Part IX-A Nutrition Products ................................................................................
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  • Predictive QSAR Tools to Aid in Early Process Development of Monoclonal Antibodies
    Predictive QSAR tools to aid in early process development of monoclonal antibodies John Micael Andreas Karlberg Published work submitted to Newcastle University for the degree of Doctor of Philosophy in the School of Engineering November 2019 Abstract Monoclonal antibodies (mAbs) have become one of the fastest growing markets for diagnostic and therapeutic treatments over the last 30 years with a global sales revenue around $89 billion reported in 2017. A popular framework widely used in pharmaceutical industries for designing manufacturing processes for mAbs is Quality by Design (QbD) due to providing a structured and systematic approach in investigation and screening process parameters that might influence the product quality. However, due to the large number of product quality attributes (CQAs) and process parameters that exist in an mAb process platform, extensive investigation is needed to characterise their impact on the product quality which makes the process development costly and time consuming. There is thus an urgent need for methods and tools that can be used for early risk-based selection of critical product properties and process factors to reduce the number of potential factors that have to be investigated, thereby aiding in speeding up the process development and reduce costs. In this study, a framework for predictive model development based on Quantitative Structure- Activity Relationship (QSAR) modelling was developed to link structural features and properties of mAbs to Hydrophobic Interaction Chromatography (HIC) retention times and expressed mAb yield from HEK cells. Model development was based on a structured approach for incremental model refinement and evaluation that aided in increasing model performance until becoming acceptable in accordance to the OECD guidelines for QSAR models.
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  • New Drug Evaluation Monograph Template
    © Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35, Salem, Oregon 97301-1079 Phone 503-947-5220 | Fax 503-947-1119 Class Update: Second Generation Antidepressant Medications Month/Year of Review: May 2014 Last Oregon Review: April 2012 PDL Classes: Psychiatric: Antidepressants Source Document: OSU College of Pharmacy New drug(s): vortioxetine (Brintellix®) Manufacturer: Takeda & Lundbeck/Forest levomilnacipran extended-release (Fetzima®) Dossier Received: Yes/Pending Current Status of Voluntary PDL Class: Preferred Agents: BUPROPION HCL TABLET/TABLET ER, CITALOPRAM TABLET/SOLUTION, FLUOXETINE CAPSULE/SOLUTION/TABLET, FLUVOXAMINE, MIRTAZEPINE TAB RAPDIS/TABLET, PAROXETINE TABLET, SERTRALINE ORAL CONC/TABLET, VENLAFAXINE TABLET, VENLAFAXINE ER Non-Preferred Agents: BUPROPRION XL, DESVENLAFAXINE (PRISTIQ ER), DULOXETINE (CYMBALTA®), ESCITALOPRAM, FLUOXETINE DF (PROZAC® WEEKLY), NEFAZODONE, PAROXETINE HCL (PAXIL CR®), SELEGILINE PATCH (ENSAM®), VILAZODONE (VIIBRYD®), OLANZAPINE/FLUOXETINE (SYMBYAX®) Status of the Voluntary Mental Health Preferred Drug List Currently, all antidepressants are available without prior authorization for non-preferred placement. Oregon law prohibits traditional methods of PDL enforcement on mental health drugs. Second generation antidepressants have been reviewed for clinical efficacy and safety and specific agents were chosen as clinically preferred; this eliminates a copay. Oregon’s Medicaid program currently
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  • Refreshing the Biologic Pipeline 2020
    news feature Credit: Science Lab / Alamy Stock Photo Refreshing the biologic pipeline 2020 In the absence of face-to-face meetings, FDA and industry implemented regulatory workarounds to maintain drug and biologics approvals. These could be here to stay. John Hodgson OVID-19 might have been expected since 1996) — a small miracle in itself “COVID-19 confronted us with the need to severely impair drug approvals (Fig. 1 and Table 1). to better triage sponsors’ questions,” says Cin 2020. In the event, however, To the usual crop of rare disease and Peter Marks, the director of the Center for industry and regulators delivered a small genetic-niche cancer treatments, 2020 Biologics Evaluation and Research (CBER) miracle. They found workarounds and also added a chimeric antigen receptor at the FDA. “That was perhaps the single surrogate methods of engagement. Starting (CAR)-T cell therapy with a cleaner biggest takeaway from the pandemic related in January 2020, when the outbreak veered manufacturing process and the first to product applications.” Marks says that it westward, the number of face-to face approved blockbuster indication for a became very apparent with some COVID- meetings declined rapidly; by March, small-interfering RNA (siRNA) — the 19-related files that resolving a single they were replaced by Webex and Teams. European Medicines Agency’s (EMA) issue can help a sponsor enormously and (Secure Zoom meeting are to be added registration of the RNA interference accelerate the development cycle. Before this year.) And remarkably, by 31 December, (RNAi) therapy Leqvio (inclisiran) for COVID-19, it was conceivable that a small the US Food and Drug Administration cardiovascular disease.
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  • 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.
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  • Atoltivimab, Maftivimab, and Odesivimab
    PATIENT & CAREGIVER EDUCATION Atoltivimab, Maftivimab, and Odesivimab This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider. What is this drug used for? It is used to treat infections caused by Ebolavirus. What do I need to tell my doctor BEFORE I take this drug? If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you are breast-feeding. Do not breast-feed while you take this drug. This drug may interact with other drugs or health problems. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. Atoltivimab, Maftivimab, and Odesivimab 1/5 What are some things I need to know or do while I take this drug? Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. Talk with your doctor before getting any vaccines. Use of some vaccines with this drug may either raise the chance of an infection or make the vaccine not work as well. Tell your doctor if you are pregnant or plan on getting pregnant.
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  • Tanibirumab (CUI C3490677) Add to Cart
    5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor
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  • PHARMACEUTICAL APPENDIX to the TARIFF SCHEDULE 2 Table 1
    Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names INN which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service CAS registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known.
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  • Download PDF Document
    Journal for ImmunoTherapy of Cancer 2019, 7(Suppl 1):283 https://doi.org/10.1186/s40425-019-0764-0 MEETINGABSTRACTS Open Access 34th Annual Meeting & Pre-Conference Programs of the Society for Immunotherapy of Cancer (SITC 2019): part 2 National Harbor, MD, USA. 10 November 2019 Published: 6 November 2019 About this supplement These abstracts have been published as part of Journal for ImmunoTherapy of Cancer Volume 7 Supplement 1, 2019. The full contents of the supplement are available online at https://jitc.biomedcentral.com/articles/supplements/volume-7-supplement-1. Please note that this is part 2 of 2. Poster Presentations median survival; 3) FTN203 did not negate the efficacy of anti- PD-1 or anti-PD-L1 immunotherapy antibody when combined; 4) Biomarkers, Immune Monitoring, and Novel FTN203 significantly improved the efficacy of anti-PD-1 by further Technologies reducing the tumor growth (by 80% on day 26, P=0.046) and in- creasing the median survival (by 5 days or 14%, Log-rank test P= P501 0.031), against the combo of COMPLETE and anti-PD-1; 5) None Dietary deprivation of non-essential amino acids improves anti-PD- of the mono or combo treatments caused body weight loss. 1 immunotherapy in murine colon cancer Conclusions Zehui Li, PhD, Grace Yang, PhD, Shuang Zhou, PhD, Xin Wang, MD, PhD, Our data supports the use of dietary NEAA deprivation to improve Xiyan Li, PhD the efficacy of anti-PD-1 or anti-PD-L1 immunotherapy for colorectal Filtricine, Inc., Santa Clara, CA, United States cancer without noticeable side effects.
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  • Clofibrate Causes an Upregulation of PPAR- Target Genes but Does Not
    tapraid4/zh6-areg/zh6-areg/zh600707/zh65828d07a xppws S� 1 4/20/07 9: 48 MS: R-00603-2006 Ini: 07/rgh/dh A " #h!si$l %egul Integr &$ ' #h!si$l 2%&' R000 (R000) 200!$ 3. Originalarbeiten *irst publis#ed "arc# + 5) 200! doi' + 0$ + + 52,a-pregu$ 0060&$ 2006$ Clofibrate causes an upregulation of PPAR-� target genes but does not alter AQ: 1 expression of SREBP target genes in liver and adipose tissue of pigs Sebastian Luci, Beatrice Giemsa, Holger Kluge, and Klaus Eder Institut fu¨r Agrar- und Erna¨hrungswissenschaften, Martin-Luther-Universita¨t Halle-Wittenberg, Halle (Saale), Ger an! Submitted 25 August 2006 accepted in final form ! "arc# 200! AQ: 2 Luci S, Giemsa B, Kluge H, Eder K. Clofibrate causes an usuall0 increased 3#en baseline concentrations are lo3 1?62$ upregulation of PPAR-� target genes but does not alter expression of Effects of PPAR-� activation #ave been mostl0 studied in SREBP target genes in liver and adipose tissue of pigs$ A " #h!si$l rodents) 3#ic# ex#ibit a strong expression of PPAR-� in liver %egul Integr &$ ' #h!si$l 2%&' R000 (R000) 200!$ *irst publis#ed and s#o3 peroxisome proliferation in t#e liver in response to "arc# + 5) 200! doi' + 0$ + + 52,a-pregu$ 0060&$ 2006$ ./#is stud0 inves- PPAR-� activation 1&62$ Expression of PPAR-� and sensitivit0 tigated t#e effect of clofibrate treatment on expression of target genes of peroxisome proliferator-activated receptor 1PPAR2-� and various to peroxisomal induction b0 PPAR-� agonists) #o3ever) var0 genes of t#e lipid metabolism in liver and adipose tissue of pigs$ An greatl0
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