DOCSLIB.ORG

2015 Medicines in Development for Neurological Disorders a Report on Disorders of the Brain, Spinal Cord and Nerves

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
2015 Medicines in Development for Neurological Disorders a Report on Disorders of the Brain, Spinal Cord and Nerves 2015 Medicines in Development for Neurological Disorders A Report on Disorders of the Brain, Spinal Cord and Nerves Alzheimer's Disease Product Name Sponsor Indication Development Phase AC-1204 Accera mild to moderate Alzheimer's disease Phase II/III (caprylic triglyceride) Broomfield, CO www.accerapharma.com ACI-35 AC Immune Alzheimer's disease Phase I (active anti-Tau vaccine) Lausanne, Switzerland www.acimmune.com Janssen Research & Development www.janssenrnd.com Raritan, NJ AD-4833/TOMM40 Takeda Pharmaceutical delay onset of mild cognitive Phase III (insulin sensitizer) Deerfield, IL impairment due to Alzheimer's www.takeda.com Zinfandel Pharmaceuticals disease Chapel Hill, NC aducanumab (BIIB037) Biogen Alzheimer's disease Phase I (amyloid beta-protein inhibitor) Cambridge, MA www.biogen.com ALZ-801 Alzheon Alzheimer's disease Phase I (amyloid beta-protein inhibitor) Framingham, MA www.alzheon.com ANAVEX Plus Anavex Life Sciences Alzheimer's disease Phase II (ANAVEX 2-73/donepezil) New York, NY www.anavex.com ASP3662 Astellas Pharma US Alzheimer's disease Phase I Northbrook, IL www.astellas.us Alzheimer's Disease Product Name Sponsor Indication Development Phase AVN-101 AllaChem Alzheimer's disease Phase II (serotonin 6 receptor antagonist) Hallandale, FL www.allachem.com Avineuro Pharmaceuticals San Diego, CA AVN-322 AllaChem Alzheimer's disease Phase II (serotonin 6 receptor antagonist) Hallandale, FL www.allachem.com Avineuro Pharmaceuticals San Diego, CA AVP-786 Avanir Pharmaceuticals agitation in Alzheimer's disease Phase I (dextromethorphan analogue/quinidine) Aliso Viejo, CA www.avanir.com Concert Pharmaceuticals www.concertpharma.com Lexington, MA AVP-923 Avanir Pharmaceuticals agitation in Alzheimer's disease Phase II (dextromethorphan/quinidine San Diego, CA (see also headache, Parkinson's) www.avanir.com fixed-dose combination) AZD3293 AstraZeneca Alzheimer's disease Phase II (beta-secretase inhibitor) Wilmington, DE www.astrazeneca.com Eli Lilly www.lilly.com Indianapolis, IN azeliragon (TTP488) vTv Therapeutics Alzheimer's disease (Fast Track) Phase III (RAGE antagonist) High Point, NC www.vtvtherapeutics.com Alzheimer's Disease Product Name Sponsor Indication Development Phase BACE inhibitor CoMentis Alzheimer's disease Phase I completed South San Francisco, CA www.comentis.com BACE inhibitor Eli Lilly Alzheimer's disease Phase I Indianapolis, IN www.lilly.com BACE inhibitor Janssen Pharmaceuticals early-stage Alzheimer's disease Phase II Titusville, NJ www.janssenpharmaceuticalsinc.com Shionogi www.shionogi.co.jp Osaka, Japan BAN2401 Biogen Alzheimer's disease Phase II (amyloid beta-protein inhibitor) Cambridge, MA www.biogen.com Eisai www.eisai.com Woodcliff Lake, NJ BI 409306 Boehringer Ingelheim Alzheimer's disease Phase II (phosphodiesterase 9A inhibitor) Pharmaceuticals www.boehringer-ingelheim.com Ridgefield, CT bisnorcymserine QR Pharma advanced Alzheimer's disease Phase I (BNC) Berwyn, PA www.qrpharma.com bryostatin-1 Neurotrope BioScience Alzheimer's disease Phase II Newark, NJ www.neurotropebioscience.com Alzheimer's Disease Product Name Sponsor Indication Development Phase CAD106 GlaxoSmithKline Alzheimer's disease Phase II completed (beta-amyloid protein inhibitor) Research Triangle Park, NC www.gsk.com CPC-201 Chase Pharmaceuticals Alzheimer's disease Phase II Washington, DC www.chasepharmaceuticals.com crenezumab Genentech mild to moderate Alzheimer's disease Phase II (beta-amyloid protein inhibitor) South San Francisco, CA www.gene.com E2609 Biogen Alzheimer's disease Phase II (BACE1 protein inhibitor) Cambridge, MA www.biogen.com Eisai www.eisai.com Woodcliff Lake, NJ ELND005 Transition Therapeutics agitation/aggression in Alzheimer's Phase II (amyloid-beta protein inhibitor) Toronto, Canada disease (Fast Track) www.transitiontherapeutics.com encenicline Forum Pharmaceuticals Alzheimer's disease Phase III (alpha-7 potentiator) Watertown, MA www.forumpharma.com gantenerumab Genentech early-stage Alzheimer's disease Phase III (amyloid-beta protein inhibitor) South San Francisco, CA www.gene.com GC021109 GliaCure mild to moderate Alzheimer's disease Phase I (purinoceptor P2Y6 agonist) Boston, MA (Fast Track) www.gliacure.com Alzheimer's Disease Product Name Sponsor Indication Development Phase idalopirdine Lundbeck Alzheimer's disease Phase III (serotonin 6 receptor antagonist) Deerfield, IL www.lundbeck.com Otsuka Pharmaceutical www.otsuka.co.jp Tokyo, Japan immune globulin Grifols USA Alzheimer's disease Phase III Los Angeles, CA www.grifols.com JNJ-54861911 Janssen Research & Development Alzheimer's disease Phase II Raritan, NJ www.janssenrnd.com LMTX TauRx Pharmaceuticals Alzheimer's disease Phase III (tau protein aggregation/ Singapore www.taurx.com TDP-43 aggregation inhibitor) Lu-AF20513 Lundbeck Alzheimer's disease Phase I (amyloid beta-protein inhibitor) Deerfield, IL www.lundbeck.com Otsuka Pharmaceutical www.otsuka.co.jp Tokyo, Japan LY3002813 Eli Lilly Alzheimer's disease Phase I (N3pG-Aß mAb) Indianapolis, IN www.lilly.com MEDI1814 MedImmune Alzheimer's disease Phase I (anti-amyloid beta mAb) Gaithersburg, MD www.medimmune.com mGlu2 agonist Eli Lilly Alzheimer's disease psychosis Phase I Indianapolis, IN www.lilly.com Alzheimer's Disease Product Name Sponsor Indication Development Phase MK-7622 Merck Alzheimer's disease Phase II (quinazolinone) Whitehouse Station, NJ (adjunct therapy) www.merck.com MK-8931 Merck Alzheimer's disease Phase III (BACE1 protein inhibitor) Whitehouse Station, NJ www.merck.com MSDC-0160 Metabolic Solutions Development Alzheimer's disease Phase II completed (mitochondrial protein stimulant) Kalamazoo, MI www.msdrx.com NIC-515 Humanetics Alzheimer's disease Phase II (amyloid precursor protein secretase Minneapolis, MN www.humaneticscorp.com inhibitor) PF-05212377 (SAM-760) Pfizer Alzheimer's disease Phase II (5HT6 antagonist) New York, NY www.pfizer.com PF-06648671 Pfizer Alzheimer's disease Phase I New York, NY www.pfizer.com Posiphen® QR Pharma Alzheimer's disease Phase II R-phenserine Berwyn, PA (see also Parkinson's) www.qrpharma.com PTI-80 ProteoTech Alzheimer's disease Phase I (amyloid beta/tau protein inhibitor) Kirkland, WA www.proteotech.com Alzheimer's Disease Product Name Sponsor Indication Development Phase RG1577 Roche Alzheimer's disease Phase II (MAO-B inhibitor) New York, NY www.roche.com RG7345 Roche Alzheimer's disease Phase I (anti-Tau mAb) New York, NY www.roche.com rilapladib GlaxoSmithKline Alzheimer's disease Phase II (Lp-PLA2 inhibitor) Research Triangle Park, NC www.gsk.com RVT-101 Axovant Sciences mild to moderate Alzheimer's disease Phase II completed (5-HT6 receptor antagonist) New York, NY www.axovant.com RVX208 Resverlogix Alzheimer's disease Phase I completed (BET protein inhibitor) Calgary, Canada www.resverlogix.com SAR228810 Sanofi US Alzheimer's disease Phase I (anti-protofibrillar AB mAb) Bridgewater, NJ www.sanofi.com sGC 1061 sGC Pharma Alzheimer's disease Phase I (nomethiazole) Vancouver, Canada sgcpharma.com solanezumab Eli Lilly Alzheimer's disease Phase III (amyloid beta protein inhibitor) Indianapolis, IN www.lilly.com SUVN-502 Suven Life Sciences Alzheimer's disease Phase I (serotonin 6 receptor antagonist) Hyderabad, India www.suven.com Alzheimer's Disease Product Name Sponsor Indication Development Phase SUVN-G3031 Suven Life Sciences cognitive dysfunction in Phase I (histamine H3 receptor antagonist) Hyderabad, India Alzheimer's disease www.suven.com T-817MA Toyama Chemical Alzheimer's disease Phase II (amyloid beta-protein inhibitor) Tokyo, Japan www.toyama-chemical.co.jp T3D-959 T3D Therapeutics Alzheimer's disease Phase I (PPAR-delta/gamma agonist) Research Triangle Park, NC www.t3dtherapeutics.com TPI 287 Cortice Biosciences mild to moderate Alzheimer's disease Phase I (abeotaxane) New York, NY (see also brain tumors, other) www.corticebio.com UB-311 United Biomedical Alzheimer's disease Phase I (amyloid beta-protein inhibitor) Hauppauge, NY www.unitedbiomedical.com VX-745 EIP Pharma Alzheimer's disease Phase II (p38 mitogen-activated protein Cambridge, MA www.eippharma.com kinase inhibitor) Amyotrophic Lateral Sclerosis Product Name Sponsor Indication Development Phase arimoclomal ALS Foundation hereditary or familial Phase II/III Orphan Drug Washington, DC amyotrophic lateral sclerosis (ALS) www.orphazyme.com Orphazyme (Fast Track) Copenhagen, Denmark University of Miami Miami, FL CC100 Chemigen ALS Phase I completed Indianapolis, IN dexpramipexole Knopp Biosciences ALS (Fast Track) Phase II Orphan Drug Pittsburgh, PA www.knoppbio.com GM6 Genervon Biopharmaceuticals ALS (Fast Track) Phase II (peptide therapeutic) Pasadena, CA (see also Parkinson's, stroke) www.genervon.com Orphan Drug H.P. Acthar® Gel Mallinckrodt Pharmaceuticals ALS Phase II repository corticotropin injection St. Louis, MO www.mallinckrodt.com MN-166 MediciNova ALS Phase II (ibudilast) La Jolla, CA (see also multiple sclerosis) www.medicinova.com neurotrophic factor-producing adult BrainStorm Cell Therapeutics ALS (Fast Track) Phase II stem cell therapy (MSC-NTF cells) Hackensack, NJ www.brainstorm-cell.com Orphan Drug Amyotrophic Lateral Sclerosis Product Name Sponsor Indication Development Phase NP001 Neuraltus Pharmaceuticals ALS Phase II (macrophage modulator) Palo Alto, CA www.neuraltus.com NSI-566 Neuralstem ALS Phase II (spinal cord-derived neural Germantown, MD (see also spinal cord injury, stroke) www.neuralstem.com stem cell therapy) Orphan Drug ozanezumab GlaxoSmithKline ALS Phase II (NOGO-A inhibitor) Research Triangle
Load more

Recommended publications
  • Uniqure N.V. Paasheuvelweg 25A 1105BP Amsterdam the Netherlands +1-339-970-7000
    uniQure N.V. Paasheuvelweg 25a 1105BP Amsterdam The Netherlands +1-339-970-7000 NOTICE OF EXTRAORDINARY GENERAL MEETING OF SHAREHOLDERS To be held on September 14, 2017 To the Shareholders of uniQure N.V.: Notice is hereby given that an Extraordinary General Meeting of Shareholders (the “Extraordinary Meeting”) of uniQure N.V., a public company with limited liability ( naamloze vennootschap ) under the laws of the Netherlands (the “Company,” “uniQure,” and “we”), will be held on September 14, 2017, at 9:30 a.m., Central European Summer Time, at the Company’s principal executive offices located at Paasheuvelweg 25a, 1105BP Amsterdam, the Netherlands, for the following purposes: I. Opening and announcements; II. Appointment of Jeremy P. Springhorn, Ph.D. as a non-executive director (voting proposal no. 1); III. Appointment of Madhavan Balachandran as a non-executive director (voting proposal no. 2); IV Any other business that may properly come before the meeting or any adjournment of the meeting; and V. Closing of the meeting. Each person authorized to attend the Extraordinary Meeting may inspect the Agenda at the office of uniQure. Our Board of Directors (our “Board”) recommends that you vote “FOR” each of the voting proposals noted above. The record date is set at the close of business on August 17, 2017 EST and, therefore, only the Company’s shareholders of record at the close of business on August 17, 2017 EST are entitled to receive this notice (this “Notice”) and to vote at the Extraordinary Meeting and any adjournment thereof. Only shareholders who have given notice in writing to the Company by September 12, 2017 of their intention to attend the Extraordinary Meeting in person are entitled to attend the Extraordinary Meeting in person.
    [Show full text]
  • 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.
    [Show full text]
  • CB2013 Committee and Board Disclosureauditlist 9.10.13
    2013-2014 Conflict of Interest Disclosure AST Activity Participant First Name Participant Last Name Degree DisclosureDate Disclsoure Item Committee Member Reza Abdi MD 4/22/2013 No Relevant Financial Relationships Committee Member Sameh R. Abul-Ezz MD, PhD 4/16/2013 No Relevant Financial Relationships Committee Member Deborah B. Adey MD 4/15/2013 No Relevant Financial Relationships Committee Member Enver Akalin MD 4/16/2013 Consultant relationship with Pfizer Fellows 2013 Maria-Luisa Alegre MD, PhD 7/12/2013 No Relevant Financial Relationships Committee Member Alessandrini Alessandro PhD 4/29/2013 No Relevant Financial Relationships Board Member James S. Allan MD 5/3/2013 Committee Member No Relevant Financial Relationships Rita R. Alloway PharmD, FCCP Grant Support relationship with Astellas Grant Support relationship with BMS Grant Support relationship with Novartis Grant Support relationship with Lifecycle Grant Support relationship with Millenium Grant Support relationship with Pfizer (previously Wyeth) Grant Support relationship with Genentech (previously Roche) Board Member Grant Support relationship with Viropharma Committee Member Grant Support relationship with Alexion Fellows 2013 7/18/2013 Grant Support relationship with Sanofi (previously Genzyme, previously Sangstat) Committee Member Sandra Amaral MD, MHS 6/18/2013 Other relationship with Bristol Myers-Squibb Hatem Amer MD 5/6/2013 Grant Support relationship with Abbott Laborartories. Committee Member Other relationship with Massacheussetts Medical Society. Committee Member William Applegate No Relevant Financial Relationships Committee Member Alexander Aussi BSN, RN, MBA 4/22/2013 Consultant relationship with Total Transplant Advantage, LLC Committee Member Jamil Azzi MD 4/30/2013 No Relevant Financial Relationships Committee Member Fellows 2013 Mark L.
    [Show full text]
  • AMGEN INC. V. SANOFI
    Case: 20-1074 Document: 159 Page: 1 Filed: 06/21/2021 NOTE: This order is nonprecedential. United States Court of Appeals for the Federal Circuit ______________________ AMGEN INC., AMGEN MANUFACTURING, LIMITED, AMGEN USA, INC., Plaintiffs-Appellants v. SANOFI, AVENTISUB LLC, FKA AVENTIS PHARMACEUTICALS INC., REGENERON PHARMACEUTICALS INC., SANOFI-AVENTIS U.S. LLC, Defendants-Appellees ______________________ 2020-1074 ______________________ Appeal from the United States District Court for the District of Delaware in Nos. 1:14-cv-01317-RGA, 1:14-cv- 01349-RGA, 1:14-cv-01393-RGA, 1:14-cv-01414-RGA, Judge Richard G. Andrews. ______________________ JEFFREY A. LAMKEN, MoloLamken LLP, Washington, DC, filed a petition for rehearing en banc for plaintiffs-ap- pellants. Also represented by SARAH JUSTINE NEWMAN, MICHAEL GREGORY PATTILLO, JR.; SARA MARGOLIS, New York, NY; EMILY JOHNSON, ERICA S. OLSON, STEVEN TANG, STUART WATT, WENDY A. WHITEFORD, Amgen Inc., Thou- sand Oaks, CA; KEITH HUMMEL, Cravath Swaine & Moore LLP, New York, NY; WILLIAM G. GAEDE, III, McDermott Case: 20-1074 Document: 159 Page: 2 Filed: 06/21/2021 2 AMGEN INC. v. SANOFI Will & Emery LLP, Menlo Park, CA; CHRISTOPHER B. MEAD, Schertler Onorato Mead & Sears LLP, Washington, DC; JAMES L. HIGGINS, MELANIE K. SHARP, Young, Cona- way, Stargatt & Taylor, LLP, Wilmington, DE. Plaintiff- appellant Amgen Inc. also represented by SARAH CHAPIN COLUMBIA, McDermott, Will & Emery LLP, Boston, MA; LAUREN MARTIN, Quinn Emanuel Urquhart & Sullivan LLP, Boston, MA. MATTHEW WOLF, Arnold & Porter Kaye Scholer LLP, Washington, DC, filed a response for defendants-appellees. Also represented by VICTORIA REINES; DAVID K. BARR, DANIEL REISNER, New York, NY; DEBORAH E.
    [Show full text]
  • Emerging Pharmacological Strategies for the Treatment
    Emerging pharmacological strategies for the treatment of fibromyalgia LAWSON, Kim Available from Sheffield Hallam University Research Archive (SHURA) at: http://shura.shu.ac.uk/15300/ This document is the author deposited version. You are advised to consult the publisher's version if you wish to cite from it. Published version LAWSON, Kim (2017). Emerging pharmacological strategies for the treatment of fibromyalgia. World Journal of Pharmacology, 6 (1), 1-10. Repository use policy Copyright © and Moral Rights for the papers on this site are retained by the individual authors and/or other copyright owners. Users may download and/or print one copy of any article(s) in SHURA to facilitate their private study or for non- commercial research. You may not engage in further distribution of the material or use it for any profit-making activities or any commercial gain. Sheffield Hallam University Research Archive http://shura.shu.ac.uk World Journal of WJ P Pharmacology Submit a Manuscript: http://www.wjgnet.com/esps/ World J Pharmacol 207 March 9; 6(): -0 DOI: 0.5497/wjp.v6.i. ISSN 2220-392 (online) MINIREVIEWS Emerging pharmacological strategies for the treatment of ibromyalgia Kim Lawson Kim Lawson, Department of Biosciences and Chemistry, Bio­ presenting with a complex of symptoms dominated by molecular Sciences Research Centre, Shefield Hallam University, chronic widespread pain associated with the existence of a Faculty of Health and Wellbeing, Sheffield S1 1WB, United range of co-morbidities, such as fatigue, sleep disturbance, Kingdom cognitive impairment, anxiety and depression. Current treatments include drugs that target serotonin and nor- Author contributions: Lawson K researched the materials for the article and wrote the manuscript.
    [Show full text]
  • Surescripts, Llc As Amicus Curiae in Support of Petitioners in No
    Nos. 19-508 and 19-825 In the Supreme Court of the United States ———————————— AMG CAPITAL MANAGEMENT, LLC, ET AL., Petitioners, v. FEDERAL TRADE COMMISSION, Respondent. ———————————— FEDERAL TRADE COMMISSION, Petitioner, v. CREDIT BUREAU CENTER, LLC, ET AL., Respondents. ———————————— ON WRITS OF CERTIORARI TO THE UNITED STATES COURTS OF APPEALS FOR THE SEVENTH AND NINTH CIRCUITS ———————————— BRIEF OF SURESCRIPTS, LLC AS AMICUS CURIAE IN SUPPORT OF PETITIONERS IN NO. 19-508 AND RESPONDENTS IN NO. 19-825 ———————————— ALFRED C. PFEIFFER, JR. ROMAN MARTINEZ LATHAM & WATKINS LLP Counsel of Record 505 Montgomery Street AMANDA P. REEVES Suite 2000 ALLYSON M. MALTAS San Francisco, CA 94111 DOUGLAS C. TIFFT BLAKE E. STAFFORD JAMES A. TOMBERLIN* LATHAM & WATKINS LLP 555 Eleventh Street, NW Suite 1000 Washington, DC 20004 (202) 637-2200 [email protected] Counsel for Amicus Curiae Surescripts, LLC TABLE OF CONTENTS Page TABLE OF AUTHORITIES ...................................... ii INTEREST OF AMICUS CURIAE ............................1 SUMMARY OF ARGUMENT .....................................3 ARGUMENT ...............................................................5 I. The FTC Has Increasingly Wielded Section 13(b) To Obtain Monetary Relief In Antitrust Cases ................................................5 II. The FTC’s Antitrust Authority Confirms That Section 13(b) Does Not Authorize Monetary Relief ..................................................22 CONCLUSION ..........................................................32 ii TABLE OF AUTHORITIES Page(s) CASES Apple Inc. v. Pepper, 139 S. Ct. 1514 (2019) .......................................... 13 Armstrong v. Exceptional Child Center, Inc., 575 U.S. 320 (2015) .............................................. 23 Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) .............................................. 26 In re Cardinal Health, Inc., No. 101-0006, 2015 WL 1849040 (F.T.C. Apr. 17, 2015) ........................ 19, 20, 28, 30 Credit Suisse Securities (USA) LLC v. Billing, 551 U.S.
    [Show full text]
  • 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.
    [Show full text]
  • Federal Register/Vol. 84, No. 232/Tuesday, December 3, 2019
    Federal Register / Vol. 84, No. 232 / Tuesday, December 3, 2019 / Notices 66191 the Assistant Attorney General, patterns, devices, manufacturing filed with and accepted, subject to final developed the HSR Rules and the processes, or customer names. approval, by the Commission, has been corresponding Notification and Report placed on the public record for a period Form. Heather Hippsley, of thirty (30) days. The following On September 11, 2019, the Deputy General Counsel. Analysis to Aid Public Comment Commission sought comment on the [FR Doc. 2019–26075 Filed 12–2–19; 8:45 am] describes the terms of the consent reporting requirements associated with BILLING CODE 6750–01–P agreement and the allegations in the the HSR Rules and corresponding complaint. An electronic copy of the Notification and Report Form. 84 FR full text of the consent agreement 47951. No relevant comments were FEDERAL TRADE COMMISSION package can be obtained from the FTC received. Pursuant to the OMB [File No. 191 0061] Home Page (for November 15, 2019), on regulations, 5 CFR part 1320, that the World Wide Web, at https:// implement the PRA, 44 U.S.C. 3501 et Bristol-Myers Squibb Company and www.ftc.gov/news-events/commission- seq., the FTC is providing this second Celgene Corporation; Analysis of actions. opportunity for public comment while Agreement Containing Consent Orders You can file a comment online or on seeking OMB approval to renew the pre- To Aid Public Comment paper. For the Commission to consider existing clearance for those information your comment, we must receive it on or collection requirements.
    [Show full text]
  • Shire Acquisition of Viropharma - Strategic Move to Strengthen Shire’S Rare Disease Business - Augments Already Strong Growth Prospects
    Shire acquisition of ViroPharma - Strategic move to strengthen Shire’s Rare Disease business - Augments already strong growth prospects Flemming Ornskov, MD Chief Executive Officer Graham Hetherington Chief Financial Officer Our purpose We enable people with life-altering conditions to lead better lives. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS Statements included in this communication that are not historical facts are forward-looking statements. Forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, results could be materially adversely affected. The risks and uncertainties include, but are not limited to, that: •Shire’s proposed acquisition of ViroPharma may not be consummated due to the occurrence of an event, change or other circumstances that gives rise to the termination of the merger agreement; •a governmental or regulatory approval required for the proposed acquisition of ViroPharma may not be obtained, or may be obtained subject to conditions that are not anticipated, or another condition to the closing of the proposed acquisition may not be satisfied; •ViroPharma may be unable to retain and hire key personnel and/or maintain its relationships with customers, suppliers and other business partners pending the consummation of the proposed acquisition by Shire, or ViroPharma’s business may be disrupted by the proposed acquisition, including increased costs and diversion of management time and resources; •difficulties in integrating ViroPharma into Shire may lead to the combined company not being able to realize the expected operating efficiencies, cost savings, revenue enhancements, synergies or other benefits at the time anticipated or at all; and risks and uncertainties detailed from time to time in Shire’s or ViroPharma’s filings with the U.S.
    [Show full text]
  • BIOGEN INTERNATIONAL GMBH, Plaintiff-Appellant
    Case: 20-1373 Document: 41 Page: 1 Filed: 04/21/2020 United States Court of Appeals for the Federal Circuit ______________________ BIOGEN INTERNATIONAL GMBH, Plaintiff-Appellant v. BANNER LIFE SCIENCES LLC, Defendant-Appellee ______________________ 2020-1373 ______________________ Appeal from the United States District Court for the District of Delaware in No. 1:18-cv-02054-LPS, Chief Judge Leonard P. Stark. ______________________ Decided: April 21, 2020 ______________________ JAMES B. MONROE, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC, for plaintiff-ap- pellant. Also represented by PAUL WILLIAM BROWNING, J. MICHAEL JAKES, LAURA POLLARD MASUROVSKY, JASON LEE ROMRELL. KYLE MUSGROVE, Parker Poe Adams & Bernstein LLP, Charlotte, NC, for defendant-appellee. Also represented by JOHN WORTHINGTON BATEMAN, ELIZABETH CROMPTON, SCOTT A. CUNNING, II, Washington, DC. ______________________ Case: 20-1373 Document: 41 Page: 2 Filed: 04/21/2020 2 BIOGEN INTERNATIONAL GMBH v. BANNER LIFE SCIENCES LLC Before LOURIE, MOORE, and CHEN, Circuit Judges. LOURIE, Circuit Judge. Biogen International GmbH (“Biogen”) appeals from a judgment of the United States District Court for the Dis- trict of Delaware that Banner Life Sciences LLC (“Banner”) does not infringe the extended portion of U.S. Patent 7,619,001 (the “’001 patent”), extended under the patent term restoration provisions of the Hatch-Waxman Act, Pub. L. No. 98-417, § 201, 98 Stat. 1585, 1598 (as codified at 35 U.S.C. § 156 (2018)). Biogen Int’l GmbH v. Banner Life Scis. LLC, No. 18-2054-LPS, 2020 WL 109499 (D. Del. Jan. 7, 2020) (“Decision”). Because the scope of a patent term extension under 35 U.S.C.
    [Show full text]
  • G Protein-Coupled Receptors
    S.P.H. Alexander et al. The Concise Guide to PHARMACOLOGY 2015/16: G protein-coupled receptors. British Journal of Pharmacology (2015) 172, 5744–5869 THE CONCISE GUIDE TO PHARMACOLOGY 2015/16: G protein-coupled receptors Stephen PH Alexander1, Anthony P Davenport2, Eamonn Kelly3, Neil Marrion3, John A Peters4, Helen E Benson5, Elena Faccenda5, Adam J Pawson5, Joanna L Sharman5, Christopher Southan5, Jamie A Davies5 and CGTP Collaborators 1School of Biomedical Sciences, University of Nottingham Medical School, Nottingham, NG7 2UH, UK, 2Clinical Pharmacology Unit, University of Cambridge, Cambridge, CB2 0QQ, UK, 3School of Physiology and Pharmacology, University of Bristol, Bristol, BS8 1TD, UK, 4Neuroscience Division, Medical Education Institute, Ninewells Hospital and Medical School, University of Dundee, Dundee, DD1 9SY, UK, 5Centre for Integrative Physiology, University of Edinburgh, Edinburgh, EH8 9XD, UK Abstract The Concise Guide to PHARMACOLOGY 2015/16 provides concise overviews of the key properties of over 1750 human drug targets with their pharmacology, plus links to an open access knowledgebase of drug targets and their ligands (www.guidetopharmacology.org), which provides more detailed views of target and ligand properties. The full contents can be found at http://onlinelibrary.wiley.com/doi/ 10.1111/bph.13348/full. G protein-coupled receptors are one of the eight major pharmacological targets into which the Guide is divided, with the others being: ligand-gated ion channels, voltage-gated ion channels, other ion channels, nuclear hormone receptors, catalytic receptors, enzymes and transporters. These are presented with nomenclature guidance and summary information on the best available pharmacological tools, alongside key references and suggestions for further reading.
    [Show full text]
  • The Two Tontti Tudiul Lui Hi Ha Unit
    THETWO TONTTI USTUDIUL 20170267753A1 LUI HI HA UNIT ( 19) United States (12 ) Patent Application Publication (10 ) Pub. No. : US 2017 /0267753 A1 Ehrenpreis (43 ) Pub . Date : Sep . 21 , 2017 ( 54 ) COMBINATION THERAPY FOR (52 ) U .S . CI. CO - ADMINISTRATION OF MONOCLONAL CPC .. .. CO7K 16 / 241 ( 2013 .01 ) ; A61K 39 / 3955 ANTIBODIES ( 2013 .01 ) ; A61K 31 /4706 ( 2013 .01 ) ; A61K 31 / 165 ( 2013 .01 ) ; CO7K 2317 /21 (2013 . 01 ) ; (71 ) Applicant: Eli D Ehrenpreis , Skokie , IL (US ) CO7K 2317/ 24 ( 2013. 01 ) ; A61K 2039/ 505 ( 2013 .01 ) (72 ) Inventor : Eli D Ehrenpreis, Skokie , IL (US ) (57 ) ABSTRACT Disclosed are methods for enhancing the efficacy of mono (21 ) Appl. No. : 15 /605 ,212 clonal antibody therapy , which entails co - administering a therapeutic monoclonal antibody , or a functional fragment (22 ) Filed : May 25 , 2017 thereof, and an effective amount of colchicine or hydroxy chloroquine , or a combination thereof, to a patient in need Related U . S . Application Data thereof . Also disclosed are methods of prolonging or increasing the time a monoclonal antibody remains in the (63 ) Continuation - in - part of application No . 14 / 947 , 193 , circulation of a patient, which entails co - administering a filed on Nov. 20 , 2015 . therapeutic monoclonal antibody , or a functional fragment ( 60 ) Provisional application No . 62/ 082, 682 , filed on Nov . of the monoclonal antibody , and an effective amount of 21 , 2014 . colchicine or hydroxychloroquine , or a combination thereof, to a patient in need thereof, wherein the time themonoclonal antibody remains in the circulation ( e . g . , blood serum ) of the Publication Classification patient is increased relative to the same regimen of admin (51 ) Int .
    [Show full text]