Pharmacological Management of Autism Spectrum Disorders
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Optumrx Brand Pipeline Forecast
RxOutlook® 1st Quarter 2019 OptumRx brand pipeline forecast Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug 2019 Possible launch date Ophthalmological DS-300 DS-300 Eton undisclosed SC Filed NDA 2019 unknown N disease anti-sclerostin Evenity romosozumab Amgen Osteoporosis SC Filed NDA 2/2019 Y N monoclonal antibody tetrahydrofolate iclaprim iclaprim Motif Bio Bacterial infections IV Filed NDA 2/13/2019 Y Y dehydrogenase inhibitor tazarotene/ IDP-118 Valeant retinoid/ corticosteroid Psoriasis TOP Filed NDA 2/15/2019 N N halobetasol adenosine deaminase Mavenclad cladribine Merck/ Teva resistant Multiple sclerosis PO Filed NDA 2/15/2019 Y N deoxyadenosine analog Lotemax Gel loteprednol Valeant corticosteroid Ocular inflammation OP Filed NDA 2/25/2019 N N Nex Gen etabonate turoctocog alfa glyco-PEGylated factor NN-7088 Novo Nordisk Hemophilia IV/SC Filed BLA 2/27/2019 Y N pegol VIII derivative selective sphingosine-1 BAF-312 siponimod Novartis phosphate receptor Multiple sclerosis PO Filed NDA 3/1/2019 Y N agonist midazolam midazolam UCB benzodiazepine Seizures Intranasal Filed NDA 3/1/2019 N Y (USL-261) XeriSol glucagon Xeris glucagon analog Diabetes mellitus SC Filed NDA 3/1/2019 N N Glucagon optum.com/optumrx 1 RxOutlook® 1st Quarter 2019 Route of Regulatory Estimated Specialty Orphan Drug name Generic name Company Drug class Therapeutic use administration status release date drug drug dopamine receptor JZP-507 sodium oxybate Jazz Narcolepsy -
Integrating Treatment for Autism Spectrum Disorders Through the Life Cycle
Integrating Treatment for Autism Spectrum Disorders Through the Life Cycle Robert L Hendren, DO Professor of Psychiatry and Behavioral Science Idaho Autism Summit November 2, 2019 Faculty Disclosure • Grants — Curemark, Roche, Otsuka • Advisory Board — Curemark, BioMarin, Janssen, Axial Biotherapeutics • Honoraria/Royalties: Oxford University Press, Taylor & Francis • Dr. Hendren does intend to discuss the use of off- label/unapproved use of drugs Learning Objectives • Identify successes and challenges in the developmental progression through the life cycle for people with developmental disabilities and their families • Identify and effectively treat comorbid medical, emotional and behavioral symptoms associated with autism spectrum disorders (ASD) • Consider integrating biomedical treatments for ASD including conventional psychotropic medication and what has been referred to as CAM/CIM into a comprehensive program. 2010 1 in 68; 2014 1 in 59 CDC Prevalence of Autism • Possible explanations include – Diagnostic expansion and substitution – Better reporting – Increased recognition – Increasing acceptability – Immigration for services – Environmental toxins – Infectious and immune vulnerability – Epigenetic processes Rutter M. Acta Pediatr. 2005;94(1):2-15. Centers for Disease Control and Prevention. Autism Spectrum Disorders. www.cdc.gov/ncbddd/autism. Accessed June 16, 2015. Hagerman R, Hendren RL (Eds). Treatment of Neurodevelopmental Disorders: Targeting Neurobiological Mechanisms. Oxford University Press; 2014. ASD Genetic Etiology (Levels 1 & 2) • Multiple genes: NRXN12q, 7q11.23, 15q11-13, 16p11.2, SHANK 3, 2, NLGN4, MTHFR 677>T, SEMA5A, 2Q22.1, GRIN2B, 5P14.1, CDH9, 10, FRX, PTEN • Identical twins: 60% to 90% – Fraternal twins: 0% to 36% – Siblings: 4% to 19% • Clear genetic etiology accounts for 25% of autism cases • Hundreds of genetic mutations, some de novo, lead to many ways to develop and treat autism • Is Precision Medicine Possible? Weiss KM, Issues Science and Technology in 2017 Levy D, et al. -
Horizon Scanning Status Report, Volume 2
PCORI Health Care Horizon Scanning System Volume 2, Issue 3 Horizon Scanning Status Report September 2020 Prepared for: Patient-Centered Outcomes Research Institute 1828 L St., NW, Suite 900 Washington, DC 20036 Contract No. MSA-HORIZSCAN-ECRI-ENG-2018.7.12 Prepared by: ECRI Institute 5200 Butler Pike Plymouth Meeting, PA 19462 Investigators: Randy Hulshizer, MA, MS Damian Carlson, MS Christian Cuevas, PhD Andrea Druga, PA-C Marcus Lynch, PhD, MBA Misha Mehta, MS Prital Patel, MPH Brian Wilkinson, MA Donna Beales, MLIS Jennifer De Lurio, MS Eloise DeHaan, BS Eileen Erinoff, MSLIS Cassia Hulshizer, AS Madison Kimball, MS Maria Middleton, MPH Diane Robertson, BA Melinda Rossi, BA Kelley Tipton, MPH Rosemary Walker, MLIS Andrew Furman, MD, MMM, FACEP Statement of Funding and Purpose This report incorporates data collected during implementation of the Patient-Centered Outcomes Research Institute (PCORI) Health Care Horizon Scanning System, operated by ECRI under contract to PCORI, Washington, DC (Contract No. MSA-HORIZSCAN-ECRI-ENG-2018.7.12). The findings and conclusions in this document are those of the authors, who are responsible for its content. No statement in this report should be construed as an official position of PCORI. An intervention that potentially meets inclusion criteria might not appear in this report simply because the Horizon Scanning System has not yet detected it or it does not yet meet inclusion criteria outlined in the PCORI Health Care Horizon Scanning System: Horizon Scanning Protocol and Operations Manual. Inclusion or absence of interventions in the horizon scanning reports will change over time as new information is collected; therefore, inclusion or absence should not be construed as either an endorsement or rejection of specific interventions. -
Lääkeaineiden Yleisnimet (INN-Nimet) 21.6.2021
Lääkealan turvallisuus- ja kehittämiskeskus Säkerhets- och utvecklingscentret för läkemedelsområdet Finnish Medicines Agency Lääkeaineiden yleisnimet (INN-nimet) 21.6. -
Stembook 2018.Pdf
The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 WHO/EMP/RHT/TSN/2018.1 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.1). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. -
Horizon Scanning Status Report June 2020 Prepared For: Patient-Centered Outcomes Research Institute 1828 L St., NW, Suite 900 Washington, DC 20036
PCORI Health Care Horizon Scanning System Volume 2 Issue 2 Horizon Scanning Status Report June 2020 Prepared for: Patient-Centered Outcomes Research Institute 1828 L St., NW, Suite 900 Washington, DC 20036 Contract No. MSA-HORIZSCAN-ECRI-ENG-2018.7.12 Prepared by: ECRI Institute 5200 Butler Pike Plymouth Meeting, PA 19462 Investigators: Randy Hulshizer, MA, MS Damian Carlson, MS Christian Cuevas, PhD Andrea Druga, PA-C Marcus Lynch, PhD Misha Mehta, MS Brian Wilkinson, MA Donna Beales, MLIS Jennifer De Lurio, MS Eloise DeHaan, BS Eileen Erinoff, MSLIS Madison Kimball, MS Maria Middleton, MPH Diane Robertson, BA Kelley Tipton, MPH Rosemary Walker, MLIS Karen Schoelles, MD, SM Statement of Funding and Purpose This report incorporates data collected during implementation of the Patient-Centered Outcomes Research Institute (PCORI) Health Care Horizon Scanning System, operated by ECRI Institute under contract to PCORI, Washington, DC (Contract No. MSA-HORIZSCAN-ECRI-ENG- 2018.7.12). The findings and conclusions in this document are those of the authors, who are responsible for its content. No statement in this report should be construed as an official position of PCORI. An intervention that potentially meets inclusion criteria might not appear in this report simply because the Horizon Scanning System has not yet detected it or it does not yet meet inclusion criteria outlined in the PCORI Health Care Horizon Scanning System: Horizon Scanning Protocol and Operations Manual. Inclusion or absence of interventions in the horizon scanning reports will change over time as new information is collected; therefore, inclusion or absence should not be construed as either an endorsement or rejection of specific interventions. -
Bionomics Presents at the 14Th Annual Bioshares Biotech Summit
ABN 53 075 582 740 ASX ANNOUNCEMENT 27 July 2018 Bionomics Presents at the 14th Annual Bioshares Biotech Summit Bionomics Limited (ASX:BNO, OTCQX:BNOEF), a global, clinical stage biopharmaceutical company leveraging proprietary platform technologies to discover and develop drug candidates targeting ion channels in CNS disorders, is presenting on BNC210, a novel small molecule therapeutic candidate in development for anxiety, panic, post-traumatic stress disorder (PTSD) and agitation at the 14th Annual Bioshares Biotech Summit in Queenstown, New Zealand. The presentation is being given on Saturday July 28th at 11.00am by the Vice President of Strategic Initiatives and Innovation, Dr Sue O’Connor, in the session CNS Drug Development and Mental Health. A copy of the presentation is attached to this announcement. FOR FURTHER INFORMATION PLEASE CONTACT: Australia US Monsoon Communications Stern Investor Relations Rudi Michelson Will O’Connor +613 9620 3333 +1 212 362 1200 [email protected] [email protected] About Bionomics Limited Bionomics (ASX: BNO) is a global, clinical stage biopharmaceutical company leveraging its proprietary platform technologies to discover and develop a deep pipeline of best in class, novel drug candidates. Bionomics’ lead drug candidate BNC210, currently in Phase 2 for the treatment of agitation and for post-traumatic stress disorder, is a novel, proprietary negative allosteric modulator of the alpha-7 (α7) nicotinic acetylcholine receptor. Beyond BNC210, Bionomics has a strategic partnership with Merck & Co., Inc (known as MSD outside the United States and Canada). www.bionomics.com.au About BNC210 BNC210 is a novel small molecule, orally-administered therapeutic candidate being developed for anxiety, panic, trauma- and stressor-related disorders and agitation, that we believe has similar efficacy but improved tolerability compared to currently available drugs such as benzodiazepines, selective serotonin reuptake inhibitors, or SSRIs, and serotonin-norepinephrine reuptake inhibitors, or SNRIs. -
Mental Health Revolution
THERAPEUTIC DIGEST MENTAL HEALTH REVOLUTION IN COLLABORATION WITH FEBRUARY 2020 THE MENTAL HEATH REVOLUTION Table of Contents The Mental Health Revolution: The Next Generation of Drug Development for Psychiatry ............................................. 4 The Current Market .................................................................................................................. 5 Table: Commonly Prescribed Psychotropic Medications .................................................... 6 The Revolution............................................................................................................................ 7 Chart: Medicines in Development by Disease and Phase .................................................... 8 The Scientific Landscape ..................................................................................................... 9 The Technological Landscape ........................................................................................... 10 The Regulatory Landscape ................................................................................................ 12 Collaborative Approaches that Support Drug Development .............................................. 13 Table: Psychiatric Drug Pipeline (2013-2019) .................................................................. 15 Conclusion ................................................................................................................................. 22 Notes ........................................................................................................................................... -
Brand Pipeline Forecast 4Th Quarter 2019
Brand Pipeline Forecast 4th Quarter 2019 Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug 2019 Possible Launch Date RVT-802 RVT-802 Enzyvant/Roivant Tissue-based therapy Congenital athymia Implant Filed NDA 12/2019 Yes Yes Zimhi naloxone Adamis opioid antagonist Opioid dependence IM Filed NDA 12/2019 No No calcitonin gene-related MK-1602 (AGN-241689) ubrogepant Allergan/ Merck peptide (CGRP) receptor Acute migraines PO Filed NDA 12/2019 No No antagonist IDP-123 IDP-123 Bausch Health retinoid Acne TOP Filed NDA 12/22/2019 No No Brinavess vernakalant Correvio potassium channel blocker Arrhythmia IV Filed NDA 12/24/2019 Yes No E-2006 lemborexant Eisai/ Purdue orexin receptor antagonist Insomnia PO Filed NDA 12/27/2019 No No ITI-007 lumateperone Intra-Cellular Therapies antipsychotic Schizophrenia PO Filed NDA 12/27/2019 No No HIV integrase inhibitor/ cabotegravir (long-acting)/ non-nucleoside reverse TMC-278-LA ViiV Healthcare HIV IM Filed NDA 12/29/2019 Yes No rilpivirine (long- acting) transcriptase inhibitor (NNRTI) S-265744 (S/GSK- 1265744) cabotegravir ViiV Healthcare HIV integrase inhibitor HIV PO Filed NDA 12/29/2019 Yes No NRL-1 diazepam Neurelis benzodiazepine Seizures Intranasal Filed NDA 2H2019 No Yes 2020 Possible Launch Date integrin receptor 12/2019 - Entyvio (SC formulation) vedolizumab Takeda Ulcerative colitis SC Filed sBLA Yes No antagonist 1/2020 methyltransferase EZH2 E-7438 (EPZ- 6438) tazemetostat Epizyme/ Eisai Sarcoma -
International Nonproprietary Names for Pharmaceutical Substances (INN)
WHO Drug Information, Vol. 30, No. 4, 2016 Proposed INN: List 116 International Nonproprietary Names for Pharmaceutical Substances (INN) Notice is hereby given that, in accordance with article 3 of the Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical Substances, the names given in the list on the following pages are under consideration by the World Health Organization as Proposed International Nonproprietary Names. The inclusion of a name in the lists of Proposed International Nonproprietary Names does not imply any recommendation of the use of the substance in medicine or pharmacy. Lists of Proposed (1–113) and Recommended (1–74) International Nonproprietary Names can be found in Cumulative List No. 16, 2015 (available in CD-ROM only). The statements indicating action and use are based largely on information supplied by the manufacturer. This information is merely meant to provide an indication of the potential use of new substances at the time they are accorded Proposed International Nonproprietary Names. WHO is not in a position either to uphold these statements or to comment on the efficacy of the action claimed. Because of their provisional nature, these descriptors will neither be revised nor included in the Cumulative Lists of INNs. Dénominations communes internationales des Substances pharmaceutiques (DCI) Il est notifié que, conformément aux dispositions de l'article 3 de la Procédure à suivre en vue du choix de Dénominations communes internationales recommandées pour les Substances pharmaceutiques les dénominations ci-dessous sont mises à l'étude par l'Organisation mondiale de la Santé en tant que dénominations communes internationales proposées. -
Brand Pipeline Forecast 3Rd Quarter 2019
Brand Pipeline Forecast 3rd Quarter 2019 Route of Estimated Release Specialty Drug Name Generic Name Company Drug Class Therapeutic Use Regulatory Status Orphan Drug Administration Date Drug 2019 Possible Launch Date S-649266 cefiderocol Shionogi/ GlaxoSmithKiline cephalosporin antibiotic Bacterial infections IV Filed NDA 8/14/2019 Yes No A2A adenosine receptor Nouriast istradefylline Kyowa Hakko Kogyo Parkinson's disease PO Filed NDA 8/27/2019 No No antagonist Rexista XR oxycodone ER IntelliPharmaCeutic opioid agonist Pain PO Filed NDA 8/28/2019 No No NKTR-181 NKTR-181 Nektar opioid agonist Pain PO Filed NDA 8/29/2019 No No phosphodiesterase-5 (PDE- tadalafil VersaFilm tadalafil VersaFilm IntelGenx Erectile dysfunction PO Filed NDA Mid-2019 Yes No 5) inhibitor fosphenytoin sodium/ fosphenytoin sodium/ sulfobutylether beta- sulfobutylether beta- Sedor anticonvulsant Seizures IM/IV Filed NDA Mid-2019 Yes No cyclodextrin sodium cyclodextrin sodium XeriSol Glucagon glucagon Xeris glucagon analog Diabetes mellitus SC Filed NDA 9/10/2019 No No sodium-hydrogen Irritable bowel syndrome- RDX-5791 (AZD- 1722) tenapanor Ardelyx exchanger-3 (NHE-3) PO Filed NDA 9/13/2019 No No constipation inhibitor Imvamune; MVA- BN Imvamune; MVA-BN Bavarian Nordic vaccine Smallpox SC Filed BLA 9/15/2019 Yes No Novo Nordisk/ Emisphere glucagon-like peptide-1 NN-9924 (OG- 217SC) semaglutide (oral) Diabetes mellitus PO Filed NDA 9/20/2019 Yes No Technologies (GLP-1) receptor agonist Valtoco diazepam Neurelis benzodiazepine Seizures Intranasal Filed NDA 2H2019 No -
Drug Repurposing Compound Library Plus (96-Well)
• Bioactive Molecules • Building Blocks • Intermediates www.ChemScene.com Drug Repurposing Compound Library Plus (96-well) Product Details: Catalog Number: CS-L035P Formulation: A collection of 3924 bioactive compounds supplied as pre-dissolved Solutions or Solid Container: 96- or 384-well Plate with Peelable Foil Seal; 96-well Format Sample Storage Tube With Screw Cap and Optional 2D Barcode Storage: -80°C Shipping: Blue ice Packaging: Inert gas Plate layout: CS-L035P-Part A-1 1 2 3 4 5 6 7 8 9 10 11 12 Flavopiridol a Empty Vonoprazan Peretinoin Tomivosertib Faropenem Flavopiridol (Hydrochlorid Semagacesta Mitoquinone Taranabant Delpazolid Empty daloxate e) t (mesylate) Varenicline AQ-13 b Empty DSM265 GSK- Varenicline (Hydrochlorid Varenicline Trifarotene 9-amino-CPT dihydrochlorid Remetinostat Isavuconazon Empty 2881078 e) (Tartrate) e ium (sulfate) K-604 c Empty Diroximel Nevanimibe dihydrochlorid Pactimibe Pactimibe Linaprazan BFH772 Odanacatib Cadazolid Treprostinil Empty fumarate hydrochloride e (sulfate) Rilmenidine d Empty Paquinimod AEE788 Plerixafor Esaxerenone Visomitin (hemifumarat Rilmenidine Fisogatinib FT011 GSK2256098 Empty e) (phosphate) e Empty Avadomide Aprepitant (S)-Crizotinib MSDC 0160 Abscisic acid Tempol Flopropione Acriflavine Davercin Spiramycin Empty Sodium Landiolol AZD5153 (6- f Empty stibogluconat Saponins (hydrochlorid BMS-986020 BMS-986020 Ticagrelor Axitinib Hydroxy-2- Fosfluconazol Pipamperone Empty e e) (sodium) naphthoic e Pirmenol g Empty Eganelisib HT-2157 Lanabecestat CXD101 Ritlecitinib Setogepram