IOPA Two-Year Progress Report
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JUSTICE NEWS Opioid Manufacturer Insys Therapeutics Agrees to Enter
JUSTICE NEWS Department of Justice Office of Public Affairs FOR IMMEDIATE RELEASE Wednesday, June 5, 2019 Opioid Manufacturer Insys Therapeutics Agrees to Enter $225 Million Global Resolution of Criminal and Civil Investigations Company Admits Illegal Conduct Regarding Promotion of Subsys, a Powerful Opioid Painkiller Opioid manufacturer Insys Therapeutics agreed to a global resolution to settle the government’s separate criminal and civil investigations, the Department of Justice announced today. As part of the criminal resolution, Insys will enter into a deferred prosecution agreement with the government, Insys’s operating subsidiary will plead guilty to five counts of mail fraud, and the company will pay a $2 million fine and $28 million in forfeiture. As part of the civil resolution, Insys agreed to pay $195 million to settle allegations that it violated the False Claims Act. Both the criminal and civil investigations stemmed from Insys’s payment of kickbacks and other unlawful marketing practices in connection with the marketing of Subsys. Insys’s drug Subsys is a sublingual fentanyl spray, a powerful, but highly addictive, opioid painkiller. In 2012, Subsys was approved by the Food and Drug Administration for the treatment of persistent breakthrough pain in adult cancer patients who are already receiving, and tolerant to, around-the-clock opioid therapy. Today, the U.S. Attorney’s Office for the District of Massachusetts filed an Information charging Insys and its operating subsidiary with five counts of mail fraud. According to the charging document, from August 2012 to June 2015, Insys began using “speaker programs” purportedly to increase brand awareness of Subsys through peer-to-peer educational lunches and dinners. -
Antiemetic/Antivertigo Agents – Dronabinol
!ntiemetic/!ntivertigo !gents – dronabinol WA.PHAR.35 Antiemetic Antivertigo Agents Dronabinol Medical necessity Drug Medical Necessity Dronabinol (MARINOL®) Dronabinol may be considered medically necessary when: Dronabinol (SYNDROS®) Used for the treatment of ONE of the following 1. Anorexia associated with weight loss in adults with AIDS 2. Nausea and vomiting associated with chemotherapy in adults Clinical policy: Drug Clinical Criteria (Initial Approval) Dronabinol (MARINOL®) 1. Anorexia associated with weight loss in adults with AIDS Dronabinol (SYNDROS®) a. Defined by ONE of the following: i. Involuntary weight loss in adults of greater than 10% of pre-illness baseline body weight ii. BMI less than 20kg/m² in the absence of concurrent illness or medical condition other than AIDS that may cause weight loss b. History of failure, contraindication or intolerance to conventional therapies (e.g. megestrol (Megace®)) c. Dose limit: i. Marinol: 20mg per day ii. Syndros: 8.4mg twice daily 2. Prescribed by or in consultation with an HIV specialist Approve for 6 months Criteria (Reauthorization) 1. Continued diagnosis of AIDS wasting with continued wasting based on reduction of BMI 2. Documentation of positive clinical benefit Approve for 6 months Clinical Criteria (Initial Approval) 1. Nausea and vomiting associated with chemotherapy in adults a. Current diagnosis or cancer or history of cancer diagnosis in last year Policy: Dronabinol Last Updated 04/18/2018 1 b. Currently receiving chemotherapy or history of chemotherapy in the last year c. History of failure, contraindication or intolerance to conventional therapy (e.g. dexamethasone, ondansetron, aprepitant) 2. Dose limit: a. Marinol: 15mg/m² per dose for 4 to 6 doses per day b. -
Safe and Secure Distribution of Controlled Substances September 2019 About This Report
Safe and Secure Distribution of Controlled Substances September 2019 About This Report AmerisourceBergen exists within a highly AmerisourceBergen is publishing this report complex and dynamic healthcare environment. both to build on the Company’s commitment to We provide both our partners and the healthcare transparency and to provide stockholders and other system deep scale, efficiency, and value. Our wholesale stakeholders information on our efforts to ensure pharmaceutical distribution business plays a key role the safe and secure distribution of opioids and in the pharmaceutical supply chain, providing safe other controlled substances, as well as information access to thousands of important medications for on the community and associated outreach healthcare providers to serve patients with a wide programs AmerisourceBergen created and supports array of clinical needs across the healthcare spectrum. to help combat the opioid epidemic. This report supplements our efforts to communicate with The driving force behind everything we do is our stakeholders through our Corporate Citizenship Purpose - we are united in our responsibility to create Report, proxy materials, and the Fighting the Opioid healthier futures. This Purpose drives every facet of Epidemic section of our website1 and supports our our business and is more important today than ever ongoing dialogue through direct engagement. as we and the country grapple with the opioid crisis. AmerisourceBergen welcomes the opportunity AmerisourceBergen has a longstanding commitment to provide this information and the Company is to ensuring a safe and efficient pharmaceutical committed to continued transparency. supply chain. We have taken substantial steps to combat the diversion of controlled substances and fight opioid misuse and abuse. -
Name Address City Zip AMERISOURCEBERGEN CORP
Name Address City Zip AMERISOURCEBERGEN CORP 322 N 3RD ST PADUCAH 42001 AMERISOURCEBERGEN CORP 6810 SHADY OAK RD EDEN PRAIRIE 55344 AMERISOURCEBERGEN CORP 172 CAHABA VALLEY PKY PELHAM 35124 AMERISOURCEBERGEN CORP 6305 LASALLE DR LOCKBOURNE 43137 AMERISOURCEBERGEN CORP 501 PATRIOT PKWY ROANOKE 76262 AMERISOURCEBERGEN CORP 1001 W TAYLOR RD ROMEOVILLE 60446 AMERISOURCEBERGEN CORP 11200 NORTH CONGRESS AVE KANSAS CITY 64153 AMERISOURCEBERGEN CORP 5100 JAINDL BLVD BETHLEHEM 18017 AMERISOURCEBERGEN CORP 004 101 NORFOLK ST MANSFIELD 2048 AMERISOURCEBERGEN CORP 008 1325 W STRIKER AVE SACRAMENTO 95834‐1164 AMERISOURCEBERGEN CORP 012 1851 CALIFORNIA AVE CORONA 92881 AMERISOURCEBERGEN CORP 017 1765 FREMONT DR SALT LAKE CITY 84104 AMERISOURCEBERGEN CORP 020 1825 S 43RD AVE PHOENIX 85009 AMERISOURCEBERGEN CORP 024 24903 AVE KEARNY VALENCIA 91355 AMERISOURCEBERGEN CORP 026 238 SAND ISLAND ACCESS RD #M‐1 HONOLULU 96819 AMERISOURCEBERGEN CORP 032 19220 64TH AVE SOUTH KENT 98032 AMERISOURCEBERGEN CORP 037 12727 W AIRPORT BLVD SUGAR LAND 77478 AMERISOURCEBERGEN CORP 038 501 W 44TH AVE DENVER 80216 AMERISOURCEBERGEN CORP 040 1085 N SATELLITE BLVD SUWANEE 30024 AMERISOURCEBERGEN CORP 041 9900 JEB STUART PKWY GLEN ALLEN 23059 AMERISOURCEBERGEN CORP 049 ONE INDUSTRIAL PARK DR WILLIAMSTON 48895 AMERISOURCEBERGEN DRUG CO 120 TRANS AIR DR MORRISVILLE 27560 AMERISOURCEBERGEN DRUG CORP 2100 DIRECTORS ROW ORLANDO 32809‐6234 AMERISOURCEBERGEN DRUG CORP 10910 VISTA BLVD SUITE 401 ORLANDO 32829 ASD SPECIALTY HEALTHCARE ABC 345 INTERNATIONAL BLVD STE 400 BROOKS 40109 -
Companies in Attendance
COMPANIES IN ATTENDANCE Abbott Diabetes Care Archbow Consulting LLC Business One Technologies Abbott Laboratories ARKRAY USA BusinessOneTech AbbVie Armory Hill Advocates, LLC CastiaRX ACADIA Artia Solutions Catalyst Acaria Health Asembia Celgene Accredo Assertio Therapeutics Celltrion Acer Therapeutics AssistRx Center for Creative Leadership Acorda Therapeutics Astellas Pharma US Inc. Cigna Actelion AstraZeneca Cigna Specialty Pharmacy AdhereTech Athenex Oncology Circassia Advantage Point Solutions Avanir Coeus Consulting Group Aerie Pharmaceuticals Avella Coherus Biosciences AGIOS AveXis Collaborative Associates LLC Aimmune Theraputics Bank of America Collegium Akcea Therapeutics Bausch Health Corsica Life Sciences Akebia Therapeutics Bayer U.S. CoverMyMeds Alder BioPharmaceuticals Becton Dickinson Creehan & Company, Inc., an Inovalon Company Alexion Biofrontera CSL Behring Alkermes Biogen Curant Health Allergan Biohaven CVS Health Almirall BioMarin D2 Consulting Alnylam BioMatrix Specialty Pharmacy Daiichi Sankyo Amarin BioPlus Specialty Pharmacy DBV Technologies Amber Pharmacy Bioventus Deloitte Consulting LLP AmerisourceBergen Blue Cross Blue Shield Association Dendreon Amgen Blue Fin Group Dermira Amicus Therapeutics bluebird bio Dexcom Amneal Boehringer Ingelheim Diplomat Pharmacy Anthem Boston Biomedical Dova Applied Policy Bowler and Company Decision Resources Group Aquestive Therapeutics Braeburn Eisai Arbor Pharmaceuticals Bristol-Myers Squibb 1 electroCore Indivior Merz Pharmaceuticals EMD Serono Inside Rx Milliman Encore Dermatology, -
BNYM Investment Port:Midcap Stock Port (Unaudited) As of Date: 09/30/2020 Common Stocks
BNYM Investment Port:MidCap Stock Port (Unaudited) As of date: 09/30/2020 Common Stocks Identifier Security Description Shares Market Value ($) 002535300 Aaron's 7,450 422,043 00404A109 Acadia Healthcare 5,480 161,550 004498101 ACI Worldwide 13,250 346,223 00508Y102 Acuity Brands 9,470 969,255 BD845X2 Adient 12,480 216,278 00737L103 Adtalem Global Education 6,800 166,872 00766T100 AECOM 4,170 174,473 018581108 Alliance Data Systems 7,130 299,317 01973R101 Allison Transmission Holdings 7,110 249,845 00164V103 AMC Networks 10,710 264,644 023436108 Amedisys 2,760 652,547 025932104 American Financial Group 3,310 221,704 03073E105 AmerisourceBergen 2,220 215,162 042735100 Arrow Electronics 5,620 442,069 04280A100 Arrowhead Pharmaceuticals 5,670 244,150 045487105 Associated Banc-Corp 47,940 605,003 05329W102 Autonation 6,980 369,451 05368V106 Avient 23,030 609,374 053774105 Avis Budget Group 10,600 278,992 05464C101 Axon Enterprise 2,410 218,587 062540109 Bank of Hawaii 4,830 244,012 06417N103 Bank OZK 6,630 141,352 090572207 Bio-Rad Laboratories 1,480 762,881 09073M104 Bio-Techne 880 218,002 05550J101 BJs Wholesale Club Holdings 11,270 468,269 09227Q100 Blackbaud 3,750 209,363 103304101 Boyd Gaming 18,350 563,162 105368203 Brandywine Realty Trust 93,500 966,790 11120U105 Brixmor Property Group 6,300 73,647 117043109 Brunswick 8,150 480,117 12685J105 Cable One 300 565,629 127190304 CACI International, Cl. A 3,980 848,377 12769G100 Caesars Entertainment 11,890 666,553 133131102 Camden Property Trust 11,390 1,013,482 134429109 Campbell Soup 4,440 -
Medical Marijuana for People Living with HIV
Medical Marijuana for People Living with HIV Jasjit Gill, B.S.Pharm., Pharm.D., R.Ph. Director of HIV Pharmacy Services – UC Denver School of Medicine Pharmacy Manager, Clinical Pharmacy Specialist Co-Chair, Vaccine Committee, Pharmacy & Therapeutics University of Colorado Hospital Infectious Disease Group Practice – Pharmacy Aurora, Colorado 1 Learning Objectives ♦ Review the laws and history of cannabinoids ♦ Describe the complexity of pharmacokinetic parameters of marijuana and how they may affect patient care ♦ Identify possible drug-drug interactions, side effects or adverse drug reactions with medical marijuana in healthcare 2 Marijuana Law ♦ Medical + recreational use is approved in 14 states ■ 34 states including District of Columbia, Guam, Puerto Rico and US Virgin Islands have medical marijuana laws ■ 12 states allow low THC, high CBD products for medical reasons in limited situations ■ Mariana Islands are the only territory to have recreational use only, no medical use http://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx laws 3 A Brief History of Medicinal Marijuana ♦ Controlled Substance Act ♦ Scheduling ■ FDA ■ DHHS – Federal registry ■ NIDA ■ DEA ♦ Colorado ■ November 2000 Amendment 20 ■ 2010 the Colorado Legislature passed HB-1284 ■ November 2012 Amendment 64 4 Medical Marijuana in Healthcare ♦ China 2737 B.C ♦ No official US standards for herbals ♦ No German Commission E monograph ♦ US Pharmacopeia 1850 – 1942 ♦ 1937 Marijuana Tax Act ♦ Merck Index until 1950 ♦ Dronabinol Orphan Drug status 1985 ♦ No federally recognized use of marijuana 5 Dosage Forms ♦ Flowered Plant Dried (oral or inhaled) ♦ Hashish – Pure Resin ♦ Oil Hashish (5-10 times more potent) ♦ Capsule Marinol® , Nabilone® ♦ Buccal Spray Sativex® ♦ Solution Epidiolex® (purified CBD) ♦ Solution Syndros® (Dronabinol) 6 New Drugs approved by FDA ♦ Epidiolex (purified CBD) - (Schedule V) approved for add-on therapy for treatment of seizures related to Lennox-Gastaut and Dravet Syndrome. -
A Critical Narrative Review of Medical Cannabis in Pediatrics Beyond Epilepsy, Part I: Background
8 Review Article Page 1 of 8 A critical narrative review of medical cannabis in pediatrics beyond epilepsy, part I: background Jill S. Simonian1, Swathi Varanasi2, Anh Van Nguyen1, Joel P. Diaz-Fong3,4, George James Richards1, Jennifer Le1 1Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, CA, USA; 2Emperor’s College of Traditional Oriental Medicine, Santa Monica, CA, USA; 3Semel Institute for Neuroscience and Human Behavior, University of California Los Angeles, Los Angeles, CA, USA; 4Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, USA Contributions: (I) Conception and design: J Simonian; (II) Administrative support: None; (III) Provision of study materials or patients: None; (IV) Collection and assembly of data: All authors; (V) Data analysis and interpretation: All authors; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors. Correspondence to: Jill S. Simonian, PharmD. Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, 9500 Gilman Drive, MC 0657, La Jolla, CA 92093, USA. Email: [email protected]. Abstract: In the past few decades, the use of marijuana, now commonly referred to as cannabis in the scientific community, has expanded globally to a myriad of medical conditions beyond epilepsy in pediatrics. In this comprehensive review, PubMed, Embase, and Clinicaltrials.gov (1966–May 2020) searches were performed using the key search terms cannabis, medical marijuana, cannabinoids, pediatrics, neuropsychiatric disorders, spasticity, pain, gastrointestinal disorders, and cancer. All article abstracts were evaluated for relevance. Only articles pertaining to cannabis were included. -
ASSERTIO THERAPEUTICS, INC. (Exact Name of Registrant As Specified in Its Charter) Delaware 94-3229046 (State Or Other Jurisdiction of (I.R.S
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark one) ፤ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 OR អ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from: to Commission File Number: 001-13111 ASSERTIO THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 94-3229046 (State or Other Jurisdiction of (I.R.S. Employer Incorporation or Organization) Identification No.) 100 South Saunders Road, Suite 300, Lake Forest, Illinois 60045 (Address of Principal Executive Offices) (Zip Code) Registrant’s telephone number, including area code: (224) 419-7106 Securities registered pursuant to Section 12(b) of the Act: Title of each class: Name of each exchange on which registered: Common Stock, $0.0001 par value The NASDAQ Stock Market LLC Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes អ No ፤ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes អ No ፤ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. -
Generics Breakout Welcome
Generics Breakout Welcome David Picard Senior Vice President, Global Generic Pharmaceuticals Discussion Agenda • CERTIO Enhancements • American Health Packaging Alan Ratliff, Director, Supplier Trade o Kyle Pudenz, Senior Vice President, o Manufacturer and Data Services Relations • Generic Sourcing • Stable Supply Initiative o Chris Doerr, Vice President, Global o Heather Ryan, Senior Manager, Drug Shortage Generic Sourcing Solutions • Q&A SM • SureSupply o Heather Odenwelder, Senior Director, Category Management o Charles Hartenstine, Senior Director, Category Management CERTIO 2020 AmerisourceBergen Switzerland Kyle Pudenz Senior Vice President, Manufacturer and Data Services CERTIO® 2020 Evolving the CERTIO solution to address key business challenges. Further Supply Chain Integration Support Proactive Communication Easier to Use Project Overview Working with key stakeholders to address your business needs CERTIO 2020 Kickoff CERTIO Champions Sessions December 14 2019 Unique CERTIO Champions 108+ 9 Engaged CERTIO Users November Enhanced CERTIO 9 Dashboards 90+ CERTIO 2020 Launch CERTIO® 2020 and Beyond Continuing to shape your preferred supply chain solution • Launching November 9, 2020 o No change in current functionality Contact Upcoming training opportunities o [email protected] • Platform Evolution 2021 o Product Oversight o Failure to Supply o …and more! Special thanks to our CERTIO® Champions! Manufacturer Partners AmerisourceBergen Ajanta Lannett Global Generics Leadership Alembic Lupin Category Management Apotex Mallinckrodt -
Cardinal Health 2019 Annual Report
2019 Annual Report Essential to care ™ Corporate Offices Cardinal Health 7000 Cardinal Place Dublin, Ohio 43017 614.757.5000 www.cardinalhealth.com © 2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks of Cardinal Health and may be registered in the US and/or in other countries. All other marks are the property of their respective owners. Lit. No. 5CR19-971925 (08/2019) DearDear fellow fellow shareholders: shareholders: CorporateCorporate and and In myIn my letter letter to toyou you last last year, year, I acknowledged I acknowledged investorinvestor information information thethe trust trust you you place place in usin usto torun run the the business business CorporateCorporate offices offices FinancialFinancial information information effectivelyeffectively and, and, in inturn, turn, be beresponsible responsible CardinalCardinal Health Health ComprehensiveComprehensive financial financial and andother other information information about about stewardsstewards of ofyour your capital. capital. I’d I’dlike like to toshare share with with 70007000 Cardinal Cardinal Place Place CardinalCardinal Health Health can can be obtainedbe obtained by visiting by visiting the theInvestor Investor Dublin,Dublin, Ohio Ohio 43017 43017 RelationsRelations page page at ir.cardinalhealth.com. at ir.cardinalhealth.com. youyou some some of ofour our accomplishments accomplishments over over 614.757.5000614.757.5000 thethe past past year year and and where where we we are are going going -
ABCDEF LAST UPDATED: 05/28/2014 This Reflects the Last Date of Any Changes Made to the List
ABCDEF LAST UPDATED: 05/28/2014 This reflects the last date of any changes made to the list. Authorized Distributors Below is a list of Roxane Laboratories, Inc. (RLI) Authorized Distributors. These distributors have met RLI's requirements to distribute RLI's products. Authorized Distributors listed below are approved to distribute the entire RLI product line provided that they have the appropriate licenses. AmerisourceBergen Drug Corp AmerisourceBergen Drug Corp 172 Cahaba Valley Pkwy PELHAM AL AmerisourceBergen Drug Corp 1825 S 43rd Ave STE B PHOENIX AZ AmerisourceBergen Drug Corp 1851 California Ave CORONA CA AmerisourceBergen Drug Corp 1325 W Striker Ave SACRAMENTO CA AmerisourceBergen Drug Corp 24903 Avenue Kearny VALENCIA CA AmerisourceBergen Drug Corp 501 W 44th Ave DENVER CO AmerisourceBergen Drug Corp 2100 Directors Row ORLANDO FL AmerisourceBergen Drug Corp 1085 N Satellite Blvd SUWANEE GA AmerisourceBergen Drug Corp 238 Sand Island Access Rd #M1 HONOLULU HI AmerisourceBergen Drug Corp 1001 W TAYLOR RD ROMEOVILLE IL AmerisourceBergen Drug Corp 322 N 3RD St PADUCAH KY AmerisourceBergen Drug Corp 101 Norfolk St MANSFIELD MA AmerisourceBergen Drug Corp One Industrial Park Dr WILLIAMSTON MI AmerisourceBergen Drug Corp 6810 Shady Oak Rd EDEN PRAIRIE MN AmerisourceBergen Drug Corp 11200 N CONGRESS AVE KANSAS CITY MO AmerisourceBergen Drug Corp 8190 Lackland Rd SAINT LOUIS MO AmerisourceBergen Drug Corp 6300 St Louis St MERIDIAN MS AmerisourceBergen Drug Corp 8605 Ebenezer Church Rd RALEIGH NC AmerisourceBergen Drug Corp 100 Friars