IOA 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. -
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, -
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. -
HIGHLIGHTSOF PRESCRIBING INFORMATION These Highlights Do
HIGHLIGHTSOF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use CAMBIA Hypertension: Patients taking some antihypertensive medications may safely and effectively. See full prescribing information for CAMBIA. have impaired response to these therapies when taking NSAIDs. Monitor blood pressure (5.4, 7) CAMBIA® (diclofenac potassium), for oral solution • Heart Failure and Edema: Avoid use of CAMBIA in patients with Initial U.S. Approval: 1988 severe heart failure unless benefits are expected to outweigh risk of worsening heart failure (5.5) WARNING: RISK OF SERIOUS CARDIOVASCULAR • Renal Toxicity: Monitor renal function in patients with renal or AND GASTROINTESTINAL EVENTS hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid See full prescribing information for complete boxed warning use of CAMBIA in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function (5.6) Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk • Anaphylactic Reactions: Seek emergency help if an anaphylactic of serious cardiovascular thrombotic events, including myocardial reaction occurs (5.7) infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (5.1) • Exacerbation of Asthma Related to Aspirin Sensitivity: CAMBIA is contraindicated in patients with aspirin-sensitive asthma. Monitor patients CAMBIA is contraindicated in the setting of coronary artery bypass with preexisting asthma (without aspirin sensitivity) (5.8) graft (CABG) surgery (4, 5.1) • Serious Skin Reactions: Discontinue CAMBIA at first appearance of skin rash or other signs of hypersensitivity (5.9). NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): events including bleeding, ulceration, and perforation of the stomach or Discontinue and evaluate clinically (5.10) intestines, which can be fatal. -
ACNP 57Th Annual Meeting: Panels, Mini-Panels and Study Groups
www.nature.com/npp ABSTRACTS COLLECTION ACNP 57th Annual Meeting: Panels, Mini-Panels and Study Groups Sponsorship Statement: Publication of this supplement is sponsored by the ACNP. Individual contributor disclosures may be found within the abstracts. Asterisks in the author lists indicate presenter of the abstract at the annual meeting. https://doi.org/10.1038/s41386-018-0265-8 Panel experiments were performed in 8-10-week-old male or female mice on a C57 background. 1. Dissecting the Contributions of Dopamine D1 and D2 Results: We observed dendritic atrophy in NAc D1-MSNs but Receptor-Expressing Neurons in Behaviors Dysregulated in not D2-MSNs in CSDS susceptible mice (P < 0.001). mRNAs of RhoA Neuropsychiatric Illness pathway molecules were significantly altered in D1-MSNs of CSDS susceptible mice (P < 0.05). Genetic overexpression of WT-RhoA in D1-MSNs induced dendritic atrophy and a susceptible outcome to 1.1 Dichotomous Structural Adaptations in Nucleus SSDS (P < 0.01), while DN-RhoA in D1-MSNs restored dendritic Accumbens Neuron Subtypes Underlie Stress Susceptibility complexity and caused a resilient outcome to CSDS (P < 0.05) compared to eYFP controls. RhoA (WT) in D1-MSNs caused reduced time grooming in splash test of female mice, reduced Mary Kay Lobo sucrose preference in male mice, and enhanced time immobile in forced swim test of both sexes (P < 0.05). Increased Egr3, the RhoA University of Maryland School of Medicine, Baltimore, Maryland, transcriptional regulator, in D2-MSNs promotes stress resiliency (P United States < 0.05) by preventing D2-MSN enhanced density of mushroom spines that occurs in stress susceptible mice (P < 0.01), without Background: Ventral striatum (nucleus accumbens-NAc) medium altering dendritic arbor. -
In Re INSYS Therapeutics, Inc. Securities Litigation 17-CV-01954
Case 1:17-cv-01954-PAC Document 30 Filed 10/27/17 Page 1 of 120 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK IN RE INSYS THERAPEUTICS, INC. Civil Action No. 1:17-cv-01954-PAC SECURITIES LITIGATION SECOND AMENDED CLASS ACTION COMPLAINT FOR VIOLATIONS OF THE FEDERAL SECURITIES LAWS Case 1:17-cv-01954-PAC Document 30 Filed 10/27/17 Page 2 of 120 TABLE OF CONTENTS SUMMARY OF THE ACTION..................................................................................................... 1 JURISDICTION AND VENUE ..................................................................................................... 4 THE PARTIES................................................................................................................................ 4 I. Lead Plaintiff........................................................................................................................ 4 II. Defendants............................................................................................................................ 5 A. Insys Therapeutics, Inc..................................................................................................... 5 B. The Individual Defendants............................................................................................... 5 STATEMENT OF FACTS ........................................................................................................... 11 I. Company Background....................................................................................................... -
ZIPSOR (Diclofenac Potassium) Capsules
NDA 022202/S-013, S-014 SUPPLEMENT APPROVAL FULFILLMENT OF POSTMARKETING REQUIREMENT Assertio Therapeutics, Inc. 100 S. Saunders Road Suite 300 Lake Forest, IL 60045 Attention: Clorey Toombs, RAC Executive Director, Regulatory Affairs Dear Ms. Toombs: Please refer to your supplemental new drug applications (sNDA) dated and received November 9, 2018, (S-013) and November 17, 2020, (S-014) and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for ZIPSOR (diclofenac potassium) capsules. Prior Approval supplement S-013 expands the approved indication for relief of mild to moderate acute pain in pediatric patients 12 years of age and older. We also refer to our letter dated October 15, 2020, notifying you, under Section 505(o)(4) of the FDCA, of new safety information that we believe should be included in the labeling for nonsteroidal anti-inflammatory drug (NSAID) products. This information pertains to the serious risks of fetal renal dysfunction, oligohydramnios, neonatal renal impairment, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Prior Approval supplement S-014 provides for safety labeling changes required under Section 505(o)(4) of the FDCA, consistent with our October 15, 2020, letter. APPROVAL & LABELING We have completed our review of these applications, as amended. They are approved, effective on the date of this letter, for use as recommended in the enclosed agreed- upon labeling. CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA automated drug registration and listing system (eLIST), as described at Reference ID: 4799720 NDA 022202/S-013, S-014 Page 2 FDA.gov.1 Content of labeling must be identical to the enclosed labeling, with the addition of any labeling changes in pending “Changes Being Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed labeling. -
Collegium Pharmaceutical Inc
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 6, 2020 COLLEGIUM PHARMACEUTICAL, INC. (Exact name of registrant as specified in its charter) Virginia 001-37372 03-0416362 (state or other jurisdiction (Commission (I.R.S. Employer of incorporation) File Number) Identification No.) 100 Technology Center Drive Suite 300 Stoughton, MA 02072 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: (781) 713-3699 (Former name or former address, if changed since last report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): ¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Indicated by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ¨ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. -
CITY of DELRAY BEACH, Plaintiff
Case 9:17-cv-81384-XXXX Document 1 Entered on FLSD Docket 12/21/2017 Page 1 of 148 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA Case No. _____-Civ-_________________ CITY OF DELRAY BEACH, ) ) Plaintiff, ) ) vs. ) ) PURDUE PHARMA L.P., CEPHALON, INC., ) DEMAND FOR JURY TRIAL TEVA PHARMACEUTICAL INDUSTRIES ) LTD., TEVA PHARMACEUTICALS USA, INC., ) ENDO INTERNATIONAL PLC, ENDO ) PHARMACEUTICALS, INC., JANSSEN ) PHARMACEUTICALS, INC., INSYS ) THERAPEUTICS, INC., MALLINCKRODT ) PLC, MALLINCKRODT PHARMACEUTICALS, ) AMERISOURCEBERGEN CORPORATION, ) CARDINAL HEALTH, INC. and McKESSON ) CORPORATION, ) ) Defendants. ) ) COMPLAINT FOR (1) VIOLATION OF THE FLORIDA DECEPTIVE AND UNFAIR TRADE PRACTICES ACT; (2) PUBLIC NUISANCE; (3) NEGLIGENCE; (4) UNJUST ENRICHMENT; AND (5) VIOLATION OF THE RACKETEER INFLUENCED AND CORRUPT ORGANIZATIONS ACT Case 9:17-cv-81384-XXXX Document 1 Entered on FLSD Docket 12/21/2017 Page 2 of 148 TABLE OF CONTENTS Page I. INTRODUCTION ...............................................................................................................1 II. PARTIES ...........................................................................................................................11 III. JURISDICTION AND VENUE ........................................................................................12 IV. FACTUAL ALLEGATIONS ............................................................................................13 A. Over the Course of More than Two Decades, the Manufacturing Defendants Misled the Public Regarding