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Magnesium Stearate
SAFETY DATA SHEET Magnesium Stearate SECTION 1 - PRODUCT AND COMPANY IDENTIFICATION 1.1 Product identifier Product Name: Magnesium Stearate Product Code(s): Magnesium Stearate Synonym(s): Octadecanoic acid, magnesium salt; Dibasic magnesium stearate; Stearic acid, magnesium salt REACH Registration Number: No data available 1.2 Relevant identified uses of the substance or mixture and uses advised against General use: For use in industrial and laboratory applications Uses advised against: None known 1.3 Details of the supplier and of the safety data sheet Manufacturer/Distributor Allan Chemical Corporation 235 Margaret King Avenue Ringwood, NJ 07456 USA +1-973-962-4014 1.4 Emergency telephone number Chem Tel +1-813-248-0585 +1-800-255-3924 SECTION 2 - HAZARDS IDENTIFICATION 2.1 Classification of substance or mixture Product definition: Substance Classification in accordance with 29 CFR 1910 (OSHA HCS) and Regulation EC No. 1272/2008 Not a dangerous substance according to OSHA or to European Union Legislation 2.2 Label Elements Not classified as dangerous according to GHS 2.3 Hazards not otherwise classified (HNOC) or not covered by GHS May form combustible dust concentrations in air SECTION 3 - COMPOSITION/INFORMATION ON INGREDIENTS 3.1 Substances % by Weight Ingredient CAS Number EC Number Index Number GHS Classification >99 Magnesium Stearate 557-04-0 209-150-3 ------------ ------------ There are no additional ingredients present which, within the current knowledge of the supplier and in the concentrations applicable, are classified as hazardous to health or the environment and hence, require reporting in this section. 3.2 Mixtures Not applicable SECTION 4 - FIRST AID MEASURES 4.1 Description of first aid measures Inhalation: If exposure to product mist causes respiratory irritation or distress, move the exposed person to fresh air immediately. -
Calcium Stearate Processing
National Organic Standards Board Technical Advisory Panel (TAP) Review Compiled by University of California Sustainable Agriculture Research and Education Program (UC SAREP) for the USDA National Organic Program Calcium Stearate Processing Executive Summary1 A petition is under consideration with respect to NOP regulations subpart G §205.605, governing the use of substances in processed products: Petitioned: Inclusion of calcium stearate on National List of nonagricultural substances allowed in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).” Calcium stearate is a compound of calcium with a mixture of solid organic acids obtained from edible sources. It is generally used as a solid-phase lubricant that reduces friction between particles of the substance to which it is added. The Petitioner’s intended use is “as a flow agent (anti-dusting agent)” to be used in dry flour based ingredients sold to bakeries (NOSB Petition). The NOP has no prior listing or ruling on the substance. All three reviewers agreed that the substance should be considered synthetic. The reviewers were divided over the use of calcium stearate in food labeled as “organic.” Two of the reviewers felt it should not be allowed in these foods, while one reviewer felt it should be accepted. One reviewer who voted to restrict its use indicated that more information was needed on the nature of the substance and its potential applications, and the other reviewer felt that inclusion of a “synthetic” substance in organics runs contrary to consumer’s expectations regarding organic products. All three reviewers agreed that the substance should be allowed in products labeled as “made with organic…” ingredients. -
Learner Notification International Society for Heart & Lung
Learner Notification International Society for Heart & Lung Transplantation (ISHLT) 41st Annual Meeting & Scientific Sessions Virtual Experience April 24 – 28, 2021 Live Virtual Acknowledgement of Financial Commercial Support Abbott Medtronic United Therapeutics Acknowledgement of In-Kind Commercial Support No in-kind commercial support was received for this educational activity. Satisfactory Completion Learners must complete an evaluation form to receive a certificate of completion. Your chosen sessions must be attended in their entirety as partial credit of individual sessions is not available. If you are seeking continuing education credit for a specialty not listed below, it is your responsibility to contact your licensing/certification board to determine course eligibility for your licensing/certification requirement. Physicians (ACCME) The International Society for Heart and Lung Transplantation (ISHLT) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Credit Designation Statement - ISHLT designates this live virtual activity for a maximum of 32.00 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Accreditation Statement In support of improving patient care, this activity has been planned and implemented by Amedco LLC and ISHLT. Amedco LLC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Nurses (ANCC) - Credit Designation Statement - Amedco LLC designates this live virtual activity for a maximum of 32.00 ANCC contact hours. Pharmacists (ACPE) - Credit Designation Statement - Amedco LLC designates this live virtual activity for a maximum of 32.00 knowledge-based CPE contact hours. -
Resource #350932
−This Clinical Resource gives subscribers additional insight related to the Recommendations published in− September 2019 ~ Resource #350932 Anticipated Availability of First-Time Generics ―To help explain the benefits of generic drugs to your patients, the FDA has patient education materials available at https://www.fda.gov/drugs/generic-drugs/patient-education ― Branda Generic Name Generic Manufacturer(s)b,1 Anticipated Availabilityc (Manufacturer) Acanya Benzoyl peroxide 2.5%/ Teva Generic now available (Valeant) Clindamycin phosphate 1.2% Cuprimine Penicillamine capsule Amerigen, Teva Generic now available (Bausch Health) Delzicol Mesalamine delayed-release Teva Generic now available (Warner Chilcott) capsule Diclegis Doxylamine/Pyridoxine Teva Generic now available (Duchesnay) Exjade Deferasirox tablets for oral Teva Generic now available (Novartis) suspension Fareston Toremifene Rising (EirGen Pharma Limited) Generic now available (Kyowa Kirin) Faslodex Fulvestrant Sandoz Generic now available (AstraZeneca) Firazyr Icatibant Teva Generic now available (Shire Orphan Therapies) Gablofen Baclofen 1 mg/mL single dose Mylan Institutional Generic now available (Piramal) vial Hemabate Carboprost tromethamine Dr. Reddy’s Generic now available (Pharmacia & Upjohn) Letairis Ambrisentan Cipla, Mylan, Par, Sigmapharm, Sun, Teva, Generic now available (Gilead) Zydus Lexiva Fosamprenavir Mylan Generic now available (Viv) More. Copyright © 2019 by Therapeutic Research Center 3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 pharmacist.therapeuticresearch.com ~ prescriber.therapeuticresearch.com ~ pharmacytech.therapeuticresearch.com ~ nursesletter.therapeuticresearch.com (Clinical Resource #350932: Page 2 of 24) Branda Generic Name Generic Manufacturer(s)b,1 Anticipated Availabilityc (Manufacturer) Lotemax Loteprednol ophthalmic Hi-tech Generic now available (Bausch & Lomb) suspension Lyrica Pregabalin capsule Alembic, Amneal, Ascend (Alkem), Cipla Generic now available (PF Prism CV) (InvaGen), Dr. -
Gilead Sciences, Inc. November 13, 2016
Student Investment Management Gilead Sciences, Inc. November 13, 2016 Gilead Sciences, Inc. NASDAQ: GILD BUY $92.00 The Fisher College of Business Student Investment Management Program is initiating coverage on Gilead Sciences with a BUY rating. Our target price is $92.00. Our implied P/E for 2016E is 7.9x versus consensus 6.5x. Our 2017 and 2018 estimates are 8.8x and 9.5x, respectively. Company overview Gilead Sciences, Inc. is a research-based biopharmaceutical Fund Manager company that discovers, develops and commercializes innovative Royce West, CFA medicines in areas of unmet medical need. Gilead strives to 614-227-2948 transform and simplify care for people with life-threatening illnesses [email protected] around the world. Gilead's portfolio of products and pipeline of investigational drugs includes treatments for HIV/AIDS, liver Analyst diseases, cancer, inflammatory and respiratory diseases, and Andrew Jasen cardiovascular conditions. 301-300-0702 [email protected] 12-Month trading performance 10.0% S&P Current share price: $72.64 7.0% 52 wk range: $71.76 - $108.13 0.0% S5HLTH Market cap: $99.9bn 1.4% P/E: 6.8x (10.0%) XBI (3.0%) Diluted shares out.: 1.3bn Last dividend (9/4/2016): $0.47 (20.0%) GILD Dividend yield: 2.4% (25.5%) Beta: 0.94 (30.0%) EV/EBITDA: 4.8x EV/Sales: 3.1x (40.0%) Nov-15 Jan-16 Mar-16 May-16 Jul-16 Sep-16 Nov-16 Investment thesis We are placing a BUY rating on GILD with a price target of $92.00, a 20.4% upside to the current trading price. -
2015 Annual Report
ANNUAL REPORT 2015 MARCH 2016 TO OUR SHAREHOLDERS ALEX GORSKY Chairman, Board of Directors and Chief Executive Officer This year at Johnson & Johnson, we are proud this aligned with our values. Our Board of WRITTEN OVER to celebrate 130 years of helping people Directors engages in a formal review of 70 YEARS AGO, everywhere live longer, healthier and happier our strategic plans, and provides regular OUR CREDO lives. As I reflect on our heritage and consider guidance to ensure our strategy will continue UNITES & our future, I am optimistic and confident in the creating better outcomes for the patients INSPIRES THE long-term potential for our business. and customers we serve, while also creating EMPLOYEES long-term value for our shareholders. OF JOHNSON We manage our business using a strategic & JOHNSON. framework that begins with Our Credo. Written OUR STRATEGIES ARE BASED ON over 70 years ago, it unites and inspires the OUR BROAD AND DEEP KNOWLEDGE employees of Johnson & Johnson. It reminds OF THE HEALTH CARE LANDSCAPE us that our first responsibility is to the patients, IN WHICH WE OPERATE. customers and health care professionals who For 130 years, our company has been use our products, and it compels us to deliver driving breakthrough innovation in health on our responsibilities to our employees, care – from revolutionizing wound care in communities and shareholders. the 1880s to developing cures, vaccines and treatments for some of today’s most Our strategic framework positions us well pressing diseases in the world. We are acutely to continue our leadership in the markets in aware of the need to evaluate our business which we compete through a set of strategic against the changing health care environment principles: we are broadly based in human and to challenge ourselves based on the health care, our focus is on managing for the results we deliver. -
Amgen-Opinion-Jan-7-2021.Pdf
IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELA WARE AMGEN INC. and AMGEN MANUFACTURING, LIMITED, Plaintiffs, v. Civil Action No. 20-0561-CFC HOSPIRA, INC. and PFIZER INC. Defendants. MEMORANDUM ORDER Having considered the merits of Defendants Hospira, Inc. and Pfizer Inc.' s Motion to Stay (D.I. 19) and the briefs filed by the parties in connection with that motion, it is HEREBY ORDERED that Defendants' motion to stay is GRANTED IN PART for the following reasons: 1. Plaintiffs Amgen Inc. and Amgen Manufacturing, Limited make and sell the biologic filgrastim under the brand name Neupogen®. Filgrastim, like many biologics, is a protein. Plaintiffs own two patents generally related to methods of purifying such proteins. These two patents are U.S. Patent Nos. 10,577,392 (the #392 patent), and 9,643,997 (the #997 patent). The #392 patent issued in March of 2020. 2. Defendants manufacture and sell a biosimilar version Neupogen® called Nivestym®. Nivestym® has been available since 2018 and is the third biosimilar version ofNeupogen® launched in the United States since Neupogen® became available almost thirty years ago. 3. Both the #392 patent and #997 patent have been asserted against the Defendants-albeit in different actions-for the manufacture ofNivestym®. The #392 patent has been asserted in this case (C.A. 20-0561 ), which was filed on April 24, 2020. The #997 patent has been asserted in the related case Amgen Inc. et al. v. Hospira, Inc. et al., No. 18-cv-1064-CFC-CJB (D. Del. 2018). That case is scheduled for a jury trial to begin on May 17, 2021. -
Magnesium Stearate
United States Department of Agriculture Agricultural Marketing Service | National Organic Program Document Cover Sheet https://www.ams.usda.gov/rules-regulations/organic/national-list/petitioned Document Type: ☐ National List Petition or Petition Update A petition is a request to amend the USDA National Organic Program’s National List of Allowed and Prohibited Substances (National List). Any person may submit a petition to have a substance evaluated by the National Organic Standards Board (7 CFR 205.607(a)). Guidelines for submitting a petition are available in the NOP Handbook as NOP 3011, National List Petition Guidelines. Petitions are posted for the public on the NOP website for Petitioned Substances. ☒ Technical Report A technical report is developed in response to a petition to amend the National List. Reports are also developed to assist in the review of substances that are already on the National List. Technical reports are completed by third-party contractors and are available to the public on the NOP website for Petitioned Substances. Contractor names and dates completed are available in the report. Magnesium Stearate Handling/Processing 1 2 Identification of Petitioned Substance 13 3 Chemical Names: 14 Trade Names: 4 Magnesium stearate 15 N/A 5 Octadecanoic acid magnesium salt 6 Magnesium octadecanoate CAS Numbers: 7 557-04-0 8 Other Name: 9 Stearic acid magnesium salt 10 Magnesium distearate Other Codes: 11 EC-No. 209-150-3 12 INS No. 470(iii) 16 17 Summary of Petitioned Use 18 Magnesium stearate is used as a lubricant or anticaking agent in food processing and handling. Magnesium 19 stearate is currently listed on the National List of Allowed and Prohibited Substances as a synthetic 20 nonagricultural (nonorganic) substance allowed as ingredients in or on processed products labeled as “organic” 21 or “made with organic (specified ingredients or food group(s))” (7 Code of Federal Regulation (CFR) 205.605(b)). -
Pharmaceutical Compositions of Rifaximin Pharmazeutische Rifaximin-Zusammensetzungen Compositions Pharmaceutiques De Rifaximine
(19) TZZ Z__ T (11) EP 2 011 486 B2 (12) NEW EUROPEAN PATENT SPECIFICATION After opposition procedure (45) Date of publication and mention (51) Int Cl.: of the opposition decision: A61K 9/20 (2006.01) A61K 31/44 (2006.01) 12.08.2015 Bulletin 2015/33 (45) Mention of the grant of the patent: 23.05.2012 Bulletin 2012/21 (21) Application number: 08252198.0 (22) Date of filing: 26.06.2008 (54) Pharmaceutical compositions of rifaximin Pharmazeutische Rifaximin-Zusammensetzungen Compositions pharmaceutiques de rifaximine (84) Designated Contracting States: (56) References cited: AT BE BG CH CY CZ DE DK EE ES FI FR GB GR EP-A1- 0 616 808 EP-B1- 1 763 339 HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT WO-A-2006/094737 WO-A2-2006/039022 RO SE SI SK TR US-A- 6 140 355 US-A1- 2005 101 598 (30) Priority: 06.07.2007 IN KO09682007 • DUPONT ET AL: "Treatment of Travelers’ 23.06.2008 EP 08252158 Diarrhea: Randomized Trial Comparing Rifaximin, Rifaximin Plus Loperamide, and (43) Date of publication of application: Loperamide Alone" CLINICAL 07.01.2009 Bulletin 2009/02 GASTROENTEROLOGY AND HEPATOLOGY, AMERICAN GASTROENTEROLOGICAL (60) Divisional application: ASSOCIATION, US, vol. 5, no. 4, 17 April 2007 11176043.5 / 2 420 226 (2007-04-17), pages 451-456, XP022029177 ISSN: 14186563.4 / 2 837 378 1542-3565 • ARYA ET AL: "Rifaximin-the promising anti- (73) Proprietor: Lupin Ltd. microbial for enteric infections" JOURNAL OF Mumbai, Maharashtra 400 098 (IN) INFECTION, ACADEMIC PRESS, LONDON, GB, vol. -
In the Supreme Court of the United States ACORDA THERAPEUTICS, INC., Petitioner
NO. 181280 In the Supreme Court of the United States ACORDA THERAPEUTICS, INC., Petitioner, v. ROXANE LABORATORIES, INC., MYLAN PHARMACEUTICALS, INC., and TEVA PHARMACEUTICALS USA, INC., Respondents. On Petition for a Writ of Certiorari to the United States Court of Appeals for the Federal Circuit BRIEF OF AMICUS CURIAE BOSTON PATENT LAW ASSOCIATION IN SUPPORT OF NEITHER PARTY SOPHIE F. WANG COUNSEL OF RECORD BRYANA T. MCGILLYCUDDY NATALIA SMYCHKOVICH CHOATE HALL & STEWART LLP TWO INTERNATIONAL PLACE BOSTON, MA 02110 (617) 248-5000 [email protected] MAY 8, 2019 COUNSEL FOR AMICUS CURIAE SUPREME COURT PRESS ʕ (888) 958-5705 ʕ BOSTON, MASSACHUSETTS i TABLE OF CONTENTS Page TABLE OF AUTHORITIES ....................................... ii INTEREST OF THE AMICUS CURIAE ................... 1 SUMMARY OF ARGUMENT .................................... 1 ARGUMENT ............................................................... 3 I. THE FEDERAL CIRCUIT’S DECISION CREATES SIGNIFICANT UNCERTAINTY CONCERNING THE SCOPE AND APPLICABILITY OF THE BLOCKING PATENT DOCTRINE. ............................................ 3 A. Clarification Is Needed as to the Definition of a “Blocking Patent.” .............. 3 B. Clarification Is Also Needed as to Whether and How the Blocking Patent Doctrine Should Be Applied to Objective Indicia of NonObviousness. ...................... 8 II. ABSENT CLARIFICATION, THE EXPANDED BLOCKING PATENT DOCTRINE HAS A CHILLING EFFECT ON INNOVATION AND INVESTMENT. .................. 11 A. Improvement Innovations Are Critical and Require Significant Investment. ....... 11 B. Objective Indicia Matter. .......................... 13 CONCLUSION .......................................................... 16 ii TABLE OF AUTHORITIES TABLE OF AUTHORITIES Page CASES Acorda Therapeutics, Inc. v. Roxane Labs., Inc., 903 F.3d 1310 (Fed. Cir. 2018) ......... passim Apple v. ITC, 725 F.3d 1356 (Fed. Cir. 2013) ......................... 14 Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990) ............................................. 6 Galderma Labs., L.P. -
Lubricants in Pharmaceutical Solid Dosage Forms
Lubricants 2014, 2, 21-43; doi:10.3390/lubricants2010021 OPEN ACCESS lubricants ISSN 2075-4442 www.mdpi.com/journal/lubricants Review Lubricants in Pharmaceutical Solid Dosage Forms Jinjiang Li * and Yongmei Wu Drug Product Science & Technology, Bristol-Myers Squibb Corporation, 1 Squibb Dr., New Brunswick, NJ 08903, USA; E-Mail: [email protected] * Author to whom correspondence should be addressed; E-Mail: [email protected]; Tel.: +1-732-227-6584; Fax: +1-732-227-3784. Received: 18 December 2013; in revised form: 21 January 2014 / Accepted: 24 January 2014 / Published: 25 February 2014 Abstract: Lubrication plays a key role in successful manufacturing of pharmaceutical solid dosage forms; lubricants are essential ingredients in robust formulations to achieve this. Although many failures in pharmaceutical manufacturing operations are caused by issues related to lubrication, in general, lubricants do not gain adequate attention in the development of pharmaceutical formulations. In this paper, the fundamental background on lubrication is introduced, in which the relationships between lubrication and friction/adhesion forces are discussed. Then, the application of lubrication in the development of pharmaceutical products and manufacturing processes is discussed with an emphasis on magnesium stearate. In particular, the effect of its hydration state (anhydrate, monohydrate, dihydrate, and trihydrate) and its powder characteristics on lubrication efficiency, as well as product and process performance is summarized. In addition, the impact of lubrication on the dynamics of compaction/compression processes and on the mechanical properties of compacts/tablets is presented. Furthermore, the online monitoring of magnesium stearate in a blending process is briefly mentioned. Finally, the chemical compatibility of active pharmaceutical ingredient (API) with magnesium stearate and its reactive impurities is reviewed with examples from the literature illustrating the various reaction mechanisms involved. -
[J-52A-2014] in the Supreme Court of Pennsylvania Middle District
[J-52A-2014] IN THE SUPREME COURT OF PENNSYLVANIA MIDDLE DISTRICT COMMONWEALTH OF PENNSYLVANIA : 84 MAP 2011 : : Appeal from the decision of the : Commonwealth Court (Opinion re Post- v. : Trial Motions of the Commonwealth and : Johnson & Johnson) dated 8/31/11 at No. : 212 MD 2004 TAP PHARMACEUTICAL PRODUCTS, : INC.; ABBOTT LABORATORIES; : ASTRAZENECA PLC; ASTRAZENECA, : HOLDINGS, INC.; ASTRAZENECA : PHARMACEUTICALS LP; : ASTRAZENECA LP; BAYER AG; BAYER : CORPORATION; SMITHKLINE : BEECHAM CORPORATION D/B/A : GLAXOSMITHKLINE; PFIZER, INC.; : PHARMACIA CORPORATION; : JOHNSON & JOHNSON; ALZA : CORPORATION; CENTROCOR, INC.; : ETHICON, INC.; JANSSEN : PHARMACEUTICAL PRODUCTS, L.P.; : MCNEIL-PPC, INC.; ORTHO BIOTECH, : INC.; ORTHO BIOTECH PRODUCTS; : L.P.; ORTHO-MCNEIL : PHARMACEUTICAL, INC.; AMGEN INC.; : IMMUNEX CORPORATION; BRISTOL- : MYERS SQUIBB COMPANY; BAXTER : INTERNATIONAL INC.; BAXTER : HEALTHCARE CORPORATION; : IMMUNO-U.S., INC.; AVENTIS : PHARMACEUTICALS, INC.; AVENTIS : BEHRING, L.L.C.; HOECHST MARION : ROUSSEL, INC., BOEHRINGER : INGELHEIM CORPORATION; : BOEHRINGER INGELHEIM : PHARMACEUTICALS, INC.; BEN VENUE : LABORATORIES; BEDFORD : LABORATORIES; ROXANE : LABORATORIES; SCHERING-PLOUGH : CORPORATION; WARRICK : PHARMACEUTICALS CORPORATION; : SCHERING SALES CORPORATION; : DEY, INC. : : DONNA A. BOSWELL, ESQ., ANN M. : VICKERY, ESQ., AND JOSEPH A. : YOUNG, ESQ., : Intervenors : : APPEAL OF: JOHNSON & JOHNSON, : ALZA CORPORATION, CENTOCOR, : INC., ETHICON, INC., JANSSEN : PHARMACEUTICAL PRODUCTS, L.P., : MCNEIL-PPC, INC., ORTHO BIOTECH, : INC., ORTHO BIOTECH PRODUCTS, : L.P., AND ORTHO-MCNEIL : PHARMACEUTICAL, INC. : (COLLECTIVELY, THE “JOHNSON & : JOHNSON DEFENDANTS”) : ORDER PER CURIAM DECIDED: June 16, 2014 AND NOW, this 16th day of June, 2014, the Order of the Commonwealth Court is VACATED, and the matter is remanded per the terms of Mr. Justice Baer’s responsive opinion in Commonwealth v. TAP Pharm. Prods., Inc., J-52B-2014, ___ A.3d ___ (Pa.