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Preliminary Injunction
UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF INDIANA INDIANAPOLIS DIVISION ELI LILLY AND COMPANY, et al. ) ) Plaintiffs, ) ) v. ) No. 1:21-cv-00081-SEB-MJD ) NORRIS COCHRAN, et al. ) ) Defendants. ) ORDER GRANTING PLAINTIFFS' MOTION FOR PRELIMINARY INJUNCTION This cause is before the Court on Plaintiffs' Motion for Preliminary Injunction [Dkt. 18], filed on January 25, 2021. Plaintiffs Eli Lilly and Company and Lilly USA, LLC (collectively, "Plaintiffs" or "Lilly") seek to have Defendants Norris Cochran, in his official capacity as Acting Secretary of Health and Human Services, Daniel J. Barry, in his official capacity as Acting General Counsel of Health and Human Services, United States Department of Health and Human Services, Diana Espinosa, in her official capacity as Acting Administrator of Health Resources and Services Administration, and Health Resources and Services Administration (collectively, "Defendants") enjoined from implementing or enforcing against Plaintiffs the Administrative Dispute Resolution Regulation published at 85 Fed. Reg. 80,632 and codified at 42 C.F.R. §§ 10.20-24 ("ADR Rule"), which sets forth the administrative dispute resolution process for certain disputes regarding the 340B Drug Pricing Program, established by § 340B of the Public Service Act, 42 U.S.C. § 256b. 1 The Court heard arguments on February 26, 2021. Having now considered those arguments, along with the parties' evidentiary and written submissions, the amicus brief, and the controlling principles of law, we hereby GRANT Plaintiffs' Motion -
PCT Gazette, Weekly Issue No. 29, 1998
29/1998 23 Jul/juil 1998 PCT Gazette - Section I - Gazette du PCT 11497 SECTION I PUBLISHED INTERNATIONAL APPLICATIONS DEMANDES INTERNATIONALES PUBLIÉES 6 (11) WO 98/31208 (13) A1 (43) 23 Jul/juil 1998 (23.07.1998) (51) A01J 7/00 // 5/017, A01K 1/12, H05K 5/00 (51)6 A01C 5/06 (21) PCT/GB98/00026 (54) A DEVICE FOR A MILKING STALL DISPOSITIF DESTINE A UNE SALLE DE (54) PLANTING UNIT TRAITE (22) 14 Jan/jan 1998 (14.01.1998) UNITE DE PLANTATION (25) en (26) en (71) ALFA LAVAL AGRI AB [SE/SE]; P.O. Box 39, (71, 72) BAUGHER, Roger, D. [US/US]; P.O. Box S–147 21 Tumba (SE). 79–A, McClure, IL 62957 (US). BAUGHER, Gar- (for all designated States except / pour tous les États (31) 9700754.6 (32) 15 Jan/jan 1997 (33) GB reth, D. [US/US]; P.O. Box 79–A, McClure, IL désignés sauf US) (15.01.1997) 62957 (US). (72, 75) KULLBERG, Marianne, Kristina, (43) 23 Jul/juil 1998 (23.07.1998) (74) MATTHEWS, Stephen, R.; Haverstock, Garrett & Åkesdotter [SE/SE]; Östmarksgatan 36, S–123 6 Roberts, Suite 1610, 611 Olive Street, St. Louis, 42 Farsta (SE). GUSTAFSON, Percy, Birger, (51) A01B 35/24 MO 63101 (US). Kenneth [SE/SE]; Björknäsvägen 25, S–151 37 Södertälje (SE). (54) TINE FOR MOUNTING ON SOIL–WORKING (81) AL AM AT AU AZ BA BB BG BR BY CA CH IMPLEMENT CN CU CZ DE DK EE ES FI GB GE GH HU IL (74) BERGLUND, Stefan et al. / etc.; Bjerkéns DENT S’ADAPTANT SUR UN ENGIN DE TRA- IS JP KE KG KP KR KZ LC LK LR LS LT LU Patentbyrå KB, Östermalmsgatan 58, S–114 50 VAIL DU SOL LV MD MG MK MN MW MX NO NZ PL PT RO Stockholm (SE). -
Eli Lilly and Company
Merrimack College Merrimack ScholarWorks Honors Senior Capstone Projects Honors Program Spring 2021 Eli Lilly and Company Alyssa Ardai Follow this and additional works at: https://scholarworks.merrimack.edu/honors_capstones Part of the Business Commons Ardai 1 Written Assignment #4 Eli Lilly and Company Alyssa Ardai Bus 4402W: Strategic Analysis and Decision Making Professor Herrmann April 30, 2021 Ardai 2 Abstract Eli Lilly and Company is a pharmaceutical company that has the goal of creating new products. Eli Lilly’s products are seen in hospitals and pharmacies around the US, with the hopes of growing internationally. By having a large number of drugs in their pipeline, they can be a key player in improving multiple types of illnesses as well as help aid the aging population. The healthcare sector is always one that is high-performing. Ardai 3 Eli Lilly and Company is positioned as a pharmaceutical company, with the goal of creating high-quality medicine for every need or to take a preexisting medicine and make it better. For the past 140 years, they have been creating medicine for various causes, but are now focusing their efforts on antibody treatments for the COVID-19 pandemic, as well as different cancers and autoimmune diseases. Everything that the company does should follow its core values: integrity, excellence, and respect for people (Eli Lilly and Company - A). Eli Lilly is found in the US, Japan, Europe, and hopes to expand to the rest of the world soon. They are broken down into Endocrinology, Oncology, Immunology, Neuroscience, & Other. The company has increased revenues from $23,832.8 - $25,925.3, a consistent tax rate of 15%, expenses increasing $300k a year, accounts receivable, or a/r, decreasing as they pay less in patents and drugs go generic, consistent inventory of $120k - $140k, showing they do not keep a lot on hand, a weighted average cost of capital, or WACC, of 5.9% showing it does not hold a lot of debt, and a long term growth rate of 2.3%, showing a healthy but stable growth (Bloomberg LP, CapitalIQ 2021). -
Abstract Book 2014.Indd
JOURNAL OF PSYCHOPHARMACOLOGY SUPPLEMENT TO VOLUME 28, ISSUE 8, AUGUST 2014 These papers were presented at the Summer Meeting of the BRITISH ASSOCIATION FOR PSYCHOPHARMACOLOGY 20 – 23 July, Cambridge, UK Indemnity The scientific material presented at this meeting reflects the opinions of the contributing authors and speakers. The British Association for Psychopharmacology accepts no responsibility for the contents of the verbal or any published proceedings of this meeting. All contributors completed a Declaration of Interests form when submitting their abstract BAP Office 36 Cambridge Place Hills Road Cambridge CB2 1NS www.bap.org.uk Aii CONTENTS Abstract Book 2014 Abstracts begin on page: SYMPOSIUM 1 Psycho-immunology (S01-S04) A1 SYMPOSIUM 2 Predictors of clinical response in depression (S05-S08) A2 SYMPOSIUM 3 ADHD and obesity: Overlapping neurobiology and development of pharmacological treatments (S09-S12) A3 SYMPOSIUM 4 Cannabinoids in psychiatry: Current understanding and future treatments (S13-S16) A4 SYMPOSIUM 5 Chickens and Eggs: Separating cause and effect in drug addiction (S17-S20) A6 SYMPOSIUM 6 Genetic pathways in psychosis: the road to new treatments? (S21-S24) A7 SYMPOSIUM 7 The adolescent brain – A key stage in the development of psychiatric disorders? (S25-S28) A8 SYMPOSIUM 8 Tobacco addiction in schizophrenia: a translational investigation (S29-S32) A9 SYMPOSIUM 9 Dopamine, impulse control disorders and Parkinson’s disease (S33-S36) A11 POSTERS Cognition (Animals) (MA01-MA14) A12 Drug Dependence (Human) (MB01-MB28) -
Chrysler Affiliate Rewards Program
Chrysler Affiliate Rewards Program If you or your spouse work, or have retired from, one of the companies listed below, you may qualify for pricing as low as 1% Below Factory Invoice on a New FIAT! Check the list of companies below to see if your company qualifies.* A F O AAA-- State of Ohio Members Freightliner Of Tampa, Llc Ocala Freightliner ABB, Inc. Freightliner Of Toledo OCE'- North America Abbott Labs Freightliner Of Utah, Llc Ocean Freightliner, Ltd. Abbott, Nicholson, Quilter, Freightliner Trucks So. Florida Inc. O'connor Gmc, Inc. Esshaki & Youngblood PC Freightliner Twin Ports O'connor Truck Sales, Inc. Abercrombie & Fitch Freightmasters Ohio Machinery Company AboveNet Fresenius Medical dba Ohio CAT Abraxis Bioscience Inc. Fresno Truck Center Oklahoma City Freightliner Accor North America FRIENDLY MOTORCARS Oklahoma Farm Bureau Ace Hardware Corporation Fru-Con Construction Corporation Oklahoma Publishing Company, Action Western Star Fujisawa Healthcare Inc. The (OPUBCO) Actelion Pharmaceuticals US, Inc. Ftl And Ws Of Maine Old Dominion Freight Lines Action Couriers Ftl And Wst Of Tifton Oldcastle Inc. ADVANTAGE Health Solutions, Inc. Ftl Stl Wst Of Odessa Omaha Truck Center Inc Advance Publications Ftl Trucks Of South Florida Omni Care Health Plan Aearo Company Ftl, Stl And Wst Of Montgomery One Call Locators Aetna Ftl,Stl, and Western Star Of Dothan One Source Management Inc Affinia Group Fyda Freightliner Cincinnati Oracle Corporation Agar Truck Sales, Inc. Fyda Freightliner Columbus,Inc Organon Pharmaceuticals USA, Inc. AGCO Corporation Fyda Freightliner Pittsburgh Orlando Freightliner AGFA Corporation Fyda Freightliner Youngstown Orlando Freightliner South Aggreko, LLC ORRIN B HAYES, INC. Agricredit Acceptance LLC G Oscient Pharmaceuticals Agrilink Foods OSI Pharmaceuticals Gabrielli Ford Truck Sales AGSTAR Financial Services Otjen, Van Ert, Stangle, Lieb & Weir, S.C. -
Modern Drugstores: Created by Civil War Soldier Eli Lilly by Norm Dasinger
Modern Drugstores: Created by Civil War Soldier Eli Lilly By Norm Dasinger Have you ever wondered why you have to see a doctor for a prescription in order to get medicine? You know what you need but you still have to visit a doctor! You can thank, or not, Eli Lilly a Union officer from the Civil War. Lilly, born in Baltimore, Maryland, grew up mostly in Indiana. He was always interested in chemistry as a boy and became an apprentice in a drugstore in Lafayette, Indiana in 1854. He loved it! By 1861 he was married, had a son, and was the owner of his own drugstore in Greencastle, Indiana. When the Civil War began, he enlisted in the US army and was soon an officer recruiting for the formation of an artillery unit. The 18th Indiana Artillery, known as Lilly’s Battery, made their initial baptism into combat in Kentucky and Tennessee in 1862. Soon attached to Wilder’s Lightening Mounted Infantry Brigade, Lilly and his men became some of the very best cannoneers in the Army of the Tennessee. By 1864, Eli had decided he needed a change and joined the 9th Indiana Cavalry. Quickly however, he was captured in Alabama, by Confederate General Nathan Bedford Forrest. Shipped to Mississippi he finished the Civil War as a POW. Eli Lilly during the Civil War He liked the climate and opportunities Mississippi might afford a young entrepreneur, so after the War he relocated to the state to become a farmer. It was a disaster. His wife died of malaria and Lilly was broken both mentally and financially. -
The Joint Pharmacokinetics UK 2005 and Rosenön Meeting
Welcome to the joint Pharmacokinetics UK 2005 and Rosenön Meeting Wednesday 23rd – Friday 25th November, 2005 De Vere Grand Hotel King’s Road Brighton BN1 2FW Programme and Abstract Book Published with the support of John Wiley & Sons Ltd, publishers of the journal BIOPHARMACEUTICS AND DRUG DISPOSITION rd Wednesday 23 November 12.30 Arrival, Coffee & Buffet Welcome & Session 1: Pharmacogenetics on PK/PD 13:50 Welcome (Steve Toon & Amin Rostami) 14:00 Introduction to the First Session: Geoff Tucker and Margareta Hammarlund-Udenaes 14:05 Geoff Tucker Pharmacogenetics on PKPD – expectations and reality 14:35 Duncan McHale Applications of Pharmacogenomics to the drug discovery and development pipeline 15:05 Leif Bertilsson Interethnic differences in drug disposition 15.30 Coffee break Viewing Posters & Exhibitions 16:00 Munir Pirmohamed Pharmacogenetics of adverse drug reactions Simulations as a tool to assess the propagation of genetic polymorphisms in drug Gemma Dickinson 16:20 metabolising enzymes into PK and PD outcomes 16:40 Marja-Liisa Dahl Pharmacogenetics in PK and PD of warfarin 17:30 Break 18:30 Poster Session – Free Bar 20:30 Dinner th Thursday 24 November Session 2: Microdosing in Drug Development 09:00 Introduction to Second Session: Anders Grahnen and Steve Toon 09:10 Colin Garner Human PK studies on microdoses of drugs - scientific and regulatory perspectives Seeing through the MIST: abundance versus percentage commentary on metabolites 09:50 Dennis Smith safety testing 10:30 Coffee break Viewing Posters & Exhibitions 11:00 -
Emergency Use Authorization (EUA)
March 2, 2021 Eli Lilly and Company Attention: Christine Phillips, PhD, RAC Advisor Global Regulatory Affairs - US Lilly Corporate Center Drop Code 2543 Indianapolis, IN 46285 RE: Emergency Use Authorization 090 Dear Ms. Phillips: On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes coronavirus disease 2019 (COVID-19).1 On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3), subject to terms of any authorization issued under that section.2 On November 9, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of bamlanivimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab is a neutralizing IgG1 monoclonal antibody that binds to the receptor binding domain of the spike protein of SARS-CoV-2. It is an investigational drug and is not currently approved for any indication. -
FOR THOSE WHO STILL HEAR the Gunsrm by William Glenn Robertson
FOR THOSE WHO STILL HEAR THE GUNSrM by William Glenn Robertson Dave Rmh of B&G The Armies (~ollide Bragg }~orces His Way Across (~hickamattga (~reek The failure of Gen. Braxton Bragg's bold and bring the remainder to La Fayette, Ga. (see Mills on the previous day by elements of effort to cripple the Federal XIV Corps in Pg. 51). By 8:30a.m., Bragg had decided upon Thomas J. Wood's Federal division, was to McLemore's Cove on September 11, 1863 (see the next offensive action to take. Believing that remain in contact with the Federals in its Maps, Pp. 10-ll) did not break the offensive Maj. Gen. Thomas L. Crittenden's XXI Corps front. On Armstrong's right, Brig. Gen. John spirit of either the Army of Tennessee or its might be vulnerable, he resolved to send forces Pegram was to deploy his two brigades in an commander. After a few hours of fitful rest, north from La Fayette to strike any elements arc stretching southeast toward the hamlet Bragg was again issuing orders as early as of that corps that could be found. ofVillanow, Ga., on the direct route from La seven o'clock the morning of the 12th. At that Accordingly, Lt. Gen. Leonidas Polk was Fayette to Resaca. When he learned around hour he directed Brig. Gen. Bushrod R. told to move Frank Cheatham's large five noon that Armstrong had broken contact with Johnson to continue shielding the army's supply brigade division ten miles north on the the Federals at Lee and Gordon's Mills, line by blocking any Federal push toward Chattanooga road to Rock Spring Church (see Bragg sternly sent him forward again. -
Appendix One the CELLTECH CASE STUDY
City Research Online City, University of London Institutional Repository Citation: Mc Namara, P. (2000). Managing the tension between knowledge exploration and exploitation: the case of UK biotechnology. (Unpublished Doctoral thesis, City University London) This is the accepted version of the paper. This version of the publication may differ from the final published version. Permanent repository link: https://openaccess.city.ac.uk/id/eprint/7870/ Link to published version: Copyright: City Research Online aims to make research outputs of City, University of London available to a wider audience. Copyright and Moral Rights remain with the author(s) and/or copyright holders. URLs from City Research Online may be freely distributed and linked to. Reuse: Copies of full items can be used for personal research or study, educational, or not-for-profit purposes without prior permission or charge. Provided that the authors, title and full bibliographic details are credited, a hyperlink and/or URL is given for the original metadata page and the content is not changed in any way. City Research Online: http://openaccess.city.ac.uk/ [email protected] Managing the Tension Between Knowledge Exploration and Exploitation: The Case of UK Biotechnology By Peter Mc Namara Presented in fulfilment of the requirements of the: Degree of Doctor of Philosophy Strategy and International Business City University Business School Department of Strategy and Marketing March 2000 TABLE OF CONTENTS ACKNOWLEDGEMENTS .......................................................................................................................... -
Emergency Use Authorization (EUA)
September 16, 2021 Eli Lilly and Company Attention: Christine Phillips, PhD, RAC Advisor Global Regulatory Affairs - US Lilly Corporate Center Drop Code 2543 Indianapolis, IN 46285 RE: Emergency Use Authorization 094 Dear Ms. Phillips: On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes coronavirus disease 2019 (COVID-19).1 On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3), subject to terms of any authorization issued under that section.2 On February 9, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab and etesevimab are neutralizing IgG1 monoclonal antibodies that bind to distinct but overlapping epitopes within the receptor binding domain of the spike protein of SARS-CoV-2. -
SHIRE PLC (Exact Name of Registrant As Specified in Its Charter)
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2009 [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 0-29630 SHIRE PLC (Exact name of registrant as specified in its charter) Jersey (Channel Islands) 98-0601486 (State or other jurisdiction of incorporation or (I.R.S. Employer Identification No.) organization) 5 Riverwalk, Citywest Business Campus, Dublin +353 1 429 7700 24, Republic of Ireland (Address of principal executive offices and zip code) (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of exchange on which registered American Depositary Shares, each representing three NASDAQ Global Select Market Ordinary Shares 5 pence par value per share Securities registered pursuant to Section 12(g) of the Act: None (Title of class) 1 Indicate by check mark whether the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act Yes [X] 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 [ ] No [X] 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.