Appendix a 2017 Financial Report Financial Review Pfizer Inc
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
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. -
Genetic Screens in Isogenic Mammalian Cell Lines Without Single Cell Cloning
ARTICLE https://doi.org/10.1038/s41467-020-14620-6 OPEN Genetic screens in isogenic mammalian cell lines without single cell cloning Peter C. DeWeirdt1,2, Annabel K. Sangree1,2, Ruth E. Hanna1,2, Kendall R. Sanson1,2, Mudra Hegde 1, Christine Strand 1, Nicole S. Persky1 & John G. Doench 1* Isogenic pairs of cell lines, which differ by a single genetic modification, are powerful tools for understanding gene function. Generating such pairs of mammalian cells, however, is labor- 1234567890():,; intensive, time-consuming, and, in some cell types, essentially impossible. Here, we present an approach to create isogenic pairs of cells that avoids single cell cloning, and screen these pairs with genome-wide CRISPR-Cas9 libraries to generate genetic interaction maps. We query the anti-apoptotic genes BCL2L1 and MCL1, and the DNA damage repair gene PARP1, identifying both expected and uncharacterized buffering and synthetic lethal interactions. Additionally, we compare acute CRISPR-based knockout, single cell clones, and small- molecule inhibition. We observe that, while the approaches provide largely overlapping information, differences emerge, highlighting an important consideration when employing genetic screens to identify and characterize potential drug targets. We anticipate that this methodology will be broadly useful to comprehensively study gene function across many contexts. 1 Genetic Perturbation Platform, Broad Institute of MIT and Harvard, 75 Ames Street, Cambridge, MA 02142, USA. 2These authors contributed equally: Peter C. DeWeirdt, -
The Role of PARP1 in Monocyte and Macrophage
cells Review The Role of PARP1 in Monocyte and Macrophage Commitment and Specification: Future Perspectives and Limitations for the Treatment of Monocyte and Macrophage Relevant Diseases with PARP Inhibitors Maciej Sobczak 1, Marharyta Zyma 2 and Agnieszka Robaszkiewicz 1,* 1 Department of General Biophysics, Faculty of Biology and Environmental Protection, University of Lodz, Pomorska 141/143, 90-236 Lodz, Poland; [email protected] 2 Department of Immunopathology, Medical University of Lodz, 7/9 Zeligowskiego, Bldg 2, Rm177, 90-752 Lodz, Poland; [email protected] * Correspondence: [email protected]; Tel.: +48-42-6354449; Fax: +48-42-6354449 or +48-42-635-4473 Received: 4 August 2020; Accepted: 4 September 2020; Published: 6 September 2020 Abstract: Modulation of PARP1 expression, changes in its enzymatic activity, post-translational modifications, and inflammasome-dependent cleavage play an important role in the development of monocytes and numerous subtypes of highly specialized macrophages. Transcription of PARP1 is governed by the proliferation status of cells at each step of their development. Higher abundance of PARP1 in embryonic stem cells and in hematopoietic precursors supports their self-renewal and pluri-/multipotency, whereas a low level of the enzyme in monocytes determines the pattern of surface receptors and signal transducers that are functionally linked to the NFκB pathway. In macrophages, the involvement of PARP1 in regulation of transcription, signaling, inflammasome activity, metabolism, and redox balance supports macrophage polarization towards the pro-inflammatory phenotype (M1), which drives host defense against pathogens. On the other hand, it seems to limit the development of a variety of subsets of anti-inflammatory myeloid effectors (M2), which help to remove tissue debris and achieve healing. -
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. -
PARP Inhibitors Sensitize Ewing Sarcoma Cells to Temozolomide
Published OnlineFirst October 5, 2015; DOI: 10.1158/1535-7163.MCT-15-0587 Cancer Biology and Signal Transduction Molecular Cancer Therapeutics PARP Inhibitors Sensitize Ewing Sarcoma Cells to Temozolomide-Induced Apoptosis via the Mitochondrial Pathway Florian Engert1, Cornelius Schneider1, Lilly Magdalena Weib1,2,3, Marie Probst1,and Simone Fulda1,2,3 Abstract Ewing sarcoma has recently been reported to be sensitive to that subsequent to DNA damage-imposed checkpoint activa- poly(ADP)-ribose polymerase (PARP) inhibitors. Searching for tion and G2 cell-cycle arrest, olaparib/TMZ cotreatment causes synergistic drug combinations, we tested several PARP inhibi- downregulation of the antiapoptotic protein MCL-1, followed by tors (talazoparib, niraparib, olaparib, veliparib) together with activation of the proapoptotic proteins BAX and BAK, mitochon- chemotherapeutics. Here, we report that PARP inhibitors syner- drial outer membrane permeabilization (MOMP), activation of gize with temozolomide (TMZ) or SN-38 to induce apoptosis caspases, and caspase-dependent cell death. Overexpression of a and also somewhat enhance the cytotoxicity of doxorubicin, nondegradable MCL-1 mutant or BCL-2, knockdown of NOXA or etoposide, or ifosfamide, whereas actinomycin D and vincris- BAX and BAK, or the caspase inhibitor N-benzyloxycarbonyl-Val- tine show little synergism. Furthermore, triple therapy of ola- Ala-Asp-fluoromethylketone (zVAD.fmk) all significantly reduce parib, TMZ, and SN-38 is significantly more effective compared olaparib/TMZ-mediated apoptosis. These findings emphasize with double or monotherapy. Mechanistic studies revealed that the role of PARP inhibitors for chemosensitization of Ewing the mitochondrial pathway of apoptosis plays a critical role in sarcoma with important implications for further (pre)clinical mediating the synergy of PARP inhibition and TMZ. -
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. -
R&D Briefing 76
The Impact of Recent Regulatory Developments on the Mexican Therapeutic Landscape Access to innovative medicines is key to El acceso a medicamentos innovadores es clave para improving overall population health, reducing mejorar la salud de toda la población, para reducir los hospitalisation time and decreasing morbidity and tiempos de hospitalización, la morbilidad y la mortalidad mortality. An efficient regulatory process can be de un país. Un proceso regulatorio eficiente tiene un reflected in measurable positive health impacts; impacto positivo medible en la salud, y por el contrario, conversely, activities that slow or impede acciones que retrasan o impiden la eficiencia regulatoria y regulatory efficiency and predictability can be su predictibilidad pueden ser perjudiciales. La parálisis detrimental. Recent developments in the Mexican reciente del Sistema regulatorio mexicano respecto a la regulatory system for the assessments of evaluación de nuevos medicamentos innovadores innovative new products have had a negative conlleva un impacto negativo en la salud de la población impact on Mexican public health. mexicana. This Briefing addresses the impact of suspending Este informe analiza el impacto de la suspensión de las the activities of the New Molecules Committee actividades del Comité de Moléculas Nuevas (NMC, por (NMC) on the Mexican therapeutic landscape. sus siglas en inglés) sobre el horizonte terapéutico de First, we compared the way that “new medicines” México. En primer lugar, comparamos la definición de are defined within the context of the Mexican nuevos medicamentos según el contexto regulatorio regulatory system, with definitions used by mexicano con las definiciones adoptadas por otras comparable regulators and health organisations. agencias reguladoras u organizaciones de salud del We have also investigated the extent to which mundo. -
Critical Analysis of Valuation and Strategical Orientation of Merger
EXPERT REVIEW OF PHARMACOECONOMICS & OUTCOMES RESEARCH, 2018 https://doi.org/10.1080/14737167.2018.1417040 REVIEW Critical analysis of valuation and strategical orientation of merger and acquisition deals in the pharmaceutical industry Raphaela Marie Louisa Dierks, Olivier Bruyère and Jean-Yves Reginster Faculty of Medicine, Department of Public Health, Epidemiology and Health Economics, CHU Sart-Tilman, Liège, Belgium ABSTRACT ARTICLE HISTORY Introduction: The pharmaceutical industry is undergoing major shifts due to changing macro and Received 21 October 2017 micro factors. As the industry is highly capital intensive and patents are expiring, the outlook is on Accepted 11 December 2017 generating inorganic growth, mainly through M&A. Using the income valuation approach, one analyses KEYWORDS two completed deals in 2016 above 1bn USD. Thereafter one outlines the main motives behind M&A Pharmaceutical industry; deals and concluded by discussing whether M&A harms medical innovations. merger and acquisitions Areas covered: The paper is based on empirical study questioning existing literature in order to (M&A); valuation; inorganic critically analyse valuation and the strategical orientation of pharmaceutical companies growth; medical innovation; Expert commentary: Pharmaceutical companies understand the changing market conditions and non-core assets; drug favour their expertise. The restructuring of the industry moves to small niche companies (I.e. pipeline; tax inversion Biopharma or biotech companies) researching key innovations and big companies purchasing them to develop them, create clinical trials and distribute them as this is a costly manner Conclusion: One can expect more M&A deals during the next years focusing on value rather than volume. Pharmaceutical players resilient to the market changes may survive if they change their business model from a traditional vertical one to outsourcing and diversification including external players. -
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. -
Amgen 2008 Annual Report and Financial Summary Pioneering Science Delivers Vital Medicines
Amgen 2008 Annual Report and Financial Summary Pioneering science delivers vital medicines About Amgen Products Amgen discovers, develops, manufactures Aranesp® (darbepoetin alfa) and delivers innovative human therapeutics. ® A biotechnology pioneer since 1980, Amgen Enbrel (etanercept) was one of the fi rst companies to realize ® the new science’s promise by bringing EPOGEN (Epoetin alfa) safe and effective medicines from the lab Neulasta® (pegfi lgrastim) to the manufacturing plant to patients. NEUPOGEN® (Filgrastim) Amgen therapeutics have changed the practice of medicine, helping millions of Nplate® (romiplostim) people around the world in the fi ght against ® cancer, kidney disease, rheumatoid Sensipar (cinacalcet) arthritis and other serious illnesses, and so Vectibix® (panitumumab) far, more than 15 million patients worldwide have been treated with Amgen products. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. 0405 06 07 08 0405 06 07 08 0405 06 07 08 0405 06 07 08 Total revenues “Adjusted” earnings Cash fl ow from “Adjusted” research and ($ in millions) per share (EPS)* operations development (R&D) expenses* (Diluted) ($ in millions) ($ in millions) 2008 $15,003 2008 $4.55 2008 $5,988 2008 $2,910 2007 14,771 2007 4.29 2007 5,401 2007 3,064 2006 14,268 2006 3.90 2006 5,389 2006 3,191 2005 12,430 2005 3.20 2005 4,911 2005 2,302 2004 10,550 2004 2.40 2004 3,697 2004 1,996 * “ Adjusted” EPS and “adjusted” R&D expenses are non-GAAP fi nancial measures. See page 8 for reconciliations of these non-GAAP fi nancial measures to U.S. -
Large Cap Value Fund Q3 Portfolio Holdings
Putnam Equity Income Fund The fund's portfolio 8/31/20 (Unaudited) COMMON STOCKS (95.5%)(a) Shares Value Aerospace and defense (3.0%) Northrop Grumman Corp. 763,179 $261,472,757 Raytheon Technologies Corp. 1,931,815 117,840,715 379,313,472 Airlines (1.0%) Southwest Airlines Co. 3,596,011 135,138,093 135,138,093 Auto components (0.8%) Delphi Automotive PLC 1,165,950 100,411,614 100,411,614 Automobiles (0.7%) General Motors Co. 2,932,830 86,899,753 86,899,753 Banks (9.9%) Bank of America Corp. 13,888,550 357,491,277 Citigroup, Inc. 6,615,251 338,171,631 JPMorgan Chase & Co. 3,413,635 342,012,091 KeyCorp 3,945,705 48,611,086 PNC Financial Services Group, Inc. (The) 1,279,414 142,270,837 1,228,556,922 Beverages (2.5%) Keurig Dr Pepper, Inc.(S) 3,097,349 92,393,921 Molson Coors Beverage Co. Class B(S) 1,663,844 62,627,088 PepsiCo, Inc. 1,123,779 157,396,487 312,417,496 Biotechnology (4.5%) AbbVie, Inc. 2,005,931 192,108,012 Amgen, Inc. 804,202 203,720,451 Regeneron Pharmaceuticals, Inc.(NON) 262,080 162,471,254 558,299,717 Building products (2.3%) Fortune Brands Home & Security, Inc. 1,681,051 141,342,768 Johnson Controls International PLC 3,432,811 139,818,392 281,161,160 Capital markets (3.5%) Apollo Global Management, Inc. 2,289,153 107,292,601 Charles Schwab Corp. (The) 2,516,793 89,421,655 Goldman Sachs Group, Inc. -
Sigma Spectrum Operator's Manual
spectrum Operator’s Manual 35700BAX & 35700ABB Generation 2 Operating System Pump Operating Software v6.05 For Use with MDL Editor v6.2.4 SIGMA, LLC 711 Park Avenue Medina, New York 14103 v 800 356 3454 f 585 798 3909 www.sigmapumps.com Manual 41018- 6.05/6.2.4 Revision D II Pump Operating Software v6.05 For Use With MDL Editor v6.2.4 ©2011 Copyright SIGMA, LLC 711 Park Avenue Medina, New York 14103 v 800 356 3454 f 585 798 3909 www.sigmapumps.com III Manual 41018- 6.05/6.2.4 Revision D IV Pump Operating Software v6.05 For Use With MDL Editor v6.2.4 TABLE OF CONTENTS Introduction and Safety . 1 Intended Device Use . 1 Related Documents . 1 Regulatory Information . 1 Contacting SIGMA Technical Support . 1 Conventions . 2 Summary of Warnings and Cautions . 2 System Components . 11 Spectrum Pump Illustrations . 12 Hardware Labeling . 13 Battery Compatibility . 14 Setting Up the Pump . 15 Unpack the Pump . 15 AC Power Adaptor . 16 Cleaning the Power Adaptor . 16 Connecting the Power Adaptor . 16 Removing the Power Adaptor . 17 Charging the Battery . 17 Configuring User Options . 18 User Options . 18 Operational Overview . 21 Starting a New Infusion Using the Dose Error Reduction System (DERS) . 24 Starting a New Infusion using the BASIC Mode . 25 Secondary Infusions . 26 Preparing the Pump and IV Sets . 27 Loading an IV Set . 28 Unloading an IV Set . 30 Preparing the Pump for a Secondary Infusion . 30 Programming the Pump . 31 Infusion Programming Modes: . 32 Keys Used to Program and Operate the Pump .