Genetic Engineering
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
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. -
AILERON THERAPEUTICS, INC. (Name of Registrant As Specified in Its Charter)
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy Statement ☐ Definitive Additional Materials ☐ Soliciting Material Pursuant to §240.14a-12 AILERON THERAPEUTICS, INC. (Name of Registrant as Specified in Its Charter) (Name of Person(s) Filing Proxy Statement, if Other Than the Registrant) Payment of Filing Fee (Check the appropriate box): ☒ No fee required. ☐ Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11. (1) Title of each class of securities to which transaction applies: (2) Aggregate number of securities to which transaction applies: (3) Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (set forth the amount on which the filing fee is calculated and state how it was determined): (4) Proposed maximum aggregate value of transaction: (5) Total fee paid: ☐ Fee paid previously with preliminary materials. ☐ Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing. (1) Amount previously paid: (2) Form, Schedule or Registration Statement No.: (3) Filing Party: (4) Date Filed: Table of Contents AILERON THERAPEUTICS, INC. -
UNITED STATES SECURITIES and EXCHANGE COMMISSION Form
Table of Contents 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, 2008 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT ☐ OF 1934 Commission file number 000-12477 Amgen Inc. (Exact name of registrant as specified in its charter) Delaware 95-3540776 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) One Amgen Center Drive, 91320-1799 Thousand Oaks, California (Zip Code) (Address of principal executive offices) (805) 447-1000 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(g) of the Act: Common stock, $0.0001 par value; preferred share purchase rights (Title of class) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ 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 ☒ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or Section 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. Yes ☒ No ☐ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. -
Reporte Anual
Clave de Cotización: ORBIA Fecha: 2019-12-31 [411000-AR] Datos generales - Reporte Anual Reporte Anual: Anexo N Oferta pública restringida: No Tipo de instrumento: Acciones,Deuda LP Emisora extranjera: No Mencionar si cuenta o no con aval u otra garantía, La emisión de Certificados Bursátiles se encuentra especificar la Razón o Denominación Social: avalada por las subsidiarias de la Compañía denominadas Mexichem Compuestos, S.A. de C.V., Mexichem Amanco Holding, S.A. de C.V., Mexichem Derivados, S.A. de C.V., Mexichem Resinas Vinílicas, S.A. de C.V., Mexichem Flúor, S.A. de C.V., y Mexichem Brasil Industria de Transformação Plástica Ltda. (“Mexichem Brasil”), esta última subsidiaria aval es una sociedad de nacionalidad brasileña y la totalidad de sus activos se encuentran ubicados fuera de México. De igual manera, en caso de insolvencia o quiebra de Mexichem Brasil, las reclamaciones de los Tenedores conforme a los Certificados Bursátiles quedarán sujetas a la preferencia que establezcan las leyes aplicables en la República Federal de Brasil. En su caso, detallar la dependencia parcial o total: No 1 de 209 Clave de Cotización: ORBIA Fecha: 2019-12-31 [412000-N] Portada reporte anual Orbia Advance Corporation, S.A.B. de C.V. Avenida Paseo de la Reforma 483, piso 47, Colonia Cuauhtémoc, Alcaldía Cuauhtémoc, Ciudad de México, 06500 Tel. 5366 4000 2 de 209 Clave de Cotización: ORBIA Fecha: 2019-12-31 Serie [Eje] I II Especificación de las características de los títulos en circulación [Sinopsis] Clase I II Serie Única Única Tipo Nominativa -
Pharmaceutical Settlements
Drug Patent Settlements Between Rivals: A Survey C. Scott Hemphill Columbia Law School Working paper available at ssrn.com/abstract=969492 March 12, 2007 Electronic copy of this paper is available at: http://ssrn.com/abstract=969492 Drug Patent Settlements Between Rivals: A Survey C. Scott Hemphill* Introduction .......................................................................................................................................... 3 I. Settlements in summary ........................................................................................................... 5 II. The mechanisms of payment for delay................................................................................. 13 A. Compensation to the generic firm............................................................................... 14 1. Cash and overpayment...................................................................................... 14 2. Preserving exclusivity........................................................................................ 16 3. Underpricing....................................................................................................... 18 4. Additional channels........................................................................................... 19 B. Delay in generic entry................................................................................................... 20 1. Neutralizing the first filer ................................................................................. 20 2. Bottleneck -
Humankind 2.0: the Technologies of the Future 6. Biotech
Humankind 2.0: The Technologies of the Future 6. Biotech Piero Scaruffi, 2017 See http://www.scaruffi.com/singular/human20.html for the full text of this discussion A brief History of Biotech 1953: Discovery of the structure of the DNA 2 A brief History of Biotech 1969: Jon Beckwith isolates a gene 1973: Stanley Cohen and Herbert Boyer create the first recombinant DNA organism 1974: Waclaw Szybalski coins the term "synthetic biology” 1975: Paul Berg organizes the Asilomar conference on recombinant DNA 3 A brief History of Biotech 1976: Genentech is founded 1977: Fred Sanger invents a method for rapid DNA sequencing and publishes the first full DNA genome of a living being Janet Rossant creates a chimera combining two mice species 1980: Genentech’s IPO, first biotech IPO 4 A brief History of Biotech 1982: The first biotech drug, Humulin, is approved for sale (Eli Lilly + Genentech) 1983: Kary Mullis invents the polymerase chain reaction (PCR) for copying genes 1986: Leroy Hood invents a way to automate gene sequencing 1986: Mario Capecchi performs gene editing on a mouse 1990: William French Anderson’s gene therapy 1990: First baby born via PGD (Alan Handyside’s lab) 5 A brief History of Biotech 1994: FlavrSavr Tomato 1994: Maria Jasin’s homing endonucleases for genome editing 1996: Srinivasan Chandrasegaran’s ZFN method for genome editing 1996: Ian Wilmut clones the first mammal, the sheep Dolly 1997: Dennis Lo detects fetal DNA in the mother’s blood 2000: George Davey Smith introduces Mendelian randomization 6 A brief History of Biotech -
03 Rafael.Indd
Terapia gênica: o que é, o que não é e o que será RAFAEL LINDEN Introdução ESDE sua fundação, pelo monge Johann (Gregor) Mendel no século XIX, aos dias de hoje, a genética evoluiu extraordinariamente e conquistou Dum lugar de destaque entre as ciências. Há dez anos foi completado o sequenciamento do genoma humano (Lander et al., 2001; Venter et al., 2001), um feito grandioso que promete acelerar o progresso da biologia e da medicina do século XXI. A medicina moderna acrescenta, a cada dia, descobertas importantes em áreas de investigação destinadas ao desenvolvimento de novos paradigmas de tratamento para doenças ainda incuráveis. Entre elas, a expectativa de curar doenças genéticas re- pousa sobre a identificação de genes responsáveis por sua patogênese e sobre o avan- ço das tecnologias de DNA recombinante, ou “engenharia genética”, que permitem a manipulação do genoma de forma cada vez mais eficiente e segura (Watson et al., 2006). Em paralelo, a determinação de fatores genéticos de suscetibilidade a certas doenças, seu curso e suas manifestações clínicas (NCBI, 2009), bem como o enor- me avanço na compreensão da biologia celular e molecular de eventos patológicos fundamentais, tais como processos inflamatórios, distúrbios de proliferação e morte celular programada (Coleman & Tsongalis, 2009), aumentam a expectativa de que a manipulação do genoma possa vir a ser aplicada a uma ampla gama de doenças. Essa é uma área ainda incipiente da medicina, praticada especialmente nos laboratórios de pesquisa fundamental, e sua aplicação ainda é estritamente ex- perimental. Já há nessa área produtos comerciais aprovados para uso médico (Pearson et al., 2004), mas a expectativa dos cientistas, bem como da indústria farmacêutica e de biotecnologia, é de que a liberação de protocolos de mani- pulação do genoma para a prática médica e o respectivo mercado de biológicos deverão avançar cautelosamente ao longo dos próximos 5-10 anos, ainda assim englobando um número restrito de aplicações. -
Healthcare Conference
25th Annual HEALTHCARE CONFERENCE Healthcare Westin St. Francis San Francisco January 8–11, 2007 JPMorgan cordially invites you to attend the 25th Annual Healthcare Conference, January 8 –11, 2007, at the Westin St. Francis in San Francisco. JPMorgan’s premier conference on the healthcare industry will feature more than 260 public and private companies over four days of simultaneous sessions. In addition, the conference will host topical panel discussions featuring leading industry experts. Preliminary List of Invited Presenting Companies Actelion Ltd Baxter International Inc. Cooper Companies Aetna Incorporated BD (Becton, Dickinson) Coventry Affymetrix, Inc. Beckman Coulter, Inc. Dade Behring Holdings, Inc. Alcon, Inc. Bioenvision, Inc. DaVita Inc. Align Technology, Inc. Biogen Idec deCODE genetics, Inc. Allscripts Healthcare Solutions Inc. Biomet, Inc. Digene Altana Boston Scientific Corporation Digirad Corporation — US American Medical Systems Holdings Inc. Bristol-Myers Squibb Company Diversa Corporation Amerigroup Corp. Cambrex Corporation DJO Incorporated AmerisourceBergen Cardinal Health, Inc. Dyax Corp. Amgen, Inc. Caremark Rx, Inc. Eclipsys Corporation AMN Healthcare Services, Inc. Celgene Corporation Edwards Lifesciences Corporation AmSurg Corporation Cell Genesys Elan Corporation, plc Anadys Pharmaceuticals CENTENE Corporation Eli Lilly and Company Applied Biosystems Group Cephalon, Inc. Emdeon Ariad Pharmaceuticals, Inc. Cerner Corporation Emergency Medical Services Corporation AstraZeneca Group plc Charles River Laboratories, -
Inside This Issue
Vol. 25, No. 21 Bayer, Generic Firms Win Oct. 29, 2008 In Antitrust Case INSIDE THIS ISSUE A federal appeals court has upheld a ruling that agreements be- tween Bayer and four generics firms on the antibiotic Cipro did not violate the Sherman Antitrust Act or state antitrust regulations or laws. Ask the Expert: Michelle Seagull comments on Cipro In its decision, the U.S. Court of Appeals for the Federal Cir- antitrust case............Page 3 cuit agreed with the In re Ciprofloxacin Hydrochloride Antitrust Litigation decision made by the U.S. District Court for the Eastern FDA: Agency seeks to District of New York in favor of Bayer, Hoechst Marion Roussel withdraw ANDAs for (HMR), Rugby Laboratories, Watson Pharmaceuticals and Barr MiraLax...................Page 5 Laboratories. Clinical Trial: UK OKs The appeals court found the companies did not engage in anti- INS-20 trial..............Page 5 competitive practices when they signed agreements with Bayer not Lawsuits: Mylan gets two (See Antitrust, Page 2) tentative approvals, faces Novartis suit ............Page 6 Court Finds Against Sandoz In Biaxin XL Case Industry News: Par to re- structure business ....Page 7 A federal appeals court upheld a preliminary injunction barring Sandoz from selling a generic version of Abbott Laboratories’ ex- Mergers/Acquisitions: tended-release antibiotic Biaxin. Stakeholder downplays Ac- tavis sale rumors......Page 7 The split decision by the U.S. Court of Appeals for the Federal Circuit moves the patent dispute back to the U.S. District Court for FTC: Court agrees to halt the Northern District of Illinois for further proceedings on the case, websites’ sale of unap- which started when Abbott sued Sandoz in 2005 for infringing on its proved drugs............Page 7 ’718, ’616 and ’407 patents on Biaxin (clarithromycin). -
1 4164-01-P Department of Health and Human Services
This document is scheduled to be published in the Federal Register on 10/04/2016 and available online at https://federalregister.gov/d/2016-23893, and on FDsys.gov 1 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0002] Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 44 new drug applications (NDAs) and 158 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Effective Date: [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601. SUPPLEMENTARY INFORMATION: The holders of the applications listed in table 1 in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) 2 is without prejudice to refiling. Table 1 Application No. -
Science, Religion, and Values
Science, Religion, and Values Institution: St. Francis University Instructor: Rosemary Bertocci SYLLABUS WEEK 1: THE RELATIONSHIP BETWEEN SCIENCE AND RELIGION. The goal is to examine and differentiate positions on ways of relating science and religion in order to establish a starting-point for discussion. The main perspectives Dr. Bertocci will introduce are: A. Barbour’s representative figures for conflict, independence, dialogue, and integration. B. Gould’s NOMA (respectful noninterference), with emphasis on historical reasons for conflict. C. Marty’s sine qua non for communication and interaction: (a) differentiate modes of inquiry and discourse, (b) promote a mutual respect across disciplines, and (c) recognize that the consciences of scientists and theologians demand “a lifelong changing in behavior” (conversatio morum) to match “a lifelong changing in intellect” (conversatio intellectus). D. McGrath’s account of interaction, with focus on its historical, theological, philosophical, and scientific aspects, and an explanation of the “anthropic principle.” E. Templeton’s introduction to humility theology, characterizing foundations for future research. F. Lonergan’s generalized empirical method, offering a key to unified science: Scientists and authentic theologians follow the same pattern of cognition – experiencing, questioning, direct insight, conceiving or formulating, reflective questioning, reflective insight, judging (with ongoing revision of judgments). Lonergan differentiates (a) authentic appropriation of authentic tradition, (b) unauthentic appropriation of unauthentic tradition, (c) authentic appropriation of unauthentic tradition, and (d) unauthentic appropriation of authentic tradition. Required Reading: Barbour, Ian G. “Ways of Relating Science and Religion.” Religion and Science: Historical and Contemporary Issues: A Revised and Expanded Edition of Religion in an Age of Science. HarperSanFrancisco, 1997. -