Table of Contents
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Appendix a 2016 Financial Report Financial Review Pfizer Inc
Appendix A 2016 Financial Report Financial Review Pfizer Inc. and Subsidiary Companies GLOSSARY OF DEFINED TERMS Unless the context requires otherwise, references to “Pfizer,” “the Company,” “we,” “us” or “our” in this 2016 Financial Report (defined below) refer to Pfizer Inc. and its subsidiaries. We also have used several other terms in this 2016 Financial Report, most of which are explained or defined below: 2016 Financial Report This Financial Report for the fiscal year ended December 31, 2016, which was filed as Exhibit 13 to the Annual Report on Form 10-K for the fiscal year ended December 31, 2016 2016 Form 10-K Annual Report on Form 10-K for the fiscal year ended December 31, 2016 AAV Adeno-Associated Virus ABO Accumulated postretirement benefit obligation ACA (Also referred to as U.S. U.S. Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Healthcare Legislation) Act. ACIP Advisory Committee on Immunization Practices ALK anaplastic lymphoma kinase Allergan Allergan plc Alliance revenues Revenues from alliance agreements under which we co-promote products discovered or developed by other companies or us AM-Pharma AM-Pharma B.V. Anacor Anacor Pharmaceuticals, Inc. Astellas Astellas Pharma U.S. Inc. ASU Accounting Standards Update ATM-AVI aztreonam-avibactam Bamboo Bamboo Therapeutics, Inc. Baxter Baxter International Inc. BMS Bristol-Myers Squibb Company CDC U.S. Centers for Disease Control and Prevention Cellectis Cellectis SA Celltrion Celltrion Inc. and Celltrion Healthcare, -
[Docket No. FDA-2017-N-3203] Wyeth Pharmaceutical
This document is scheduled to be published in the Federal Register on 06/21/2017 and available online at https://federalregister.gov/d/2017-12908, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-3203] Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 New Drug Applications and 161 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 121 new drug applications (NDAs) and 161 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: The withdrawal is effective on [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) is without prejudice to refiling. 2 Table 1 Application No. -
Transcept Pharmaceuticals, Inc
Table of Contents SCHEDULE 14A (RULE 14A 101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION PROXY STATEMENT PURSUANT TO SECTION 14(A) OF THE SECURITIES EXCHANGE ACT OF 1934 (AMENDMENT NO. ) Filed by the Registrant x 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 x Definitive Proxy Statement Rule 14a-6(e)(2)) ¨ Definitive Additional Materials ¨ Soliciting Material Pursuant to §240.14a-12 Transcept Pharmaceuticals, 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): x 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 NOTICE OF ANNUAL MEETING OF STOCKHOLDERS JUNE 23, 2011 To Our Stockholders: NOTICE IS HEREBY GIVEN that the Annual Meeting of Stockholders of Transcept Pharmaceuticals, Inc., a Delaware corporation, will be held on Thursday, June 23, 2011, at 8:30 a.m., local time, at our office located at 1003 West Cutting Blvd., Suite 110, Point Richmond, California 94804, for the following purposes: 1. -
Curriculum Vitae: Daniel J
CURRICULUM VITAE: DANIEL J. WALLACE, M.D., F.A.C.P., M.A.C.R. Up to date as of January 1, 2019 Personal: Address: 8750 Wilshire Blvd, Suite 350 Beverly Hills, CA 90211 Phone: (310) 652-0010 FAX: (310) 360-6219 E mail: [email protected] Education: University of Southern California, 2/67-6/70, BA Medicine, 1971. University of Southern California, 9/70-6/74, M.D, 1974. Postgraduate Training: 7/74-6/75 Medical Intern, Rhode Island (Brown University) Hospital, Providence, RI. 7/75-6/77 Medical Resident, Cedars-Sinai Medical Center, Los Angeles, CA. 7/77-6/79 Rheumatology Fellow, UCLA School of Medicine, Los Angeles, CA. Medical Boards and Licensure: Diplomate, National Board of Medical Examiners, 1975. Board Certified, American Board of Internal Medicine, 1978. Board Certified, Rheumatology subspecialty, 1982. California License: #G-30533. Present Appointments: Medical Director, Wallace Rheumatic Study Center Attune Health Affiliate, Beverly Hills, CA 90211 Attending Physician, Cedars-Sinai Medical Center, Los Angeles, 1979- Clinical Professor of Medicine, David Geffen School of Medicine at UCLA, 1995- Professor of Medicine, Cedars-Sinai Medical Center, 2012- Expert Reviewer, Medical Board of California, 2007- Associate Director, Rheumatology Fellowship Program, Cedars-Sinai Medical Center, 2010- Board of Governors, Cedars-Sinai Medical Center, 2016- Member, Medical Policy Committee, United Rheumatology, 2017- Honorary Appointments: Fellow, American College of Physicians (FACP) Fellow, American College of Rheumatology (FACR) -
RESI Boston Program Guide 09-26-2017 Digital
SEPTEMBER 26 , 2017 BOSTON, MA Early stage investors, fundraising CEOs, scientist-entrepreneurs, strategic partners, and service providers now have an opportunity to Make a Compelling Connection ONSITE GUIDE LIFE SCIENCE NATION Connecting Products, Services & Capital #RESIBOS17 | RESIConference.com | Boston Marriott Copley Place FLOOR PLAN Therapeutics Track 2 Investor Track 3 & track4 Track 1 Device, Panels Workshops & Diagnostic & HCIT Asia Investor Panels Panels Ad-Hoc Meeting Area Breakfast & Lunch DINING 29 25 30 26 31 27 32 28 33 29 34 30 35 Breakfast / LunchBreakfast BUFFETS 37 28 24 27 23 26 22 25 21 24 20 23 19 22 exhibit hall 40 15 13 16 14 17 15 18 16 19 17 20 18 21 39 INNOVATION 14 12 13 11 12 10 11 9 10 8 9 7 8 EXHIBITORS CHALLENGE 36 38 FINALISTS 1 1 2 2 3 3 4 4 5 5 6 6 7 Partnering Check-in PARTNERING Forum Lunch BUFFETS Breakfast / Breakfast RESTROOM cocktail reception REGISTRATION content Welcome to RESI - - - - - - - - - - - - - - - 2 RESI Agenda - - - - - - - - - - - - - - - - - - 3 BOSTON RESI Innovation Challenge - - - - - - - 5 Exhibiting Companies - - - - - - - - - - 12 Track 1: Therapeutics Investor Panels - - - - - - - - - - - - - - - 19 Track 2: Device, Diagnostic, & HCIT Investor Panels - - - - 29 Track 3: Entrepreneur Workshops - - - - - - - - - - - - - - - - - - 38 Track 4: Asia-North America Workshop & Panels - - - - - - 41 Track 5: Partnering Forum - - - - - - - - - - - - - - - - - - - - - - - - 45 Sponsors & Media Partners - - - - - - - - - - - - - - - - - - - - - - - 46 1 welcome to resi On behalf of Life Science Nation (LSN) and our title sponsors WuXi AppTec and Johnson & Johnson Innovation JLABS, I would like to thank you for joining us at RESI Boston. LSN is very happy to welcome you all to Boston, the city where it all began, for our 14th RESI event. -
Manufacturers and Wholesalers Street
Nevada AB128 Code of Conduct Compliant Companies Manufacturers and Wholesalers Street City ST Zip 10 Edison Street LLC 13 Edison Street LLC Abbott Diabetes Care Division Abbott Diagnostic Division Abbott Electrophysiology (including Kalila Medical 2- 2016)) Abbott Laboratories 100 Abbott Park Road, Dept. EC10, Bldg. APGA-2 Abbott Park IL 60064 Abbott Medical Optics Abbott Molecular Division Abbott Nutrition Products Division Abbott Vascular Division (includes Tendyne 9-2015) AbbVie, Inc. 1 N. Waukegan Road North Chicago IL 60064 Acadia Phamaceuticals 3611 Valley Centre Drive, Suite 300 San Diego CA 92130 Accelero Health Partners, LLC Acclarent, Inc. 1525-B O'Brien Dr. Menlo Park CA 94025 Accuri Cyometers, Inc. Ace Surgical Supply, Inc. 1034 Pearl St. Brockton MA 02301 Acorda Therapeutics, Inc. 420 Sawmill River Road Ardsley NY 10532 AcriVet, Inc. Actavis W.C. Holding, Inc. Morris Corporate Center III, 400 Interpace Parkway Parsippany NJ 07054 Actavis , Inc. Actelion Pharmaceuticals US, Inc. 5000 Shoreline Court, Suite 200 S. San Francisco CA 94080 Activis 400 Interpace parkway Parsippany NJ 07054 A-Dec, Inc. 2601 Crestview Dr. Newberg OR 97132 Advanced Respiratory, Inc. Advanced Sterilization Products 33 Technology Drive Irvine CA 92618 Advanced Vision Research, Inc., dba Akorn Consumer Health Aegerion Pharmaceuticals, Inc. 101 Main Street, Suite 1850 Cambridge MA 02142 Aesculap Implant Systems, Inc. Aesculap, Inc. 3773 Corporate Parkway Center Valley PA 18034 Aesthera Corporation Afaxys, Inc. PO Box 20158 Charleston SC 29413 AGMS, Inc. Akorn (New Jersey) Inc. Page 1 of 23 Pages 2/15/2017 Nevada AB128 Code of Conduct Compliant Companies Akorn AG (formerly Excelvision AG) Akorn Animal Health, Inc. -
OSI Pharmaceuticals and AVEO Pharmaceuticals Expand Oncology Discovery and Translational Research Collaboration
OSI Pharmaceuticals and AVEO Pharmaceuticals Expand Oncology Discovery and Translational Research Collaboration July 21, 2009 9:24 PM ET MELVILLE, NY and CAMBRIDGE, Mass., July 21, 2009 – OSI Pharmaceuticals, Inc. (NASDAQ:OSIP) and AVEO Pharmaceuticals, Inc. today announced that they have expanded the drug discovery and translational research collaboration announced in October of 2007. The alliance is anchored around developing molecular targeted therapies to target the underlying mechanisms of epithelial-mesenchymal transition (EMT) in cancer and to develop proprietary datasets of associated patient selection biomarkers to support OSI’s targeted medicine pipeline. EMT is a process of emerging significance in tumor development and disease progression and the focal point of OSI’s proprietary oncology research efforts. The companies are expanding their efforts to validate cancer targets and to deploy key elements of AVEO’s proprietary translational research platform in support of OSI’s clinical development programs. Under the terms of the expanded discovery and research agreement, OSI will pay AVEO a total of $20 million at closing, $5 million of which is an upfront cash payment and $15 million of which is the purchase of additional equity in AVEO. OSI will also provide AVEO research funding over the next two years to support the collaboration, and the potential to achieve additional royalties and milestones. In return, OSI will immediately receive rights beyond the original collaboration including rights to additional EMT targets (including up to 4 antibody targets) and increased access to AVEO technology (i.e. tumor models, archives and biomarkers). OSI is also acquiring non-exclusive access to AVEO’s proprietary bioinformatics platform. -
PULSE: Speaker Biographies March 2019
PULSE: Speaker Biographies March 2019 Supported by @BIA_UK www.bioindustry.org In order of appearance: Dr Barbara Domayne-Hayman Entrepreneur-in-residence, Francis Crick Institute, CBO, Autifony Therapeutics Ltd and formerly Chairman, Puridify Barbara has worked on the commercial side of life sciences for thirty years, first in a large organisation (ICI/Zeneca/AstraZeneca), before transitioning to the entrepreneurial world of biotech. Barbara joined the Francis Crick Institute in January 2018 as Entrepreneur-in- residence. She is also Chief Business officer of Autifony, where she is responsible for strategic partnering, fundraising and commercial aspects of drug development for CNS disorders. In December 2017 Autifony signed a major collaboration with Boehringer Ingelheim. Barbara was also Chair of Puridify, a UCL spin-out with a breakthrough biotherapeutics purification technology, which was acquired by GE in November 2017. She chairs the LifeArc Seed Fund investment committee, and is on the Cambridge Enterprise Seed Fund Investment Committee. Previously, Barbara was CEO of Stabilitech, and she was Commercial Director at Arrow Therapeutics until the company was acquired by AstraZeneca. Barbara was also Senior Business Development Manager at Celltech. Barbara has a BA and D Phil in Chemistry from the University of Oxford, and is a Sloan Fellow from London Business School. Steve Bates, OBE CEO, BioIndustry Association Since his appointment as Chief Executive of the BioIndustry Association in 2012, Steve has led major BIA campaigns for, amongst other things, improved access to finance, the refilling of the Biomedical Catalyst, anti-microbial resistance and the opportunity the sector presents to generalist long term investors. Steve champions the adaptive pathway approach to the licensing of new drugs, the need for Early Access and is particularly proud of the working relationship the BIA has established with the UK’s leading medical research charities. -
IPR2016-01284 Patent 6,900,221 B1 ______
[email protected] Paper No. 49 571.272.7822 Filed: January 8, 2018 UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ APOTEX INC., APOTEX CORP., APOTEX PHARMACEUTICALS HOLDINGS INC., AND APOTEX HOLDINGS, INC., Petitioner, v. OSI PHARMACEUTICALS LLC, Patent Owner. ____________________ Case IPR2016-01284 Patent 6,900,221 B1 ____________ Before LORA M. GREEN, RAMA G. ELLURU, and ZHENYU YANG, Administrative Patent Judges. GREEN, Administrative Patent Judge. FINAL WRITTEN DECISION Determining That Claims 44‒46 and 53 Are Shown to Be Unpatentable 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73 IPR2016-01284 Patent 6,900,221 B1 I. INTRODUCTION Apotex Inc., Apotex Corp., Apotex Pharmaceuticals Holdings Inc., and Apotex Holdings, Inc., (“Apotex” or “Petitioner”) filed a Petition requesting an inter partes review of claims 44–47 and 53 of U.S. Patent No. 6,900,221 B1 (Ex. 1001, “the ’221 patent”). Paper 3 (“Pet.”). OSI Pharmaceuticals LLC1 (“OSI” or “Patent Owner”) filed a Preliminary Response to the Petition.2 Paper 7 (“Prelim. Resp.”). We determined that the information presented in the Petition and the Preliminary Response demonstrated that there was a reasonable likelihood that Petitioner would prevail in challenging claims 44–47 and 53 as unpatentable under 35 U.S.C. § 103(a). Pursuant to 35 U.S.C. § 314, we instituted trial on January 9, 2017, as to all of the challenged claims of the ’221 patent. Paper 8 (“Institution Decision” or “Dec. Inst.”). On February 8, 2017, the parties filed a Joint Motion to Limit Petition Under 37 C.F.R. -
Management Team
Management Team Bruce C. Cozadd Executive Chairman Bruce Cozadd joined Jazz Pharmaceuticals at its inception. From 2001 until he joined Jazz Pharmaceuticals, Mr. Cozadd served as a consultant to companies in the biopharmaceutical industry. From 1991 until 2001, he held various positions with ALZA Corporation, a pharmaceutical company now owned by Johnson & Johnson, most recently as its Executive Vice President and Chief Operating Officer, with responsibility for research and development, manufacturing and sales and marketing. Previously at ALZA Corporation he held the roles of Chief Financial Officer and Vice President, Corporate Planning and Analysis. Mr. Cozadd received a B.S. from Yale University and an M.B.A. from the Stanford Graduate School of Business. Mr. Cozadd serves on the boards of Cerus Corporation, a biopharmaceutical company; Threshold Pharmaceuticals, a biotechnology company; and The Nueva School and Stanford Hospital and Clinics, both non-profit organizations. Samuel R. Saks, MD Chief Executive Officer Samuel Saks, M.D., joined Jazz Pharmaceuticals at its inception. From 2001 until he joined Jazz Pharmaceuticals, Dr. Saks was Company Group Chairman of ALZA Corporation and served as a member of the Johnson & Johnson Pharmaceutical Group Operating Committee. From 1992 until 2001, he held various positions with ALZA Corporation, most recently as its Chief Medical Officer and Group Vice President, where he was responsible for clinical and commercial activities. Dr. Saks received a B.S. and an M.D. from the University of Illinois. Dr. Saks serves on the board of Trubion Pharmaceuticals and Cougar Biotechnology. Robert M. Myers President Robert Myers joined Jazz Pharmaceuticals at its inception and was appointed as Jazz Pharmaceuticals’ President in March 2007. -
CONCERT PHARMACEUTICALS, INC. (Exact Name of Registrant As Specified in Its Charter)
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 Filed by the Registrant x 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)) x Definitive Proxy Statement ¨ Definitive Additional Materials ¨ Soliciting Material under §240.14a-12 CONCERT PHARMACEUTICALS, INC. (Exact 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): x 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: 1 Concert Pharmaceuticals, Inc. -
The Impact of Secondary Innovation on Firm Market Value in the Pharmaceutical Industry
The Impact of Secondary Innovation on Firm Market Value in the Pharmaceutical Industry By: Maitri Punjabi Honors Thesis Economics Department The University of North Carolina at Chapel Hill March 2016 Approved: ______________________________ Dr. Jonathan Williams Punjabi 2 Abstract This paper analyzes the effect of the changing nature of innovation on pharmaceutical firm market value from the years 1987 to 2010 by using U.S. patent and claim data. Over the years, firms have started shifting focus from primary innovation to secondary innovation as new ideas and new compounds become more difficult to generate. In this study, we analyze the impact of this patent portfolio shift on the market capitalization of pharmaceutical firms. After using firm fixed effects and the instrumental variable approach, we find that there exists a strong positive relationship between secondary innovations and the market value of the firm– in fact, we find a stronger relationship than is observed between primary innovation and market value. When focusing on the different levels of innovation within the industry, we find that this relationship is stronger for less-innovative firms (those that have produced fewer patents) than it is for highly- innovative firms. We also find that this relationship is stronger for firms that spend less on research and development, complementing earlier findings that research productivity is declining over time. Punjabi 3 Acknowledgements I would primarily like to thank my adviser, Dr. Jonathan Williams, for his patience and constant support. Without his kind and helpful attitude, this project would have been a much more frustrating process. Through his knowledge of the industry, I have gained valuable insight and have learned a great deal about a unique and growing field.