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BIOWORLD TODAY Inquiry
BIOWORLDTM TODAY THE DAILY BIOPHARMACEUTICAL NEWS SOURCE JUNE 30 , 2016 BIOTECH’S MOST RESPECTED NEWS SOURCE FOR MORE THAN 20 YEARS VOLUME 27, NO. 126 LIPID JAM NOT OVER EASILY STOPPED FOR FUTILITY Waffle house? FDA Galena Biopharma implodes as PRESENT review fidgets endpoint, puts cancer vaccine Neuvax future in doubt outcome details; By Jennifer Boggs, Managing Editor Esperion grilled on holdup With the bulk of Galena Biopharma Inc.’s value riding on cancer vaccine Neuvax By Randy Osborne, Staff Writer (nelipepimut-S), the firm’s shares predictably plunged to a new 52-week low Wednesday as an independent data monitoring committee (IDMC) recommended the Analysts had plenty of questions but PRESENT phase III study in breast cancer be stopped for futility following a planned Esperion Therapeutics Inc. offered few interim analysis. But it’s the troubling language in the IDMC’s letter, suggesting the answers regarding the FDA’s stalling on placebo arm might actually have bested the treatment arm, that could signal the end oral, once-daily bempedoic acid (ETC- of the road for Neuvax. 1002) for lipid lowering, after the agency See Galena, page 3 See Esperion, page 4 CHINA DEALS AND M&A IN THE CLINIC Pfizer invests in Asia Merck strikes cancer SUPER ‘NOVA’ with $350M biotech vaccines deal with Tesaro shares blast plant in Hangzhou Moderna, delivering off as niraparib hits By Haky Moon, Staff Writer $200M up front PFS in ovarian cancer HONG KONG – China’s economy may By Michael Fitzhugh, Staff Writer By Marie Powers, News Editor be slowing down, but multinationals Findings from the phase III NOVA trial are positioning themselves to leverage Cancer vaccines tailored to fit tumor- specific profiles are at the heart of a new of niraparib in women with recurrent it as best they can while navigating a ovarian cancer blasted shares of still-complex regulatory environment. -
Snippet Roundup: CETP Kaput and Biogen Buys Into Amyloid
October 27, 2017 Snippet roundup: CETP kaput and Biogen buys into amyloid Edwin Elmhirst Welcome to your weekly roundup of EP Vantage’s snippets – short takes on smaller news items. This week, October 23 to 27, 2017, we had thoughts on the following: Amgen puts another CETP out of its misery; Stryker buys Vexim without waiting for US approval; How much is aducanumab worth? At least $8bn, Biogen reckons; Alcon delay puts dampener on Novartis; Soliris sitting pretty with complementary new indication; Smith & Nephew acquires, but divestments could follow; Global Blood drops IPF programme. These snippets were previously published daily via twitter. Amgen puts another CETP out of its misery October 26, 2017 If the once-promising CETP drug class lives on, it might only be in a rather restricted group of heart disease patients with a very specific mutation. Amgen became the last big biopharma group to cancel work on a drug in the HDL-raising class when it announced plans to seek a partner for AMG 899, following the lead of Merck & Co, which recently terminated its work with anacetrapib after disappointing results in the Reveal trial. Although big pharma groups obviously believe that it is unlikely for a CETP inhibitor to succeed commercially, it is not out of the realm of possibility that a partner could emerge for AMG 899 – Roche licensed its project, dalcetrapib, to the Canadian group Dalcor Pharmaceuticals, which has been researching its use in a genetic subtype, patients with an AA polymorphism at the rs1967309 location in the ADCY9 gene. Amgen will write off the $300m it paid for AMG 899’s originator, Dezima Pharma, in 2015, which at the time was seen as a cheap bet on the CETP sector. -
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, -
Abbvie Allergan Acquisition
Creating a New Diversified Biopharmaceutical Company The Combination of AbbVie and Allergan Investor Presentation June 25, 2019 NO OFFER OR SOLICITATION This presentation is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities or the solicitation of any vote or approval in any jurisdiction pursuant to the acquisition or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. In particular, this presentation is not an offer of securities for sale into the United States. No offer of securities shall be made in the United States absent registration under the U.S. Securities Act of 1933, as amended, or pursuant to an exemption from, or in a transaction not subject to, such registration requirements. Any securities issued in the acquisition are anticipated to be issued in reliance upon available exemptions from such registration requirements pursuant to Section 3(a)(10) of the U.S. Securities Act of 1933, as amended. The acquisition will be made solely by means of the Scheme Document (or, if applicable, the Takeover Offer document), which will contain the full terms and conditions of the acquisition, including details with respect to the AbbVie shareholder vote in respect of the acquisition. Any decision in respect of, or other response to, the acquisition, should be made only on the basis of the information contained in the Scheme Document. IMPORTANT ADDITIONAL INFORMATION WILL BE FILED WITH THE SEC In connection with the proposed Acquisition, Allergan will file with the Securities Exchange Commission (the “SEC”) a Proxy Statement, which will include the Scheme Document. -
Biotech Investing 2020
BIOTECH INVESTING 2020 Bill Cara www.billcara.com [email protected] 647-868-6013 JULY 20, 2020 A. Report Overview This Greenfield Capital (billcara.com) report on the Biotechnology industry is written by a registered investment consultant & portfolio manager, not by a scientist. Our objective is to provide education and information to investors who lack the tools to trade successfully in an industry made vitally important to the world by the coronavirus pandemic of 2020. If we want to live through this pandemic -- and future ones -- where it is possible that hundreds of millions of us could perish because of the lack of diagnostics, vaccines, and therapeutics, then as investors we should be keenly interested in the Biotech industry. News reports state that in just six and a half months, COVID-19, initially called SARS- CoV-2, has killed more people than the number of Americans who die each year from opioid overdose (46,000), traffic accidents (36,500), and gun violence (40,000) combined. But, currently, there is no vaccine for COVID-19, and the treatment options for patients with severe or life-threatening symptoms are limited. As the world struggles to contain the deadly virus, there are, fortunately, over 140 coronavirus vaccines in development. News is breaking every day. At the same time, however, many individuals who are trading in Biotech stocks remain woefully uninformed and are speculating wildly. Some Biotech stocks that have appreciated 100% or more in a few months on hopefulness may have trouble sustaining gains beyond the news peak. Still, for investors who study this industry, there are opportunities right now to buy Biotech stocks that will grow in price well into the future. -
[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. -
The Top 100 November, 2016 a List of Stocks Topping Our Custom 'Torpedo’ Screen
The Top 100 November, 2016 A list of stocks topping our custom 'torpedo’ screen. Updated monthly. GPRO GoPro, Inc. Class A Consumer Discretionary TSLA Tesla Motors, Inc. Consumer Discretionary UA Under Armour, Inc. Class A Consumer Discretionary CRC California Resources Corp Energy CRZO Carrizo Oil & Gas, Inc. Energy CWEI Clayton Williams Energy, Inc. Energy FANG Diamondback Energy, Inc. Energy GST Gastar Exploration, Inc. Energy MPLX MPLX LP Energy RSPP RSP Permian, Inc. Energy SLCA U.S. Silica Holdings, Inc. Energy AAC AAC Holdings, Inc. Health Care ABEO Abeona Therapeutics, Inc. Health Care ACAD ACADIA Pharmaceuticals Inc. Health Care ADMP Adamis Pharmaceuticals Corporation Health Care ADMS Adamas Pharmaceuticals, Inc. Health Care ADXS Advaxis, Inc. Health Care AIMT Aimmune Therapeutics Inc Health Care AKBA Akebia Therapeutics, Inc. Health Care ALDR Alder Biopharmaceuticals, Inc. Health Care ARDM Aradigm Corporation Health Care ARDX Ardelyx, Inc. Health Care ARLZ Aralez Pharmaceuticals Inc. Health Care ATRA Atara Biotherapeutics Inc Health Care BCRX BioCryst Pharmaceuticals, Inc. Health Care BLUE bluebird bio, Inc. Health Care CARA Cara Therapeutics Inc Health Care CDNA CareDx, Inc. Health Care CEMP Cempra, Inc. Health Care CERS Cerus Corporation Health Care CFMS ConforMIS Inc Health Care CLVS Clovis Oncology, Inc. Health Care COLL Collegium Pharmaceutical, Inc. Health Care CORI Corium International, Inc. Health Care CRMD CorMedix Inc. Health Care CSU Capital Senior Living Corporation Health Care DERM Dermira Inc Health Care DVAX Dynavax Technologies Corporation Health Care DXCM DexCom, Inc. Health Care EPZM Epizyme, Inc. Health Care FOLD Amicus Therapeutics, Inc. Health Care HRTX Heron Therapeutics Inc Health Care ICPT Intercept Pharmaceuticals, Inc. -
NASDAQ Stock Market
Nasdaq Stock Market Friday, December 28, 2018 Name Symbol Close 1st Constitution Bancorp FCCY 19.75 1st Source SRCE 40.25 2U TWOU 48.31 21st Century Fox Cl A FOXA 47.97 21st Century Fox Cl B FOX 47.62 21Vianet Group ADR VNET 8.63 51job ADR JOBS 61.7 111 ADR YI 6.05 360 Finance ADR QFIN 15.74 1347 Property Insurance Holdings PIH 4.05 1-800-FLOWERS.COM Cl A FLWS 11.92 AAON AAON 34.85 Abiomed ABMD 318.17 Acacia Communications ACIA 37.69 Acacia Research - Acacia ACTG 3 Technologies Acadia Healthcare ACHC 25.56 ACADIA Pharmaceuticals ACAD 15.65 Acceleron Pharma XLRN 44.13 Access National ANCX 21.31 Accuray ARAY 3.45 AcelRx Pharmaceuticals ACRX 2.34 Aceto ACET 0.82 Achaogen AKAO 1.31 Achillion Pharmaceuticals ACHN 1.48 AC Immune ACIU 9.78 ACI Worldwide ACIW 27.25 Aclaris Therapeutics ACRS 7.31 ACM Research Cl A ACMR 10.47 Acorda Therapeutics ACOR 14.98 Activision Blizzard ATVI 46.8 Adamas Pharmaceuticals ADMS 8.45 Adaptimmune Therapeutics ADR ADAP 5.15 Addus HomeCare ADUS 67.27 ADDvantage Technologies Group AEY 1.43 Adobe ADBE 223.13 Adtran ADTN 10.82 Aduro Biotech ADRO 2.65 Advanced Emissions Solutions ADES 10.07 Advanced Energy Industries AEIS 42.71 Advanced Micro Devices AMD 17.82 Advaxis ADXS 0.19 Adverum Biotechnologies ADVM 3.2 Aegion AEGN 16.24 Aeglea BioTherapeutics AGLE 7.67 Aemetis AMTX 0.57 Aerie Pharmaceuticals AERI 35.52 AeroVironment AVAV 67.57 Aevi Genomic Medicine GNMX 0.67 Affimed AFMD 3.11 Agile Therapeutics AGRX 0.61 Agilysys AGYS 14.59 Agios Pharmaceuticals AGIO 45.3 AGNC Investment AGNC 17.73 AgroFresh Solutions AGFS 3.85 -
Monday, April 22 Chicago Bears Room Chicago Bulls Room Chicago Cubs Room Merck KLOX Technologies Immune Design Leading Biote
As of 4/23/2013 Schedule subject to change Monday, Chicago Bears Room Chicago Bulls Room Chicago Cubs Room April 22 Merck KLOX Technologies Immune Design 1:00 PM Leading Biotech/Big Pharma Medical Devices Vaccines Eli Lilly NewSouth Innovations Syntiron 1:15 PM Leading Biotech/Big Pharma University/Academia Vaccines Amgen Radius Health BioCrea 1:30 PM Leading Biotech/Big Pharma Musculoskeletal Neurology/CNS Nat. Inst. of Neurological Dis. & Stroke Cytokinetics Xenon Pharmaceuticals 1:45 PM Neurology/CNS Musculoskeletal Neurology/CNS Curis OrgaNext Research BV Trigemina 2:00 PM Oncology Regenerative Medicine Neurology/CNS Verastem Flexion Therapeutics Neurocrine Biosciences 2:15 PM Oncology Musculoskeletal Hormone Therapy/CNS Michael J. Fox Foundation Antisense Pharma GmbH Versartis 2:30 PM Non-profit/Patient Advocacy Oncology Hormone Therapy Takeda Pharmaceutical Company TBD KODE Biotech 2:45 PM Leading Biotech/Big Pharma Drug Delivery Resverlogix Corp. Advaxis Q Chip 3:00 PM Cardiovascular Disease Oncology Drug Delivery Grünenthal GmbH Array BioPharma 3:15 PM Neurology/CNS Oncology/Drug Discovery Discovery Labs Mersana Therapeutics 3:30 PM Drug Delivery/Pulmonary Oncology Bayer HealthCare Igenica 3:45 PM Leading Biotech/Big Pharma Oncology Presentations are open to all Convention attendees and are located outside the main entrance of the BIO Business Forum As of 4/23/2013 - Schedule subject to change Tuesday, Chicago Bears Room Chicago Bulls Room Chicago Cubs Room Chicago Blackhawks Room April 23 Pfizer 8:00 AM Leading Biotech/Big Pharma -
Medicaid System (Mmis) Illinois Department of Run Date: 08/08/2015 Provider Subsystem Healthcare and Family Services Run Time: 21:25:58 Report Id 2794D052 Page: 01
MEDICAID SYSTEM (MMIS) ILLINOIS DEPARTMENT OF RUN DATE: 08/08/2015 PROVIDER SUBSYSTEM HEALTHCARE AND FAMILY SERVICES RUN TIME: 21:25:58 REPORT ID 2794D052 PAGE: 01 ALPHA COMPLETE LIST OF PHARMACEUTICAL LABELERS WITH SIGNED REBATE AGREEMENTS IN EFFECT AS OF 10/01/2015 NDC NDC PREFIX LABELER NAME PREFIX LABELER NAME 68782 (OSI) EYETECH 65162 AMNEAL PHARMACEUTICALS LLC 00074 ABBOTT LABORATORIES 69238 AMNEAL PHARMACEUTICALS, LLC 68817 ABRAXIS BIOSCIENCE, LLC 53150 AMNEAL-AGILA, LLC 16729 ACCORD HEALTHCARE INCORPORATED 00548 AMPHASTAR PHARMACEUTICALS, INC. 42192 ACELLA PHARMACEUTICALS, LLC 66780 AMYLIN PHARMACEUTICALS, INC. 10144 ACORDA THERAPEUTICS, INC. 55724 ANACOR PHARMACEUTICALS 00472 ACTAVIS 10370 ANCHEN PHARMACEUTICALS, INC. 00228 ACTAVIS ELIZABETH LLC 62559 ANIP ACQUISITION COMPANY 45963 ACTAVIS INC. 54436 ANTARES PHARMA, INC. 46987 ACTAVIS KADIAN LLC 52609 APO-PHARMA USA, INC. 49687 ACTAVIS KADIAN LLC 60505 APOTEX CORP. 14550 ACTAVIS PHARMA MFGING PRIVATE LIMITED 63323 APP PHARMACEUTICALS, LLC. 67767 ACTAVIS SOUTH ATLANTIC 42865 APTALIS PHARMA US, INC 66215 ACTELION PHARMACEUTICALS U.S., INC. 58914 APTALIS PHARMA US, INC. 52244 ACTIENT PHARMACEUTICALS 13310 AR SCIENTIFIC, INC. 75989 ACTON PHARMACEUTICALS 08221 ARBOR PHARM IRELAND LIMITED 76431 AEGERION PHARMACEUTICALS, INC. 60631 ARBOR PHARMACEUTICALS IRELAND LIMITED 50102 AFAXYS, INC. 24338 ARBOR PHARMACEUTICALS, INC. 10572 AFFORDABLE PHARMACEUTICALS, LLC 59923 AREVA PHARMACEUTICALS 27241 AJANTA PHARMA LIMITED 76189 ARIAD PHARMACEUTICALS, INC. 17478 AKORN INC 24486 ARISTOS PHARMACEUTICALS, INC. 24090 AKRIMAX PHARMACEUTICALS LLC 67877 ASCEND LABORATORIES, L.L.C. 68220 ALAVEN PHARMACEUTICAL, LLC 76388 ASPEN GLOBAL INC. 00065 ALCON LABORATORIES, INC. 51248 ASTELLAS 00998 ALCON LABORATORIES, INC. 00469 ASTELLAS PHARMA US, INC. 25682 ALEXION PHARMACEUTICALS 00186 ASTRAZENECA LP 68611 ALIMERA SCIENCES, INC. -
Galena Biopharma, Inc. (Exact Name of Registrant As Specified in Its Charter) ______
ANNUAL REPORT 201 OUR MISSION GALENA BIOPHARMA DEVELOPS AND COMMERCIALIZES INNOVATIVE, TARGETED ONCOLOGY TREATMENTS THAT ADDRESS MAJOR UNMET MEDICAL NEEDS TO ADVANCE CANCER CARE. MANAGEMENT TEAM Mark J. Ahn, Ph.D., President & Chief Executive Officer Remy Bernarda, Vice President, Marketing & Communications Gavin Choy, Pharm.D., Senior Vice President, Clinical Operations & Cinical Science Ryan Dunlap, CPA, Vice President, Chief Financial Officer Brian Hamilton, M.D., Ph.D., Executive Vice President & Chief Medical Officer Robert Laliberte, MS, Vice President, Clinical Operations & Clinical Science Christopher Lento, Vice President, Sales & Commercial Operations Hana B. Moran, Ph.D., Senior Vice President, Regulatory & Compliance Patricia Murphy, Vice President, Regulatory Affairs & Compliance Mark W. Schwartz, Ph.D., Executive Vice President & Chief Operating Officer SCIENTIFIC ADVISORY BOARD COL George Peoples, M.D., F.A.C.S., Chief, Surgical Oncology, Brooke Army Medical Center; Director and Principal Investigator, Cancer Vaccine Development Program, San Antonio Military Medical Center Hope S. Rugo, M.D., Clinical Professor of Medicine, Division of Hematology and Oncology at the University of California San Francisco Helen Diller Family Comprehensive Cancer Care Center Robert Figlin, M.D., F.A.C.P., Dr. Figlin is a fellow of the American College of Physicians and the International Society for Biologic Therapy as well as a member of the American Society of Clinical Oncology, the American Association for Cancer Research, and the American Urological Association. Dr. Gabriel N. Hortobagyi, M.D., F.A.C.P., is a Professor of Medicine and Chairman of the Department of Breast Medical Oncology and holds the Nellie B. Connally Chair in Breast Cancer Research at the University of Texas MD Anderson Cancer Center (MDACC). -
Abbott Abbvie ACE Pharmaceuticals Alcon Alfasigma ALK Abello
Abbott Eisai MSD Animal Health Abbvie Elanco Mundipharma Pharmaceuticals ACE Pharmaceuticals Eli Lilly Mylan Alcon Essity Mylan Healthcare Alfasigma Eurocept Nevro Medical ALK Abello Eurocept Pharmaceuticals Nobel Biocare Allergan EUSA Pharma Nordic Pharma AllweCare Medical Ferring Norgine Pharma Almirall Flen Health Novartis Pharma Amgen FMH Medical Novo Nordisk Amomed Pharma Focus Care Pharmaceuticals Olympus Amryt Pharmaceuticals Fresenius Kabi Otsuka Pharmaceuticals Amryt Research Fresenius Medical Care Paion Apceth Galapagos Biopharma Pentax Arega Medical Galderma Pfizer Arthrex GDM Philips Electronics Astellas Pharma GE Healthcare PIERRE FABRE AstraZeneca Gedeon Richter PIERRE FABRE SANTE AtriCure Genzyme Pro Care AveXis Getinge Recordati B.Braun Medical Gilead Sciences ResMed Bausch&Lomb OPS GlaxoSmithKline Roche Diabetes Care Baxter Goodlife Pharma Roche Diagnostics Bayer Grünenthal Roche Pharma Bayer Animal Health Guerbet Sandoz Becton Dickinson GW Pharma Sanofi Beldico Horus Pharma Sanquin Plasma Products Benu Direct HRA Pharma Santen Biogen IDB Holland Santhera Bio-Rad Laboratories Incyte Biosciences Sarepta Biotronik InSpine Seagen Bioventus Intercept Pharma Seqirus Bluebird Bio Ipsen Farmaceutica Servier Boehringer Ingelheim Janssen -Cilag Shire Boehringer Ingelheim Animal Health Janssen-Cilag (Actelion) Siemens Healthineers Boston Scientific Jazz Pharmaceuticals SkylineDX Bracco Imaging Johnson & Johnson Medical Smith & Nephew Bristol-Myers Squibb Khondrion SoBi (Swedish Orphan Biovitrum) Cablon Medical Kyowa Kirin Pharma