2017 Vaccines in Development
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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. -
Fact Sheet: COVID Vaccines & Fetal Cell Lines
Fact Sheet: COVID Vaccines & Fetal Cell Lines What is a fetal cell line? A cell taken from an aborted baby is multiplied into many cells of the same kind. These can be grown indefinitely and further multiplied, creating lines of cells that are sometimes used for science experiments. Fetus Kidney Tissue Human Cell Fetal Cell Line Expand and Multiply How are fetal cell lines used in vaccines? Fetal cell lines have been used to grow viruses and then create inactive viruses for vaccines. Historical fetal cell lines (WI-38 and MRC-5) derived in the 1960’s and 1970’s were used to create vaccines for diseases such as Rubella, Hepatitis A, and rabies. These and other historical cell lines (HEK293 and PER.C6) are sometimes used today in the creation of vaccines. Any vaccine that relies on these historic cell lines will not require new abortions. Are fetal cell lines necessary for vaccines? Most vaccines use non-human cells. Vaccines can be developed ethically using no cells or cells from animals, insects, chicken eggs, or yeast. Do COVID vaccines being developed in Operation Warp Speed use fetal cell lines? Six vaccines do not use fetal cell lines. Two vaccines do, using the historically derived fetal cell lines HEK293 and PER.C6. Table: Vaccines being developed in Operation Warp Speed Sponsor(s) Type of Vaccine Production Astrazeneca & Univ. Oxford Adenovirus carrier ❌ HEK293 abortion-derived cell line Janssen and Johnson & Adenovirus carrier ❌ PER.C6 abortion-derived cell line Johnson VSV (animal virus) Merck and IAVI ✅ Vero monkey cells carrier Novavax Protein vaccine ✅ Sf9 insect cells Sanofi and GSK Protein vaccine ✅ Sf9 insect cells Moderna with NIAID mRNA vaccine ✅ No cells used Pfizer and BioNTech mRNA vaccine ✅ No cells used Inovio Pharmaceuticals DNA vaccine ✅ No cells used In order to increase the rates of COVID vaccination among the public, many of whom are opposed to the use of fetal cell lines, policymakers may want to encourage the production and availability of vaccines that do not use fetal cell lines. -
Infectious Diseases
2013 MEDICINES IN DEVELOPMENT REPORT Infectious Diseases A Report on Diseases Caused by Bacteria, Viruses, Fungi and Parasites PRESENTED BY AMERICA’S BIOPHARMACEUTICAL RESEARCH COMPANIES Biopharmaceutical Research Evolves Against Infectious Diseases with Nearly 400 Medicines and Vaccines in Testing Throughout history, infectious diseases hepatitis C that inhibits the enzyme have taken a devastating toll on the lives essential for viral replication. and well-being of people around the • An anti-malarial drug that has shown Medicines in Development world. Caused when pathogens such activity against Plasmodium falci- For Infectious Diseases as bacteria or viruses enter a body and parum malaria which is resistant to multiply, infectious diseases were the current treatments. Application leading cause of death in the United Submitted States until the 1920s. Today, vaccines • A potential new antibiotic to treat methicillin-resistant Staphylococcus Phase III and infectious disease treatments have proven to be effective treatments in aureus (MRSA). Phase II many cases, but infectious diseases still • A novel treatment that works by Phase I pose a very serious threat to patients. blocking the ability of the smallpox Recently, some infectious pathogens, virus to spread to other cells, thus 226 such as pseudomonas bacteria, have preventing it from causing disease. become resistant to available treatments. Infectious diseases may never be fully Diseases once considered conquered, eradicated. However, new knowledge, such as tuberculosis, have reemerged new technologies, and the continuing as a growing health threat. commitment of America’s biopharma- America’s biopharmaceutical research ceutical research companies can help companies are developing 394 medicines meet the continuing—and ever-changing and vaccines to combat the many threats —threat from infectious diseases. -
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). -
Biotech Watchlist 2013 Update: Exciting Ideas Have Explosive Potential
Biotech Watchlist 2013 Update: Exciting Ideas Have Explosive Potential The Life Sciences Report www.TheLifeSciencesReport.com 05/02/2013 In January 2013, The Life Sciences Report debuted its biotech COMPANIES MENTIONED Watchlist, which outlined ideas for investors keyed to catalysts in Amarin Corp. the drug development process that typically move biotechnology Astellas Pharma Inc. stocks. All stocks are affected by catalysts, but nowhere do they Bayer provide more leverage (or deleverage) than in biotech. We Cardinal Health Inc. predicted the new year would present legitimate prospects for Celsion Corp. portfolio growth. So far, that has been the case. Although the party has given Galena Biopharma Inc. way to some fatigue, the punch bowl is still on the table and the biotech Hyperion Therapeutics upswing continues. Inc. Medivation Inc. Source: George S. Mack of The Life Sciences Report Navidea Biopharmaceuticals Inc. Back in January, our friends and collaborators at San Diego-based Sagient Novartis AG Research, publishers of the BioMedTracker, offered important information about Onyx Pharmaceuticals market-moving data and events that can make or break smaller companies. In Inc. addition, a group of key biotech analysts weighed in on their best ideas—17 stocks Peregrine Pharmaceuticals Inc. in all. It was the perfect storm of individual ideas combined with a biotech wind from Pfizer Inc. 2012 still billowing the sails. As of April 22, the NASDAQ Biotechnology (NBI) Pharmacyclics Inc. index is up 26.6%. Have the biotech companies that made inaugural Biotech Prana Biotechnology Ltd. Watchlist—and their stocks—met the targets identified in the first quarter of 2013? Sangamo BioSciences Are there new catalysts? Check out the progress in the updated April 2013 Biotech Inc. -
Vaccines in Development to Target COVID-19 Disease April 9, 2020
Vaccines in Development to Target COVID-19 Disease April 9, 2020 BACKGROUND development, including funding research into the development and use of platform technologies and investigational vaccines Since its emergence in December 2019 in Wuhan, China, the against novel pathogens.6 Given the abundance of vaccines under SARS-CoV-2 virus has caused more than 1.3 million cases and development, this fact sheet will focus on the vaccine candidates nearly 75,000 deaths globally as of April 06, 2020.1 Currently, for which research is currently being funded at least in part by no vaccine or proven treatment exists for this virus or any CEPI, as well as candidates that are undergoing clinical trials. coronavirus. The rapid spread and unprecedented dramatic rise Vaccine candidates are listed by developer below. of COVID-19 deaths and cases has led many research groups worldwide to explore potential vaccine candidates against SARS-CoV-2.2 The World Health Organization (WHO) has Phase I Clinical Trials worked to develop a Research and Development Blueprint that outlines key areas for research and innovation to address gaps • CanSino Biological, Inc., and Beijing Institute of in controlling COVID-19.3 Additionally, as of April 4, 2020, Biotechnology WHO has identified more than 60 vaccine candidates currently CanSino Biological, Inc., a China-based company, is being investigated against the SARS-CoV-2 virus across a range collaborating with the Beijing Institute of Biotechnology to of platforms, including nucleic acid, live attenuated, protein develop a nonreplicating viral vector vaccine2 and has recently subunit, and viral vector (Table 1).2 Of these, 2 are undergoing begun phase I clinical trials, with more than 100 participants 7,8 phase 1 clinical trials, while the remaining candidates are aged 18 to 60 years old, in a hospital located in Wuhan, China. -
Inovio Welcomes Biotech Leader to Its Board of Directors
NEWS RELEASE Inovio Welcomes Biotech Leader to its Board of Directors 1/15/2020 Inovio also announces retirement of long-serving board member PLYMOUTH MEETING, Pa., Jan. 15, 2020 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced the appointment of Jay Shepard to its Board of Directors. Mr. Shepard brings broad healthcare and nancial experience to the board given his tenure as CEO of several biotech companies, his multiple corporate board appointments and his expertise as a healthcare venture capitalist. Dr. J. Joseph Kim, Inovio's President & CEO said, "We are fortunate to have Jay Shepard join Inovio's Board of Directors. Jay's expertise in health care, corporate nancing and M&A in the industry will be an asset to our company as we execute on our strategic deliverables in the next year and the next decade." Inovio also announced the retirement of Mort Collins from its Board. Dr. Collins had been a founding Board member of Inovio's predecessor, VGX Pharmaceuticals. Regarding Mort Collins, Dr. Kim said, "For nearly two decades Mort has been a guiding hand for Inovio helping us grow and make the right choices in science and business. For me, Mort has been more than a corporate board member. He has been a mentor to me and a strong voice I've relied on to manage innovation as we develop and commercialize our DNA medicines." About Jay Shepard Mr. Shepard is currently Non-executive Chairman and formerly President and Chief Executive Ocer of Aravive, a clinical-stage biopharmaceutical company developing treatments designed to halt the progression of life- threatening diseases, including cancer and brosis. -
11/09/2016 Provider Subsystem Healthcare and Family Services Run Time: 20:25:21 Report Id 2794D051 Page: 01
MEDICAID SYSTEM (MMIS) ILLINOIS DEPARTMENT OF RUN DATE: 11/09/2016 PROVIDER SUBSYSTEM HEALTHCARE AND FAMILY SERVICES RUN TIME: 20:25:21 REPORT ID 2794D051 PAGE: 01 NUMERIC COMPLETE LIST OF PHARMACEUTICAL LABELERS WITH SIGNED REBATE AGREEMENTS IN EFFECT AS OF 01/01/2017 NDC NDC PREFIX LABELER NAME PREFIX LABELER NAME 00002 ELI LILLY AND COMPANY 00145 STIEFEL LABORATORIES, INC, 00003 E.R. SQUIBB & SONS, LLC. 00149 WARNER CHILCOTT PHARMACEUTICALS INC. 00004 HOFFMANN-LA ROCHE 00168 E FOUGERA AND CO. 00006 MERCK & CO., INC. 00169 NOVO NORDISK, INC. 00007 GLAXOSMITHKLINE 00172 IVAX PHARMACEUTICALS, INC. 00008 WYETH LABORATORIES 00173 GLAXOSMITHKLINE 00009 PFIZER, INC 00178 MISSION PHARMACAL COMPANY 00013 PFIZER, INC. 00182 GOLDLINE LABORATORIES, INC. 00015 MEAD JOHNSON AND COMPANY 00185 EON LABS, INC. 00023 ALLERGAN INC 00186 ASTRAZENECA LP 00024 SANOFI-AVENTIS, US LLC 00187 VALEANT PHARMACEUTICALS NORTH AMERICA 00025 PFIZER, INC. 00206 LEDERLE PIPERACILLIN 00026 BAYER HEALTHCARE LLC 00224 KONSYL PHARMACEUTICALS, INC. 00029 GLAXOSMITHKLINE 00225 B. F. ASCHER AND COMPANY, INC. 00032 SOLVAY PHARMACEUTICALS, INC. 00228 ACTAVIS ELIZABETH LLC 00037 MEDA PHARMACEUTICALS, INC. 00245 UPSHER-SMITH LABORATORIES, INC. 00039 SANOFI-AVENTIS, US LLC 00258 FOREST LABORATORIES INC 00046 AYERST LABORATORIES 00259 MERZ PHARMACEUTICALS 00049 PFIZER, INC 00264 B. BRAUN MEDICAL INC. 00051 UNIMED PHARMACEUTICALS, INC 00281 SAVAGE LABORATORIES 00052 ORGANON USA INC. 00299 GALDERMA LABORATORIES, L.P. 00053 CSL BEHRING 00300 TAP PHARMACEUTICALS INC 00054 ROXANE LABORATORIES, INC. 00310 ASTRAZENECA LP 00056 BRISTOL-MYERS SQUIBB PHARMA CO. 00327 GUARDIAN LABS DIV UNITED-GUARDIAN INC 00062 ORTHO MCNEIL PHARMACEUTICALS 00338 BAXTER HEALTHCARE CORPORATION 00064 HEALTHPOINT, LTD. 00378 MYLAN PHARMACEUTICALS, INC. -
Recombinant Antigens/Proteins
Vaccine Candidate Clinical Trial Information Results Reporting Information Developer Name (Specify) Candidate Name (Specify) Target Antigen(s) Vaccine Platform Proposed Immune Delivery Method Adjuvant R&D Status Registry ID number(s) Trial Status Sponsor Name Sponsor Type Phase Study Start Date Primary Study Sample Size, Location Results Reporting Status Mechanism of Action (Type: Specify name) Completion Date Completion Date Enrollment and Age Recombinant Antigens/Proteins Altimmune (UK) FP-01.1 Nucleoprotein (NP), Matrix Synthetic peptide-based T cell response (e.g., cytotoxic Intramuscular None Inactive, no longer in NCT01265914 Completed Immune Targeting Systems Ltd Industry Phase 1 8/1/10 3/1/11 8/1/11 49 Adults (18 to 55 London, United Kingdom Results reported in peer- (Immune Targeting Systems Ltd) protein (M1), RNA T-lymphocytes) development years) reviewed journal polymerase PB1, RNA polymerase PB2, HA head domain, conserved epitopes Altimmune (UK) FP-01.1 Nucleoprotein (NP), Matrix Synthetic peptide-based T cell response (e.g., cytotoxic Intramuscular None Inactive, no longer in NCT02071329 Completed Immune Targeting Systems Ltd Industry Phase 1 1/1/14 12/1/14 12/1/14 111 Adults (18 to 45 London, United Kingdom Results not yet reported (Immune Targeting Systems Ltd) protein (M1), RNA T-lymphocytes) development years) polymerase PB1, RNA polymerase PB2, HA head domain, conserved epitopes Altimmune (UK) FP-01.1 Nucleoprotein (NP), Matrix Synthetic peptide-based T cell response (e.g., cytotoxic Intramuscular Other: Unspecified -
COVID-19 Vaccines: Summary of Current State-Of-Play Prepared Under Urgency 21 May 2020 – Updated 16 July 2020
Office of the Prime Minister’s Chief Science Advisor Kaitohutohu Mātanga Pūtaiao Matua ki te Pirimia COVID-19 vaccines: Summary of current state-of-play Prepared under urgency 21 May 2020 – updated 16 July 2020 The COVID-19 pandemic has spurred a global effort to find a vaccine to protect people from SARS- CoV-2 infection. This summary highlights selected candidates, explains the different types of vaccines being investigated and outlines some of the potential issues and risks that may arise during the clinical testing process and beyond. Key points • There are at least 22 vaccine candidates registered in clinical (human) trials, out of a total of at least 194 in various stages of active development. • It is too early to choose a particular frontrunner as we lack safety and efficacy information for these candidates. • It is difficult to predict when a vaccine will be widely available. The fastest turnaround from exploratory research to vaccine approval was previously 4–5 years (ebolavirus vaccine), although it is likely that current efforts will break this record. • There are a number of challenges associated with accelerated vaccine development, including ensuring safety, proving efficacy in a rapidly changing pandemic landscape, and scaling up manufacture. • The vaccine that is licensed first will not necessarily confer full or long-lasting protection. 1 Contents Key points .................................................................................................................................. 1 1. Types of vaccines ...............................................................................................................