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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. -
In the United States District Court for the District Of
IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE FOREST LABORATORIES, LLC and ) FOREST LABORATORIES ) HOLDINGS, LTD., ) ) Plaintiffs, ) ) v. ) Civ.No.14-1119-SLR ) SIGMAPHARM LABORATORIES, LLC, ) et al., ) ) Defendants. ) Jack B. Blumenfeld, Esquire and Maryellen Noreika, Esquire of Morris, Nichols, Arsht & Tunnell LLP, Wilmington, Delaware. Counsel for Plaintiffs. Of Counsel: Howard W. Levine, Esquire, Sanya Sukduang, Esquire, Jonathan R. Davies, Esquire, Courtney B. Gasp, Esquire, and Charles E. Lipsey, Esquire of Finnegan, Henderson, Farabow, Garrett & Dunner LLP. John C. Phillips, Esquire, David A. Bilson, Esquire and Megan C. Haney of Phillips, Goldman, Mclaughlin & Hall, P.A., Wilmington, Delaware. Counsel for Defendant Sigmapharm Laboratories, LLC. Of Counsel: Anthony G. Simon, Esquire, Anthony R. Friedman, Esquire, Benjamin R. Askew, Esquire, and Michael P. Kella, Esquire of The Simon Law Firm, P.C. Karen Elizabeth Keller, Esquire and Jeffrey Thomas Castellano, Esquire of Shaw Keller, LLP, Wilmington, Delaware. Counsel for Defendants Hikma Pharmaceuticals LLC, Hikma Pharmaceuticals PLC, and West-Ward Pharmaceutical Corp. Of Counsel: lmron T. Aly, Esquire, Joel M. Wallace, Esquire, and Helen H. Ji, Esquire of Schiff Hardin LLP. Richard D. Kirk, Esquire, Stephen B. Brauerman, Esquire and Sara E. Bussiere, Esquire of Bayard, P.A., Wilmington, Delaware. Counsel for Defendant Breckenridge Pharmaceutical, Inc. Of Counsel: Beth D. Jacob, Esquire, Clifford Katz, Esquire, and Malavika A. Rao, Esquire of Kelley, Drye & Warren LLP. Karen Pascale, Esquire and Pilar G. Kraman, Esquire of Young, Conaway, Stargatt & Taylor, LLP, Wilmington, Delaware. Counsel for Defendants Alembic Pharmaceuticals Ltd., Alembic Global Holding SA and Alembic Pharmaceuticals, Inc. Of Counsel: Steven J. Lee, Esquire, Michael K. -
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. -
Responding to Mylan's Inadequate Tender Offer
Responding To Mylan’s Inadequate Tender Offer: Perrigo’s Board Recommends That You Reject the Offer and Do Not Tender September 2015 Important Information Forward Looking Statements Certain statements in this presentation are forward-looking statements. These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company’s control, including future actions that may be taken by Mylan in furtherance of its unsolicited offer. These and other important factors, including those discussed under “Risk Factors” in the Perrigo Company’s Form 10-K for the year ended June 27, 2015, as well as the Company’s subsequent filings with the Securities and Exchange -
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. -
Preclinical Development & IND Filing: Nuts, Bolts, Best Practices
“Preclinical Development & IND Filing: Nuts, Bolts, Best Practices and Regulatory Aspects.” Speakers: Amit Kalgutkar (Pfizer), Chandra Prakash (Agios), Sanjeev Thohan (Novartis), Li- Chun Wang (Takeda), Wei Yin (Biogen) Organizers: Sanjeev Thohan and Chandra Prakash Date: 6/29/2017 Time: 8:30 am – 5.00 pm Location: Boston/Cambridge Area: Marriott Kendall Square, 50 Broadway, Cambridge MA 02142 Fees: $175 - Regular (before June 1st, 2017), $225 - Regular (after June 1st, 2017); $125 - Unemployed & Academic; $2000 - Major Sponsorship; $475 - Vendor Show Registration: www.PBSS.org Workshop Description: An investigational new drug application (IND) is an important milestone that marks the entry of a molecule into clinical development. Knowing the objectives, expectations and processes of assembling an IND is a key to not only successful filing, but also a promising clinical development path forward. Often there are cases where too many of our “nice-to-have” studies crowd the package at the expense of critical study needs/issues. This can lead to significant delays in clinical developments with back-and-forth of Q&A sessions both internally and with regulatory agencies. As we have seen, the regulatory landscape is changing as rapidly as the industry innovates into new therapeutic modalities. Therefore, it is critical to keep up to date on regulatory requirements and the industry’s best practices in different aspects of the IND: non- clinical safety, PK, CMC, and clinical plans. In this workshop, our speakers who bring years of experience with multiple successful IND filings, will discuss systematically the preclinical studies required for small molecule IND’s as well as the nuts and bolts of putting together a high–quality IND package. -
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. -
2020 Annual Report Products
Products 2020 Annual Report From the CEO Dear Fellow Shareholders, Perrigo’s transformation to a pure-play Consumer Self-Care Company has come a long way LQMXVWWZRVKRUW\HDUV:HKDYHUHVWRUHGVXVWDLQDEOHWRSOLQHJURZWKGHOLYHUHGRQRXU¿QDQFLDO SURPLVHVUHFRQ¿JXUHGRXUSRUWIROLRRIEXVLQHVVHVXSGDWHGWKH,7LQIUDVWUXFWXUHDQGSURFHVVHV of the Company, expanded capacity, upgraded leadership talent, installed business intelligence capabilities, built a new product pipeline of over $500 million and re-instilled a sense of pride and energy among our 11,000 team members. Making this even more remarkable, is that we kept the WUDQVIRUPDWLRQRQWUDFNLQWKHIDFHRIWKHJOREDO&29,'SDQGHPLF,KRSH\RXDUHDVSURXGRI3HUULJR¶VJOREDOWHDP DV,DPIRUKRZWKH\ZRUNHGWRNHHSHDFKRWKHUVDIHNHSWRXUHVVHQWLDOSURGXFWVÀRZLQJDQGNHSWRXUWUDQVIRUPDWLRQ to a consumer self-care company on track through all of the personal and professional uncertainty that came their way LQ7KH\DUHKHURHV As a result of their efforts, Perrigo delivered strong net sales growth for the second year in a row in 2020 and World-wide Consumer sales reached a new record high. Equally important, the team stabilized adjusted operating income after a few years of decline even as we invested over $50 million in our business and overcame $35 million RIXQSODQQHGKHDGZLQGVGXHSULPDULO\WR&29,'UHODWHGVDIHW\FRVWVDQGEXVLQHVVLPSDFWIURPWKHZHDNFROG FRXJKDQGÀXVHDVRQUHODWHGWR&29,'¶VLPSDFWRQSXEOLFOLIH$OOLQDOOZHKDGDYHU\VWURQJ\HDU Our transformation efforts reached an essential milestone after the year closed when we announced the sale of RXU3UHVFULSWLRQ3KDUPDFHXWLFDOVEXVLQHVVWR$OWDULV&DSLWDO3DUWQHUV//&7KHWUDQVDFWLRQUHLQIRUFHVRXUDELOLW\ -
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 -
The Year of Investment, Innovation and Implementation
2017 the year of investment, innovation and implementation 2017 annual report healthcare businesswomen’s association table of contents LETTER FROM CHAIR 1 INVESTMENT 2017 BY THE NUMBERS 2 MEMBERSHIP 2 CHAPTER BREAKDOWN 2 40 YEARS OF MILESTONES 2 MEMBER/VOLUNTEER SURVEY RESULTS 3 FINANCIALS 4 INNOVATION AND IMPLEMENTATION 2017 FLAGSHIP EVENTS 7 WOMAN OF THE YEAR 8 LUMINARIES 10 RISING STARS 11 ANNUAL CONFERENCE 13 ACE AWARDS 14 THE GENDER PARITY COLLABORATIVE CLICK HERE HBA “NOW” THE NEW OPERATING MODEL CLICK HERE IN APPRECIATION—WE COULDN’T DO IT WITHOUT YOU 2017 CORPORATE PARTNERS 15 2017 SPONSORS 16 2017 MEDIA PARTNERS 17 HBA ADVISORY BOARD 18 HBA BOARD OF DIRECTORS 19 LETTER FROM CEO LAURIE COOKE 20 HBA 2017 II annual report letter from the chair In my long career as a healthcare executive, I have seen firsthand the benefits of diversity in leadership time and again. From gender to ethnicity to age and other factors, the best engagement and the most powerful results always arise when there is a diversity of perspectives in the room. This is why I joined the HBA board. This year marks the 40th anniversary of the organization’s founding. And though I am a relatively new member, I quickly became a believer in the HBA’s rich history and deep commitment to both the advancement of women individually, and to the achievement of gender parity in healthcare overall. This is also why I am proud of the HBA’s aggressive—but achievable—strategic plan to move the needle on gender parity through partnership by 2020. -
Biocentury 8.15.16
WEEK OF AUGUST 15, 2016 6 PRODUCT DEVELOPMENT: NO ANTIGEN LEFT BEHIND Amgen has added to its immuno-oncology arsenal with its deal for Advaxis’ pan- epitope neoantigen vaccine platform. SERVING RETURNS 9 EMERGING COMPANY PROFILE: RESTRAINING TRANSLATION BY STEVE EDELSON, SENIOR EDITOR Bantam is developing small molecule eIF4E inhibitors to treat a range of cancers, China’s Ally Bridge Group hit the investment world’s starting with B cell malignancies. radar in 2015 with its audacious move to take CRO WuXi PharmaTech Inc. private. If the firm and its partners can engineer the first fruits of that move with REGULATION: the listing of WuXi’s biologics unit in Hong Kong this 10 year, the question is what will be its next moves to ADAPTING FOR THE REAL WORLD generate outsized returns for its investors. EMA says better strategies for real-world evidence and more patient and payer involvement are necessary Ally Bridge, which has a about $1.5 billion under next steps for its adaptive pathway initiative. management across three funds and an international base of LPs, thinks its returns and continued visibility will come from a handful of public and private portfolio companies with transformative data events, the first of EBB & FLOW: 13 which should come this half. LION’S SHARE OF THE WORK Aslan’s validating event. Plus: Cutting a check The firm also says it is working on new private equity to Cleave; and Ironwood’s operating leverage. deals that will rival WuXi in terms of size and impact. Ally Bridge is keeping its private equity plans under wraps, and does not disclose names of investments in its Asia hedge fund.