Abbvie R&D Deep Dive
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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. -
Faculty Disclosure
Faculty Disclosure In accordance with the ACCME Standards for Commercial Support, course directors, planning committees, faculty and all others in control of the educational content of the CME activity must disclose all relevant financial relationships with any commercial interest that they or their spouse/partner may have had within the past 12 months. If an individual refuses to disclose relevant financial relationships, they will be disqualified from being a part of the planning and implementation of this CME activity. Owners and/or employees of a commercial interest with business lines or products relating to the content of the CME activity will not be permitted to participate in the planning or execution of any accredited activity. Nature of Relevant Financial Relationship Last Name Commercial Interest What Was Received For What Role AbbVie, Allergan/ Tobira Therapeutics Inc, Gilead Research Grant Research Balart Sciences Inc, Pfizer, Salix Pharmaceuticals AbbVie, Merck Honorarium Advisory Board Bau None N/A N/A Benz None N/A N/A AbbVie, Arbutus Biopharma, Dieterich Gilead Sciences, Inc., Bristol- Research Grant Consultant Myers Squibb, Merck Bayer HealthCare Pharmaceuticals, Gilead Sciences Honorarium Speaking, Consultant Inc. Bristol-Myers Squibb, Gilead Speaking, Advisory Sciences, Inc, Salix Honorarium Frenette Board Pharmaceuticals, Inc, Merck Intercept Pharmaceuticals Honorarium Advisor Conatus Pharmaceuticals Inc Honorarium Consulting Principle Investigator, Research Grant, Han Gilead Sciences, -
AMGEN INC. V. SANOFI
Case: 20-1074 Document: 159 Page: 1 Filed: 06/21/2021 NOTE: This order is nonprecedential. United States Court of Appeals for the Federal Circuit ______________________ AMGEN INC., AMGEN MANUFACTURING, LIMITED, AMGEN USA, INC., Plaintiffs-Appellants v. SANOFI, AVENTISUB LLC, FKA AVENTIS PHARMACEUTICALS INC., REGENERON PHARMACEUTICALS INC., SANOFI-AVENTIS U.S. LLC, Defendants-Appellees ______________________ 2020-1074 ______________________ Appeal from the United States District Court for the District of Delaware in Nos. 1:14-cv-01317-RGA, 1:14-cv- 01349-RGA, 1:14-cv-01393-RGA, 1:14-cv-01414-RGA, Judge Richard G. Andrews. ______________________ JEFFREY A. LAMKEN, MoloLamken LLP, Washington, DC, filed a petition for rehearing en banc for plaintiffs-ap- pellants. Also represented by SARAH JUSTINE NEWMAN, MICHAEL GREGORY PATTILLO, JR.; SARA MARGOLIS, New York, NY; EMILY JOHNSON, ERICA S. OLSON, STEVEN TANG, STUART WATT, WENDY A. WHITEFORD, Amgen Inc., Thou- sand Oaks, CA; KEITH HUMMEL, Cravath Swaine & Moore LLP, New York, NY; WILLIAM G. GAEDE, III, McDermott Case: 20-1074 Document: 159 Page: 2 Filed: 06/21/2021 2 AMGEN INC. v. SANOFI Will & Emery LLP, Menlo Park, CA; CHRISTOPHER B. MEAD, Schertler Onorato Mead & Sears LLP, Washington, DC; JAMES L. HIGGINS, MELANIE K. SHARP, Young, Cona- way, Stargatt & Taylor, LLP, Wilmington, DE. Plaintiff- appellant Amgen Inc. also represented by SARAH CHAPIN COLUMBIA, McDermott, Will & Emery LLP, Boston, MA; LAUREN MARTIN, Quinn Emanuel Urquhart & Sullivan LLP, Boston, MA. MATTHEW WOLF, Arnold & Porter Kaye Scholer LLP, Washington, DC, filed a response for defendants-appellees. Also represented by VICTORIA REINES; DAVID K. BARR, DANIEL REISNER, New York, NY; DEBORAH E. -
1 Contributors of Finngen
BMJ Publishing Group Limited (BMJ) disclaims all liability and responsibility arising from any reliance Supplemental material placed on this supplemental material which has been supplied by the author(s) BMJ Open Resp Res Contributors of FinnGen Steering Committee Aarno Palotie Institute for Molecular Medicine Finland, HiLIFE, University of Helsinki, Finland Mark Daly Institute for Molecular Medicine Finland, HiLIFE, University of Helsinki, Finland Pharmaceutical companies Howard Jacob Abbvie, Chicago, IL, United States Athena Matakidou Astra Zeneca, Cambridge, United Kingdom Heiko Runz Biogen, Cambridge, MA, United States Sally John Biogen, Cambridge, MA, United States Robert Plenge Celgene, Summit, NJ, United States Mark McCarthy Genentech, San Francisco, CA, United States Julie Hunkapiller Genentech, San Francisco, CA, United States Meg Ehm GlaxoSmithKline, Brentford, United Kingdom Dawn Waterworth GlaxoSmithKline, Brentford, United Kingdom Caroline Fox Merck, Kenilworth, NJ, United States Anders Malarstig Pfizer, New York, NY, United States Kathy Klinger Sanofi, Paris, France Kathy Call Sanofi, Paris, France University of Helsinki & Biobanks Tomi Mäkelä HiLIFE, University of Helsinki, Finland, Finland Jaakko Kaprio Institute for Molecular Medicine Finland, HiLIFE, Helsinki, Finland, Finland Petri Virolainen Auria Biobank / Univ. of Turku / Hospital District of Southwest Finland, Turku, Finland Kari Pulkki Auria Biobank / Univ. of Turku / Hospital District of Southwest Finland, Turku, Finland Terhi Kilpi THL Biobank / Finnish Institute -
The Covid–19 Pandemic and Haemoglobin Disorders
THE COVID–19 PANDEMIC AND HAEMOGLOBIN DISORDERS VACCINATIONS & THERAPEUTIC DRUGS An Informational Guide from the Thalassaemia International Federation (TIF) Prepared by: Dr Androulla Eleftheriou, Executive Director, TIF Last Updated: 12 May 2020 VACCINATIONS & THERAPEUTIC DRUGS Introduction It is important to note that there are currently no FDA1 or EMA2-approved or even recommended agents for the treatment of the novel coronavirus (COVID-19), for which the World Health Organization (WHO) declared as pandemic on Wednesday 11th of March 2020. Any agent being used at this time is being administered in an experimental setting under controlled conditions. Thalassaemia International Federation (TIF) has made an effort to compile a list of studies/clinical trials for treatment and vaccines, which is by no means exhaustive as this situation is extremely labile and research in this area is dramatically intensified. New information is anticipated to be added to this guide which is prepared exclusively for TIF’s global thalassemia community. The viral genome was mapped very soon as rom early January 2020 and shared globally. In February 2020, the WHO published an overview of the potential therapeutic candidates for the treatment of COVID-19. The document outlines 76 regimens that have been proposed (as of February 17, 2020) for the treatment of patients infected with the virus. Thirty-eight of these candidates are in the preclinical state with minimal information available on their proposed mechanism, uses, doses routes, or planned trials. Sixteen of the remaining regimens contain an interferon-based product. The rest include a variety of antimicrobials, corticosteroids, convalescent plasma, and biologics. The Director-General of the WHO, Mr Tedros Adhanom, stated on the 10th of April 2020, that more than 70 countries have joined WHO’s trial to accelerate research on effective treatments and 20 Institutions and companies ‘are racing to develop a vaccine’. -
Appendix (Finngen Partner List)
Appendix (FinnGen partner list): Coordinators: Biobank of Eastern Finland Northern Savo Hospital District University of Helsinki, HiLIFE, University of Eastern Finland Institute for Molecular Medicine Finland FIMM South Savo Social and Health Care Authority Helsinki University Hospital (HUS) Joint Municipal Authority for North Karelia Social The National Institute of Health and Welfare (THL) and Health services (Siun sote) Eastern Savo Hospital District Funders: Central Finland Biobank Central Finland Health Care District Business Finland University of Jyväskylä Abbvie AstraZeneca Northern Finland Biobank Borealis Biogen Northern Ostrobothnia Hospital District Celgene University of Oulu Genentech, a member of the Roche Group Joint Municipal Public Utility for Northern Finland GlaxoSmithKline (GSK) central laboratory Nordlab Merck & Co., Inc., Kenilworth, NJ, USA Central Ostrobothnia Joint Municipal Authority Pfizer for Social and Health Care Sanofi Kainuu Social and Health Care Joint Municipal Authority Finnish Biobanks and their host organisations: Lappi Hospital District Länsi-Pohja Hospital District Auria Biobank Hospital District of Southwest Finland Finnish Clinical Biobank Tampere University of Turku Pirkanmaa Hospital District Satakunta Hospital District University of Tampere Vaasa Hospital District Kanta-Häme Hospital District South Ostrobothnia Hospital District Helsinki Biobank Hospital District of Helsinki and Uusimaa (HUS) THL Biobank University of Helsinki The National Institute of Health and Welfare (THL) Kymenlaakso Social and Health Services (Carea) South Karelia Social and Health Care District Blood Service Biobank (Eksote) Finnish Red Cross Blood Service Finnish Hematology Registry and Clinical Biobank (FHRB) Finnish Red Cross Blood Service Finnish Association of Hematology Institute for Molecular Medicine Finland (FIMM), University of Helsinki . -
1:19-Cv-02226 Document #: 1 Filed: 04/01/19 Page 1 of 74 Pageid #:1
Case: 1:19-cv-02226 Document #: 1 Filed: 04/01/19 Page 1 of 74 PageID #:1 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS WELFARE PLAN OF THE INTERNATIONAL UNION OF OPERATING ENGINEERS LOCALS 137, 137A, 137B, 137C, 137R, on behalf of itself Civil Action No.______________ and all others similarly situated, CLASS ACTION Plaintiff, v. JURY TRIAL DEMANDED ABBVIE INC., ABBVIE BIOTECHNOLOGY LTD, and AMGEN INC., Defendants. CLASS ACTION COMPLAINT Case: 1:19-cv-02226 Document #: 1 Filed: 04/01/19 Page 2 of 74 PageID #:2 TABLE OF CONTENTS I. INTRODCUTION ...............................................................................................................1 II. PARTIES .............................................................................................................................3 III. JURISDICTION AND VENUE ..........................................................................................5 IV. THE REGULATORY FRAMEWORK OF BIOLOGICS ..................................................6 A. Cost Concerns Prompt Congress to Enact the Biologics Price Competition and Innovation Act ..............................................................................6 1. New biologic drug approval under the BPCIA ............................................7 2. Biosimilar drug approval under the BPCIA .................................................8 3. Biosimilar entrants’ effect on marketplace ..................................................9 B. Patent Challenges Under the BPCIA .....................................................................11 -
Effectiveness of Pfizer-Biontech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021
Morbidity and Mortality Weekly Report Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021 Mark W. Tenforde, MD, PhD1; Samantha M. Olson, MPH1; Wesley H. Self, MD2; H. Keipp Talbot, MD2; Christopher J. Lindsell, PhD2; Jay S. Steingrub, MD3; Nathan I. Shapiro, MD4; Adit A. Ginde, MD5; David J. Douin, MD5; Matthew E. Prekker, MD6; Samuel M. Brown, MD7; Ithan D. Peltan, MD7; Michelle N. Gong, MD8; Amira Mohamed, MD8; Akram Khan, MD9; Matthew C. Exline, MD10; D. Clark Files, MD11; Kevin W. Gibbs, MD11; William B. Stubblefield, MD2; Jonathan D. Casey, MD2; Todd W. Rice, MD2; Carlos G. Grijalva, MD2; David N. Hager, MD, PhD12; Arber Shehu, MD12; Nida Qadir, MD13; Steven Y. Chang, MD, PhD13; Jennifer G. Wilson, MD14; Manjusha Gaglani, MBBS15,16; Kempapura Murthy, MPH15; Nicole Calhoun, LMSW, MPA15; Arnold S. Monto, MD17; Emily T. Martin, PhD17; Anurag Malani, MD18; Richard K. Zimmerman, MD19; Fernanda P. Silveira, MD19; Donald B. Middleton, MD19; Yuwei Zhu, MD2; Dayna Wyatt2; Meagan Stephenson, MPH1; Adrienne Baughman2; Kelsey N. Womack, PhD2; Kimberly W. Hart2; Miwako Kobayashi, MD1; Jennifer R. Verani, MD1; Manish M. Patel, MD1; IVY Network; HAIVEN Investigators On April 28, 2021, this report was posted as an MMWR Early ≥65 years. Vaccination is a critical tool for reducing severe Release on the MMWR website (https://www.cdc.gov/mmwr). COVID-19 in groups at high risk. Adults aged ≥65 years are at increased risk for severe outcomes Randomized clinical trials of vaccines that have received an from COVID-19 and were identified as a priority group to EUA in the United States showed efficacy of 94%–95% in receive the first COVID-19 vaccines approved for use under preventing COVID-19–associated illness (4,5).§ However, an Emergency Use Authorization (EUA) in the United States hospitalization is a rare outcome among patients with (1–3). -
2019 Annual Report on Form 10-K
2 0 1 9 A n n u a l R e p o r t o n AbbVie F o r m 1 0 - K 2 0 2 0 . N Here Now o t i c e o f A n n u a l M e e t i n g & P r o x y S t a t e m e n t 2019 Annual Report on Form 10-K 2020 Notice of AbbVie 1 North Waukegan Road, North Chicago, IL 60064 U.S.A. Annual Meeting Copyright© 2020 AbbVie. All rights reserved. abbvie.com & Proxy Statement 3033_Cover.indd 1 3/18/20 6:36 PM AbbVie’s Commitment to Corporate Responsibility Stockholder Information We strive to make a remarkable impact on patients and drive sustainable growth by discovering and AbbVie Inc. Corporate Headquarters delivering a consistent stream of innovative medicines that address serious health problems. 1 North Waukegan Road North Chicago, IL 60064 IIn accordance wiitth our Priinciiplles:: 847.932.7900 abbvie.com Transforming lives Embracing diversity and inclusion Acting with integrity Serving the community Investor Relations Driving innovation Dept. ZZ05, AP34 Our Corporate Responsibility priorities are: Corporate Secretary Dept. V364, AP34 Using our expertise to Stewarding our ethical and Supporting long-term Stock Listing improve health sustainable business community strength The ticker for AbbVie’s common stock Creating real health improvement is We recognize that health is of The health of our business is is ABBV. The principal market for our mission and the premise of our fundamental importance to all people. intertwined with that of our communities. -
BIOGEN INTERNATIONAL GMBH, Plaintiff-Appellant
Case: 20-1373 Document: 41 Page: 1 Filed: 04/21/2020 United States Court of Appeals for the Federal Circuit ______________________ BIOGEN INTERNATIONAL GMBH, Plaintiff-Appellant v. BANNER LIFE SCIENCES LLC, Defendant-Appellee ______________________ 2020-1373 ______________________ Appeal from the United States District Court for the District of Delaware in No. 1:18-cv-02054-LPS, Chief Judge Leonard P. Stark. ______________________ Decided: April 21, 2020 ______________________ JAMES B. MONROE, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC, for plaintiff-ap- pellant. Also represented by PAUL WILLIAM BROWNING, J. MICHAEL JAKES, LAURA POLLARD MASUROVSKY, JASON LEE ROMRELL. KYLE MUSGROVE, Parker Poe Adams & Bernstein LLP, Charlotte, NC, for defendant-appellee. Also represented by JOHN WORTHINGTON BATEMAN, ELIZABETH CROMPTON, SCOTT A. CUNNING, II, Washington, DC. ______________________ Case: 20-1373 Document: 41 Page: 2 Filed: 04/21/2020 2 BIOGEN INTERNATIONAL GMBH v. BANNER LIFE SCIENCES LLC Before LOURIE, MOORE, and CHEN, Circuit Judges. LOURIE, Circuit Judge. Biogen International GmbH (“Biogen”) appeals from a judgment of the United States District Court for the Dis- trict of Delaware that Banner Life Sciences LLC (“Banner”) does not infringe the extended portion of U.S. Patent 7,619,001 (the “’001 patent”), extended under the patent term restoration provisions of the Hatch-Waxman Act, Pub. L. No. 98-417, § 201, 98 Stat. 1585, 1598 (as codified at 35 U.S.C. § 156 (2018)). Biogen Int’l GmbH v. Banner Life Scis. LLC, No. 18-2054-LPS, 2020 WL 109499 (D. Del. Jan. 7, 2020) (“Decision”). Because the scope of a patent term extension under 35 U.S.C. -
Human Sequencing Resource with UK Biobank
January 8, 2018 Regeneron Forms Consortium of Leading Life Sciences Companies to Accelerate Largest Widely-Available 'Big Data' Human Sequencing Resource with UK Biobank By end of 2019, Regeneron plans to sequence the exomes of all 500,000 people within the UK Biobank resource, all with associated health records, creating an unprecedented resource linking human genetic variations to human biology and disease AbbVie, Alnylam Pharmaceuticals, AstraZeneca, Biogen and Pfizer will join Regeneron to co-fund one of the industry's most ambitious 'pre-competitive' research efforts Exome sequencing data and findings will be openly available to other researchers TARRYTOWN, N.Y., Jan. 8, 2018 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), along with new collaborators AbbVie, Alnylam Pharmaceuticals, AstraZeneca, Biogen and Pfizer Inc., today announced the formation of a major 'pre-competitive' consortium to fund the generation of genetic exome sequence data from the 500,000 volunteer participants who make up the UK Biobank health resource. The newly announced collaborators will each commit $10 million to enable a dramatic acceleration of sequencing timelines, and additional companies are considering joining the consortium. Regeneron will conduct the sequencing effort. The sequencing data will be paired with detailed, de-identified medical and health records within the UK Biobank resource, including enhanced measures such as brain, heart and body imaging, to create an unparalleled resource for linking human genetic variations to human biology and disease. It was originally planned that sequencing of all 500,000 samples in the UK Biobank would be completed by 2022, with the first 50,000 people sequenced during 2017 with funding from Regeneron and GlaxoSmithKline. -
FDA Listing of Authorized Generics As of July 1, 2021
FDA Listing of Authorized Generics as of July 1, 2021 Note: This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications (NDAs). Because the annual reports seldom indicate the date an AG initially entered the market, the column headed “Date Authorized Generic Entered Market” reflects the period covered by the annual report in which the AG was first reported. Subsequent marketing dates by the same firm or other firms are not included in this listing. As noted, in many cases FDA does not have information on whether the AG is still marketed and, if not still marketed, the date marketing ceased. Although attempts have been made to ensure that this list is as accurate as possible, given the volume of d ata reviewed and the possibility of database limitations or errors, users of this list are cautioned to independently verify the information on the list. We welcome comments on and suggested changes (e.g., additions and deletions) to the list, but the list may include only information that is included in an annual report. Please send suggested changes to the list, along with any supporting documentation to: [email protected] A B C D E F G H I J K L M N O P Q R S T U V X Y Z NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 1 ACANYA Gel 1.2% / 2.5% Bausch Health 07/2018 Americas, Inc.