Abbvie Allergan Acquisition
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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. -
[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. -
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 -
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, -
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’. -
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 -
Sample of Current Attendees
SAMPLE OF CURRENT ATTENDEES TITLE COMPANY Sr Mgr Global Meetings Mgmt Amgen Prin Tradeshow Spec Boston Scientific Events Mgr PR Medical Events Sr Buyer Pharma Ops ITA Group Travel Services Supv Grifols Asia Pacific Pte Ltd Compliance Specialist GCO Spend Jouney Lead Global Mtgs Travel Events UCB Category Project Specialist Roche Events & Travel Mgr Teva Brasil Mgr Event Mgmt Bayer Congress Mgr MediCongress Services Global Events Mgmt Sr Assoc Amgen Assoc Dir Congresses & Events MSD Internal Event Mgr Gilead Sourcing Mgr BMS Dir Sourcing Meeting Alliance Custoerm Srvs Meetings Mgr Eli Lilly & Company Sr Congress Mgr Novartis Pharmaceuticals Sourcing Mgr BCD Meetings & Events Sr Buyer Meetings & Incentives Worldwide Sourcing Mgr American Express GBT Acct Mgr Venue Sourcing Ashfield Meetings & Events Mtg Planner AbbVie Sr Sourcing Mgr CWT Dir Sourcing Planning Partners International Meetings Mgr ACOG Meeting Mgr Pfizer Canada Global Event Lead Astellas Meeting & Events Sanofi Events Specialist Cook Medical Meetings & Events Mgr Pfizer Spain Pfizer Spain Sr Mgr Hotel Procurement Meetings & Incentives WorldWide Inc Event Planner SFU BCcampus Mgr Global Strategic Mtg Mgmt Teva Pharmaceuticals Global Mtgs & Events Virtual Mtgs Specialist AstraZeneca Global Congress Strategy Lead MSD Assoc Dir Congresses & Events Alnylam Pharmaceuticals Event Planner AbbVie Institutional & Scientific Events Coordr Almirall Congress Mgr AO Spine Sr Meeting Planner Medtronic Mgr Global Mtgs Mgmt Alnylam Pharmaceuticals Meeting Planner AbbVie Global Audit Meetings -
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. -
Alcon-20-F-2020.Pdf
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) or 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring the shell company report __________ Commission file number: 001-31269 Alcon Inc. (Exact name of Registrant as specified in its charter) N/A (Translation of Registrant's name into English) Switzerland (Jurisdiction of incorporation or organization) Rue Louis-d'Affry 6, 1701 Fribourg, Switzerland (Address of principal executive office) Royce Bedward, Chemin de Blandonnet 8, 1214 Vernier, Geneva, Switzerland; Tel: +41 58 911 20 00; Fax +41 58 911 32 22 (Name, Telephone, Email and/or Facsimile number and Address of Company Contact Person) Securities registered or to be registered pursuant to Section 12(b) of the Act. Title of each class Trading Symbol(s) Name of each exchange on which registered SIX Swiss Exchange Ordinary Shares, nominal value CHF 0.04 per share ALC New York Stock Exchange Securities registered or to be registered pursuant to Section 12(g) of the Act. None Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act. -
Influential Women in Securities: Michele Johnson by Carmen Germaine
Portfolio Media. Inc. | 111 West 19th Street, 5th Floor | New York, NY 10011 | www.law360.com Phone: +1 646 783 7100 | Fax: +1 646 783 7161 | [email protected] Influential Women In Securities: Michele Johnson By Carmen Germaine Law360, New York (June 17, 2016, 10:54 PM ET) -- Latham & Watkins LLP's Michele Johnson has fought shareholder challenges to billions of dollars' worth of acquisitions, but her most significant success to date came in representing Allergan as it fought a hostile takeover from Valeant and Pershing Square, developing an argument that blazed new ground in securities law and landing her among Law360's Influential Women in Securities Law. In the highly publicized case, Johnson and the Latham team were on the frontline defending Allergan Inc. from the hostile bid using a novel, untested theory — that Valeant Pharmaceuticals International Inc., billionaire activist investor Bill Ackman and Michele Johnson his fund Pershing Square Capital Management LP had committed insider trading in Latham & Watkins LLP developing their scheme. "It was all-out war," Johnson recalled. As Johnson explained, Valeant and Pershing publicly announced the takeover offer on April 22, 2014, a day after Pershing revealed that it had covertly amassed a 9.7 percent stake in Allergan. Allergan's board rebuffed the offer, concerned about the long-term viability of Valeant's strategy, which involved acquiring pharmaceutical rivals, slashing their research budgets and jacking up drug prices. As Valeant and Pershing pushed forward with their hostile bid, the Botox manufacturer filed a lawsuit to halt the purchase. The suit, filed Aug. 1, made immediate waves.