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(2) January 2020 CVJ.Pmd
DOI: https://doi.org/10.3329/cardio.v12i2.47994 Special Article Clarence Walton Lillehei: The Pioneer Open Heart Surgeon Md Anisuzzaman, Nazmul Hosain Department of Cardiac Surgery, Chattogram Medical College Key Words : (Cardiovasc. j. 2020; 12(2): 145-148) Walton Lillehei, Open heart surgery. Introduction: Wangensteen provided a creative environment that Heart as an organ was always a difficult territory produced many brilliant surgeons, and he took a for the surgeons. Famous surgeon Stephen Paget special interest in young Lillehei. in 1895 wrote, “Surgery of the heart has probably In 1949, Dr. Lillehei was appointed a fulltime reached the limit set by the nature, no new instructor of surgery at the University of methods, and no new discovery can overcome the Minnesota Medical School. He began to work his natural difficulties that attend a wound of the way up the academic ladder towards a clinical heart”. But surgeons like Axel Cappelen of Norway professorship. The following year, however fate in 1895, Ludwig Rehn of Germany in 1896 did the dealt him a cruel blow: he was diagnosed with job very well by repairing stab injuries of the heart. lymphosarcoma of the parotid gland and was given But these were rare achievements. Virtually there at most, a 10% chance of surviving for 5 years. was no safe surgical approach or method to deal The day after he finished his senior residency, the heart well before the 1950s. C W Lillehei and Lillehei underwent extensive head and neck his colleagues brought about these changes to surgery at the hands of Dr. Wangensteen and Dr. -
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. -
Recommendations for the Primary Analysis of Continuous Endpoints in Longitudinal Clinical Trials
02-DIJ42(4) 2348.qxd 6/9/08 1:46 PM Page 303 STATISTICS 303 Recommendations for the Primary Analysis of Continuous Endpoints in Longitudinal Clinical Trials Craig H. Mallinckrodt, PhD Research Advisor, Lilly This position paper summarizes relevant theo- simple methods in favor of joint analysis of Research Laboratories, Eli ry and current practice regarding the analysis data from all time points based on a multivari- Lilly and Company, of longitudinal clinical trials intended to sup- ate model (eg, of a mixed-effects type). One Indianapolis, Indiana port regulatory approval of medicinal prod- such newer method, a likelihood-based mixed- Peter W. Lane, MA, CStat ucts, and it reviews published research regard- effects model repeated measures (MMRM) ap- Director of Consultancy and Training, Research Statistics ing methods for handling missing data. It is proach, has received considerable attention in Unit, GlaxoSmithKline, one strand of the PhRMA initiative to improve the clinical trials literature. We discuss specif- Harlow, United Kingdom efficiency of late-stage clinical research and ic concerns raised by regulatory agencies with Dan Schnell, PhD gives recommendations from a cross-industry regard to MMRM and review published evi- Section Head, Pharmaceutical Statistics, team. We concentrate specifically on continu- dence comparing LOCF and MMRM in terms Procter & Gamble ous response measures analyzed using a linear of validity, bias, power, and type I error. Our Pharmaceuticals, model, when the goal is to estimate and test main conclusion is that the mixed model ap- Mason, Ohio treatment differences at a given time point. proach is more efficient and reliable as a Yahong Peng, PhD Traditionally, the primary analysis of such tri- method of primary analysis, and should be Senior Biometrician, Clinical Biostatistics, Merck als handled missing data by simple imputation preferred to the inherently biased and statisti- Research Lab, Upper using the last, or baseline, observation carried cally invalid simple imputation approaches. -
EIR) Expertise Guide
v MEDICAL INDUSTRY LEADERSHIP INSTITUTE 2019–2020 Executive in Residence (EIR) Expertise Guide John J. Alexander, ChEng, MDA [email protected] President, Business Development Advisors, Inc.; Chairman, Twin Cities Angels Funds Roles: Corporate Development, CEO, Management Team Coach Background: St. Jude Medical, Baxter Healthcare, W.R. Grace, GE, Alcoa. Private companies—Wide Range Expertise: (Markets) Medical Technology: devices, diagnostics (Functions) Corporate Development: M&A, strategic alliances, divestitures, licensing, corporate ventures, internal startups starting, building emerging technology businesses and turning-around established businesses; (Functions) venture capital & angel capital, PIPE, venture debt, debt Susan Alpert, PhD, MD [email protected] Principal, SFA Consulting Roles: Regulatory affairs, device evaluation, pediatrician with specialty in infectious disease Background: Medtronic, C.R. Bard, FDA Expertise: Regulatory affairs, FDA, clinical trials, medical devices, business strategy Daniel L. Cosentino, MBA [email protected] CEO, ElectroSea ROLES: CEO, Entrepreneur, Board Advisor, Investor BACKGROUND: Founder & CEO, Cardiocom; VP/GM, Medtronic; Board Advisor, Minnetronix Neuro EXPERTISE: Digital health, medical devices, entrepreneurship, new product development, general management Michael Finch, PhD [email protected] Research Manager, Children’s Hospital MN Roles: Faculty, instructor, research director Background: Carlson School of Management, Children’s Hospital, School of Public Health, UMN, UnitedHealth Group Expertise: Cost, quality and financing of health care in public and private market, research methods and evaluation, valuation of medical innovations, hospital safety, role of physician communication in health care Paul J. Gam, MBA, CGMA, CPA (Inactive) [email protected] Founder and CEO, Zurich Medical Roles: Various management and advisory roles Background: Founder and CEO, Zurich Medical; Board Member, Blue Cross Blue Shield of MN; Partner, Grace Associates; VP International Development, St. -
Executive Compensation 14 ITEM 12
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K/A (Amendment No. 1) ☑ Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Fiscal Year Ended December 31, 2016 OR ☐ Transition Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to . Commission file number 333-199861 MYLAN N.V. (Exact name of registrant as specified in its charter) The Netherlands 98-1189497 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) Building 4, Trident Place, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL, England (Address of principal executive offices) +44 (0) 1707 853 000 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of Each Class: Name of Each Exchange on Which Registered: Ordinary shares, nominal value €0.01 The NASDAQ Stock Market Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☑ No ☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☑ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. -
Endo Pharmaceuticals Inc. V. Actavis
United States Court of Appeals for the Federal Circuit ______________________ ENDO PHARMACEUTICALS INC., MALLINCKRODT LLC, Plaintiffs-Appellees v. ACTAVIS LLC, FKA ACTAVIS INC., ACTAVIS SOUTH ATLANTIC LLC, TEVA PHARMACEUTICALS USA, INC., Defendants-Appellants ______________________ 2018-1054 ______________________ Appeal from the United States District Court for the District of Delaware in No. 1:14-cv-01381-RGA, Judge Richard G. Andrews. ______________________ Decided: May 3, 2019 ______________________ MARTIN JAY BLACK, Dechert LLP, Philadelphia, PA, ar- gued for plaintiffs-appellees. Also represented by SHARON K. GAGLIARDI; BLAKE GREENE, Austin, TX; JONATHAN LOEB, Mountain View, CA; ROBERT RHOAD, Princeton, NJ. JEFFREY J. TONEY, Kasowitz, Benson, Torres & Fried- man LLP, Atlanta, GA, for plaintiff-appellee Mallinckrodt LLC. Also represented by RODNEY R. MILLER, PAUL GUNTER WILLIAMS. 2 ENDO PHARM. INC. v. ACTAVIS LLC JOHN C. O'QUINN, Kirkland & Ellis LLP, Washington, DC, argued for defendants-appellants. Also represented by WILLIAM H. BURGESS; CHARLES A. WEISS, ERIC H. YECIES, Holland & Knight, LLP, New York, NY. ______________________ Before WALLACH, CLEVENGER, and STOLL, Circuit Judges. Opinion for the court filed by Circuit Judge WALLACH. Dissenting opinion filed by Circuit Judge STOLL. WALLACH, Circuit Judge. Appellees Endo Pharmaceuticals Inc. (“Endo Pharma- ceuticals”) and Mallinckrodt LLC (“Mallinckrodt”) (collec- tively, “Endo”) sued Appellants Actavis LLC, Actavis South Atlantic LLC, and Teva Pharmaceuticals USA, Inc. (collec- tively, “Actavis”) in the U.S. District Court for the District of Delaware (“District Court”), alleging that two Abbrevi- ated New Drug Applications filed by Actavis infringed claims 1–6 (“the Asserted Claims”) of Mallinckrodt’s U.S. Patent No. 8,871,779 (“the ’779 patent”), which Endo Phar- maceuticals licenses. -
ALEXION PHARMACEUTICALS, INC. (Exact Name of Registrant As Specified in Its Charter)
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 4, 2021 ALEXION PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 000-27756 13-3648318 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) 121 Seaport Boulevard, Boston, Massachusetts 02210 (Address of principal executive offices, including zip code) (475) 230-2596 (Registrant’s telephone number, including area code) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☒ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act: Trading Name of each exchange Title of each class Symbol on which registered Common Stock, par value $0.0001 per share ALXN The Nasdaq Global Select Market Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). -
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 -
1976 3M Medical Solutions Division 2019 Electrocore, Inc. 2019 Optinose 1985 Abbott Laboratories, Inc
CURRENT SUSTAINING MEMBER COMPANIES MEMBER FOR OVER: 10 Years 25 Years 50 Years Member Since (alphabetical order) 1976 3M Medical Solutions Division 2019 electroCore, Inc. 2019 Optinose 1985 Abbott Laboratories, Inc. 2010 Endo Pharmaceuticals 2018 Organogenesis 2013 AbbVie Inc. 2017 Exelixis 2004 Otsuka America Pharmaceutical, Inc. 2021 Adaptive Biotechnologies 2016 Express Scripts Federal Pharmacy 2018 Pacira BioSciences, Inc. 2017 ACADIA Pharmaceuticals, Inc. 2010 Federal Practitioner 2018 Paratek Pharmaceuticals 2020 AcelRx Pharmaceuticals, Inc. 2018 Foundation Medicine, Inc. 1990 Pfizer Pharmaceuticals 2020 Acorda Therapeutics 2021 Frontier Technology Inc. (FTI) 2017 Pharmacyclics, LLC 2019 Aimmune 2020 Fresenius Medical Care North America 2020 RedHill BioPharma 2003 Alcon Laboratories, Inc. 1989 Genentech Inc. 2019 Red One Medical 2019 Alexion Pharmaceuticals, Inc. 2006 Gilead Sciences 2020 Regeneron 2017 Alkermes, Inc. 1983 GLAXOSMITHKLINE 2009 Regenesis Biomedical, Inc. 2019 Alnylam Pharmaceuticals 2013 Golden State Medical Supply, Inc. 2011 Remund Group, LLC 2019 Altarum Institute 2020 GRAIL 2018 Rigel Pharmaceuticals 2020 Amarin Corporation 2019 Greenwich Biosciences 2000 Sanofi 1994 AmerisourceBergen 2013 Gulf Coast Pharmaceuticals Plus, LLC 2020 Seattle Genetics 1992 Amgen 2008 Heritage Health Solutions, Inc. 2004 Siemens Medical Solutions 2020 Amneal Pharmaceutical 2017 Hill-Rom Company 2019 SK Life Science, Inc. 2019 Aptive Resources LLC 2020 Immunomedics 2002 Smith & Nephew, Inc. 2020 The Arbinger Institute 2019 ImmunoVation, LLC 2019 Sobi Inc. 2011 Arbor Pharmaceuticals, LLC 2019 Incyte Corporation 2013 Stryker Orthopaedics 2010 Argentum Medical, LLC 2019 Indivior 2018 Sun Pharmaceutical 2019 ASM Research, LLC 2015 Intercept Pharmaceuticals 1999 Sunovion Pharmaceuticals, Inc. 1986 Astellas Pharma US, Inc. 2019 Ipsen Biopharmaceuticals, Inc. 2016 Taiho Oncology, Inc. 1995 AstraZeneca 2018 IT Cadre 2015 Takeda Oncology 2020 Baudax Bio, Inc. -
Amgen Inc. V. Sanofi, No
No. IN THE Supreme Court of the United States ———— AMGEN INC., AMGEN MANUFACTURING LIMITED, AND AMGEN USA, INC., Petitioners, v. SANOFI, AVENTISUB LLC, REGENERON PHARMACEUTICALS INC., AND SANOFI-AVENTIS U.S., LLC, Respondents. ———— On Petition for a Writ of Certiorari to the United States Court of Appeals for the Federal Circuit ———— PETITION FOR A WRIT OF CERTIORARI ———— STUART L. WATT JEFFREY A. LAMKEN WENDY A. WHITEFORD Counsel of Record ERICA S. OLSON MICHAEL G. PATTILLO, JR. EMILY C. JOHNSON SARAH J. NEWMAN AMGEN INC. MOLOLAMKEN LLP One Amgen Center Drive The Watergate, Suite 660 Thousand Oaks, CA 91320 600 New Hampshire Ave., NW (805) 447-1000 Washington, D.C. 20037 (202) 556-2000 [email protected] Counsel for Petitioners :,/621(3(635,17,1*&2,1&± ±:$6+,1*721'& QUESTION PRESENTED The 1952 Patent Act requires patents to “contain a written description of the invention, and of the manner and process of making and using it.” 35 U.S.C. §112(a). The “written description” must be “in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.” Ibid. “The object of the statute is to require the patentee to describe his invention so that others may construct and use it after the expiration of the patent.” Schriber-Schroth Co. v. Cleveland Tr. Co., 305 U.S. 47, 57 (1938). The Federal Circuit has construed §112(a) as impos- ing separate “written description” and “enablement” re- quirements subject to different standards. -
Pharma: Strategic Realignment for a 112/113 Better Future Prism / 2 / 2020
Pharma: Strategic realignment for a 112/113 better future Prism / 2 / 2020 Pharma: Strategic realignment for a better future ... and how the industry will be forced to overcome its hesitation to innovate in operations Ben van der Schaaf, Aurelien Guichard The life sciences sector faces significant impact from Amid the search for COVID-19 – and although the race for treatments and vaccines effective COVID-19 treatments and vaccines, is dominating the headlines, the effect on the industry will the pandemic will have not solely be positive. long-term side effects for the global pharmaceutical In the short term, some companies industry. As our article explains, companies are laying people off and reducing will need to focus on operations, whereas others are change in three areas reallocating resources to focus on (portfolio reprioritization, COVID-19, or even ramping up accelerated R&D and technology efforts in other areas. Stock-market transformation) if they performance has been as diverse are to position (Figure 1). themselves successfully for the future. Organizations need to consider major strategic questions now, to ensure their success in the longer term. The industry is clearly in the middle of the efforts to combat COVID-19: - More than 20 companies are trying to find a treatment with either new or approved drugs1. - More than 15 companies globally are mobilizing resources to develop new vaccines2. - Globally, by the end of May, more than 1,300 clinical trials related to COVID-19 were recruiting patients3. 1. Marketwatch.com, 6 May 2020 2. Drugtargetreview.com, 9 April 2020 3. clintrials.gov, 31 May 2020 Pharma: Strategic realignment for a 114/115 better future Prism / 2 / 2020 2. -
Final Programme CONTENT
48th EDTNA/ERCA International Conference September 14th-17th, 2019 Prague, Czech Republic Conference Theme New Pathways in the Renal Setting-Caring Together by Integrating Modern Technology based on Knowledge & Education Final Programme CONTENT Welcome Message from the President 3 Acknowledgement – Corporate Members 4 Acknowledgement – Conference Support 5 EDTNA/ERCA Booth 6 Conference Accreditation 6 The Conference Application – Instructions and Logistics 7 Conference Venue – Floor plans 8 Programme at a Glance 9 Scientific Programme Highlights 11 Scientific Programme 14 List of E-Posters 24 The Exhibition Floor Plan 30 The Exhibitors 31 Practical Conference Information 36 Opening Hours Summary 38 Good to know about Prague 38 Conference Contacts 39 2 WELCOME MESSAGE FROM THE PRESIDENT Dear Colleagues, We are very happy to welcome you to Prague for the 48th EDTNA/ERCA Conference. Last time the Conference was held in Prague was in 2008, now, 11 years later we are back in Prague. The Scientific Programme is well prepared and there will be several Workshops, Educational Sessions and Poster sessions. New this year are the Courses which will be interactive sessions allowing everybody to share their expertise. We are, as an Association, in the forefront of Online Communication and it has been a focus for some years and will continue to be one of our focuses for the coming years. Take the opportunity to download the Conference App. It works both for iPhones and Androids. We should never forget that face to face meetings gives us so much more than just to be in a Video call. It has an important role of educating, exchanging information and experience, utilizing the expertise of all of us i.e.