2020 Ncbiotech Company Directory Lists 735 Life Science Companies Across the State
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Dovato, INN-Dolutegravir, Lamivudine
26 April 2019 EMA/267082/2019 Committee for Medicinal Products for Human Use (CHMP) Assessment report Dovato International non-proprietary name: dolutegravir / lamivudine Procedure No. EMEA/H/C/004909/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Downloaded from wizmed.com Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 6 1.1. Submission of the dossier ...................................................................................... 6 1.2. Steps taken for the assessment of the product ......................................................... 7 2. Scientific discussion ................................................................................ 8 2.1. Problem statement ............................................................................................... 8 2.1.1. Disease or condition ........................................................................................... 8 2.1.2. Epidemiology .................................................................................................... 9 2.1.3. Biologic features ............................................................................................... -
Second Quarter 2017
Press release Second quarter 2017 Issued: Wednesday, 26 July 2017, London U.K. GSK delivers further progress in Q2 and sets out new priorities for the Group Q2 sales of £7.3 billion, +12% AER, +3% CER Total loss per share of 3.7p, +59% AER, +29% CER; Adjusted EPS of 27.2p, +12% AER, -2% CER Financial highlights • Pharmaceutical sales, £4.4 billion, +12% AER, +3% CER, Vaccines sales, £1.1 billion, +16% AER, +5% CER, Consumer Healthcare sales, £1.9 billion,+10% AER, flat at CER • Group operating margin 28.5%; Pharmaceuticals 33.6%; Vaccines 33.7%; Consumer 17.7% • Total Q2 loss per share of 3.7p reflecting charges resulting from increases in the valuation of Consumer and HIV businesses and new portfolio choices • Updated 2017 guidance: Adjusted EPS growth now expected to be 3% to 5% CER reflecting impact of Priority Review Voucher • H1 Free Cash Flow £0.4 billion (H1 2016: £0.1 billion) • 19p dividend declared for Q2; continue to expect 80p for FY 2017 Product and pipeline highlights • New product sales of £1.7 billion, +62% AER, +47% CER • HIV two drug regimen (dolutegravir and rilpivirine) filed for approval in US and EU • Shingrix filed for approval in Japan • FDA approval received for subcutaneous Benlysta for treatment of SLE New business priorities to 2020 • New priorities to strengthen innovation, improve performance and build trust • Pharmaceutical R&D pipeline reviewed with target over time to allocate 80% of capital to priority assets in two current (Respiratory and HIV/infectious diseases) and two potential (Oncology and Immuno-inflammation) -
Dovato, INN-Dolutegravir, Lamivudine
26 April 2019 EMA/267082/2019 Committee for Medicinal Products for Human Use (CHMP) Assessment report Dovato International non-proprietary name: dolutegravir / lamivudine Procedure No. EMEA/H/C/004909/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 6 1.1. Submission of the dossier ...................................................................................... 6 1.2. Steps taken for the assessment of the product ......................................................... 7 2. Scientific discussion ................................................................................ 8 2.1. Problem statement ............................................................................................... 8 2.1.1. Disease or condition ........................................................................................... 8 2.1.2. Epidemiology .................................................................................................... 9 2.1.3. Biologic features ............................................................................................... -
Product Monograph for CELSENTRI
PRODUCT MONOGRAPH PrCELSENTRI maraviroc Tablets 150 and 300 mg CCR5 antagonist ViiV Healthcare ULC 245, boulevard Armand-Frappier Laval, Quebec H7V 4A7 Date of Revision: July 05, 2019 Submission Control No: 226222 © 2019 ViiV Healthcare group of companies or its licensor. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. Page 1 of 60 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION.........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS..................................................................................4 ADVERSE REACTIONS....................................................................................................9 DRUG INTERACTIONS ..................................................................................................19 DOSAGE AND ADMINISTRATION..............................................................................28 OVERDOSAGE ................................................................................................................31 ACTION AND CLINICAL PHARMACOLOGY ............................................................31 STORAGE AND STABILITY..........................................................................................36 -
Product Monograph for COMBIVIR
PRODUCT MONOGRAPH PrCOMBIVIR® lamivudine and zidovudine 150 mg of lamivudine and 300 mg zidovudine tablets Antiretroviral Agent ViiV Healthcare ULC 245 Boulevard Armand-Frappier Laval, Quebec H7V 4A7 Date of Revision: June 06, 2019 Submission Control No: 226229 © 2019 ViiV Healthcare ULC. All Rights Reserved. COMBIVIR is a registered trademark of the ViiV Healthcare group of companies. Page 1 of 49 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ..................................................................................................10 DRUG INTERACTIONS ..................................................................................................15 DOSAGE AND ADMINISTRATION ..............................................................................20 OVERDOSAGE ................................................................................................................20 ACTION AND CLINICAL PHARMACOLOGY ............................................................21 STORAGE AND STABILITY ..........................................................................................23 -
Building Innovation, Performance and Trust
Building Innovation, Performance and Trust Emma Walmsley, CEO Cautionary statement regarding forward-looking statements This presentation may contain forward-looking statements. Forward-looking statements give the Group’s current expectations or forecasts of future events. An investor can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as ‘anticipate’, ‘estimate’, ‘expect’, ‘intend’, ‘will’, ‘project’, ‘plan’, ‘believe’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. Other than in accordance with its legal or regulatory obligations (including under the Market Abuse Regulations, UK Listing Rules and the Disclosure and Transparency Rules of the Financial Conduct Authority), the Group undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Investors should, however, consult any additional disclosures that the Group may make in any documents which it publishes and/or files with the US Securities and Exchange Commission (SEC). All investors, wherever located, should take note of these disclosures. Accordingly, no assurance can be given that any particular expectation will be met and investors are cautioned not to place undue reliance on the forward-looking statements. Forward-looking statements are subject to assumptions, inherent risks and uncertainties, many of which relate to factors that are beyond the Group’s control or precise estimate. -
SHIRE PLC (Exact Name of Registrant As Specified in Its Charter)
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2009 [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 0-29630 SHIRE PLC (Exact name of registrant as specified in its charter) Jersey (Channel Islands) 98-0601486 (State or other jurisdiction of incorporation or (I.R.S. Employer Identification No.) organization) 5 Riverwalk, Citywest Business Campus, Dublin +353 1 429 7700 24, Republic of Ireland (Address of principal executive offices and zip code) (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of exchange on which registered American Depositary Shares, each representing three NASDAQ Global Select Market Ordinary Shares 5 pence par value per share Securities registered pursuant to Section 12(g) of the Act: None (Title of class) 1 Indicate by check mark whether the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act Yes [X] 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 [X] 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. -
Pristine English Pm Tivicay 25-Jan-2021
PRODUCT MONOGRAPH PrTIVICAY Dolutegravir tablets Tablets, 10, 25 and 50 mg dolutegravir (as dolutegravir sodium) Dolutegravir dispersible tablets Dispersible tablets, 5 mg dolutegravir (as dolutegravir sodium) Antiretroviral Agent ViiV Healthcare ULC 245, boulevard Armand-Frappier Laval, Quebec H7V 4A7 Date of Revision: January 25, 2021 Submission Control No: 235583 © 2021 ViiV Healthcare group of companies or its licensor Trademarks are owned by or licensed to the ViiV Healthcare group of companies. Page 1 of 59 TABLE OF CONTENTS PAGE PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ................................................................... 3 INDICATIONS AND CLINICAL USE ........................................................................ 3 CONTRAINDICATIONS ........................................................................................... 4 WARNINGS AND PRECAUTIONS............................................................................ 4 ADVERSE REACTIONS............................................................................................ 8 DRUG INTERACTIONS .......................................................................................... 16 DOSAGE AND ADMINISTRATION ........................................................................ 21 OVERDOSAGE....................................................................................................... 24 ACTION AND CLINICAL PHARMACOLOGY........................................................ -
Life Science District
Fitzsimons Life Science District a great place to raise an idea Located in Aurora, Colorado, it’s one of the largest bioscience developments in the country, a place where there’s plenty of room to grow an idea from discovery to market viability. Whether you start in the bioscience incubator or move into a state-of-the art lab facility, everything you need is close at hand. A cluster of talent and resources is available to you, including direct access to the more than 80 core laboratories at the University of Colorado Anschutz Medical Campus – all just steps away. Features throughout the district, such as parks and conference facilities, are designed to inspire collaboration. And a nearby mix of shops, restaurants and homes let your people thrive right along with your ideas. For leasing and land purchase opportunities at the Colorado Science + Technology Park, within the Fitzsimons Life Science District, call 720-941-7100. Join the conversation at FitzScience.com FIT 110352 Brand Ad_M.indd 1 3/23/11 1:32 PM Improve the health of your business. Collaborations between bioscience 227 acres of state-of-the-art patient successful Colorado companies such companies and faculty researchers at care, research and education, the as Myogen/ Gilead Sciences Colorado, the University of Colorado Anschutz Anschutz Medical Campus provides GlobeImmune, ARCA, and ApopLogic Medical Campus are flourishing. unique opportunities for business Pharmaceuticals. And with Denver Which means the opportunities for development. The University’s International Airport being only 15 improvement—in the health of Technology Transfer o ce, ranked minutes away, access to both coasts Coloradoans and in the health of among the top 20 universities for takes only a few hours. -
Product Monograph
PRODUCT MONOGRAPH PrTIVICAY Dolutegravir (as dolutegravir sodium) 10, 25 and 50 mg tablets Antiretroviral Agent ViiV Healthcare ULC 245, boulevard Armand-Frappier Laval, Quebec H7V 4A7 Date of Revision: January 31, 2020 Submission Control No: 233258 © 2020 ViiV Healthcare group of companies or its licensor Trademarks are owned by or licensed to the ViiV Healthcare group of companies. Page 1 of 53 TABLE OF CONTENTS PAGE PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ................................................................... 3 INDICATIONS AND CLINICAL USE ........................................................................ 3 CONTRAINDICATIONS ........................................................................................... 4 WARNINGS AND PRECAUTIONS ............................................................................ 4 ADVERSE REACTIONS ............................................................................................ 7 DRUG INTERACTIONS .......................................................................................... 14 DOSAGE AND ADMINISTRATION ........................................................................ 19 OVERDOSAGE ....................................................................................................... 21 ACTION AND CLINICAL PHARMACOLOGY ......................................................... 22 STORAGE AND STABILITY .................................................................................. -
ЗМШИ ВНЕСЕНО Наказ Y1ihicerepctba Охорони Здоров'я Укратни
ЗАТВЕРДЖЕНО Наказ MiHic•cpcTBa охорони здоров'я УкраТни ЗМШИ ВНЕСЕНО Наказ Y1iHicerepcTBa охорони здоров'я УкраТни 1 Н СТРУКЦIЯ для медичного застосування засобу БЮВЕН (BIOVEN) СктаД: ДЈючаречовина: Нитап normal immunoglobulin for intravenous administration; мл препарату активноТ 6iJIk0B0T G —(),l г; Допомјжнј речовини: (кислота вода для форма. Розчин для ОсновнЈ властивостј.• прозора або з незначното опалесцен[јею, безбарвна або злегка жовтуватого кольору Фармакотерапевтична трупа. людини нормальний для введення. код АТХ Ј06В А02. властивостј. Препарат е активною G у IgGl: 52 %, lgG2: 32 %, IgG3: 7 %, IgG4: 4 %), граничний BMiCT А у становить 400 мкг/мл. компонентом препарату е що akTIIBHicT10проти захворювань —BipyciB i у т.ч. гепатиту А i В, Bipycy герпеса людини 1 типу, 2 типу та 6 типу, Bipycy Епштейна-Барр, грипу, кору, паротиту, краснухи, коклюшу, кишковоТ налички, пневмокока, правцевого та токсину. Мас також що проявлясгься у Препарат низькою спонтанною антикомплементарною Препарат с нативним О, BCi комплементу, ефекторну та опсоно-фагоцитарну Препаратс активною 6iJIk0B010 що з сироватки або плазми kPOBi людини, на до BlJl-l, до Bipycy гепатиту С та поверхневого антигену Bipycy гепатиту В, очищеною та концентрованою методом спиртоводними осадниками, яка пройшла BipycH0T сольвент-детергентним методом. про модельних BipyciB у табл. 1. Таблиця BipyciB Результат випробування Bipyc Фактор титру методомПЛР Bi с iM оде людини 5.01 ТСП)ю/см Bi с гепап С 5,51 Bi сп стогоге пес 11-готип 6,01 ТСП)5Ысм Bipyc BipycH0T великоТ рога- 5,5 тот х доби Bi с псевдосказ 10ТСЮ5Ысм Енте Bi с свиней 1-го тип 4,6 1 с людини У-го тип 10ТСП)$Ысм Bi с гепа каченят 1-го тип н/д Bi с вези ля ного стомати 7,01 10 н/д ж/д —немае даних Фарл:акокгнетика. -
Immunogenicity and Safety of Fractional Doses of Yellow Fever Vaccines: a Randomized
medRxiv preprint doi: https://doi.org/10.1101/2020.08.18.20177527; this version posted October 29, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . 1 Immunogenicity and safety of fractional doses of yellow fever vaccines: a randomized, 2 double-blind, non-inferiority trial 3 4 Aitana Juan-Giner, MSc1,*, Derick Kimathi, MBChB2,3*, Kyra H. Grantz, BA4,5,6, Mainga M. 5 Hamaluba, MD2, Patrick Kazooba, MBChB7, Patricia Njuguna, MMed2, Gamou Fall, PhD8, 6 Moussa Dia, MSc8, Ndeye S. Bob, PhD8, Thomas P. Monath, MD9, Alan D. Barrett, PhD10, 7 Joachim Hombach, PhD11, Edgar M. Mulogo, PhD12, Immaculate Ampeire, MBChB13, Henry 2 7 7 8 K. Karanja, MSc , Dan Nyehangane, MSc , Juliet Mwanga-Amumpaire, MMed , Derek A.T. 9 Cummings, PhD4,5, Philip Bejon, Prof2,3, George M. Warimwe, PhD2,3,#, Rebecca F. Grais, 10 PhD1,#. 11 12 1 Epicentre, Paris, France 13 2 Kenya Medical Research Institute – Wellcome Trust Research Programme, Kilifi, Kenya 14 3 Centre for Tropical Medicine & Global Health, University of Oxford, UK 15 4 Department of Biology, University of Florida 16 5 Emerging Pathogens Institute, University of Florida 17 6 Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health 18 7 Epicentre Mbarara Research Centre, Uganda 19 8 Institut Pasteur Dakar, Senegal 20 9 Crozet BioPharma LLC, Devens MA, USA 21 10 Sealy Institute for Vaccines Sciences and Department of Pathology, University of Texas 22 Medical Branch, USA 23 11 Immunization, Vaccines & Biologicals, World Health Organization, Geneva, Switzerland 24 12 Department of Community Health, Mbarara University of Science & Technology, Uganda 25 13 Expanded Program on Immunization, Ministry of Health, Uganda 26 27 *Co-first author; #Co-senior author 28 1 NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.