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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) -
Cholesterol How Kos Beat Big Pharma to HDL
The Other Cholesterol How Kos Beat Big Pharma to HDL www.pharmexec.com | ANADVANSTAR★ PUBLICATION Kos CEO Adrian Adams PHARMACEUTICAL EXECUTIVE Contents OCTOBER 2004 www.pharmexec.com Cover Story Under Construction Patrick Clinton Editor-in-Chief How Kos Pharmaceuticals turned a 50-year-old drug for raising HDL cholesterol into a brand-new, burgeoning business. Mulling the Future Kos CEO Adrian Adams, seated, maps strategy with key executives: (from left) Ralf Rosskamp, Christopher Kiritsy, Richard King, and Mark McGovern “We didn’t start with the idea of being a $200 million company. Growing as fast as possible: That was our goal from the get-go.” Kos Pharmaceuticals was first to market with a product to raise HDL cholesterol, and it wants to join pharma’s billion-dollar club by 2007. Big plan. Under Here’s how it’s going. Construction t’s hard to imagine that many pharma companies experienced more plain old good news this summer than Kos Pharmaceuticals. First, there were the second-quarter financials. Revenues for the quarter were $120.3 million, almost double last year’s figure. Net income for the quarter grew 245 percent to $38.5 million. The company raised its guidance for the year, predicting that full-year sales would be $480 million, 60 percent over last year— and CEO Adrian Adams boasted that Kos was the fastest-growing specialty pharma company in the United States. A few weeks later came encouraging results from a Phase II trial of IKos’ new inhalable insulin product for diabetes, and recruitment began for pivotal trials of a new combination product to consolidate Kos’ position in the burgeoning cholesterol market. -
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 -
Board of Director Candidates
2021 Annual General Meeting Board of Director Candidates James I. Healy, M.D., Ph.D. (Current Board Member) James I. Healy, M.D., Ph.D. has served as a member of our board of directors since November 2014. Dr. Healy has been a General Partner of Sofinnova Investments, Inc. (formerly Sofinnova Ventures), a venture capital firm, since June 2000. Prior to June 2000, Dr. Healy held various positions at Sanderling Ventures, Bayer Healthcare Pharmaceuticals (as successor to Miles Laboratories) and ISTA Pharmaceuticals, Inc. Dr. Healy is currently on the board of directors of Bolt Therapeutics, Inc. (Nasdaq: BOLT), Coherus BioSciences, Inc. (Nasdaq: CHRS), Karuna Therapeutics, Inc. (Nasdaq: KRTX), Natera, Inc. (Nasdaq: NTRA), NuCana plc (Nasdaq: NCNA), ObsEva SA (Nasdaq: OBSV) and Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) and two private companies. Previously, he served as a board member of Amarin Corporation, Auris Medical Holding AG, Edge Therapeutics, Inc., Hyperion Therapeutics, Inc., InterMune, Inc., Iterum Therapeutics PLC, Anthera Pharmaceuticals, Inc., Durata Therapeutics, Inc., CoTherix, Inc., Movetis NV and several private companies. Dr. Healy holds an M.D. and a Ph.D. in Immunology from Stanford University School of Medicine and holds a B.A. in Molecular Biology and a B.A. in Scandinavian Studies from the University of California, Berkeley. Jan Møller Mikkelsen (Current Board Member) Jan Møller Mikkelsen founded Ascendis Pharma and has served as President and Chief Executive Officer as well as Board member since December 2007 and currently serves on the board of Visen. From 2002 to 2006, Mr. Mikkelsen served as President and Chief Executive Officer of LifeCycle Pharma A/S, now Veloxis Pharmaceuticals A/S, which was a publicly traded biotechnology company. -
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. -
Medication Precautions
MEDICATION PRECAUTIONS If you want to be pro-active to decrease bruising during injection treatments such as Restylane, Botox and Mesotherapy; the following prescriptions and non-prescription medications may be discontinued for at least two weeks prior to having any injection procedure to ensure that your platelets have time to recover. These specific preparations have been found to affect your blood by decreasing the amount of time it takes for coagulation and decreasing the amount of red blood cell production which can lead to increased bruising. If you are taking any antiarthritics or anticoagulants for control of a medical disorder, you will need to consult your treating physician for recommendations as to the alternatives. If you must take these medications, appropriate determinations as to whether they may be a detriment during the procedure may be discussed. NONPRESCRIPTION MEDICATIONS • Aspirin combinations • Alka-Seltzer Effervescent Antacid & Pain Reliever (Miles Laboratories) • Alka-Seltzer (Flavored) Effervescent Antacid & Pain Reliever (Miles Laboratories) • Alka-Seltzer Extra Strength Effervescent Antacid & Pain Reliever (Miles Laboratories) • Anacin Analgesic Coated Caplets (Whitehall) • Anacin Analgesic Coated Tablets (Whitehall) • Anacin Maximum Strength Coated Analgesic Tablets (Whitehall) • Arthritis Pain Formula by the Makers of Anacin Analgesic Tablets and Caplets (Whitehall) • Arthritis Strength BC Powder (Block) • Ascriptin Tablets (Rorer) • Ascriptin A/D Tablets (Rorer) • Bayer Children’s Chewable Aspirin (Glenbrook) -
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........................................................ -
Editorial Board L
EDITORIAL BOARD L. LEON CAMPBELL, Editor-in-Chief University ofIllinois, Urbana L. S. BARON, Editor (1969) L. JOE BERRY, Editor (1968) Ifalter Reed Army Institute ofResearch, Washington, D.C. Bryn Mawr College, Bryn Mawr, Pa. R. D. DeMOSS, Editor (1970) University ofIllinois, Urbana R. L. Anderson (1969) Herman Friedman (1969) Robert C. Parlett (1969) Robert Austian (1969) Lorraine Friedman (1968) Harry D. Peck (1970) W. Lane Barksdale (1969) Ruth E. Gordon (1969) Michael J. Pelczar, Jr. (1969) S. S. Barkulis (1969) Joseph S. Gots (1969) H. J. Phaff (1969) Alan W. Berheimer (1969) Leonard Hayflick (1969) Roy Repaske (1969) Robert W. Bernlohr (1970) James G. Hirsch (1969) H. V. Rickenberg (1970) S. Gaylen Bradley (1969) John G. Holt (1969) C. F. Robinow (1969) Arnold F. Brodie (1970) Paul Howard-Flanders (1969) W. R. Romig (1969) Allan Campbell (1969) Jerard Hurwitz (1969) NM R. J. Salton (1969) George B. Chapman (1969) Arthur G. Johnson (1969) Russell W. Schaedler (1969) V. P. Cirillo (1970) Elliot Juni (1967) W. R. Sistrom (1969) A. J. Clark (1969) R. E. Kallio (1969) Louis DS. Smith (1968) V. W. Cochrane (1969) Carl Lamanna (1970) Paul F. Smith (1970) S. F. Conti (1969) Maurice Landy (1970) Roger Y. Stanier (1970) C. D. Cox (1969) H. S. Levinson (1969) M. P. Starr (1970) William J. Cromartie (1969) H. C. Lichstein (1970) B. A. D. Stocker (1969) Roy Curtiss m (1969) W. R. Lockhart (1969) Bernard S. Strauss (1969) A. L. Demain (1969) Donald G. Lundgren (1968) Curtis B. Thorne (1969) Eliznbe McCoy (1969) John A. DeMoss (1969) H.