ViiV Healthcare receives FDA approval for Triumeq(R) (abacavir, dolutegravir and lamivudine), a new single-pill regimen for the treatment of HIV-1 infection
PR Newswire Europe - Fri Aug 22, 3:01PM CDT
ViiV Healthcare announced today that the US Food and Drug Administration (FDA) has approved Triumeq((R)) (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection.(1) Triumeq is ViiV Healthcare's first dolutegravir-based fixed-dose combination, offering many people living with HIV the option of a single-pill regimen that combines the integrase strand transfer inhibitor (INSTI) dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine.
ViiV Healthcare receives FDA approval for Triumeq® (abacavir, dolutegravir and lamivudine), a new single-pill regimen for the treatment of HIV-1 infection
CNW Group - Fri Aug 22, 2:46PM CDT
ViiV Healthcare announced today that the US Food and Drug Administration (FDA) has approved Triumeq(®) (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection.(1) Triumeq is ViiV Healthcare's first dolutegravir-based fixed-dose combination, offering many people living with HIV the option of a single-pill regimen that combines the integrase strand transfer inhibitor (INSTI) dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine.
GlaxoSmithKline's (GSK) Arnuity Ellipta Approved by FDA - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Thu Aug 21, 4:05PM CDT
GlaxoSmithKline (GSK) received positive news when the FDA approved its asthma treatment Arnuity Ellipta.
Novel Fixed-Dose Combinations for COPD in Brazil and Mexico Will Compete With Well-Established Therapies in an Environment Dominated by Aggressive Cost-Control Mechanisms
PR Newswire - Thu Aug 21, 10:00AM CDT
Decision Resources Group finds that, for the treatment of COPD, physicians in Brazil and Mexico manage to follow clinical guidelines and commonly prescribe long-acting beta-agonist (LABA)- and long-acting muscarinic antagonist (LAMA)- containing regimens, although they do so within current severe cost/coverage constraints. Therefore, new brands of LABA/LAMA fixed-dose combinations (FDCs) that are expected to launch in these countries--which will considerably expand the chronic obstructive pulmonary disease (COPD) market--will compete with well-established marketed therapies, especially the twice-daily LABA/ inhaled corticosteroids (ICS) FDCs. New LABA/LAMA FDCs will also compete with recently launched once-daily Relvar/Relvare (GlaxoSmithKline/Theravance). According to payers, improvements in dosing and delivery of new FDCs of current drugs/drug classes are important but may not be enough to justify a premium price over comparator drugs or its separate components.
The Zacks Analyst Blog Highlights: Hewlett-Packard, IBM, Safe Bulkers, GlaxoSmithKline and Frank's International
PR Newswire - Thu Aug 21, 8:30AM CDT
Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include the Hewlett-Packard (NYSE:HPQ-Free Report), IBM (NYSE:IBM-Free Report), Safe Bulkers, Inc. (NYSE:SB-Free Report), GlaxoSmithKline plc (NYSE:GSK-Free Report) and Frank's International N.V. (NYSE:FI-Free Report).
Pharma Stocks Review -- Eli Lilly, Zogenix, GlaxoSmithKline, Novo Nordisk, and Valeant Pharma Intl.
PR Newswire - Thu Aug 21, 8:20AM CDT
The trading session on Wednesday, August 20, 2014 ended on a mixed note as the Dow Jones Industrial Average finished at 16,979.13, up 0.35% and the NASDAQ Composite closed at 4,526.48, down 0.02%. The S&P 500 finished the day 0.25% higher at 1,986.51. During the trading session, eight out of ten sectors finished on a positive note. The S&P 500 Health Care Sector Index finished the day at 726.51, up 0.01%, and the index has advanced 8.10% in the previous three months. Investor-Edge has initiated coverage on the following equities: Eli Lilly and Co. (NYSE: LLY), Zogenix Inc. (NASDAQ: ZGNX), GlaxoSmithKline PLC (NYSE: GSK), Novo Nordisk A/S(NYSE: NVO) and Valeant Pharmaceuticals International Inc. (NYSE: VRX). Free research on these five companies can be accessed at:
GSK wins US FDA's approval for Arnuity Ellipta for the treatment of asthma
M2 - Thu Aug 21, 7:51AM CDT
Healthcare company GlaxoSmithKline (NYSE:GSK) revealed on Wednesday the receipt of approval from the US FDA for Arnuity Ellipta for maintenance treatment of asthma in patients 12 years and older.
Pernix Therapeutics acquires US rights to TREXIMET for migraine attacks
M2 - Thu Aug 21, 7:40AM CDT
Pharmaceutical company POZEN (NasdaqGS
Novartis to Invest $35M in Gamida Cell for 15% Equity - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Wed Aug 20, 5:13PM CDT
Novartis (NVS) recently entered into an investment and option agreement with Israel-based Gamida Cell.
GSK receives FDA approval for Arnuity(TM) Ellipta® (fluticasone furoate) in the US for the treatment of asthma
PR Newswire - Wed Aug 20, 2:33PM CDT
GlaxoSmithKline plc today announced that the FDA has approved Arnuity(TM) Ellipta® (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Arnuity is not indicated for relief of acute bronchospasm.
Why Mylan (MYL) Stock Is Advancing Today
at The Street - Wed Aug 20, 2:01PM CDT
The drug company, along with private equity groups and others, reportedly made it to the second round of bidding for a portfolio of mature drugs being sold by GlaxoSmithKline (GSK).
3 Reasons GlaxoSmithKline plc Stock Could Rise
George Budwell, The Motley Fool - Motley Fool - Wed Aug 20, 11:13AM CDT
Like most big pharmas these days, the U.K.'s GlaxoSmithKline is going through a transitory period as key medicines like Advair and Lovaza lose market share to new products. Compounding these problems, Glaxo is facing bribery allegations that have...
Eurozone Recovery Stalls in Q2: 3 Stocks to Sell Now - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Wed Aug 20, 8:59AM CDT
Economic growth in the euro area stalled in Q2 with a 0.2% contraction in Germany and Italy sliding to recession.
If You Want Dividend Income, Look No Further than GlaxoSmithKline plc Stock
Sean Williams, The Motley Fool - Motley Fool - Wed Aug 20, 7:44AM CDT
Dividends: They're the cornerstone to any healthy, long-term-focused portfolio. But when it comes to the health care industry, securing dividend income isn't as easy as it sounds. Finding a great dividend involves locating businesses that strike a...
Pernix Therapeutics Closes Acquisition of Treximet. Raises $220m Senior Notes. Issues Updated 2014 Guidance.
Business Wire - Wed Aug 20, 7:01AM CDT
Pernix Therapeutics Holdings, Inc. (NASDAQ GM: PTX) ("Pernix" or the "Company"
POZEN Announces U.S. Rights For TREXIMET(R) Have Been Acquired by Pernix Therapeutics
Business Wire - Wed Aug 20, 7:00AM CDT
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that the acquisition of all of GlaxoSmithKline's (GSK) rights to Treximet(R) (sumatriptan / naproxen sodium) have been acquired by Pernix Therapeutics Holdings, Inc. (Pernix). The previously announced transaction was contingent upon Pernix securing financing, which is now complete. As part of the divestiture, GSK has assigned the Product Development and Commercialization Agreement between POZEN and GSK to Pernix, and POZEN and Pernix have amended the agreement to address rights of the parties and future development.
Poland Healthcare, Regulatory and Reimbursement Landscape Report 2014-2020
M2 - Wed Aug 20, 6:59AM CDT
Research and Markets (http://www.researchandmarkets.com/research/6hf9wd/countryfocus) has announced the addition of the "CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Poland" report to their offering. In 2013, Poland's population was estimated at 38.5 million, having grown at a Compound Annual Growth Rate (CAGR) of 0.2% from 2008. It is however expected to decrease to approximately 38.4 million by 2020 due to a drop in the birth rate. The value of the pharmaceutical market in the country amounted to $8.6 billion in 2013, and it is expected to increase at a CAGR of 8.3% to approximately $15 billion in 2020. Generics accounted for the majority of the market in 2012 with a share of 66%. This positive trend can be attributed primarily to the following factors - Government initiatives and support from the EU to improve healthcare services - An improved and updated regulatory environment Scope - An overview of the pharmaceutical and medical device markets, comprising market size, segmentation, and key drivers and barriers - Profiles and SWOT analyses for the major players in the pharmaceutical market (Sanofi, Novartis, GlaxoSmithKline, Polpharma and F. Hoffmann-La Roche) - Profiles and SWOT analyses for the major players in the medical device market (F. Hoffmann-La Roche, Medtronic, Essilor International, Abbott Laboratories and Siemens Healthcare) - An insightful review of the reimbursement and regulatory landscape, including details of the healthcare reimbursement process, regulatory agencies, and approval processes for new drugs and medical devices - Detailed analysis of the political and economic environment, covering economic indicators, demographics, healthcare infrastructure, and healthcare expenditure - An overview of the opportunities for and challenges facing growth in the healthcare market Key Topics Covered: 1 Tables & Figures 2 Introduction 3 Overview of the Pharmaceutical and Medical Device Market - Pharmaceutical Market - Medical Device Market - Market Drivers and Barriers 4 Market Access - Reimbursement and Payer Landscape - Regulatory Landscape 5 Country Analysis - Political Environment - Economic Landscape - Economic Indicators - Demographics - Healthcare Infrastructure - Healthcare Expenditure - Trade Associations - Trade Fairs 6 Opportunities and Challenges 7 Appendix For more information visit http://www.researchandmarkets.com/research/6h...untryfocus
North American Pharma-Biotech Sector to Wrap Up Construction on 157 Projects Worth $1.3 Billion in Third-Quarter 2014, an Industrial Info News Alert
Marketwire - Wed Aug 20, 5:15AM CDT
Reported by Annette Kreuger, Industrial Info Resources (Sugar Land, Texas) -- Midway through the third quarter of 2014, the Pharmaceutical-Biotech Industry is busy finishing an impressive array of capital construction projects. The sector is on target to complete construction on a total of 156 North American capital projects. A recent survey of reported projects in Industrial Info's Pharmaceutical Tracker - Online Database reveals that the projects represent a total investment value (TIV) of $1.3 billion.
Yes, Call it a Comeback: Amicus Fabry Drug Posts Big Study Win
at The Street - Wed Aug 20, 5:01AM CDT
Based on the positive study results, Amicus intends to seek European approval for migalastat early next year.