Gilead Announces U.S. FDA Priority Review Designation for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV
10.8.2017 23:01 | Business Wire
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for an investigational, fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection. Gilead filed the NDA for BIC/FTC/TAF with a Priority Review voucher on June 12, 2017, and FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of February 12, 2018.
The NDA is supported by data from four Phase 3 studies that evaluated the fixed-dose combination among treatment-naïve patients and among virologically suppressed patients. A marketing application for BIC/FTC/TAF is also under review in the European Union, and was validated by the European Medicines Agency (EMA) in July. Bictegravir in combination with FTC/TAF as a single tablet regimen is an investigational treatment that has not been determined to be safe or efficacious and is not approved anywhere globally.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
For nearly 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it’s estimated that more than 10 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that FDA and other regulatory authorities may not approve BIC/FTC/TAF in the currently anticipated timelines or at all, and any marketing approvals, if granted, may have significant limitations on their use. As a result, BIC/FTC/TAF may never be successfully commercialized. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences, Inc.
Sung Lee, 650-524-7792 (Investors)
Kelsey Grossman, 650-378-2103 (Media)
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
PsiOxus Therapeutics Announce Two New Board Appointments: New Board Appointments Strengthen Company’s US Presence17.8.2017 10:00 | Tiedote
PsiOxus Therapeutics, Ltd. (PsiOxus) today announced the appointment of Charles Rowland and Duncan Higgons to the Board of Directors as part of an ongoing drive to expand in the US. Charles Rowland was most recently the President and Chief Executive Officer (CEO) of Aurinia Pharmaceuticals, a clinical stage pharmaceutical company focused on the global lupus nephritis market. Prior to this, he served as the Vice President and Chief Financial Officer (CFO) of ViroPharma, during which time the company grew into a global biopharmaceutical business with $500 million in annual revenues until it was acquired by Shire plc for $4.2 billion. Before joining ViroPharma, Mr. Rowland was executive Vice President, CFO, and interim co-CEO, for Endo Pharmaceuticals. In his earlier career, Charles held finance and operational positions at Biovail Pharmaceuticals, Breakaway Technologies, Pharmacia
Smarsh Adds Voice Archiving Offering with Acquisition of London-Based Cognia17.8.2017 09:59 | Tiedote
Smarsh®, providing information archiving solutions for compliance, e-discovery and risk management, has completed the acquisition of Cognia, a worldwide leader in cloud-based voice archiving, audio search and analytics. Smarsh will leverage Cognia’s intellectual property and development resources to offer its global customer base enhanced capabilities around mobile and fixed-line voice communication – alongside a market-leading range of electronic communications – within The Archiving Platform. The acquisition will expand the existing presence of Smarsh in Europe and is central to its MiFID II compliance solution for financial firms. In addition to capturing incoming and outgoing communication from fixed-line recording solutions, Cognia uniquely captures voice content directly from leading mobile carriers. Carrier-direct capture is the most reliable and automated method for capt
Schlumberger Announces Third-Quarter 2017 Results Conference Call17.8.2017 00:23 | Tiedote
Schlumberger Limited (NYSE:SLB) will hold a conference call on October 20, 2017 to discuss the results for the third quarter ending September 30, 2017. The conference call is scheduled to begin at 8:30 am US Eastern time and a press release regarding the results will be issued at 7:00 am US Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (800) 288-8967 within North America or +1 (612) 333-4911 outside of North America approximately 10 minutes prior to the start of the call, and ask for the “Schlumberger Earnings Conference Call.” A webcast of the conference call will be broadcast simultaneously at www.slb.com/irwebcast on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call,
Rimini Street Named to Inc. 5000 List for Seventh Consecutive Year16.8.2017 21:20 | Tiedote
Rimini Street, Inc., a global provider of enterprise software products and services, and the leading independent support provider for Oracle and SAP products, today announced that it was named to Inc. magazine’s 36th annual Inc. 5000 list for the seventh consecutive year. The Inc. 5000 list is an exclusive ranking of the nation’s fastest-growing private companies and represents the most comprehensive look at America’s entrepreneurs. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170816005908/en/ Rimini Street has earned a place on the annual Inc. 5000 list since 2011, joining an elite group – approximately 2% – of Inc. 5000 honorees to ever achieve this milestone. (Photo: Business Wire) Rimini Street has earned a place on the annual Inc. 5000 list since 2011, joining an elite group – approximatel
Keio Plaza Hotel Tokyo Starts "Ikebana" Flower Arrangement Workshops16.8.2017 17:00 | Tiedote
Keio Plaza Hotel Tokyo, one of Japan’s most prestigious international hotels located in Shinjuku, Tokyo, starts special 45 minute classes to teach overseas guests about “Ikebana” flower arrangement which will be held on every other Thursday beginning from August in a private room for JPY3,000 per participant. Instruction and commentary will be provided by the renowned flower arrangement artist Hiroki Maeno. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170816005431/en/ From August, 2017, Keio Plaza Hotel Tokyo starts special 45 minute classes to teach overseas guests about "Ikebana" flower arrangement workshops. (Photo: Business Wire) Flower arrangement artist Hiroki Maeno has created special and unique flower arrangements for display in the main lobby of our hotel with each cha
Maxion Wheels to Feature Market Leading Commercial Vehicle Steel Wheels at COMTRANS 201716.8.2017 16:00 | Tiedote
Maxion Wheels, the world’s largest wheel manufacturer, announced today its participation in the biennial COMTRANS / 17 International Commercial Vehicle Show held in Moscow, Russia from September 4 – 9, 2017, in Hall 15/ Stand 15-432. Customers and visitors to the Maxion Wheels exhibit will have the opportunity to learn more about the state-of-the-art commercial vehicle steel wheels that have supported the success of global original equipment manufacturers for almost 100 years. One of the key products on display will be the new 8.5” x 24” wheel for tubeless tire applications in Russia, the Middle East and Africa. The wheel boasts 15 percent less weight than the prior generation wheel, enhancing tire life and improving fuel efficiency. ABOUT MAXION WHEELS Maxion Wheels, a division of IOCHPE-MAXION S.A., is a leading wheel manufacturer for passenger cars,
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme