FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) and granted a six-month Priority Review for once-daily Truvada® (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults. Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the United States.
The FDA grants priority review status to drug candidates that provide major advances in treatment or provide a treatment where no adequate therapy exists. Gilead submitted the Truvada for PrEP sNDA on December 15, 2011. The FDA has set a target review date for Truvada for PrEP under the Prescription Drug User Fee Act (PDUFA) of June 15, 2012. The agency has also indicated that Truvada for PrEP will be discussed at the FDA Antiviral Drugs Advisory Committee meeting scheduled in May.
If the sNDA is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV. The sNDA is based on the results of two large placebo-controlled trials of Truvada as PrEP sponsored by the U.S. National Institutes of Health and the University of Washington. Several other clinical studies support the use of Truvada for HIV risk reduction.
Truvada is not currently indicated to reduce the risk of HIV infection.
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 worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.
Forward-Looking Statement
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 risk that the FDA may not approve Truvada for HIV-1 risk reduction, and any approval, if granted, may have significant limitations on its use. Additionally, even if approved, physicians may be reluctant to prescribe the product for HIV risk reduction, and payers may be reluctant to approve or provide reimbursement for the product for HIV risk reduction. As a result, there may not be significant use of Truvada as a risk reduction tool. 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 September 30, 2011, 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.
U.S. full prescribing information for Truvada is available at www.Truvada.com.
Truvada is a registered trademark of Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences, Inc.Patrick O’Brien, 650-522-1936 (Investors)Cara Miller, 650-522-1616 (Media)
Source: Gilead Sciences, Inc.
TED’s First-ever Business School Partnership Designed to Immerse UCLA Anderson Community in TED Experience
LOS ANGELES--(BUSINESS WIRE)-- In its pursuit to cultivate thought leaders and advance ideas, UCLA Anderson School of Management today announced a multi-faceted partnership with globally renowned nonprofit, TED. This represents TED’s first partnership with a business school.
The unique association will launch with UCLA Anderson’s “TED Takeover,” a series of collaborative experiences that will enable the UCLA Anderson community to take an active role in the annual TED conference in Long Beach and the simultaneous TEDActive conference in Palm Springs. The partnership will continue post-conference, with students consulting in class on TED’s brand management and ongoing mission.
“The UCLA Anderson community looks to engage in the big issues of the day as a forum for discussion, and as a source of solutions,” says Judy Olian, Dean of UCLA Anderson School of Management. “TED does that, attracting the best minds and creative ideas as part of the dialogue. This partnership represents a tremendous opportunity to add our faculty and students to that discussion.”
The partnership will begin February 27, 2012, with the four-day TED Takeover, designed to immerse the UCLA Anderson community in the TED experience – inviting faculty and students to hear some of the world’s most innovative thought leaders, encouraging them to engage in dialogue, share and exchange ideas and develop connections that will help advance those efforts. To facilitate that process, monitors around the school will live-stream the exclusive content from the TED conference in its entirety, and an idea incubation lounge will be set up in the center of the UCLA Anderson complex, featuring signature TED décor and serving as the “thought hub” for the week. Here, students can watch an uninterrupted simulcast of the TED conference and contribute to the discussion in real time via social media and through other means.
Six panel discussions will occur at UCLA Anderson, along with the TED events, to stimulate dialogue among students, faculty, and alumni based on presentations by selected TED speakers, such as Chairman of BP Capital Management T. Boone Pickens, UCLA Anderson Adjunct Professor of Marketing and former Global Marketing Officer at Procter & Gamble Jim Stengel, Oscar-winning Director Andrew Stanton, and Greylock Partner and Linked In Co-Founder and Executive Chairman Reid Hoffman. Each panel at UCLA Anderson will view a TED speaker and afterwards discuss ways to advance the ideas that emerge. The discussions will be sponsored by one of six UCLA Anderson student clubs that include, High-Tech Business Association (HTBA), Entrepreneur Association (EA), Net Impact/Energy Management Group (NI/EMG), Marketing Association (MA), and Design for America (DFA).
UCLA Anderson students will also have a unique part to play in the concurrent Palm Springs TEDActive conference – by providing consultation on the TEDActive 2012 “projects.” These projects are based on questions posed by international corporations such as American Express, HP, TOMS shoes, Shell, in critical areas of social challenge, such as Urbanization, Health, Community and Commerce, and Giving. For more information on TEDActive go to http://conferences.ted.com/TEDActive2012/.
After the conference UCLA Anderson students will remain engaged with TED, giving input on how to go beyond sharing ideas, and into advancing them. The TED partnership will extend into the classroom, providing students an in-class opportunity to consult with TED on its larger brand management.
TED’s connection with UCLA Anderson extends to the geographic locations that these entities share. Both TED and UCLA Anderson are committed to advancing thought leadership and sharing ideas in Southern California’s vibrant economy, known for its technological innovation, entrepreneurship, venture capital availability and new product introduction.
“TED’s core mission of Ideas Worth Spreading fits perfectly with UCLA Anderson’s mission to develop the next generation of influential leaders who will create their own ideas worth spreading through a learning culture that values individual vision, intellectual discipline and teamwork,” said Jim Stengel, UCLA Anderson adjunct professor of marketing and former global marketing officer at Procter & Gamble. Stengel, who was selected to speak at this year’s TED main stage conference, entitled TED2012: Full Spectrum, added, “We anticipate this to be a long-term relationship that prompts continuous discussion and explores collaborative initiatives with far-reaching impacts on both businesses and communities.”
Schedule for TED2012 Full Spectrum (February 27 – March 2): http://conferences.ted.com/TED2012/program/guide.php
About UCLA Anderson School of Management
UCLA Anderson School of Management is among the leading business schools in the world. UCLA Anderson faculty members are globally renowned for their teaching excellence and research in advancing management thinking. Each year, UCLA Anderson provides a distinctive approach to management education to more than 1,800 students enrolled in its MBA, Fully-Employed MBA, Executive MBA, Global Executive MBA for Asia Pacific, Global Executive MBA for the Americas, Master of Financial Engineering, doctoral and executive education programs. Combining selective admissions, varied and innovative learning programs, and a world-wide network of 37,000 alumni, UCLA Anderson develops and prepares global leaders.
Follow UCLA Anderson on Twitter at http://twitter.com/UCLAAnderson, or on Facebook at http://www.facebook.com/uclaanderson.
About TED
TED is a nonprofit organization devoted to Ideas Worth Spreading. Started as a four-day conference in California 25 years ago, TED has grown to support those world-changing ideas with multiple initiatives. The annual TED Conference invites the world’s leading thinkers and doers to speak for 18 minutes. Their talks are then made available, free, at TED.com. TED speakers have included Bill Gates, Al Gore, Jane Goodall, Elizabeth Gilbert, Sir Richard Branson, Nandan Nilekani, Philippe Starck, Ngozi Okonjo-Iweala, Isabel Allende and former UK Prime Minister Gordon Brown. The annual TED Conference takes place each spring in Long Beach, California, along with the TEDActive simulcast in Palm Springs; the annual TEDGlobal conference is held each summer in Edinburgh, Scotland.
TED’s media initiatives include TED.com, where new TEDTalks are posted daily, the Open Translation Project, which provides subtitles and interactive transcripts as well as the ability for any TEDTalk to be translated by volunteers worldwide, and TEDBooks, short e-books by speakers that elaborate on a single idea originally presented on TED’s stage. TED has established the annual TED Prize, where exceptional individuals with a wish to change the world are given the opportunity to put their wishes into action; TEDx, which offers individuals or groups a way to host local, self-organized events around the world, and the TED Fellows program, helping world-changing innovators from around the globe to become part of the TED community and, with its help, amplify the impact of their remarkable projects and activities.
Follow TED on Twitter at http://twitter.com/TEDTalks, or on Facebook at http://www.facebook.com/TED
UCLA Anderson School of ManagementElise Anderson, 310-206-7707elise.anderson@anderson.ucla.edu
Source: UCLA Anderson School of Management
MILPITAS, Calif. & LOS GATOS, Calif.--(BUSINESS WIRE)-- Steel Excel Inc. (Other OTC:SXCL.PK) (Steel Excel) and BNS Holding, Inc. (Other OTC:BNSSA.PK) (“BNS”) announced today that they are engaged in preliminary discussions regarding a possible acquisition by Steel Excel of BNS. BNS is a holding company the operating subsidiary of which is Sun Well Services, Inc, a provider of premium well services to oil and gas exploration and production companies operating in the Williston Basin in North Dakota and Montana.
Steel Partners Holdings LP and its affiliates own approximately 85% of BNS. BNS has appointed a special committee of its independent director to consider the transaction on behalf of its unaffiliated stockholders. Steel Partners also owns approximately 40% of Steel Excel. Steel Excel has appointed a special committee of independent directors to consider and negotiate the transaction. No assurances can be given that an agreement between the parties can be reached or, if an agreement is reached, that any such transaction will be completed. Neither Steel Excel nor BNS intend to make any further public announcement concerning this possible transaction unless and until a definitive agreement has been signed.
Steel Excel recently announced its acquisition of the business and assets of Eagle Well Services, a leader in the oilfield service industry serving customers in the Williston basin in North Dakota and Montana. In December 2011, Steel Excel announced that it had purchased all of the business and assets of Rogue Pressure Services, LLC, a leader in the oilfield service industry located primarily in Williston, North Dakota and Eagle Ford, Texas.
About Steel Excel Inc.
Steel Excel's business is to identify and acquire profitable business operations in which it can utilize its existing working capital and maximize the use of Steel Excel’s net operating losses. The identification of new business operations includes, but is not limited to, businesses in the oilfield services, sports, training, education, entertainment and lifestyle industries. More information is available at Steel Excel's web site: www.steelexcel.com.
Safe Harbor Statement
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. Forward-looking statements such as “will,” “believe,” “are projected to be” and similar expressions are statements regarding future events or the future performance of Steel Excel, and include statements regarding projected operating results. These forward-looking statements are based on current expectations, forecasts and assumptions and involve a number of risks and uncertainties that could cause actual results to differ materially from those anticipated by these forward-looking statements. These risks include, but are not limited to: Steel Excel's ability to identify suitable acquisition candidates or business and investment opportunities; the ability to realize the benefits of our net tax operating losses; the possibility of being deemed a “shell company” under the federal securities laws, which may adversely impact our ability to offer our stock to officers, directors and consultants, and would likely increase the costs of registration compliance following the completion of a business combination; the possibility of being deemed an investment company under the Investment Company Act of 1940, as amended, which may make it difficult for us to complete future business combinations or acquisitions; the potential need to record additional impairment charges for long-lived assets or marketable securities based on current market conditions; the necessity to record material tax provisions or pay additional tax payments in the future as a result of estimates for tax provisions that materially differ from actual outcomes and tax audits and redetermination by the United States and foreign taxing authorities in which we operate or formerly operated; the ability to reduce our operating costs; general economic conditions and our expected liquidity in future periods. For a more complete discussion of risks related to our business, reference is made to the section titled “Risk Factors” included in our Transition Report on Form 10-K for the nine month period ended December 31, 2010 on file with the Securities and Exchange Commission. Except as required by law, we assume no obligation to update any forward-looking information that is included in this release.
Steel Excel Inc.Investor Relations, 408-957-7811Investor_Relations@steelexcel.comorBNS Holding, Inc.Terry Gibson, 401-848-6300 (Investor Relations)
Source: Steel Excel Inc.
AAPA pleased with boost in Corps' navigation, DOT infrastructure investment budgets
ALEXANDRIA, Va., Feb. 13, 2012 /PRNewswire-USNewswire/ -- With the release today of President Obama's fiscal 2013 budget, the American Association of Port Authorities (AAPA)—representing seaports in the United States and throughout the Americas—is expressing both accolades, and some disappointment, over various aspects of the budget pertaining to ports and the efficient and secure movement of freight.
(Logo: http://photos.prnewswire.com/prnh/20110412/MM82129LOGO)
Kurt Nagle, AAPA's president and CEO, said that, even though the Administration's budget includes cuts in order to meet the Budget Control Act passed by Congress last year, there are bright spots for seaports, such as a much-needed increase in the portion of the U.S. Army Corps of Engineers' funding pertaining to deep-draft navigation maintenance, and funding for the Department of Transportation's budget that pertains to enhancing America's freight mobility.
The president's 2013 budget proposal includes a request for reimbursement from the federal Harbor Maintenance Trust Fund (HMTF) of $848 million. This represents a nearly 12 percent increase ($90 million) over the fiscal 2012 request of $758 million and would be $28 million more than the $830 million Congress appropriated for maintenance dredging in fiscal 2012. While still not close to the $1.4 billion collected annually from importers and domestic shippers for deep-draft navigation maintenance dredging, the Administration's fiscal 2013 request is a significant increase from prior years.
"The President's proposed Civil Works program increase for navigation is the highest budget request ever, and is a very positive step toward AAPA's long-stated goal of full utilization of the Harbor Maintenance Tax for its intended purpose," said Mr. Nagle.
"Maintaining our federal navigation channels to their authorized and required dimensions will also help make U.S. exports more internationally competitive and is critical for safe access in and out of America's seaports," he said.
Since the Harbor Maintenance Tax's inception in 1986, AAPA has advocated for full use of its collections for their intended purpose of dredging America's deep-draft navigation channels to their authorized and required depths and widths. Mr. Nagle added that, currently, importers and domestic shippers pay approximately double the annual amount that is drawn from the HMTF for maintenance dredging, leaving a surplus that exceeds $6.3 billion today. Because this surplus has been used for other programs, there are serious dredging needs that have gone unheeded.
Another area of the proposed budget important to America's freight competitiveness falls under the Department of Transportation, which contains a robust, six-year transportation authorization proposal funded at $476 billion. Additionally, the budget request funds immediate transportation investments in fiscal 2012 totaling $50 billion. These investments include $26 billion for the National Highway Program and $4 billion for the National Infrastructure Investments (NII) program—formerly TIGER—which in the past three years has funded more than a quarter-billion dollars in seaport-related infrastructure. All of these elements would have strong and positive effect on freight system improvement.
The proposal also authorizes the NII program at $3.4 billion cumulatively through 2018 as part of the Administration's six-year authorization proposal. AAPA has long advocated for authorizing a TIGER-style program and dedicating at least 25 percent of the grants to port-related infrastructure.
"AAPA lauds the Administration's desire to prioritize both land- and water-side transportation infrastructure investments with the Department of Transportation and Corps of Engineers budgets," said Mr. Nagle. "As the Administration and Congress continue to seek ways to reduce spending, it's imperative to focus scarce federal dollars in those areas, such as seaport-related infrastructure, that can have the greatest impact on economic growth, immediate and long-term job creation, and our current and future competitiveness in the global economy."
With regard to seaport security, Mr. Nagle said that the AAPA is both supportive and appreciative of the portion of the administration's proposed budget that calls for $2.9 billion—more than double last year's funding level—for FEMA State and Local Programs, which houses the Port Security Grant Program. The budget request, however, also bundles all funds into one pot and gives the Homeland Security secretary the authority to determine funding levels.
The association has opposed similar proposals in the past because first responder programs are substantially different than port security programs and because states may not adequately allocate funds for port security if the programs are combined at the state level.
AAPA continues to advocate for a separate port security funding program at a $400 million annual level to aid ports in beefing up their security infrastructure, technology and personnel programs, and to ensure that terrorist threats don't become terrorist realities.
In the environmental arena, funding for the Diesel Emissions Reduction Act—which has been highly successful in helping ports reduce dangerous emissions from older diesel engines—includes $15 million. While a huge improvement over the president's fiscal 2012 budget request to zero-out the program, it represents only half of what Congress appropriated in 2012. The budget also calls for eliminating the former grant funding strategy in favor of a program that provides rebates on the purchase of pollution control technology and grants for revolving loan programs. The budget proposal states that communities with the greatest need, such as a limited set of low-income and high exposure areas near ports and freight distribution hubs, would be targeted.
"While we're encouraged by the focus on funding diesel emission projects near ports and freight distribution hubs, AAPA will need to carefully evaluate the effect of moving away from grants, which have been highly successful in port areas and used by many AAPA-member port authorities," said Mr. Nagle.
AAPA will continue to press Congress for full funding of DERA at the authorized amount of $100 million per year.
"As the Administration and Congress grapple with the multiple goals of reducing the nation's deficit while growing jobs and the economy, federal investments in ports and connecting infrastructure are an essential, effective utilization of limited resources paying dividends through increased trade, jobs and tax revenues," said Mr. Nagle.
About AAPAFounded in 1912, AAPA today represents 160 of the leading seaport authorities in the United States, Canada, Latin America and the Caribbean and more than 300 sustaining and associate members, firms and individuals with an interest in seaports. As a critical link for access to the global marketplace, each year, Western Hemisphere seaports generate trillions of dollars of economic activity, support the employment of millions of people and import and export more than 4.5 billion tons of cargo including food, clothing, medicine, fuel and building materials, as well as consumer electronics and toys. The volume of cargo shipped by water is expected to dramatically increase by 2020 and the number of passengers traveling through our seaports will continue to grow. To meet these demands, the AAPA and its members are committed to keeping seaports navigable, secure and sustainable.
SOURCE American Association of Port Authorities
NEW YORK, Feb. 13, 2012 /PRNewswire/ -- Public voting for PR Newswire's earned media awards program, The Earnies, ends tomorrow, Tuesday, February 14th, 2012 at 9 p.m. ET, and final winners will be announced on February 16th, 2012 through AGILITY@work and @AgilityAtWork.
(Photo: http://photos.prnewswire.com/prnh/20120213/NY52876 )
(Logo: http://photos.prnewswire.com/prnh/20110719/NY37427LOGO )
The Earnies, which recognizes strategic innovation and creativity of campaigns executed through social media, is the first earned media awards program in which the final winners are determined by the broader community. An expert panel of judges narrowed down the submissions to a short list of three finalists in each category. Entries were judged based on strategy, creativity, results and overall 'awesomeness' of the campaigns and three finalists were named in each of the following categories
"The influx of votes has been very impressive, with over a thousand votes cast within the first few days," said Rachel Meranus, vice president of marketing and communications, PR Newswire. "We are looking forward to tallying the final votes and announcing the community chosen winners and awarding the first ever Earnie award in just a few days."
Best Use of Video in Social Media:
- Status Creative – Refuting the claim that Grand Rapids, MI is a dying city
- New Media Strategies – NFL Players Association fighting the PR battle over the NFL lockout
- New Media Strategies - Celebrating 70 years of Jeep
To learn more about the "Best Use of Video in Social Media" entries and to cast your vote, click here.
Best Connection to Twitter, LinkedIn or Facebook Audience
- Esurance – supporting The Trevor Project
- Child's Play Communications – creating awareness and excitement about the Mega Bloks Family Club
- Redken – increasing brand awareness through fashion, pop culture and branded content
To learn more about the "Best Connection to Twitter, LinkedIn or Facebook Audience" entries and to cast your vote, click here.
We Can't Believe That Worked!
- St. Jude Children's Research Hospital – leveraging a reality TV feature spot to interact with fans in real-time
- Motion Marketing & Media – introducing Michigan to the world through "Meet Michigan"
- Byron Fernandez – conducting a public relations & marketing job search
To learn more about the "We Can't Believe That Worked" entries and to cast your vote, click here.
The Earnies Grand Prix
- St. Jude Children's Research Hospital – raising awareness for 'Hoops For St. Jude'
- Redken – celebrating Fall/Winter 2012 Fashion Week through Social Media
- BuzzFeed – reinvigorating BIC Razors for Men through the "Get Real" campaign
To learn more about the "Earnies Grand Prix" entries and to cast your vote, click here.
About PR Newswire:
PR Newswire is the premier global provider of multimedia platforms that enable marketers, corporate communicators, sustainability officers, public affairs and investor relations officers to leverage content to engage with all their key audiences. Having pioneered the commercial news distribution industry 57 years ago, PR Newswire today provides end-to-end solutions to produce, optimize and target content — from rich media to online video to multimedia — and then distribute content and measure results across traditional, digital, mobile and social channels. Combining the world's largest multi-channel, multi-cultural content distribution and optimization network with comprehensive workflow tools and platforms, PR Newswire enables the world's enterprises to engage opportunity everywhere it exists. PR Newswire serves tens of thousands of clients from offices in the Americas, Europe, Middle East, Africa and the Asia-Pacific region, and is a UBM plc company.
Media Contacts:
Rachel MeranusVice President, Marketing & Communications201-360-6776Rachel.Meranus@prnewswire.com
Meryl SerouyaMarketing & Communications Associate201-360-6009Meryl.Serouya@prnewswire.com
SOURCE PR Newswire Association LLC
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