LYNBROOK, N.Y., Oct. 21, 2014 /PRNewswire/ -- BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. and XIAPEX® in the EU, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) submitted by BioSpecifics' partner, Auxilium Pharmaceuticals, Inc. (Auxilium) for XIAFLEX for the treatment of up to two Dupuytren's contracture cords in the same hand during a single treatment visit. XIAFLEX obtained FDA approval in 2010 as the first and only nonsurgical treatment for adult Dupuytren's contracture patients with a palpable cord in the palm.
As stated in Auxilium's press release, issued yesterday, the expanded label also allows the ability to delay the finger manipulation procedure from 24 to up to 72 hours.
"We are very excited by this label expansion for XIAFLEX as it allows physicians to treat more than one Dupuytren's cord at the same time, bringing added convenience to the physician and offering broadened treatment options to patients who would prefer to avoid an invasive surgical procedure. Market share of XIAFLEX for Dupuytren's contracture has been steadily increasing, across all procedures, and we believe this label expansion will lead to even more growth since it is estimated that 35 to 40 percent of Dupuytren's surgeries treat more than one cord," commented Thomas L. Wegman, President of BioSpecifics. "In addition to growth from the expanded label, we also look forward to broadening the commercial reach of XIAFLEX into markets outside the U.S. with the potential approval in Japan for Dupuytren's contracture and in the EU for Peyronie's disease. With all of these avenues to reach new patients with XIAFLEX, we expect to see continued commercial success through 2015."
The sBLA was based on positive results from the global, multicenter Phase 3b MULTICORD (MULtiple Treatment Investigation of Collagenase Optimizing the Resolution of Dupuytren's) trial, together with data from Auxilium's earlier studies. The MULTICORD study evaluated the use of CCH to treat two Dupuytren's cords concurrently in the same hand with multiple affected joints, and also examined efficacy and safety of the finger extension procedure at 24, 48 or 72 hours post injection. In Phase 3b clinical trials, two concurrent XIAFLEX injections were safely used in the treatment of one hand with multiple affected joints.
Auxilium has also worked with the FDA to modify the XIAFLEX Risk Evaluation and Mitigation Strategy (REMS) to communicate a change to the wording of the contraindication in patients with a history of hypersensitivity to XIAFLEX or other collagenase and to add information related to the risk of skin lacerations in the treated finger or hand of patients with Dupuytren's contracture.
About Dupuytren's Contracture
Dupuytren's contracture is caused by an abnormal accumulation of collagen in the palm of the hand characterized by the formation of nodules or lumps in the early stages. As the disease progresses, a cord is formed and the fingers may become progressively contracted. Patients may present with multiple collagen cords that limit finger joint movement. It is estimated that 35 to 40 percent of annual U.S. surgical procedures to treat Dupuytren's have been performed to treat at least two cords at a time.
About BioSpecifics Technologies Corp.
BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for twelve clinical indications to date. Injectable collagenase is approved for marketing as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. for the treatment of adult Dupuytren's contracture patients with up to two palpable cords in the same hand during a single treatment visit and for Peyronie's disease in men with a palpable plaque and a curvature deformity of 30 degrees or greater at the start of therapy by BioSpecifics' partner, Auxilium Pharmaceuticals, Inc. (Auxilium). Auxilium has the following partnerships outside the United States for XIAFLEX; Swedish Orphan Biovitrum AB has marketing rights for XIAPEX® (the EU tradename for CCH) in 71 Eurasian and African countries, Actelion Pharmaceuticals Ltd. has rights in Canada, Australia, Mexico and Brazil, and Asahi Kasei Pharma Corporation in Japan. CCH is in clinical development for the treatment of several additional promising indications. Auxilium is managing studies of CCH for frozen shoulder syndrome currently in a Phase 2b study, and also for cellulite. BioSpecifics is currently managing the development of CCH for the treatment of human and canine lipomas. For more information, please visit www.biospecifics.com.
This release includes "forward-looking statements" within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, expected revenue growth, and the assumptions underlying or relating to such statements, are "forward-looking statements". The forward-looking statements in this release include statements concerning, among other things, the potential medical and commercial benefit of the multicord label expansion for the use of XIAFLEX for Dupuytren's contracture; the potential regulatory approval in Japan for Dupuytren's contracture and in the EU for Peyronie's disease; and the continued commercial success through 2015. In some cases, these statements can be identified by forward-looking words such as "believe," "expect," "anticipate," "plan," "estimate," "likely," "may," "will," "could," "continue," "project," "predict," "goal," the negative or plural of these words, and other similar expressions. These forward-looking statements are predictions based on our' current expectations and our projections about future events and various assumptions. There can be no assurance that we will realize our expectations or that our beliefs will prove correct. There are a number of important factors that could cause BioSpecifics' actual results to differ materially from those indicated by such forward-looking statements, including the timing of regulatory filings and action; the ability of Auxilium and its partners, Asahi Kasei Pharma Corporation, Actelion Pharmaceuticals Ltd. and Swedish Orphan Biovitrum AB, to achieve their objectives for XIAFLEX in their applicable territories; the market for XIAFLEX in, and timing, initiation and outcome of clinical trials for, additional indications including frozen shoulder, cellulite, human lipoma and canine lipoma and uterine fibroids, all of which will determine the amount of milestone, royalty, mark-up on cost of goods sold and sublicense income BioSpecifics may receive; the potential of CCH to be used in additional indications; and other risk factors identified in BioSpecifics' Annual Report on Form 10-K for the year ended December 31, 2013, its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2014 and June 30, 2014 and its Current Reports on Form 8-K filed with the Securities and Exchange Commission. All forward-looking statements included in this release are made as of the date hereof, are expressly qualified in their entirety by the cautionary statements included in this release and, except as may be required by law, we assume no obligation to update these forward-looking statements.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/biospecifics-technologies-corp-announces-fda-approval-of-sbla-for-xiaflex-for-the-concurrent-treatment-of-two-dupuytrens-contracture-cords-233857415.html
SOURCE BioSpecifics Technologies Corp.
NTT DATA’s Global Reach Provides Lombard Risk Collateral Management Solution on a Worldwide Scale
BOSTON--(BUSINESS WIRE)-- NTT DATA, Inc., a leading IT services provider, and Lombard Risk Management plc, a leading provider of integrated collateral management, regulatory reporting, and compliance solutions for the financial services industry, today announced a joint collaboration to offer a globally-scalable collateral management solution. Lombard Risk’s best-of-breed COLLINE® collateral, clearing and optimization solution combines with NTT DATA Group’s knowledge of country-specific regulatory environments, business and operational expertise, and cost-effective global delivery to provide customers with a solution that increases the efficiency of their collateral operations.
While fundamental reform of derivatives and secured lending markets in the aftermath of the 2008 financial crisis has rested on the efficient exchange of collateral as a key to counterparty credit risk mitigation, collateral management represents an ongoing challenge for most Financial Services institutions. By combining Lombard Risk’s collateral management solution COLLINE®, and NTT DATA’s blend of critical business and technology expertise, clients are provided with an innovative and cost-effective solution supporting region-specific regulatory requirements, and enabling collateral optimization across multiple business lines.
Executives from both companies jointly presented at the recent Sibos convention in Boston to showcase the solution, currently being delivered to multi-national clients with operations in global locations. NTT DATA offers the solution as part of its risk and compliance solution portfolio.
“Financial service firms continue to balance growing customer expectations with increased regulatory demands,” said Krishna Prabhu, Senior Vice President, NTT DATA Inc. Financial Services. “The joint solution brings together Lombard Risk’s sophisticated collateral management solution with NTT DATA’s deep data management expertise and global reach to solve our client’s critical business challenges.”
“Collateral Management represents a rapidly evolving opportunity to deliver value to the business and address a frequent source of operational pain,” says Cliff van Tonder, Global Alliances Director at Lombard Risk. “Our partnership with NTT DATA delivers one of the most powerful relationships in the Collateral Risk and Regulatory software arena today.”
About Lombard Risk
Lombard Risk is a leading provider of integrated collateral management and liquidity, regulatory, compliance, transaction and MIS reporting solutions — enabling firms in the financial services industry to significantly improve their approach to managing the risk in their businesses. Founded in 1989 and headquartered in London, Lombard Risk has offices in New York and New Jersey in the US; Hong Kong, Shanghai, Singapore and Tokyo in Asia Pacific, and service centers in Atlanta, Cape Town, Luxembourg and Miami. Clients include banking businesses – over 30 of the world’s “Top 50” financial institutions – as well as investment firms, asset managers, hedge funds, fund administrators, insurance firms and large corporations worldwide.
For more information: www.lombardrisk.com
About NTT DATA
NTT DATA is your Innovation Partner anywhere around the world, with operations in over 40 countries. NTT DATA emphasizes long-term commitment and combines global reach and local intimacy to provide premier professional services from consulting, application services, business process and IT outsourcing to cloud-based solutions.
Visit www.nttdata.com/americas to learn how our consultants, projects, managed services, and outsourcing engagements deliver value for a range of businesses and government agencies.
NTT DATA, Inc.
Stacy Grange, 1 972-624-7676
Mike Nourie, 1 617-624-3200
Source: NTT DATA
SAN FRANCISCO, CA -- (Marketwired) -- 10/21/14 -- Moogsoft, a leader in providing next-generation manager of managers (MoM) services for IT operations, today announced that Cisco Investments and another large public company invested in a second closing to its previously announced Series B round of funding, now totaling $14.3 million. With a first closing in July, the round was led by Wing Venture Capital, with existing investors, including Redpoint Ventures.
"The additional funds will accelerate our plans for a new era of operational tools that are smarter and more effective for this new era of IT," said Phil Tee, CEO of Moogsoft. "Today, IT Ops, DevOps, and DevQA teams require a solution that analyzes the massive amounts of data produced by applications, tools and infrastructures and identifies service-affecting situations as they happen."
Moogsoft's flagship product, Incident.MOOG, is a next-generation manager of managers used by web-scale enterprises and service providers to create collaborative situational awareness for their IT Operations Management (ITOM) and IT Service Management (ITSM) teams. Using patent-pending machine learning technology, Incident.MOOG automates the early detection of service failures, reduces the noise without dependence on preset rules or models, creates contextualized situations and then orchestrates rapid restoral of business services.
Companies like RetailNext, a leader in applied Big Data for physical retail, have deployed Incident.MOOG to ensure continuous availability and service quality of its Internet of Things-driven data analytics solutions.
The additions to the Series B financing, together with Moogsoft's Series A financing, which closed in 2013, brings the total raised by Moogsoft to more than $23 million. Moogsoft began customer deliveries in February 2012 and was immediately recognized as a "Cool Vendor in Application Performance Monitoring" by Gartner. Since then, the company has established partnerships with leading vendors in the ITSM and DevOps sectors and expanded its presence across Europe, North America, and Asia, winning customers who are reinventing IT Operations Management for competitive advantage.
Moogsoft is the leading provider of Collaborative Situation Management for web-scale IT operations, merging adaptive machine learning and socialized workflow into a next-generation manager of managers platform. Its flagship product, Incident.MOOG, detects anomalies in real time to reveal incidents as they unfold, dramatically reducing mean-time-to-repair (MTTR), and enabling knowledge capture and reuse through collaborative workflow and "Situation Rooms." Moogsoft's founders are the original team behind IBM Tivoli Netcool and RiverSoft. For more information, visit www.moogsoft.com and follow us on Twitter at http://twitter.com/Moogsoft.
Media Contact Sarah McDonough Trainer Communications firstname.lastname@example.org (415) 800-5362
PlatinumGames Delivers Another Action-Game Masterpiece, Exclusively on Wii U
REDMOND, Wash.--(BUSINESS WIRE)-- Over the top. Breathtaking. Out of control. Stylish. Critically acclaimed. Any of these words can be used to describe the Bayonetta 2 game, the latest action classic from PlatinumGames, launching exclusively for the Wii U console on Oct. 24. Fans of the original Bayonetta game know that the series delivers some of the most intense action, massive set pieces, gorgeous graphics and slick controls of any video game series out there. With Bayonetta 2, everything is taken to the next level. Main character Bayonetta is more powerful than ever, using wild new moves and weapons in various single- and multiplayer modes to take down both angels and demons in a thrilling quest to save a friend from eternal damnation. Just another day in the life of the Umbra Witch herself.
Bayonetta is back in Bayonetta 2 with more moves, more weapons and more climax action. (Photo: Business Wire)
“The action-game geniuses at PlatinumGames have done it again. Bayonetta 2 is the kind of exclusive game that fans are going to devour like Halloween candy,” said Scott Moffitt, Nintendo of America’s executive vice president of Sales & Marketing. “With its challenging but rewarding game play and over-the-top content, Bayonetta 2 proves the depth and diversity of the library of games that can only be played on Wii U.”
With her magic-imbued hair, chic glasses and gun-toting high heels, Bayonetta is one of the most original characters in video games. She doesn’t just sit back and wait to be rescued. In Bayonetta 2, players take control of this damsel-that-causes-distress and slash, shoot and guillotine through multiple levels that find our heroine going head-to-head with a towering enemy while flying outside a skyscraper, slicing through an army on the back of a speeding train or confronting an angel while standing on the wing of a fighter jet, among other magnificent set pieces. By performing well in battles, players earn medals that reflect their performance, ranging from the room-for-improvement Stone medal to the perfect Pure Platinum.
For the first time in the series, players who want to take on battles with a friend can team up with another player in Tag Climax. In this online co-op mode, players with a broadband Internet connection destroy legions of enemies together, playing as a variety of characters from the game. As players journey through the main story mode, they will unlock Verse Cards that can be used to unlock additional stages in Tag Climax.
Anyone who purchases Bayonetta 2 in retail stores at a suggested retail price of $59.99 will also get the definitive version of the original Bayonetta game at no additional cost, with an additional disc right in the box. When buying the digital version of either game in the Nintendo eShop on Wii U, an automatic discount will be applied to the purchase of the other game, making the total for both games just $59.98.
Both the original Bayonetta and Bayonetta 2 games include in-game costumes that will be a treat for any Nintendo fan. Bayonetta can wear exclusive costumes modeled after fan-favorite Nintendo characters such as Princess Peach, Samus Aran and Link. These amazing outfits aren’t just for looks, either. When wearing these costumes, the game changes in fun and unexpected ways. For example, while wearing the Princess Peach costume, Bayonetta summons Bowser’s hands and feet instead of infernal demons. Dressed as Link? Listen for a familiar chime after Bayonetta solves a puzzle.
The packaged and Nintendo eShop versions of Bayonetta 2 (with the original Bayonetta) will be available on Oct. 24. For players who want to take the game for a spin, a free demo for Bayonetta 2 can be downloaded in the Nintendo eShop on Wii U. For more information about the game, visit http://bayonetta2.nintendo.com.
Remember that Wii U features parental controls that let adults manage the content their children can access. For more information about this and other features, visit http://www.nintendo.com/wiiu.
About Nintendo: The worldwide pioneer in the creation of interactive entertainment, Nintendo Co., Ltd., of Kyoto, Japan, manufactures and markets hardware and software for its Wii U™ and Wii™ home consoles, and Nintendo 3DS™ and Nintendo DS™ families of portable systems. Since 1983, when it launched the Nintendo Entertainment System™, Nintendo has sold more than 4.2 billion video games and more than 670 million hardware units globally, including the current-generation Wii U, Nintendo 3DS and Nintendo 3DS XL, as well as the Game Boy™, Game Boy Advance, Nintendo DS, Nintendo DSi™ and Nintendo DSi XL™, Super NES™, Nintendo 64™, Nintendo GameCube™ and Wii systems. It has also created industry icons that have become well-known, household names such as Mario™, Donkey Kong™, Metroid™, Zelda™ and Pokémon™. A wholly owned subsidiary, Nintendo of America Inc., based in Redmond, Wash., serves as headquarters for Nintendo’s operations in the Western Hemisphere. For more information about Nintendo, please visit the company’s website at http://www.nintendo.com.
Note to editors: Nintendo press materials are available at http://press.nintendo.com, a password-protected site. To obtain a login, please contact Deanna Avila at 213-438-8742 or email@example.com. Users can receive instant Nintendo information by subscribing to the site’s RSS feed.
Staples and Steelcase make more happen by bringing high-performance, ergonomic chairs and furnishings to staples.com
FRAMINGHAM, Mass.--(BUSINESS WIRE)-- Many small business owners and their employees are sitting in pain, according to a new study released by Staples (NASDAQ: SPLS) and Steelcase.
Staples survey shows small business owners are working in pain. (Photo: Business Wire)
The study shows that 88 percent of small business owners say office chairs impact employee productivity, yet 13 percent say their chair is so uncomfortable it prevents them from doing their job to the best of their ability.
Pain is common, with 31 percent of business owners saying they often experience pain or discomfort in their lower back due to their office chair; 19 percent experience pain in their neck; and 17 percent experience pain in the mid-back. Eighty percent of respondents say their office chair has caused numbness or tingling in their hands. The average office chair is 7.2 years old, and 44% of those surveyed can’t remember the last time anyone in their office received a new office chair. On average, employees spend 5.3 hours per day sitting in their chairs.
Ergonomic experts agree, workers should sit, stand and walk throughout the day. Experts recommend that a chair keep the worker oriented to their work, even when reclining. A chair should allow for adjustable height to keep both feet flat on the floor, and the worker should be able to sit in contact with the backrest at all times while the backrest supports the chosen posture, with even pressure on both the lower and upper back.
For small businesses that want to support employees with a better ergonomic experience at work, Staples now offers a full portfolio of seating solutions from Steelcase (NYSE: SCS) on Staples.com. Steelcase products, including global bestsellers Leap®, cobi®, and Buoy® have been internationally recognized for their insight-led design and quality.
“Staples is always looking for ways to make more happen for our small business customers,” said Mike Edwards, executive vice president of merchandising, Staples. “By partnering with Steelcase, we’re excited to bring more innovative products that can improve workplace wellbeing and productivity.”
When asked what they desire most in an office chair, over half of small business owners (52%) wish their office chair had adjustable lower back support while one-third (34%) wish it had the ability to adjust the seat height and three in ten (30%) wish it had adjustable arm rests.
“As this survey reveals, many small business employees are sitting in pain, especially as they work with new technologies which cause new postures,” said Allan Smith, vice president, global marketing for Steelcase. “Workers today require an ergonomic sitting experience designed for the new ways in which we work. When workers have access to high-performance seating they can remain attentive, engaged and achieve their highest potential.”
Staples makes it easy to make more happen with more products and more ways to shop. Through its world-class retail, online and delivery capabilities, Staples lets customers shop however and whenever they want, whether it’s in-store, online or on mobile devices. Staples offers more products than ever, such as technology, facilities and break room supplies, furniture, safety supplies, medical supplies, and Copy and Print services. Staples also offers free shipping for Staples Rewards Members, in most cases overnight. Headquartered outside of Boston, Staples operates throughout North and South America, Europe, Asia, Australia and New Zealand. More information about Staples (SPLS) is available at www.staples.com.
About Steelcase Inc.
For over 100 years, Steelcase Inc. has helped to create great experiences – wherever work happens – for the world’s leading organizations, across industries. We demonstrate this through our family of brands – including Steelcase®, Coalesse®, Designtex®, Details®, PolyVision® and Turnstone®. Together, they offer a comprehensive portfolio of architecture, furniture and technology products and services designed to unlock human promise and support social, economic and environmental sustainability. We are globally accessible through a network of channels, including over 800 dealer locations. Steelcase is a global, industry-leading and publicly traded company with fiscal 2014 revenue of $3.0 billion.
This survey was conducted online within the United States by Nielsen on behalf of Staples from July 17, 2014 through July 25, 2014 among U.S. small business owners with 2-24 employees. This online survey is not based on a probability sample and therefore no estimate of theoretical sampling error can be calculated.
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