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Visit One News Page for Europe news from around the world, aggregated from leading sources including newswires, newspapers and broadcast media. Search millions of archived news headlines. This feed provides the Europe news headlines.

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    NEW YORK, Dec. 03, 2018 (GLOBE NEWSWIRE) -- As the weather gets cooler and our palates turn from simple quaffers to something more complex, now’s the time to discover a range of lesser-known, but expressively unique whites from Alto Adige - Südtirol.Kerner
    This frost-resistant grape thrives in the high-altitude vineyards of Valle Isarco and Val Venosta. Originally from Germany, this fruity, floral, and spicy wine is quickly becoming a signature variety for the region.

    Grüner Veltliner
    Unlike Gruner’s widespread fame in Austria, the variety is concentrated in the sweeping terrain of Valle Isarco. Here, just a handful of producers focused on its cultivation give this normally easy sipper a bit of swagger.

    Müller-Thurgau
    This hybrid grape that counts Riesling and Madeleine Royale as its parents can showcase floral and nutty notes, as well as an essence of baking spice. It can be insipid in other regions, but the cool climate of Alto Adige ensures it develops bright acid and a lively personality.

    Moscato Giallo
    If the name wasn’t a tipoff, this grape from the Muscat family is delectably sweet, but it can be vinified both dry — which brings out an elegant spice character — and as a dessert wine. Thought to have been brought over by the Romans in 15 B.C., it happily grows in the region’s warmer sites.

    Sylvaner
    Originally from Austria, this thick-skinned grape made its way through Germany and other parts of Central Europe before settling in Valle Isarco. Savory, herbaceous and mineral-rich, these full-bodied whites age beautifully.

    For more information visit www.altoadigewinesusa.com or join us on Facebook at Alto Adige Wine, and Instagram and Twitter at @AltoAdigeWines.

    ALTO ADIGE - SÜDTIROL WINE MARKETING BOARD
    The Alto Adige Wine Board was formed in 1975 by a group of winemaking companies to promote and strengthen the image of the wines from Alto Adige. The promotional campaigns are implemented by IDM Südtirol/Alto Adige on behalf of the Consortium of Alto Adige Wines. The Alto Adige Wine Board is active in Italy, Germany, Austria, England, Benelux, Russia, Japan, Switzerland, and in the United States.

    ALTO ADIGE WINES PRORUS MARKETING CAMPAIGN
    The objectives of the PRORUS campaign, co-financed by the Italian State and the European Union, are to increase overall US awareness of the DOC wines from Alto Adige, demonstrate their versatility with a wide range of foods, and showcase the diverse palette of wines that emanate from such a unique winegrowing region.

    CONTACT: Marisa Jetter
    AltoAdigeWines@tewuwen.com Reported by GlobeNewswire 1 hour ago.

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    Five of Mexico’s top chefs came together last month at Grand Velas Riviera Maya for an intimate panel on the current landscape of Mexican cuisine, focusing on the process of nixtamalization for corn which is seeing a major revival.

    RIVIERA MAYA, Mexico (PRWEB) December 03, 2018

    Five of Mexico’s top chefs came together last month for an intimate panel on the current landscape of Mexican cui-sine, focusing on the process of nixtamalization for corn which is seeing a major revival. The discussion was part of The Best of Mexico´s Culinary Traditions Riviera Maya, held at the AAA Five Diamond Grand Velas Riviera Maya resort. Corn nixtamalization is the process of soaking dry corn overnight in hot water with limestone. The process makes the corn become more nutritious by releasing the vitamin B3, shifting the balance of proteins. Some kitchens in the US ad-ditionally are starting to employ the process, which has been around in Mayan cooking since 1500 BC. Additional high-lights of the discussion included the growth of interest in traditional cuisine versus modern and contemporary alterna-tives, the Chilhuacle chili as the next big ingredient, and regional specialties. The event also included a multi-course dinner focused on traditional Mexican flavors, cooking techniques and ingredients combined with a Mexican wine and mezcal tasting, traditional Barbacoa barbecue, artisanal beverage tasting and storytelling dinners.

    Participating guest chefs included Oaxacan food authority Reyna Mendoza; Ricardo Muñoz Zurita, author of Dic-cionario Enciclopédico de la Gastronomía Mexicana; Yucatan chef David Cetina; Joel Ornelas of Tintoque in Puerto Val-larta; and Pablo Salas, who operates Pueblo in Chicago in cooperation with Richard Sandoval and Lona in Fort Lauder-dale. They teamed up with chefs Humberto May Tamay and Laura Avalos of Grand Velas' Mayan restaurant, Chaka, and Executive Chef Mario Lopez.

    Under the direction of Maître Cuisinier de France Michel Mustiere, Culinary Director of Mexico’s Velas Resorts, The Best Of series is part of the resort’s commitment to promote local and international gastronomy. For the fourth con-secutive year, the resort invited renowned chefs based on a special culinary theme to prepare a standout dining expe-rience alongside the top chefs at the resort. In 2019, the resort is set to explore the Best of Asia hosted by Chef Wayu “Light” Wattanakamin of the resort’s AAA Four Diamond Restaurant Sen Lin.

    For reservations or additional information, call 1-888-407-4869, or visit https://rivieramaya.grandvelas.com/.

    About Grand Velas Riviera Maya:
    The AAA Five Diamond Grand Velas Riviera Maya is an ultra-luxury all-inclusive resort set on 206 acres of pristine jungle and mangroves and with the finest white sand beach in the Riviera Maya. Guests can choose accommodations among oceanfront, ocean view and a Zen-like tropical setting, embraced by the flora and fauna of the Yucatan Peninsula’s jungle. All 539 designer-like suites are exceptionally spacious, more than 1,100 square feet each, all with balconies, and some with private plunge pools. All feature fully stocked mini bars, L’Occitane amenities, artisanal mezcal, and Nespresso coffee machines. Bathrooms deserve special mention with walk in glass shower, deep soaking Jacuzzi tubs and marble interior. Eight restaurants, including five gourmet offerings, present a tour through Mexico, Europe and Asia. Cocina de Autor, at the hands of world renowned celebrity chefs Bruno Oteiza and Mikel Alonso, holds the AAA Five Diamond Award, the first all-inclusive res-taurant in the world to win this prestigious distinction. Se Spa is the region's largest spa sanctuary at more than 90,000 square feet, known for its authentic Mexican treatments, offerings from around world and signature seven-step water journey. Other features include 24-hour Personal Concierge; 24/7 in-suite service; three swimming pools; two fitness centers; water sports; innovative Kids’ Clubs and Teens’ Club; baby concierge; Karaoke Bar; Koi Bar; Piano Bar, and business center. The resort offers more than 91,000 square feet of meeting space and outdoor areas for events inclusive of a 31,000-square-foot Convention Center, able to accommodate up to 2,700 guests. The resort has won numerous awards from Travel + Leisure, Conde Nast Traveler, USA Today and several other magazines and major companies worldwide, including Virtuoso’s Best Spa and TripAdvisor’s Hall of Fame. A member of the Virtuoso Hotels & Resorts Program, Grand Velas Riviera Maya was built and is operated by Eduardo Vela Ruiz, founder and president of Velas Resorts, with brother Juan Vela, vice president of Velas Resorts, by his side. For reservations or additional information, call 1-888-407-4869, or visit https://rivieramaya.grandvelas.com/. Reported by PRWeb 52 minutes ago.

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    Innovest Systems is FedRAMP Assessment-Ready in Less than 6 Months Partnering with Coalfire and Amazon Web Services (AWS) GovCloud (US)

    NEW YORK (PRWEB) December 03, 2018

    Innovest Systems, LLC (“Innovest”), a leading provider of financial technology solutions, announced today that it had become FedRAMP assessment ready in less than 6 months. Innovest engaged with Coalfire, a provider of cybersecurity advisory services, utilizing their Federal Risk and Authorization Management Program (FedRAMP) consulting and engineering service and using AWS Security Automation and Orchestration (SAO) methodology. Coalfire is one of the security providers to collaborate with AWS in developing the SAO methodology, which helps reduce risk and ease the burden of deploying solutions that meet FedRAMP compliance.

    Using the new AWS SAO methodology, Coalfire completed Innovest’s FedRAMP SAO cloud migration and documentation in far less time than traditional approaches that can take 12 months or more. Innovest is pursuing a FedRAMP Agency Authority to Operate (ATO) through a civilian agency within the AWS GovCloud (US) region.

    "We are very pleased to have engaged with Coalfire and AWS to accelerate our FedRAMP process. Their approach allowed us to meet our deliverables and exceed our client’s expectations. We have also gained valuable experience and insights into the process that will enable us to bring FedRAMP readiness to a broader audience," said Joanne Smith, Chief Operating Officer at Innovest.

    ABOUT INNOVEST SYSTEMS
    Innovest Systems, LLC is a leading provider of financial technology solutions delivered to forward-thinking trust, wealth management, and retirement professionals. Innovest's solutions empower its clients to acquire new customers, invest assets effectively, manage trust and investment portfolios efficiently, and flexibly report results to customers. Innovest has over $600 billion in assets under administration on its trust and wealth management platform servicing over three hundred global financial institutions.

    The Innovest Trust & Wealth Management Solution provides a Software-as-a-Service (SaaS)-based principal and income accounting, investment management and reporting system for institutions that need to control, account for and report on assets held in trust, wealth and retirement accounts. The Trust & Wealth Management Solution is comprised of the InnoTrust and InnoVue offerings from Innovest. InnoTrust is browser-based and is the core application deployed by Innovest to support the accounting and reporting needs of banks, trust companies, wealth management firms, retirement plan administrators and custodians. InnoTrust is also webservices/API enabled to more readily integrate with internal programs and third-party applications. InnoVue is browser-based and provides access for end clients to view account information anytime, anywhere.

    ABOUT COALFIRE
    Coalfire is the trusted cybersecurity advisor that helps private and public-sector organizations avert threats, close gaps and effectively manage risk. By providing independent and tailored advice, assessments, technical testing and cyber engineering services, we help clients develop scalable programs that improve their security posture, achieve their business objectives and fuel their continued success. Coalfire is the leading FedRAMP Third Party Assessment Organization (3PAO) with over 80 cloud service provider (CSP) clients achieving a FedRAMP JAB P-ATO or Agency ATO. Coalfire's FedRAMP advisory team works with many other CSPs to prepare, design and document systems for FedRAMP. Coalfire has been a cybersecurity thought leader for more than 17 years and has offices throughout the United States and Europe.

    SOURCE Innovest Reported by PRWeb 52 minutes ago.

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    Julie Albrecht to Assume Chief Financial Officer Duties

    HARTSVILLE, S.C., Dec. 03, 2018 (GLOBE NEWSWIRE) -- Sonoco (NYSE: SON), one of the largest diversified global packaging companies, today announced Barry Saunders, Senior Vice President and Chief Financial Officer, has announced his plans to retire after nearly 30 years with the Company, effective March 1, 2019.Sonoco also announced plans to appoint Julie Albrecht who will be named Vice President and Chief Financial Officer, effective following Saunders’ retirement. On March 1, 2019, Albrecht is expected to assume CFO duties for the Company’s 2019 financial year and report to Rob Tiede, President and Chief Executive Officer. She is a member of the Company’s Executive Committee.

    Albrecht, 51, joined Sonoco in March 2017 and has served as Corporate Vice President, Treasurer and Assistant CFO, holding responsibility for the Company’s treasury, tax and risk management functions. During that time she has been responsible for the Company’s relationships with the credit rating agencies and commercial banks and has handled financings for four acquisitions totaling approximately $690 million. She also has been instrumental in the Company’s efforts to drive significant improvement in cash flow from operations and free cash flow in 2018, and has been responsible for management of the Company’s retirement benefit plans.

    Albrecht spent nearly 20 years at Goodrich Corporation/United Technologies Aerospace Systems, progressing through several finance positions, including Assistant Treasurer while at Goodrich. In 2012, Goodrich was acquired by United Technologies, and Albrecht became Finance Director of an $800 million business unit and also led financial planning and analysis for a $3.5 billion aftermarket business. Prior to joining Sonoco, she was Vice President, Finance, Investor Relations and Treasurer for Esterline Technologies Corporation in Bellevue, Washington. Albrecht began her career in public accounting with PricewaterhouseCoopers after graduating from Wake Forest University with a BS in Accounting with honors.

    “I am excited about the prospect of Julie becoming CFO upon Barry’s retirement. Her experience and leadership in several key financial roles, both inside and outside Sonoco, positions her well to continue building upon the strong financial footing Sonoco has developed over its nearly 120-year history,” said Tiede.

    Saunders, 59, became Sonoco’s CFO in May 2011. In this position, he led the Company’s financial and accounting operations on a global basis and more recently took over leadership of Sonoco’s Business Technology function. Saunders joined Sonoco in 1989 after working as an audit manager with Ernst & Young. He worked in leadership positions in the Company’s Treasury Department for seven years before becoming Director of Corporate Reporting and Accounting.  He then moved to Europe for four years as Director of Finance for the Company’s European operations before returning as Staff Vice President and Global Controller of the Company’s Industrial businesses. He was promoted to Staff Vice President and Corporate Controller in 2003 and became Vice President, Corporate Controller and Chief Accounting Officer in 2008. Saunders holds a B.S. in Accounting and an MBA from the University of South Carolina.

    “Barry has played a crucial role in driving profitable growth across Sonoco’s Consumer and Industrial businesses, as well as being a vital part of the executive leadership team during the development and execution of our current business strategy,” said Tiede. “Barry has built a very strong team of financial leaders throughout our businesses who serve as important business partners across our global operations. I want to personally thank Barry for being a trusted advisor and for his significant contributions to Sonoco throughout his career.”

    A photo of Albrecht can be found here.

    *About Sonoco*
    Founded in 1899, Sonoco (NYSE: SON) is a global provider of a variety of consumer packaging, industrial products, protective packaging, and displays and packaging supply chain services. With annualized net sales of approximately $5 billion, the Company has 21,000 employees working in approximately 300 operations in 33 countries, serving some of the world’s best known brands in some 85 nations. Sonoco is committed to Better Packaging. Better Life., and ranked first in the Packaging sector on Fortune’s World’s Most Admired Companies 2018 list. For more information, visit www.sonoco.com.

    CONTACT:
    Contact:
    Roger Schrum
    +843-339-6018
    roger.schrum@sonoco.com Reported by GlobeNewswire 39 minutes ago.

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    CAMBRIDGE, Mass., Dec. 03, 2018 (GLOBE NEWSWIRE) -- Scholar Rock Holding Corporation (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced that the European Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending SRK-015 (human anti-promyostatin monoclonal antibody) for designation as an orphan medicinal product for the treatment of Spinal Muscular Atrophy (SMA).  SRK-015 was previously granted orphan drug designation by the U.S. Food and Drug Administration (FDA) in March 2018.“We are delighted with the EMA COMP’s adoption of a positive opinion for SRK-015 orphan drug designation, which represents another important milestone for this clinical program,” said Nagesh Mahanthappa, PhD, President and CEO of Scholar Rock.  “We believe SRK-015 has the potential to be the first muscle-directed therapy to improve muscle function in patients with SMA and look forward to working with the EMA as we progress the program, including our intention to initiate a Phase 2 proof-of-concept study in the first quarter of 2019.”

    Orphan Medicinal Product Designation by the European Commission is available to companies developing products intended to treat a life-threatening or chronically debilitating condition that affects fewer than five in 10,000 people in the EU, and has the potential to be of significant benefit.  This designation could allow for a number of incentives, including protocol assistance, access to the centralized authorization procedure, reduced regulatory fees, and a 10-year period of marketing exclusivity in the EU after product approval.

    *About SRK-015*
    SRK-015 is a selective inhibitor of the activation of myostatin and is an investigational product candidate for the treatment of patients with spinal muscular atrophy (SMA).  Myostatin, a member of the TGF-beta superfamily of growth factors, is expressed primarily by skeletal muscle cells and the absence of its gene is associated with an increase in muscle mass and strength in multiple animal species.  Scholar Rock believes the inhibition of the activation of myostatin with SRK-015 may promote a clinically meaningful increase in muscle mass and strength.  A Phase 1 clinical trial in healthy volunteers is ongoing.  The effectiveness and safety of SRK-015 have not been established and SRK-015 has not been approved by the FDA or any other regulatory agency.

    *About SMA*
    Spinal muscular atrophy (SMA) is a rare, and often fatal, genetic disorder that typically manifests in young children. An estimated 30,000 to 35,000 patients are afflicted with SMA in the United States and Europe. It is characterized by the loss of motor neurons, atrophy of the voluntary muscles of the limbs and trunk and progressive muscle weakness. The underlying pathology of SMA is caused by insufficient production of the SMN (survival of motor neuron) protein, essential for the survival of motor neurons and is encoded by two genes, SMN1 and SMN2.  While there has been progress in the development of therapeutics that address the underlying SMA genetic defect, there continues to be a high unmet need for therapeutics that directly address muscle atrophy.

    *About Scholar Rock*
    Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role.  Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia.  Scholar Rock’s newly elucidated understanding of the molecular mechanisms of growth factor activation enabled it to develop a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level.  By developing product candidates that act in the disease microenvironment, the Company intends to avoid the historical challenges associated with inhibiting growth factors for therapeutic effect.  Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path. For more information, please visit www.ScholarRock.com or follow Scholar Rock on Twitter (@ScholarRock) and LinkedIn (https://www.linkedin.com/company/scholar-rock/).Scholar Rock^® is a registered trademark of Scholar Rock, Inc.

    *Forward-Looking Statements*
    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Scholar Rock’s future expectations, plans and prospects, including without limitation, Scholar Rock’s expectations regarding the potential of SRK-015 as a therapy in SMA and the timeline for and progress in developing SRK-015. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include those risks more fully discussed in the section entitled "Risk Factors" in Scholar Rock’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, as well as discussions of potential risks, uncertainties, and other important factors in Scholar Rock’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Scholar Rock’s views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Scholar Rock undertakes no duty to update this information unless required by law.

    CONTACT: Scholar Rock Contact:
    Investors/Media
    Catherine Hu, 917-601-1649
    chu@scholarrock.com

    Media Contact:
    The Yates Network
    Kathryn Morris, 914-204-6412
    kathryn@theyatesnetwork.com Reported by GlobeNewswire 39 minutes ago.

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    Delta Air Lines' pre-select meal option will soon be available on all Delta One routes, expanding the food option to more business customers traveling between the U.S. and Europe, Middle East, Africa, Asia and South America. Beginning Dec. 6, pre-select meals will be available in more than 200 markets around the world, marking a relatively speedy expansion since its initial launch in March. Delta One is the airline's latest update to its business-class cabin that features lie-flat beds and… Reported by bizjournals 19 minutes ago.

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    Company Executed Approximately $200 Million in Share Repurchases Quarter-to-Date and $664 Million Year-to-Date

    MIAMI, Dec. 03, 2018 (GLOBE NEWSWIRE) -- Norwegian Cruise Line Holdings Ltd. (NYSE: NCLH) (together with NCL Corporation Ltd., “Norwegian Cruise Line Holdings”, “Norwegian” or the “Company”) today announced that in connection with the closing of the previously announced secondary public offering by certain funds affiliated with Apollo Global Management, LLC (“Apollo”) and Star NCLC Holdings Ltd. (together, the “Sponsors”), the Sponsors will no longer beneficially own any ordinary shares of Norwegian.“Apollo Global Management and our other sponsors played key roles in the turnaround and expansion of Norwegian Cruise Line Holdings.  We could not have asked for a better business partner than Apollo and we are grateful for their support and contributions over the last eleven years,” said Frank Del Rio, president and chief executive officer of Norwegian Cruise Line Holdings Ltd. “As we look ahead to the next chapter of Norwegian’s storied history, we find our company at an inflection point to further maximize shareholder returns by building on our key strengths, executing on our disciplined newbuild program and continuing to deliver strong financial results.”

    In connection with the offering, the Company repurchased approximately $85 million of ordinary shares of Norwegian from the underwriter under its existing $1.0 billion share repurchase program, of which approximately $600 million remains for future share repurchases.

    *About Norwegian Cruise Line Holdings Ltd.*

    Norwegian Cruise Line Holdings Ltd. (NYSE:NCLH) is a leading global cruise company which operates the Norwegian Cruise Line, Oceania Cruises and Regent Seven Seas Cruises brands.

    With a combined fleet of 26 ships with approximately 54,400 berths, these brands offer itineraries to more than 450 destinations worldwide. The Company will introduce eight additional ships through 2027.

    Norwegian Cruise Line is the innovator in cruise travel with a 51-year history of breaking the boundaries of traditional cruising.  Most notably, Norwegian revolutionized the cruise industry by offering guests the freedom and flexibility to design their ideal cruise vacation on their schedule with no set dining times, a variety of entertainment options and no formal dress codes. Today, Norwegian invites guests to enjoy a relaxed, resort- style cruise vacation on some of the newest and most contemporary ships at sea with a wide variety of accommodations options, including The Haven by Norwegian®, a luxury enclave with suites, private pool and dining, concierge service and personal butlers. Norwegian Cruise Line sails around the globe, offering guests the freedom and flexibility to explore the world on their own time and experience up to 27 dining options, award-winning entertainment, superior guest service and more across all of the brand’s 16 ships.

    Oceania Cruises is the world’s leading culinary- and destination-focused cruise line. The line’s six intimate and luxurious ships which carry only 684 or 1,250 guests offer an unrivaled vacation experience featuring the finest cuisine at sea and destination-rich itineraries that span the globe. Expertly crafted voyages aboard designer-inspired, intimate ships call on more than 450 ports across Europe, Alaska, Asia, Africa, Australia, New Zealand, New England-Canada, Bermuda, the Caribbean, Panama Canal, Tahiti and the South Pacific and epic Around The World Voyages that range from 180 to 200 days.  

    Regent Seven Seas Cruises offers the industry’s most inclusive luxury experience aboard its all-suite fleet. Seven Seas Mariner’s 2018 dry-dock refurbishment concluded the line’s $125 million refurbishment program to elevate the elegance of the whole fleet to the standard set by Seven Seas Explorer. In early 2020, Regent will perfect luxury with the launch of Seven Seas Splendor. A voyage with Regent Seven Seas Cruises includes all-suite accommodations, round-trip air, highly personalized service, exquisite cuisine, fine wines and spirits, unlimited internet access, sightseeing excursions in every port, gratuities, ground transfers and a pre-cruise hotel package for guests staying in concierge-level suites and higher.

    *Cautionary Statement Concerning Forward-Looking Statements*
    Certain statements in this release or that may be mentioned on our conference call constitute forward-looking statements within the meaning of the U.S. federal securities laws intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this release or that may be mentioned on our conference call, including, without limitation, those regarding our business strategy, financial position, results of operations, plans, potential share repurchases or dividends, future deleveraging, prospects and objectives of management for future operations (including expected fleet additions, development plans, demand environment, objectives relating to our activities and expected performance in new markets), are forward-looking statements. Many, but not all, of these statements can be found by looking for words like "expect,""anticipate,""goal,""project,""plan,""believe,""seek,""will,""may,""forecast,""estimate,""intend,""future," and similar words. Forward-looking statements do not guarantee future performance and may involve risks, uncertainties and other factors which could cause our actual results, performance or achievements to differ materially from the future results, performance or achievements expressed or implied in those forward-looking statements. Examples of these risks, uncertainties and other factors include, but are not limited to the impact of: adverse events impacting the security of travel, such as terrorist acts, armed conflict and threats thereof, acts of piracy, and other international events; adverse incidents involving cruise ships; adverse general economic and related factors, such as fluctuating or increasing levels of unemployment, underemployment and the volatility of fuel prices, declines in the securities and real estate markets, and perceptions of these conditions that decrease the level of disposable income of consumers or consumer confidence; the spread of epidemics and viral outbreaks; our expansion into and investments in new markets;  the risks and increased costs associated with operating internationally; breaches in data security or other disturbances to our information technology and other networks; changes in fuel prices and/or other cruise operating costs; fluctuations in foreign currency exchange rates; overcapacity in key markets or globally; the unavailability of attractive port destinations; evolving requirements and regulations regarding data privacy and protection and any actual or perceived compliance failures by us; our indebtedness and restrictions in the agreements governing our indebtedness that limit our flexibility in operating our business; the significant portion of our assets pledged as collateral under our existing debt agreements and the ability of our creditors to accelerate the repayment of our indebtedness; volatility and disruptions in the global credit and financial markets, which may adversely affect our ability to borrow and could increase our counterparty credit risks, including those under our credit facilities, derivatives, contingent obligations, insurance contracts and new ship progress payment guarantees; our inability to recruit or retain qualified personnel or the loss of key personnel; delays in our shipbuilding program and ship repairs, maintenance and refurbishments; our reliance on third parties to provide hotel management services to certain ships and certain other services; future increases in the price of, or major changes or reduction in, commercial airline services; amendments to our collective bargaining agreements for crew members and other employee relation issues; our inability to obtain adequate insurance coverage; future changes relating to how external distribution channels sell and market our cruises; pending or threatened litigation, investigations and enforcement actions; our ability to keep pace with developments in technology; seasonal variations in passenger fare rates and occupancy levels at different times of the year; changes involving the tax and environmental regulatory regimes in which we operate; and other factors set forth under "Risk Factors" in our most recently filed Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings by the Company with the Securities and Exchange Commission. The above examples are not exhaustive and new risks emerge from time to time. Such forward-looking statements are based on our current beliefs, assumptions, expectations, estimates and projections regarding our present and future business strategies and the environment in which we expect to operate in the future. These forward-looking statements speak only as of the date made. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement contained herein or that may be mentioned on our conference call to reflect any change in our expectations with regard thereto or any change of events, conditions or circumstances on which any such statement was based, except as required by law.

    *Investor Relations & Media Contacts*

    Andrea DeMarco                                                                                                                                    
    (305) 468-2339
    InvestorRelations@nclcorp.com

    Jordan Kever
    (305) 436-4961 Reported by GlobeNewswire 29 minutes ago.

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    NEW YORK, Dec. 03, 2018 (GLOBE NEWSWIRE) -- Guggenheim Investments today announced that certain closed-end funds have declared their distributions. The table below summarizes the distribution schedule for each closed-end fund (collectively, the “Funds” and each, a “Fund”).*The following dates apply to the distributions:*

    *Record Date* December 14, 2018
       
    *Ex-Dividend Date       * December 13, 2018
       
    *Payable Date* December 31, 2018

    *Distribution Schedule*
    *NYSE Ticker* *Closed-End Fund Name* *Distribution *
    * Per Share* *Change from Previous Distribution* *Frequency*
    AVK Advent Claymore Convertible Securities and Income Fund $0.1172^1   Monthly
    GBAB Guggenheim Taxable Municipal Managed Duration Trust $0.12573^2   Monthly
    GGM Guggenheim Credit
    Allocation Fund $0.1813^1   Monthly
    GOF Guggenheim Strategic Opportunities Fund $0.1821^2   Monthly
    GPM Guggenheim Enhanced Equity Income Fund $0.24^1,3   Quarterly

    ^1 A portion of this distribution is estimated to be a return of capital rather than income. Final determination of the character of distributions will be made at year-end. The Section 19(a) notice referenced below provides more information and can be found at www.guggenheiminvestments.com.

    ^2 It is estimated that approximately 46% of GBAB’s December 2018 distribution and 40% of GOF’s December 2018 distribution will consist of long-term capital gains.

    ^3 Guggenheim Enhanced Equity Income Fund (“GPM”) adopted a managed distribution policy (the “Distribution Policy”) effective with the June 30, 2017 distribution. Under the terms of the Distribution Policy, GPM will pay a quarterly distribution in a fixed amount until such amount is modified by the Board of Trustees. If sufficient net investment income is not available, the distribution will be supplemented by capital gains and, to the extent necessary, return of capital.

    The following table sets forth the estimated amounts of GPM’s current distribution and the cumulative distributions paid this fiscal year to date from the following sources: net investment income; net realized short-term capital gains; net realized long-term capital gains and return of capital. All amounts are expressed per common share.

      Estimated
    Amounts of
    the
    Current
    Quarterly
    Distribution ($) Estimated
    % Breakdown of
    the Current
    Quarterly
    Distribution Estimated
    Amounts of the
    Total Cumulative
    Distributions for
    the Fiscal Year to
    Date ($) Estimated
    % Breakdown of
    the Total
    Cumulative
    Distributions for the
    Fiscal Year to Date
    Net Investment Income - - - -
    Net Realized Short-Term Capital Gains - - - -
    Net Realized Long-Term Capital Gains $0.2400 100.00% $0.5914 61.60%
    Return of Capital - - $0.3686 38.40%
    Total Distribution $0.2400 100.00% $0.9600 100.00%

    If the Fund estimates that it has distributed more than its income and net realized capital gains, a portion of your distribution may be a return of capital. A return of capital may occur, for example, when some or all of the money that you invested in the Fund is paid back to you. A return of capital distribution does not necessarily reflect the Fund’s investment performance and should not be confused with “yield” or “income”.

    The amounts and sources of distributions reported are only estimates and are not being provided for tax reporting purposes. The actual amounts and sources of the amounts for tax reporting purposes will depend upon the Fund’s investment experience during the remainder of its fiscal year and may be subject to changes based on tax regulations. The Fund will send you a Form 1099-DIV for the calendar year that will tell you how to report these distributions for federal income tax purposes.

    The following table provides GPM’s total return performance based on net asset value (NAV) over various time periods compared to GPM’s annualized and cumulative distribution rates.

    Annualized total return (in relation to NAV) for the five-year period ending November 30, 2018 7.91%  
    Annualized current distribution rate expressed as a percentage of NAV as of November 30, 2018 11.88%  
    Cumulative total return (in relation to NAV) for the fiscal year through November 30, 2018 -2.54%  
    Cumulative fiscal year distributions as a percentage of NAV as of November 30, 2018 8.91%  

    Performance data quoted represents past performance, which is no guarantee of future results and current performance may be lower or higher than the figures shown. Total returns in relation to NAV reflect the Fund's total annual expenses.

    You should not draw any conclusions about the Fund’s investment performance from the amount of this distribution or from the terms of the Fund’s Distribution Policy.

    *Past performance is not indicative of future performance.* As of this announcement, the sources of each fund distribution are estimates. Distributions may be paid from sources of income other than ordinary income, such as short-term capital gains, long-term capital gains or return of capital. Unless otherwise noted, the distributions above are not anticipated to include a return of capital. If a distribution consists of something other than ordinary income, a Section 19(a) notice detailing the anticipated source(s) of the distribution will be made available. The Section 19(a) notice will be posted to a Fund’s website and to the Depository Trust & Clearing Corporation so that brokers can distribute such notices to Shareholders of the Fund. Section 19(a) notices are provided for informational purposes only and not for tax reporting purposes. The final determination of the source and tax characteristics of all distributions in 2018 will be made after the end of the year. This information is not legal or tax advice. Consult a professional regarding your specific legal or tax matters.

    *About Guggenheim Investments*

    Guggenheim Investments is the global asset management and investment advisory division of Guggenheim Partners, LLC (“Guggenheim”), with $207 billion^* in assets under management across fixed income, equity, and alternative strategies. We focus on the return and risk needs of insurance companies, corporate and public pension funds, sovereign wealth funds, endowments and foundations, consultants, wealth managers, and high-net-worth investors. Our 300+ investment professionals perform rigorous research to understand market trends and identify undervalued opportunities in areas that are often complex and underfollowed. This approach to investment management has enabled us to deliver innovative strategies providing diversification opportunities and attractive long-term results.

    Guggenheim Investments includes Guggenheim Funds Investment Advisors, LLC (“GFIA”), Guggenheim Partners Investment Management (“GPIM”), and Guggenheim Funds Distributors, LLC (”GFD”). GFD serves as servicing agent for AVK. GFIA serves as Investment Adviser for FMO, GBAB, GGM and GOF. GPIM serves as Investment Sub-Adviser for GBAB, GGM and GOF. Advisory Research, Inc. serves as Investment Sub-Adviser for FMO and is not affiliated with Guggenheim. The Investment Adviser for AVK is Advent Capital Management, LLC and is not affiliated with Guggenheim.

    *Assets under management is as of 09.30.2018 and includes leverage of $11.8bn. Guggenheim Investments represents the following affiliated investment management businesses of Guggenheim Partners, LLC: Guggenheim Partners Investment Management, LLC, Security Investors, LLC, Guggenheim Funds Investment Advisors, LLC, Guggenheim Funds Distributors, LLC, Guggenheim Real Estate, LLC, GS GAMMA Advisors, LLC, Guggenheim Partners Europe Limited and Guggenheim Partners India Management.

    This information does not represent an offer to sell securities of the Funds and it is not soliciting an offer to buy securities of the Funds. There can be no assurance that the Funds will achieve their investment objectives. Investments in the Funds involve operating expenses and fees. The net asset value of the Funds will fluctuate with the value of the underlying securities. It is important to note that closed-end funds trade on their market value, not net asset value, and closed-end funds often trade at a discount to their net asset value. Past performance is not indicative of future performance. An investment in closed-end funds is subject to investment risk, including the possible loss of the entire amount that you invest. Some general risks and considerations associated with investing in a closed-end fund may include: Investment and Market Risk; Lower Grade Securities Risk; Equity Securities Risk; Foreign Securities Risk; Interest Rate Risk; Illiquidity Risk; Derivative Risk; Management Risk; Anti-Takeover Provisions; Market Disruption Risk and Leverage Risk. See www.guggenheiminvestments.com/cef for a detailed discussion of Fund-specific risks.

    *Investors should consider the investment objectives and policies, risk considerations, charges and expenses of any investment before they invest. For this and more information, visit www.guggenheiminvestments.com or contact a securities representative or Guggenheim Funds Distributors, LLC 227 West Monroe Street, Chicago, IL 60606, 800-345-7999.*

    *Analyst Inquiries
    *William T. Korver
    cefs@guggenheiminvestments.com

    Not FDIC-Insured | Not Bank-Guaranteed | May Lose Value
    Member FINRA/SIPC (12/18) Reported by GlobeNewswire 29 minutes ago.

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    NEW YORK, Dec. 03, 2018 (GLOBE NEWSWIRE) -- Guggenheim Investments today announced that Guggenheim Energy & Income Fund (the “Fund”) (XGEIX) declared its quarterly distribution. The table below summarizes the distribution schedule for the Fund. The Fund’s CUSIP is 40169Q105.*The following dates apply to the distribution:**Record Date* 

    December 14, 2018

    *Ex-Dividend Date*

    December 13, 2018

    *Payable Date*

    December 31, 2018

    *Distribution**
    ** *
    *Closed-End Fund Name** * *Distribution *
    * Per Share*
    Guggenheim Energy & Income Fund^1   $26.8125

    ^1It is estimated that approximately 2% of XGEIX’s December 2018 distribution will consist of long-term capital gains.

    The Fund’s primary investment objective is to provide high income. As a secondary investment objective, the Fund will seek capital appreciation. There can be no assurance the Fund will achieve its investment objectives.

    Under normal market conditions, the Fund will invest at least 80% of its Managed Assets in (i) securities of energy companies and (ii) income producing securities of other issuers. Under normal market conditions, the Fund will invest at least 70% of its Managed Assets in securities of energy companies. The Fund intends to focus its energy company investments in debt securities, including bonds, debentures, notes, loans and loan participations, mezzanine and preferred securities, convertible securities and structured products.

    The Fund may invest in debt securities of any credit quality, and may invest without limitation in securities of below investment grade quality (also known as “high yield securities” or “junk bonds”).

    The Fund's common shares are not listed for trading on any securities exchange. Accordingly, no secondary market for the common shares is expected to exist, and an investment in the common shares should be considered illiquid. The Fund is designed primarily for long-term investors who are prepared to hold common shares until the occurrence of a shareholder liquidity event.

    The Fund intends to complete an event intended to provide liquidity for the holders of common shares on or before July 28, 2023. You should consider that you may not have access to the money you invest until that time, and may never recover your entire initial investment in the Fund. An investment in common shares is not suitable for you if you need access to the money you invest.

    Because the common shares will not be listed on a securities exchange, you should not expect to be able to sell your common shares regardless of how the Fund performs and, as a result, you may be unable to reduce your exposure during any market downturn. If you are able to sell your common shares, you may receive less than your original investment. The Fund's net asset value is available through Nasdaq under the symbol XGEIX.

    *Past performance is not indicative of future performance.* As of this announcement, the sources of the distribution are estimates. Distributions may be paid from sources of income other than ordinary income, such as short-term capital gains, long-term capital gains or return of capital. Unless otherwise noted, the distribution above is not anticipated to include a return of capital. If a distribution consists of something other than ordinary income, a Section 19(a) notice detailing the anticipated source(s) of the distribution will be made available. The Section 19(a) notice will be posted to the Fund’s website and to the Depository Trust & Clearing Corporation so that brokers can distribute such notices to Shareholders of the Fund. Section 19(a) notices are provided for informational purposes only and not for tax reporting purposes. The final determination of the source and tax characteristics of all distributions in 2018 will be made after the end of the year. This information is not legal or tax advice. Consult a professional regarding your specific legal or tax matters.

    *About Guggenheim Investments*

    Guggenheim Investments is the global asset management and investment advisory division of Guggenheim Partners, LLC (“Guggenheim”), with $207 billion^* in assets under management across fixed income, equity, and alternative strategies. We focus on the return and risk needs of insurance companies, corporate and public pension funds, sovereign wealth funds, endowments and foundations, consultants, wealth managers, and high-net-worth investors. Our 300+ investment professionals perform rigorous research to understand market trends and identify undervalued opportunities in areas that are often complex and underfollowed. This approach to investment management has enabled us to deliver innovative strategies providing diversification opportunities and attractive long-term results.

    Guggenheim Investments includes Guggenheim Funds Investment Advisors, LLC (“GFIA”), Guggenheim Partners Investment Management (“GPIM”), and Guggenheim Funds Distributors, LLC (”GFD”). GFD serves as servicing agent for AVK. GFIA serves as Investment Adviser for FMO, GBAB, GGM and GOF. GPIM serves as Investment Sub-Adviser for GBAB, GGM and GOF. Advisory Research, Inc. serves as Investment Sub-Adviser for FMO and is not affiliated with Guggenheim. The Investment Adviser for AVK is Advent Capital Management, LLC and is not affiliated with Guggenheim.

    *Assets under management is as of 09.30.2018 and includes leverage of $11.8bn. Guggenheim Investments represents the following affiliated investment management businesses of Guggenheim Partners, LLC: Guggenheim Partners Investment Management, LLC, Security Investors, LLC, Guggenheim Funds Investment Advisors, LLC, Guggenheim Funds Distributors, LLC, Guggenheim Real Estate, LLC, GS GAMMA Advisors, LLC, Guggenheim Partners Europe Limited and Guggenheim Partners India Management.

    This information does not represent an offer to sell securities of the Fund and it is not soliciting an offer to buy securities of the Fund. An investment in the Fund involves a high degree of risk. The Fund should be considered an illiquid investment. The Fund does not intend to apply for an exchange listing, and it is highly unlikely that a secondary market will exist for the purchase and sale of the Fund’s common shares. You could lose some or all of your investment. An investment in the Fund is not appropriate for all investors and is not intended to be a complete investment program. The Fund is designed as a long-term investment for investors who are prepared to hold the Fund’s common shares until the date of the Liquidity Event, and is not a trading vehicle. All investments are subject to risk, including possible loss of principal. Fixed income securities are subject to numerous risks, including but not limited to: credit, inflation, income, prepayment and interest rates risks. As interest rates rise, the value of fixed income securities fall. The Fund may invest without limitation in high-yield (“junk bonds”). High yield bonds (“junk bonds”) are subject to higher credit risk and a greater risk of default. The Fund may invest all or a portion of its Managed Assets in illiquid securities. The Fund may make significant investments in securities for which there are no observable market prices; the prices of which must be estimated by the investment adviser. Investments in foreign securities involve risks, including the possibility of losses due to changes in currency exchange rates and negative developments in the political, economic or regulatory structure of specific countries or regions. These risks are greater in emerging markets. Leverage may result in greater volatility of net asset value (NAV) of common shares and increases a shareholder’s risk of loss. Derivative instruments can be illiquid, may disproportionately increase losses and have a potentially large impact on Fund performance. Distributions are not guaranteed and are subject to change.

    *Investors should consider the investment objectives and policies, risk considerations, charges and expenses of any investment before they invest. For this and more information, visit www.guggenheiminvestments.com or contact a securities representative or Guggenheim Funds Distributors, LLC 227 West Monroe Street, Chicago, IL 60606, 800-345-7999.*

    *Analyst Inquiries
    *William T. Korver
    cefs@guggenheiminvestments.com

    Not FDIC-Insured | Not Bank-Guaranteed | May Lose Value
    Member FINRA/SIPC (12/18) Reported by GlobeNewswire 29 minutes ago.

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    Reported by SeekingAlpha 25 minutes ago.

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    ROSH HA’AYIN, Israel, Dec. 03, 2018 (GLOBE NEWSWIRE) -- Kornit Digital Ltd. (NASDAQ: KRNT), a company that develops, designs and markets innovative digital printing solutions for the global printed textile industry, announced today the launch of an underwritten secondary public offering of 3,132,481 ordinary shares by Fortissimo Capital Fund II (Israel) L.P. (“Fortissimo”). The company will not receive any of the proceeds from the sale of the ordinary shares.Barclays and Citigroup are acting as joint bookrunners for this offering.

    The offering will be made only by means of a prospectus supplement and the accompanying prospectus. When available, a copy of the preliminary prospectus supplement relating to the offering and accompanying prospectus may be obtained from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (888) 603-5847, or by emailing barclaysprospectus@broadridge.com; or Citigroup c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (800) 831-9146.

    The offering of these securities is being made under an effective shelf registration statement on file with the U.S. Securities and Exchange Commission. The registration statement can be accessed through the SEC’s website at www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    *About Kornit* *Digital*

    Kornit Digital Ltd. (NASDAQ: KRNT) develops, manufactures and markets industrial digital printing technologies for the garment, apparel and textile industries. Kornit delivers complete solutions, including digital printing systems, inks, consumables, software and after-sales support. Leading the digital direct-to-garment printing market with its exclusive eco-friendly NeoPigment printing process, Kornit caters directly to the changing needs of the textile printing value chain. Kornit’s technology enables innovative business models based on web-to-print, on-demand and mass customization concepts. With its immense experience in the direct-to-garment market, Kornit also offers a revolutionary approach to the roll-to-roll textile printing industry: digitally printing with a single ink set onto multiple types of fabric with no additional finishing processes. Founded in 2003, Kornit Digital is a global company, headquartered in Israel with offices in the USA, Europe and Asia Pacific, and serves customers in more than 100 countries worldwide.

    Investor Contact:
    Michael Callahan, ICR
    (203) 682-8311
    Michael.Callahan@icrinc.com Reported by GlobeNewswire 19 minutes ago.

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    PRESS RELEASE: 3 December 2018, 22:30 CET/16:30 EST

    Genomic Health and Biocartis Expand Collaboration to Urology with the Development of an Idylla(TM) Oncotype DX Genomic Prostate Score^® Test

    *REDWOOD CITY, Calif., United States, and MECHELEN, Belgium, 3 December 2018* - Genomic Health, Inc. the world's leading provider of genomic-based diagnostic tests (NASDAQ: GHDX) and Biocartis Group NV, an innovative molecular diagnostics company (Euronext Brussels: BCART), today announce they have expanded their exclusive collaboration into the field of urology with the development of an in vitro diagnostic (IVD) version of the Oncotype DX Genomic Prostate Score^® (GPS(TM)) Test on Biocartis' Idylla(TM) platform and potentially additional cancer tests that can be performed locally by laboratory partners and in hospitals around the world. 

    Although prostate cancer is the most common cancer among men, it can fortunately often be treated successfully^[1]. The Oncotype DX GPS test is the only commercially available tissue biopsy-based, multi-gene test that has been clinically validated to assess the aggressiveness of prostate cancer in men with clinically low-risk or favorable intermediate-risk cancer at the time of diagnosis, helping to make better informed and more personalized treatment decisions^[2]. Today, this test has been validated in more than 4,500 patients, which is described in 18 publications^[3].

    The Idylla(TM) Oncotype DX GPS Test will be the first urology test to be developed on Biocartis' fully automated PCR^[4]-based Idylla(TM) platform, which offers a unique sample-to-result molecular diagnostics solution. Through this development, Genomic Health intends to enable local pathology labs and urology centers to generate accurate Oncotype DX GPS test results with efficient turnaround time and the consistent high quality and clinical utility that physicians and patients have come to expect when making treatment decisions with Oncotype DX.

    *Herman Verrelst, Chief Executive Officer of Biocartis, commented*: "I am very happy to announce the expansion of our collaboration with Genomic Health, with whom we are now entering the domain of urological cancer testing which is a promising new market for Idylla(TM). Once available, the Idylla(TM) Oncotype DX GPS test can support pathology labs and also local urology centers across the world in making better informed treatment decisions for patients with prostate cancer."

    *Frederic Pla, Ph.D., Chief Operating Officer, Genomic Health*, *continued*: "Today's announcement follows the successful progress in our development of an IVD version of the Oncotype DX Breast Recurrence Score® test on Biocartis' Idylla(TM) platform that we announced last year. Expanding our collaboration to initiate development of the Oncotype DX GPS test on this fully automated sample-to-answer platform reflects our confidence in the Idylla(TM) platform as a best-in-class solution to accelerate access to Oncotype tests around the world."

    The expanded collaboration will provide Genomic Health with exclusive worldwide rights to develop and commercialize its Oncotype DX Genomic Prostate Score test on the Idylla(TM) platform, with the option to expand the collaboration to include additional tests in oncology and urology. Development of the IVD version of the GPS test is expected to begin in early 2019.

    As part of the agreement, Genomic Health will make a payment of EUR 2.5 million to Biocartis, which is expected to be expensed in the fourth quarter of 2018. Upon commercialization, Genomic Health will make royalty payments to Biocartis based on net sales. 

    *--- END ---*

    *More information: *

    Biocartis
    Renate Degrave
    Manager Corporate Communications & Investor Relations
    e-mail   rdegrave@biocartis.com
    tel         +32 15 631 729
    mobile   +32 471 53 60 64 

    Genomic Health
    Emily Faucette
    Vice President Corporate Communications & Investor Relations, Genomic Health
    Email    efaucette@genomichealth.com
    Tel        +1 650 569 2824

    *About Biocartis *
    Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx Idylla(TM) platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis launched the Idylla(TM) platform in September 2014. Biocartis is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology. This area represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers fifteen oncology tests and two infectious disease tests in Europe. More information: www.biocartis.com. Press Photo Library available here. Follow us on Twitter: @Biocartis_.

    *About Genomic Health*

    Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that help optimize cancer care, including addressing the overtreatment of the disease, one of the greatest issues in healthcare today. With its Oncotype IQ^® Genomic Intelligence Platform, the company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of clinical and genomic big data into actionable results for treatment planning throughout the cancer patient journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company's flagship line of Oncotype DX^® gene expression tests that have been used to guide treatment decisions for more than 900,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid- and tissue-based tests, including the recently launched Oncotype DX^® AR-V7 Nucleus Detect(TM) test. The company is based in Redwood City, California, with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.

    Biocartis and Idylla(TM) are registered trademarks in Europe, the United States and other countries. Biocartis trademark and logo and Idylla(TM) trademark and logo are used trademarks belonging to Biocartis. This press release is not for distribution, directly or indirectly, in any jurisdiction where to do so would be unlawful. Any persons reading this press release should inform themselves of and observe any such restrictions. Biocartis takes no responsibility for any violation of any such restrictions by any person. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. This press release does not constitute an offer or invitation for the sale or purchase of securities in any jurisdiction. No securities of Biocartis may be offered or sold in the United States of America absent registration with the United States Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act of 1933, as amended.

    *Biocartis forward-looking statements
    *This press release may contain forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements speak only as of the date of this press release. Biocartis expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements.

    *Genomic Health forward-looking statements
    *This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to Genomic Health's beliefs regarding its future performance; the company's ability to successfully develop and commercialize an in vitro diagnostic (IVD) version of the Oncotype Dx Genomic Prostate Score test on the Idylla(TM) platform; the expected benefits of an IVD version of the company's prostate cancer test, and its expectations regarding timing and geographic rollout of any such test; the company's belief that the collaboration will allow it to accelerate adoption, reimbursement and access to the test and broaden other partnership opportunities; the commercial performance of its tests; the attributes and focus of the company's product pipeline; the ability of any potential tests the company may develop to optimize cancer treatment; and the ability of the company to develop and commercialize, and collaborate with third parties to commercialize, additional tests in the future. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to Genomic Health's ability to execute its business model; the regulation of Genomic Health's tests or any tests offered through its commercial channel; the applicability of clinical study results to actual outcomes; Genomic Health's ability to develop, commercialize or collaborate to offer any new test, including an IVD version of its prostate cancer test, in new markets domestically and internationally; the risk that sufficient levels of reimbursement may not be obtained or maintained, domestically or abroad, for Genomic Health's tests or tests offered through its commercial channel; competition; unanticipated costs or delays in research and development efforts; Genomic Health's ability or the ability of its collaborators to obtain capital when needed to support the activities contemplated by the collaboration described in this press release; and the other risks and uncertainties set forth in Genomic Health's filings with the Securities and Exchange Commission, including the risks set forth in Genomic Health's Quarterly Report on Form 10-Q for the quarter ended September 30, 2018. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

    NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Recurrence Score, Oncotype DX AR-V7 Nucleus Detect, Oncotype DX Breast DCIS Score, Oncotype DX Genomic Prostate Score and Oncotype IQ are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.^[1] Source: https://www.cancer.org/cancer/prostate-cancer/about.html, last consulted on 28 November 2018.

    ^[2] The vast majority of men currently diagnosed with low-risk prostate cancer undergo surgery or radiation treatment, although there is only a three percent chance that their disease will become life-threatening. In response to this issue, Genomic Health's tissue biopsy-based, multi-gene test has been clinically validated to predict aggressive cancer at the time of diagnosis, helping to identify those men who need immediate surgery or radiation therapy versus those who can confidently choose active surveillance. The result is a more precise and accurate assessment of risk, which helps more men avoid the lifelong complications associated with treatments they do not need, while directing aggressive therapy to those men who require immediate treatment. Source: website Genomic Health, last consulted on 28 November 2018.

    ^[3] Source: website Genomic Health, last consulted on 28 November 2018.

    ^[4] Polymerase Chain Reaction. Reported by GlobeNewswire 19 minutes ago.

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    GERMANTOWN, Md., Dec. 03, 2018 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS), a manufacturer, service provider and developer of advanced cell therapies, today announced that Dr. Ohad Karnieli, Ph.D., MBA, Chief Executive Officer and Co-Founder of Atvio Biotech Ltd., which is wholly-owned by Orgenesis’ Masthercell Global subsidiary, will be presenting at the Cell Therapy Manufacturing & Gene Therapy Congress, being held December 4-5, 2018 in Amsterdam.  Dr. Karnieli will provide opening remarks during the plenary session in a presentation entitled, “Patient specific therapies and the need for a paradigm shift.” He will also participate in a panel entitled, “What does industry need to innovate the cell and viral vector industries?” He will also provide a presentation entitled, “Manufacturing and Process Development – Analytical Strategies, Design Space, QbD and Cost of Goods Considerations.”The Cell Therapy Manufacturing and Gene Therapy Congress agenda  brings together key players from the industry to discuss the critical issues facing the development, scale-up and manufacture of cell-based and gene therapies, all in line with international regulations, from scale-up to scale-out, characterization to process release, freeze/thaw to needle-to-needle logistics.

    *About Orgenesis*
    Orgenesis is a vertically-integrated biopharmaceutical company with expertise and unique experience in cell therapy development and support services.  Through its Israeli subsidiary, Orgenesis Ltd., Orgenesis is developing technology designed to successfully reprogram human liver cells into glucose-responsive, fully functional, Insulin Producing Cells (IPCs).  Orgenesis believes that converting the diabetic patient's own tissue into insulin-producing cells has the potential to overcome the significant issues of donor shortage, cost and exposure to chronic immunosuppressive therapy associated with islet cell transplantation.  Through its Masthercell Global subsidiary, a global contract development and manufacturing organization (CDMO), Orgenesis is able to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies onto the market.  From technology selection to business modeling, GMP manufacturing, process development, and quality management, Masthercell’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.  Masthercell operates in a validated and flexible facility located in the strategic center of Europe within the Walloon healthcare cluster, Biowin. This integrated approach supports the Company's business philosophy of bringing to market significant life-improving medical treatments.  For more information, visit www.orgenesis.com.

    *Notice Regarding Forward-Looking Statements
    *This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities and Exchange Act of 1934, as amended.  These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release.  We caution readers that forward-looking statements are predictions based on our current expectations about future events.  These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict.  Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, the success of our reorganized CDMO operations, the success of our partnership with Great Point Partners, our ability to achieve and maintain overall profitability, the sufficiency of working capital to realize our business plans, the development of our transdifferentiation technology as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes; our technology not functioning as expected; our ability to retain key employees; our ability to satisfy the rigorous regulatory requirements for new procedures; our competitors developing better or cheaper alternatives to our products and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1A of our Annual Report on Form 10-K for the fiscal year ended November 30, 2017, and in our other filings with the Securities and Exchange Commission.  We undertake no obligation to revise or update any forward-looking statement for any reason.

    *Contact for Orgenesis:*
    David Waldman
    Crescendo Communications, LLC
    Tel: 212-671-1021
    Orgs@crescendo-ir.com Reported by GlobeNewswire 1 hour ago.

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    Mamelodi Sundowns coach Pitso Mosimane reckons returning defender Rivaldo Coetzee is still destined to play in Europe one day. Reported by News24 55 minutes ago.

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    AGC Enters Agreement to Acquire Synthetic Pharmaceutical Active Ingredient-manufacturing Plant in Spain - Acquisition Will Give AGC Foothold in Europe and Broaden Its Pharma CDMO Business -

    TOKYO, Dec. 4, 2018 /PRNewswire/ -- AGC Inc., a world-leading manufacturer of glass, chemicals and high-tech materials, has announced that it has entered into an agreement with Boehringer Ingelheim to acquire Malgrat Pharma Chemicals S.L.U. ("MPC"). MPC is a subsidiary of Boehringer Ingelheim that manufactures synthetic pharmaceutical active ingredients (*1) for the group. By acquiring MPC, AGC will have its first FDA-registered site in Europe in the synthetic pharmaceutical CDMO (*2) business.(Photo: https://kyodonewsprwire.jp/prwfile/release/M000303/201812031010/_prw_PI1im_gPsXryOQ.jpg) The deal remains subject to approval from the relevant antitrust authorities and the fulfillment of closing conditions under the share purchase agreement.MPC has vast experience manufacturing cGMP (*3)-compliant commercialized synthetic pharmaceuticals as well as compounds in clinical development on a range of scales. Leveraging AGC's fluorination technologies and extensive experience in in-house drug discovery and the CDMO business built up in Japan, AGC, with the addition of MPC, will be able to offer its CDMO services from a broader asset base, catering to European customer requirements and expanding its presence in the European market.The AGC Group's "AGC plus" management policy identifies life sciences as one of its strategic businesses. AGC will continue to actively invest in this field so as to be able to provide globally unified high-quality services to customers in both the synthetic drug and biopharmaceutical businesses. Further, by maximizing the synergies of each location, the group's technical capabilities will be enhanced, making it possible to better contribute to pharmaceutical companies, patients, and wider society in general.

    Notes
    (*1) Synthetic pharmaceutical intermediates and active ingredients: Intermediates and active ingredients for pharmaceutical products that are produced by chemical synthesis.
    (*2) CDMO: Contract development and manufacturing organization (a company that manufactures and develops production methods under contract for other companies).
    (*3) cGMP: current Good manufacturing practice (standards governing the production and quality control of pharmaceutical and quasi-drugs).
    *The company changed its name from Asahi Glass Co., Ltd. to AGC Inc. on July 1, 2018. Its President is Takuya Shimamura.*Handling of personal information is governed by AGC's privacy policy.For reference, please visit:
    https://kyodonewsprwire.jp/prwfile/release/M000303/201812031010/_prw_PA1fl_zUT4075I.pdf  View original content:http://www.prnewswire.com/news-releases/agc-enters-agreement-to-acquire-synthetic-pharmaceutical-active-ingredient-manufacturing-plant-in-spain-300759480.html Reported by PR Newswire Asia 51 minutes ago.

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    Yesterday morning, the Zur Rose Group announced that, in the context of its capital increase it had just completed, the subscription rights of its largest shareholder, KWE Beteiligungen AG, had not been exercised by mistake. KWE Beteiligungen AG's principal bank which reconfirmed receipt of the order to exercise its subscription rights, omitted to forward the order subsequently to the mandated banks.

    Yesterday evening, the Zur Rose Group was informed by KWE Beteiligungen AG that it had reached a settlement with its principal bank. The settlement does not include the delivery of shares or their procurement on the market by the principal bank to increase KWE Beteiligungen AG’s shareholding back to the pre-rights offering level.

    The Board of Directors, in which KWE Beteiligungen AG is represented, regretfully takes note of this information. Ahead of the capital increase KWE Beteiligungen AG declared vis-à-vis the Zur Rose Group as well as a financial newspaper that it would support the capital increase proportionally by exercising its subscription rights.

    *Investors and analyst contact*
    Marcel Ziwica, Chief Financial Officer
    Email: ir@zurrose.com, phone: +41 58 810 11 49

    *Media contact
    *Lisa Lüthi, Head of Corporate Communications
    Email: media@zurrose.com, phone: +41 52 724 08 14

    *Zur Rose Group*

    The Swiss Zur Rose Group is Europe's largest online pharmacy and one of the leading medical wholesalers in Switzerland. With its business model, it offers high-quality, safe and cost-effective pharmaceutical care and thus contributes to reducing healthcare costs. It is also characterized by the continuous further development of digital services in the field of drug management in order to increase therapy safety. The creation of added value and a pronounced patient orientation make the Group an important strategic partner for service providers, cost units and industry.

    The Zur Rose Group is internationally present with strong brands, including Germany's best-known pharmacy brand DocMorris. The company employs over 1,000 people at various locations and generated a turnover of CHF 983 million in the 2017 financial year. The shares of Zur Rose Group AG are listed on the SIX Swiss Exchange (securities number 4261528, ISIN CH0042615283, ticker ROSE). The CHF 115 million corporate bond issued in July 2018 is also listed on the SIX Swiss Exchange (securities number 42146044, ISIN CH0421460442, ticker ZRO18). Further information at zurrosegroup.com

    *Disclaimer*

    This document and the information contained herein are not for distribution in or into (directly or indirectly) the United States, Canada, Australia or Japan or any other jurisdiction in which the distribution or release would be unlawful. This document does not constitute an offer of securities for sale in or into the United States, Canada, Australia or Japan.

    This document does not constitute an offer to sell, or a solicitation of an offer to purchase, any securities in the United States. The securities of Zur Rose Group AG to which these materials relate have not been and will not be registered under the United States Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There will not be a public offering of securities in the United States. Any sale in the United States of the securities mentioned in this communication will be made solely to “qualified institutional buyers” as defined in, and in reliance on, Rule 144A under the Securities Act.

    This document is not an issuance or listing prospectus or a similar document in the sense of article 652a, article 752 and/or article1156 of the Swiss Code of Obligations or articles 27 et seq. of the Listing Rules of the SIX Swiss Exchange and was not reviewed by any competent authority. Any offer of securities of Zur Rose Group AG will be made solely by means of, and on the basis of, an offering memorandum that will contain detailed information about the group and its management as well as risk factors and financial statements. Any person considering the purchase of any securities of Zur Rose Group AG must inform itself independently based solely on such offering memorandum (including any supplement thereto).

    This document does not constitute an "offer of securities to the public" within the meaning of Directive 2003/71/EC of the European Union, as amended (the "Prospectus Directive") of the securities referred to herein in any member state of the European Economic Area (the "EEA"). Any offers of the securities referred to in this document to persons in the EEA will be made pursuant to an exemption under the Prospectus Directive, as implemented in member states of the EEA, from the requirement to produce a prospectus for offers of the Securities. In any EEA Member State that has implemented the Prospectus Directive, this document is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Directive, i.e., only to investors who can receive the offer without an approved prospectus in such EEA Member State.

    In the United Kingdom, this document is only being distributed to and is only directed at persons who (i) are investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended) (the "Order") or (ii) are persons falling within Article 49(2)(a) to (d) of the Order (high net worth companies, unincorporated associations, etc.) (all such persons together being referred to as "Relevant Persons"). This document is directed only at Relevant Persons and must not be acted on or relied on by persons who are not Relevant Persons. Any investment or investment activity to which this document relates is available only to Relevant Persons and will be engaged in only with Relevant Persons.

    This communication may contain statements about the future that use words such as, for example, "believe", "assume", "expect" and other similar expressions. Such statements about the future are subject to risks, uncertainties, and other factors, which can cause the true results of the company to differ significantly from that which is expressly or implicitly assumed in these statements. In view of these uncertainties, the reader should not depend on this type of statement about the future. The company gives no undertaking whatever to update such statements regarding the future, or to adapt them to future events or developments. Reported by EQS Group 58 minutes ago.

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    Most downloaded Bible app continues to gain momentum

    OKLAHOMA CITY, Dec. 04, 2018 (GLOBE NEWSWIRE) -- The YouVersion Bible App, which has been installed on more than 350 million devices worldwide, continued to see Bible engagement increase throughout its 10-year anniversary this year. Today, YouVersion announces the most popular Bible verse of 2018.

    The most shared, bookmarked, and highlighted verse by YouVersion community members around the world this year is Isaiah 41:10: “Don’t be afraid, for I am with you. Don’t be discouraged, for I am your God. I will strengthen you and help you. I will hold you up with my victorious right hand.”

    “This year’s data shows people worldwide are continuing to turn to the Bible in search of comfort, encouragement, and hope,” said Bobby Gruenewald, Pastor, Innovation Leader for Life.Church and YouVersion Founder. “We’re humbled that 10 years after its release, people continue to use the YouVersion Bible App in record numbers to connect with God’s Word.”

    With more than 1,800 versions in more than 1,250 languages, Bible reading in the app is on the rise across several continents. With the addition of a new Japanese Bible version within the app, Bible engagement in Japan saw year-over-year growth of 104 percent. Additionally, Bible engagement in Eastern Europe is growing quickly with Romania seeing an increase of 100 percent. In South America, Chile and Argentina are the fastest growing countries with 79 percent and 60 percent growth in Bible engagement, respectively.

    “Many of us grew up with the ability to read the Bible in our heart language, but countless people around the world don’t have that privilege. That’s why we’re passionate about making the Bible available in more languages through the app,” said Gruenewald. “We’re eternally grateful to the generous publishers and Bible societies who have joined us in the mission of increasing worldwide access and engagement with the Bible.”

    Bible engagement reached new heights this year as YouVersion data showed a 27 percent increase in daily active users compared to last year. In fact, the YouVersion community listened to 4.2 billion chapters and read more than 27.2 billion chapters of the Bible this year, which is a year-over-year increase of 40 percent and 62 percent.

    Additionally, the YouVersion community has been taking advantage of habit formation features like Bible Plans, which help users develop the discipline of daily Scripture reading. This year, users completed more than 950 million Bible Plan days, a 59 percent increase compared to 2017. Contributing to this increase is the addition of more than 1,800 Bible plans this year, 34 percent of which are in non-English languages.

    Throughout 2018, the YouVersion community also took advantage of social sharing features to share a record-breaking 409 million Bible verses, including text and Verse Images. To further this momentum, YouVersion launched Bible Lens in August as a new way to help people see how the Bible intersects with their daily lives. Bible Lens is a free app that matches relevant Bible verses with a person’s photos and automatically creates visually appealing, sharable artwork. Within the first weekend, app users drove Bible Lens to the top of Apple's App Store charts as it reached #2 of all apps and #1 in the Lifestyle category.

    YouVersion also saw significant growth in its Bible App for Kids, which released in 2013. With 9 languages added this year, children can now experience the animated Bible stories and interactive games in 42 different languages. Compared to last year, the number of app installs has increased by 55 percent, totaling nearly 27 million devices worldwide.

    “This generation is on pace to become the most Bible-engaged generation ever, and we believe the Church should keep investing in new technologies to help adults and children connect with the Bible,” said Gruenewald. “We’re honored to be a part of how God is reaching people around the globe through His Word, and we’re eager to see how Bible-engaged people make a difference in this world for decades to come.”

    For more information about the YouVersion community’s Bible engagement in 2018, visit share.bible.com/2018.

    *About YouVersion             *
    Created by Life.Church, YouVersion is on a mission to help people engage with the Bible. The team designs and builds experiences that make it easy for people to integrate the Bible into their everyday lives. Since 2008, the Bible App has offered a free Bible experience that can be accessed on smartphones, browsers, voice platforms, and more. The Bible App for Kids launched in 2013 and engages children with Bible stories on an age-appropriate level. The newest app, Bible Lens, analyzes objects in photos, finds the most relevant Bible verse to match, and automatically creates beautiful, shareable artwork. For more information about YouVersion, visit youversion.com.

    *MEDIA CONTACTS:*
    Rachel Feuerborn
    405-216-7072
    rachel.feuerborn@life.church

    Photos accompanying this announcement are available at: 

    http://www.globenewswire.com/NewsRoom/AttachmentNg/36eb6a4c-cc72-41ec-bdc3-bc4ab49dd1df

    http://www.globenewswire.com/NewsRoom/AttachmentNg/350e9089-4a1b-455a-ab07-7dcd399b9357

    http://www.globenewswire.com/NewsRoom/AttachmentNg/85736d34-290b-4088-818c-96ef061e6e29 Reported by GlobeNewswire 54 minutes ago.

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    Atomico survey shows no progress has been made in three years despite focus on diversity Reported by FT.com 1 hour ago.

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    *Press release*

    Paris La Défense, 4 December 2018

    Great success of the issue of BSAAR warrants

    Albioma announces that the issue of redeemable share subscription and/or purchase warrants (BSAAR warrants) reserved for 42 employees of the Company and its subsidiaries and the Company's Chief Executive Officer, without preferential subscription rights of the shareholders, launched on 9 November 2018, met with great success.

    With a subscription rate over 140%, the transaction results in the issue of 1,071,731 BSAAR warrants of 0.90 euro each (representing 964,557.90 euros gross proceeds), allocated to 31 subscribers including the Chief Executive Officer, who subscribed for 110,650 BSAAR warrants.

    The exercise of the totality of the BSAAR warrants would result in the creation, between 6 December 2021 and 4 December 2024, of a number of new shares representing c. 3.46% of the share capital as at 30 November 2018 (3.35% of the share capital post exercise of the BSAAR warrants). The exercise price of the BSAAR warrants was set at 20.90 euros, i.e. a price equal to 120% of the average closing prices quoted for the Company's shares over a period of 20 consecutive trading days preceding 8 November 2018. The terms and conditions of the BSAAR warrants are available on the Company's website, www.albioma.com.

    Albioma was accompanied by Europe Offering as advisor to the issuer, and Banque Transatlantique as centralising agent of the transaction.

    Next on the agenda: annual results for the 2018 financial year, on 8 March 2019 (before trading).

    About Albioma Contacts
    An independent renewable energy producer, Albioma is committed to the energy transition thanks to biomass and photovoltaics.

    The Group, which is established in Overseas France, Mauritius and Brazil, has developed a unique partnership for 20 years with the sugar industry, to produce renewable energy from bagasse, a fibrous residue from sugar cane.

    Albioma is also the leading generator of photovoltaic power overseas where it constructs and operates innovative projects with integrated storage capabilities. *Investor
    *Julien Gauthier
    +33 (0)1 47 76 67 00

    *Media
    *Charlotte Neuvy
    +33 (0)1 47 76 66 65
    presse@albioma.com
       
    Albioma shares are listed on NYSE EURONEXT PARIS (sub B) and eligible for the deferred settlement service (SRD) and PEA-PME plans (ISIN FR0000060402 - ticker: ABIO). www.albioma.com

     

    *Attachment*

    · Albioma_CP_20181204_ENG.pdf Reported by GlobeNewswire 54 minutes ago.

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    · *New analyses from the phase III MURANO study in previously treated chronic lymphocytic leukaemia show continued benefit from fixed-duration regimen after a median follow-up of three years*
    · *Updated results from two studies in newly-diagnosed acute myeloid leukaemia demonstrate Venclexta combinations continued high rates of deep remission*

    Basel, 4 December 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data from the Venclexta®/Venclyxto® (venetoclax) clinical development programme, including longer-term results from the phase III MURANO study in people with previously treated chronic lymphocytic leukaemia (CLL) and updated data from two phase Ib/II studies in people with previously untreated acute myeloid leukaemia (AML) ineligible for intensive chemotherapy due to coexisting medical conditions. Data from the Venclexta/Venclyxto clinical development programme that ranges across multiple blood cancers, including CLL, AML, non-Hodgkin lymphoma and multiple myeloma, will be featured in more than 30 abstracts, including 12 oral presentations, at the 60th American Society of Hematology (ASH) 2018 Annual Meeting.

    "We're excited by the versatility of Venclexta/Venclyxto in treating a range of distinct types of blood cancer, including difficult-to-treat forms with limited options," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "These data support our broad clinical development programme through which we hope to discover more ways Venclexta/Venclyxto can be used alone or in combination with other medicines to treat additional types of cancer."

    *Updated data in CLL
    *Two new analyses of the phase III MURANO study in relapsed or refractory (R/R) CLL demonstrated the continued clinical benefit of Venclexta/Venclyxto plus MabThera®/Rituxan® (rituximab) was sustained after patients completed the chemotherapy-free, two-year fixed-duration course of therapy.

    · An analysis showed the combination reduced the risk of disease progression or death (progression-free survival; PFS, as assessed by investigator) by 84% (HR=0.16; 95% CI: 0.12-0.23; p · A separate analysis showed higher rates of minimal residual disease (MRD)-negativity observed with Venclexta/Venclyxto plus MabThera/Rituxan compared to BR were sustained after patients completed treatment (62% vs. 13%). MRD-negativity means no cancer can be detected using a specific, highly sensitive test, and was defined as less than 1 CLL cell in 10,000 leukocytes. Importantly, these results were observed in the majority of patients in the Venclexta/Venclyxto arm, including patients in high-risk subgroups and were consistent with the maintained PFS benefit seen with longer follow-up. These data support the utility of MRD in peripheral blood as a predictive marker of clinical outcome. No new safety signals were observed with the treatment combination of Venclexta/Venclyxto plus MabThera/Rituxan. These data will be presented in an oral session on Monday, 3 December at 11:30 PST (Abstract #695).*Updated data in AML
    *Updated data from the phase Ib M14-358 and phase I/II M14-387 studies evaluating Venclexta/Venclyxto in combination with a hypomethylating agent or low-dose cytarabine (LDAC) in people with previously untreated AML who are ineligible for intensive chemotherapy, will also be presented. These results showed that among patients who were dependent upon blood transfusions at baseline, about half were able to achieve transfusion independence (the absence of transfusions during any consecutive 56 days during the study treatment period). No unexpected safety signals were observed with Venclexta/Venclxyto in combination with hypomethylating agents or LDAC.

    · The M14-358 study showed high rates of complete remission (with at least partial blood count recovery, CR+CRh) of 67% for those who received Venclexta/Venclyxto plus azacitidine and 71% for those who received Venclexta/Venclyxto plus decitabine. For people taking Venclexta/Venclyxto and azacitadine or decitabine who were dependent on blood transfusions at baseline, 50% and 52% achieved red blood cell transfusion independence, respectively; and 58% or 60% achieved platelet transfusion independence, respectively.
    · The M14-387 study showed rates of complete remission (with or without full recovery of normal blood cell count, CR+CRi) of 54% in people who received Venclexta/Venclyxto in combination with LDAC and a median duration of remission of 8.1 months. For people taking Venclexta/Venclyxto with LDAC, 48% achieved red blood cell transfusion independence and 60% achieved platelet transfusion independence.

    Results from the two studies were presented in an oral session on Sunday, December 2 at 7:45 PST and 8:00 PST, respectively (Abstract #284 and #285).

    Based on earlier results from the M14-358 and M14-387 studies, Venclexta was granted accelerated approval by the US Food and Drug Administration (FDA) for the treatment of people with newly-diagnosed AML who are age 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions. A robust clinical development programme for Venclexta/Venclyxto in AML is ongoing, including two ongoing phase III studies evaluating Venclexta/Venclyxto in combination with azacitidine or with LDAC for people with previously untreated AML who are ineligible for intensive chemotherapy based on results from the M14-358 and M14-387 studies.

    Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States, and commercialised by AbbVie outside of the United States.
    *
    About the MURANO study
    *MURANO (NCT02005471) is a phase III open-label, international, multicentre, randomised study evaluating the efficacy and safety of Venclexta/Venclyxto in combination with MabThera/Rituxan compared to bendamustine in combination with MabThera/Rituxan (BR) in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL). All treatments were of fixed duration. Following a five-week dose ramp-up schedule for Venclexta/Venclyxto, patients on the Venclexta/Venclyxto plus MabThera/Rituxan arm received six cycles of Venclexta/Venclyxto plus MabThera/Rituxan followed by Venclexta/Venclyxto monotherapy for up to two years total. Patients on the BR arm received six cycles of BR. The study included 389 patients with CLL who had been previously treated with at least one line of therapy. Patients were randomly assigned in a 1:1 ratio to receive either Venclexta/Venclyxto plus MabThera/Rituxan or BR. The primary endpoint of the study was progression-free survival (PFS). Secondary endpoints included overall survival, overall response rate and complete response rate (with or without complete blood count recovery).

    *About the M14-358 study
    *The M14-358 study (NCT02203773) is an open-label, non-randomised, phase Ib dose escalation and expansion study evaluating the safety and efficacy of Venclexta/Venclyxto in combination with hypomethylating agents, azacitidine or decitabine, in 115 newly-diagnosed people with acute myeloid leukaemia who were 60 years or older, or ineligible to receive intensive induction chemotherapy due to coexisting medical conditions. Study endpoints included complete remission rates, transfusion independence, overall survival and safety.

    *About the M14-387 study
    *The M14-387 study (NCT02287233) is an open-label, single-arm, phase I/II dose escalation and expansion study evaluating the safety and efficacy of Venclexta/Venclyxto in combination with low-dose cytarabine (LDAC) in 82 newly-diagnosed people with acute myeloid leukaemia who were 60 years or older, or ineligible to receive intensive induction chemotherapy due to coexisting medical conditions. Study endpoints included complete remission rates, transfusion independence, overall survival and safety.

    *About Venclexta/Venclyxto
    *Venclexta/Venclyxto is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumours, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta/Venclyxto blocks the BCL-2 protein and works to restore the process of apoptosis.

    Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States, and commercialised by AbbVie outside of the United States. Together, the companies are committed to research with Venclexta/Venclyxto, which is currently being studied in clinical trials across several types of blood and other cancers.

    In the US, Venclexta has been granted four Breakthrough Therapy Designations by the FDA: in combination with Rituxan for people with relapsed or refractory chronic lymphocytic leukaemia (CLL); as a monotherapy for people with relapsed or refractory CLL with 17p deletion; in combination with hypomethylating agents (azacitidine or decitabine) for people with untreated acute myeloid leukaemia (AML) ineligible for intensive chemotherapy; and in combination with low-dose cytarabine for people with untreated AML ineligible for intensive chemotherapy.

    *About Chronic Lymphocytic Leukaemia
    *Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in the Western world.[1] CLL mainly affects men and the median age at diagnosis is about 70 years. [2] Worldwide, the incidence of all leukaemias is estimated to be more than 400,000 [3] and CLL is estimated to affect around one-third of all people newly diagnosed with leukaemia. [1]

    *About Acute Myeloid Leukaemia
    *Acute myeloid leukaemia (AML) is an aggressive form of leukaemia that starts in immature forms of blood-forming cells, known as myeloid cells, found in the bone marrow. [4] AML is the most common type of aggressive leukaemia in adults. It has the lowest survival rates of all types of leukaemia. [5] Even with the best available therapies, older patients aged 65 and over have survival rates comparable to patients with advanced lung cancer, with a five year overall survival rate of
    *About Roche in haematology
    *For more than 20 years, Roche has been developing medicines that redefine treatment in haematology. Today, we are investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. In addition to approved medicines MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), and Venclexta/Venclyxto®/Venclyxto® (venetoclax) in collaboration with AbbVie, Roche's pipeline of investigational haematology medicines includes Tecentriq® (atezolizumab), an anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and a small molecule which inhibits the interaction of MDM2 with p53 (idasanutlin/RG7388). Roche's dedication to developing novel molecules in haematology expands beyond malignancy, with the development of Hemlibra® (emicizumab), a bispecific monoclonal antibody for the treatment of haemophilia A.

    *About Roche
    *Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare - a strategy that aims to fit the right treatment to each patient in the best way possible.

    Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
    Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the tenth consecutive year, Roche has been recognised as the most sustainable company in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

    The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

    All trademarks used or mentioned in this release are protected by law.*References
    *[1] Wendtner CM, et al. Chronic lymphocytic leukemia. Onkopedia guidelines 2012 [Internet; cited 2018]. Available from: https://www.onkopedia-guidelines.info/en/onkopedia/guidelines/chronic-lymphocytic-leukemia-cll/@@view/html/index.html
    [2] SEER Stat Fact Sheets: Chronic Lymphocytic Leukemia (CLL) [Internet; cited 2018]. Available from: http://seer.cancer.gov/statfacts/html/clyl.html.
    [3] GLOBOCAN 2018. World Fact Sheet. [Internet; accessed 2018]. Available from: http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf
    [4] American Cancer Society: What is acute myeloid leukemia? [Internet; cited 2018]. Available from: https://www.cancer.org/cancer/acute-myeloid-leukemia/about/what-is-aml.html
    [5] Leukemia & Lymphoma Society: Facts and statistics overview - Leukemia. [Internet; cited 2018]. Available from: http://www.lls.org/http%3A/llsorg.prod.acquia-sites.com/facts-and-statistics/facts-and-statistics-overview/facts-and-statistics#Leukemia.
    [6] Sekeres MA. Treatment Of Older Adults With Acute Myeloid Leukemia: State Of The Art And Current Perspectives. Haematologica 2008;93:1769-1772
    [7] Cancer Research UK: Survival statistics for acute myeloid leukaemia (AML). [Internet; cited 2018]. Available from: http://www.cancerresearchuk.org/about-cancer/acute-myeloid-leukaemia-aml/survival?_ga=2.239561667.1384102361.1500450925-993068745.1500450925
    [8] National Cancer Institute. Adult Acute Myeloid Leukemia Treatment (PDQ®)-Health Professional Version [Internet; cited 2018 May]. Available from: https://www.cancer.gov/types/leukemia/hp/adult-aml-treatment-pdq.
    [9] Visser O, et al. (RARECARE Working Group). Incidence, survival and prevalence of myeloid malignancies in Europe. Eur J Cancer. 2012;48:3257-3266.*Roche Group Media Relations
    *Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
    - Nicolas Dunant (Head)
    - Patrick Barth
    - Ulrike Engels-Lange
    - Simone Oeschger
    - Anja von Treskow

    *Attachment*

    · Roche-Media-Release-ASH_Venclexta_EN.pdf Reported by GlobeNewswire 54 minutes ago.

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