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Clovis Oncology Initiates Early Access Program for Rucaparib as Treatment and as Maintenance Therapy in Recurrent Ovarian Cancer in Europe23.3.2018 15:52 | Tiedote

Clovis Oncology, Inc. (NASDAQ:CLVS) today announced the initiation of an early access program in Europe for rucaparib for treatment and as maintenance therapy in recurrent ovarian cancer. The program will be overseen and implemented by Caligor Coghlan, which specializes in early access to medicines. The program, to be known as the Rucaparib Access Program (RAP), will enable participation from certain countries in Europe, where permitted by applicable rules, procedures and regulatory authorities. The RAP protocol allows for rucaparib treatment of an individual patient with third-line or greater BRCA mutant epithelial, fallopian tube, or primary peritoneal ovarian cancer who has platinum-sensitive disease and is unable to tolerate further platinum-based chemotherapy or has platinum-resistant disease and needs treatment with single agent rucaparib. The RAP protocol will also provide access to rucaparib for maintenance therapy of an individual patient with recurrent epithelial ovarian, fal

CHMP Grants Positive Opinion for Clovis Oncology’s Rubraca® (rucaparib) Tablets23.3.2018 15:50 | Tiedote

Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that the European Union’s (EU) European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a conditional marketing authorization for Rubraca as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy. The European Marketing Authorization application for the treatment indication was based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA mutant ovarian cancer who had progressed after two or more prior chemotherapies. “The recommendation

Janssen Announces Positive CHMP Opinion for JULUCATM▼ (dolutegravir/rilpivirine)23.3.2018 15:46 | Tiedote

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending marketing authorisation for JULUCA™ (dolutegravir 50mg [ViiV Healthcare UK Ltd]/rilpivirine 25mg [Janssen Sciences Ireland UC]). Dolutegravir/rilpivirine is a single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase strand transfer inhibitor (INSTI).1 “We are delighted to be one step closer to bringing JULUCA™ to people living with HIV in Europe,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. “Building on our 25-year c

Aitheon Executives Educate World Leaders on Benefits, Challenges of AI at the Annual World Government Summit in Dubai23.3.2018 15:00 | Tiedote

Aitheon, makers of the world’s first blockchain-powered platform to solve real problems by integrating AI, robotics, IoT, human specialists and cryptocurrency, announced today that executives from the company held a series of high-level briefings with world leaders at the Annual World Government Summit in Dubai. Briefings covered the benefits and challenges of AI, and revolutionary new solutions to world challenges made possible by transformative new technologies. (Read the full release at This press release features multimedia. View the full release here: Aitheon founder and CEO, Andrew Archer, and Chief Strategy Officer, Ryan Burleson, were invited to brief leaders at the Summit by Cyrus Hodes, Co-founder and Director of the AI Initiative, an undertaking of the Future Society at Harvard University’s Kennedy School. Archer and Burleson addressed a variety of AI-related topics, including the impact of AI on

ViiV Healthcare Gains CHMP Positive Opinion for Juluca (dolutegravir/rilpivirine) in Europe23.3.2018 14:27 | Tiedote

ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for Juluca (dolutegravir/rilpivirine) for the treatment of HIV infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor. The 2-drug regimen comprises dolutegravir 50mg (ViiV Healthcare) and rilpivirine 25mg (Janssen Sciences Ireland UC). Deborah Waterhouse, Chief Executive Officer at ViiV Healthcare commented: “Today is an important milestone for people living with HIV in Europe. It takes us a step closer to offering the first, single-pill, 2-drug regi

Elliott Advisors (UK) Limited Statement on Telecom Italia23.3.2018 10:00 | Tiedote

Given the momentum behind Elliott's campaign at Telecom Italia to improve both performance and governance, Elliott was not surprised to see yesterday's resignation of seven board members affiliated with Vivendi. Unable to advance any meritorious arguments, the Board has simply abandoned their posts to stall for time. Elliott regards this action as cynical and self-serving, in that it delays the ability of Telecom Italia shareholders to express their votes at the upcoming AGM. This is yet another example of minority shareholder rights at Telecom Italia being abrogated and the continued disregard of corporate governance best practice. Finally, Vivendi should note Elliott's forty-year track record of consistent value creation, and sustained, long-term commitments to expose poor governance and catalyse positive change; Elliott's investment history in Telecom Italia dates back to 1999, well before Vivendi became a shareholder in the Company. About Elliott Elliott Management Corporation mana

Smiths Detection Hold Baggage Scanner Meets Highest Security Standards in EU23.3.2018 10:00 | Tiedote

The Smiths Detection HI-SCAN 10080 XCT has achieved ECAC approval as a Standard 3.1 explosives detection system for hold baggage – the highest, defined security standard in the EU. This significant advance was made possible by using a dual-view, dual-energy line scanner with high resolution 3D Computed Tomography (CT) to deliver exceptional data. This press release features multimedia. View the full release here: Smiths Detection HI-SCAN 10080 XCT (Graphic: Business Wire) This achievement gives airports currently upgrading to Standard 3 technology, the option to increase detection levels even further to 3.1; and any standard 3 systems already installed can be easily elevated to 3.1 via a software upgrade. The detection algorithms are interchangeable on a bag by bag basis depending on the destination and associated risk level. This offers additional flexibility and productivity. “With the capability to meet detection requirements

Sofinnova Partners Leads SafeHeal’s €6 Million Series a Financing Round23.3.2018 10:00 | Tiedote

SafeHeal, an early-stage medtech company specialized in digestive surgery and focused on the development of the Colovac device, announces today that it has closed a €6 million Series A financing round led by Sofinnova Partners. Based in Paris, SafeHeal develops an innovative digestive anastomosis protection device, called Colovac, designed to reduce complications and obviate the need for ostomies for colectomy patients. This technology consists of a minimally invasive and fully reversible implant that remains in place until the body’s natural healing and tissue repair processes are complete, for approximately two weeks, after which it is removed. SafeHeal’s device has the potential to radically transform the market while significantly improve patients’ quality of life by enabling them to resume their normal life without having to bear an artificial anus and wear ostomy pouches for several months. About 270,000 colectomy patients receive an ostomy every year in Europe and the USA, repre

Ipsen Receives Positive CHMP Opinion for Cabometyx® (cabozantinib) for the First-Line Treatment of Adults with Intermediate- or Poor- Risk Advanced Renal Cell Carcinoma23.3.2018 09:00 | Tiedote

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA) provided a positive opinion for Cabometyx® (cabozantinib) 20, 40, 60 mg for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinoma (aRCC).The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Alexandre Lebeaut, Executive Vice President, R&D and Chief Scientific Officer said: “Today’s positive opinion from the CHMP is important news for patients with previously untreated advanced renal cell carcinoma, who can shortly benefit from Cabometyx ® as a new first-line treatment option. Following the evidence of its clinical value after a prior VEGF-targeted treatment, we are pleased to be able to expand the benefit of Cabometyx ® for treatment-naïve patients wit

Swiss Wearable Brand MyKronoz Breaks Worldwide Records with its Hybrid Smartwatch ZeTime, on the Sidelines of a Challenging Baselworld 201822.3.2018 19:32 | Tiedote

On the sidelines of a downsized Baselworld 2018, MyKronoz, the premier watchmaking brand of the smart generation today announces record-breaking crowdfunding results of its hybrid smartwatch ZeTime, with more than $8,000,000 raised in less than a year. The international success of its unique and groundbreaking flagship wearable is followed by the release of a new digital video campaign “I’m a watch; I’m a smartwatch”. This press release features multimedia. View the full release here: MyKronoz ZeTime Petite & Regular top $8M in crowdfunding (Photo: Business Wire) After a historic 35-days Kickstarter campaign launched in March 2017, ZeTime has pursued, since then, its crowdfunding journey on a variety of international and local platforms: Indiegogo, Makuake in Japan, Zec Zec in Taïwan, Wadiz in Korea and on the leading chinese e-commerce website Further to this online momentum, MyKronoz has successfully shipped to over 10

Redwood Software Announces First Industry Robotic Licensing Model to Revolutionize Transparent Marketplace Pricing22.3.2018 17:59 | Tiedote

Redwood Software, the pioneer behind ‘The Robotic Enterprise’, today announced the launch of a revolutionary new robotic licensing model, where customers only pay for the robotic services they consume within their business. Available now, this new licensing model allows customers to directly compare the costs of manual work against processes that are robotized. With the unique Robotic Service Charge, Redwood only charges for the delivery of a robotic service, equivalent to a unit of work that can done by a person (send an email, download a report, reconcile two reports etc.). Redwood delivers a catalogue of 35,000 of these ready built robotic services that can be linked together by business users in a visual plug and play interface. End-to-end business processes can be modelled, robotized, tested and deployed without cost and risk. Only when the robotic service is consumed is a charge made, always replacing work that would otherwise be done manually. Within the Robotic Service Charge,

German Chemical Major Covestro Awards L&T Technology Services Multi-Million Dollar ER&D Project22.3.2018 17:34 | Tiedote

Germany’s Covestro, a world-leading manufacturer of high-tech polymer materials, has chosen L&T Technology Services Limited (NSE: LTTS), as one of its major engineering services partners to implement digitalization based Engineering Programs across Covestro’s global locations. L&T Technology Services, a global leading pureplay ER&D services company, has been awarded a multi-million dollar contract by Covestro to execute these engineering transformational programs. This press release features multimedia. View the full release here: (L to R) Amit Chadha, President Sales & Business Development and Member of the Board, LTTS, Ferry Feldbrugge, Head of Global Projects & Engineering and Global Technical Contracting, Covestro and Stephan Krebber, Program Director, OSI2020 Program, Covestro signing the Master Service Agreement for Digital Transformation and Global Standardization Programs (Photo: Business Wire) Covestro is running a digi

The Saga Foundation Announces Its Plan to Create a Non-Anonymous, Reserve-Backed Digital Currency22.3.2018 16:00 | Tiedote

The Saga Foundation ( announces today its mission to create Saga (SGA), the first non-anonymous blockchain-based digital currency. The currency is designed with a tamed volatility mechanism. These characteristics can set the ground for the currency to become a store of value and a medium of exchange. Saga is designed to address legitimate concerns expressed by policy makers, regulators and market participants regarding cryptocurrencies; mainly their anonymity, lack of underlying value and high volatility. Saga holders must satisfy full KYC (Know Your Customer) qualification and AML (Anti Money Laundering) requirements under Swiss law. With such disclosures, Saga resolves concerns about participant accountability, an issue that is generally raised regarding cryptographic currencies. Saga aims to promote a low-volatility environment, combining the virtues of blockchain technologies with algorithmic representations of financial tools. For this reason, Saga is backed by a variable Celebrates the Launch of Their Spring Collection & the Zendaya Edit with a 90s Throwback Block Party!22.3.2018 15:48 | Tiedote

This evening, international etailer,, celebrated the launch of their newest Spring collection at an exclusive launch party in Los Angeles at The Dream Hollywood for media, influencers, and friends of the brand. This press release features multimedia. View the full release here: Celebrates the Launch of their Spring Collection & the Zendaya Edit with a 90s Throwback Block Party! Taking note from the product aesthetic, the event served as the ultimate 90s nostalgia trip with bright and bold décor from neon signs to giant boom boxes and life-size cassette tapes. Throughout the night, guests engaged in various activations including 90s dance lessons, cocktail making, cooking lessons, firework displays and interactive arcade games. Attendees also enjoyed 90s-inspired catering including retro treats Bubble Tape and Candy Necklaces, as well as Slush Puppies and Sunny D cocktails. Surprise musical guests, Snoop Dog

Takeda Announces Publication of Final Data from ICLUSIG® (ponatinib) Pivotal Phase 2 PACE Trial in Blood22.3.2018 15:00 | Tiedote

Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that final data from the pivotal Phase 2 PACE clinical trial of ICLUSIG (ponatinib) in refractory chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) were published in Blood . The manuscript is available online today and will be included in a future print edition of Blood. The final five-year results support ICLUSIG as an effective treatment option for patients with chronic-phase CML (CP-CML) whose prior therapies have failed. ICLUSIG, a tyrosine kinase inhibitor (TKI) with potent activity against native and mutant forms of BCR-ABL1 (an abnormal tyrosine kinase that is expressed in CML and Ph+ ALL), received full approval from the U.S. Food and Drug Administration in 2016. ICLUSIG is indicated for the treatment of adult patients with CML or Ph+ ALL for whom no other TKI is indicated, including those with T315I-positive CML or T315I-positive Ph+ ALL. ICLUSIG is not ind

Synchronoss Renews Agreement to Power Verizon Cloud22.3.2018 15:00 | Tiedote

Synchronoss Technologies, Inc. (NASDAQ:SNCR), a global leader and innovator of cloud, messaging, digital and IoT products, today announced that it has renewed its existing agreement with Verizon to power Verizon’s Cloud solution for its wireless customers for an additional five years. Synchronoss’ Personal Cloud Platform and solutions will continue to provide Verizon customers with simple, secure access to all personal content, including photos, videos, messages and more, from any device. “We’re delighted to be renewing our contract with one of our longest-serving and most valued customers,” said Glenn Lurie, President & CEO at Synchronoss. “The fully agnostic and secure Synchronoss Personal Cloud solution maintains high levels of customer trust in operators by meeting their mutual need for additional storage and capacity head on.” Synchronoss is the world’s leading provider of operator cloud solutions, with more than 160 million people currently using the Synchronoss Personal Cloud so

German Company Develops New Solution for Monetizing News Content22.3.2018 14:41 | Tiedote

MulTra GmbH has created an innovative solution to monetize digital content for newspaper publishers while simultaneously paying consumers for reading the news through their Pumped App. Pumped claims to be the first platform which pays people for reading news content while guaranteeing 100% ad revenue to publishers at no-sign up cost. “We developed the Pumped App working with feedback from major international publishers to address the challenge of monetizing news content,” said MulTra GmbH CEO Onik Mia. “By using the Pumped App, consumers are paid in the Ethereum-based MulTra Token (MTT) to read publisher content and earn cryptocurrency.” MulTra GmbH is a member of the Enterprise Ethereum Alliance. The Pumped App is platform independent and any publisher, regardless of size, can participate in the Pumped ecosystem for free. Media industry leaders and blockchain experts recently gathered at the Soho House Berlin to discuss how Pumped can increase monetization of content independent of th

Liquidnet Rolls Out Virtual High Touch Solution for Best Execution Analysis22.3.2018 14:00 | Tiedote

Liquidnet, the global institutional trading network today announced the launch of Best Ex Replay, the newest addition to the Liquidnet Virtual High Touch suite powered by data and analytics from OTAS Technologies. Best Ex Replay™ enables traders to recall precise market conditions to explain the context of execution decisions, investigate orders that experienced exceptional market conditions, and to help their firm meet regulatory reporting requirements such as MiFID II. It also enables traders to provide detailed execution feedback to Portfolio Managers. “What we’ve heard from our global Membership is that every minute that goes into manual, administrative tasks such as compliance requests and best execution analysis—while valuable—is time that comes at the expense of alpha generation,” said Natasha Shamis, Global Head of Product. “Traders need to spend their time on achieving best execution, not proving it. That’s what Best Ex Replay is for.” When a trader uses Best Ex Replay to rese

Workiva Leads Global Adoption of Inline XBRL22.3.2018 13:00 | Tiedote

Workiva (NYSE:WK), a leading provider of solutions for enterprise productivity, today announced Wdesk users filed more than 84 percent of all Inline XBRL facts with the U.S. Securities and Exchange Commission (SEC) in the fourth quarter of 2017. Wdesk has also been used to file more than 69 percent of all Inline XBRL filings. Inline XBRL (eXtensible Business Reporting Language), also known as iXBRL, creates a single, standardized, machine-readable report that is integrated within companies’ human-readable HTML filings. Inline XBRL combines the advantages of both filing types into a single, browser-friendly document. “XBRL was arguably the biggest thing to come along to enable machine readable financial data, and Inline XBRL is how we advance toward the common goal of providing better data,” said Marty Vanderploeg, President and Chief Operating Officer of Workiva. “Workiva is committed to improving data quality, increasing efficiencies and easing regulatory burdens for our customers.” W

Energy Through Education! The Renewables Academy AG (RENAC) Celebrates 10 Successful Years of Disseminating Know-How on Renewable Energy and Energy Efficiency around the World22.3.2018 11:00 | Tiedote

The Renewables Academy AG (RENAC), based in Berlin (Germany), is very proud to celebrate its 10th anniversary. Since its founding in 2008, RENAC has become an important and innovative provider of international trainings and capacity building for renewable energy and energy efficiency all around the world. More than 10,000 participants from over 140 countries have joined RENAC programmes. In 2008, Berthold Breid, RENAC’s founder and director, had the dream to support the international development of green energy markets through know-how transfer and exchange of expertise on renewable energy and energy efficiency. “Knowledge is one of the key factors for the sustainable development of clean and secure energy supplies”, said Mr. Breid. “Through our activities, we aim at satisfying the increasing demand for expertise throughout the public sector, private sector, finance sector, and potential investors in the green energy markets. Thanks to our participants, clients, partners, and, of cours

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For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.