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Sunday, 22 October 2017

Supermicro Launches New Enterprise Class 8-Socket Server for Intel Xeon Scalable Processors

 
Supermicro Launches New Enterprise Class 8-Socket Server for Intel Xeon Scalable Processors
Mission-Critical, Scale-Up Server with industry leading 12TB memory in a single 7U node SAN JOSE, California, Oct. 20, 2017 /PRNewswire/ -- Super Micro Computer, Inc. (NASDAQ: SMCI), a global leader in enterprise computing, storage, networking solutions and green computing technology,...
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India $45 Billion Outbound Tourism Market to 2022: Outbound Tourists, Purpose of Visit, Tourists Spending and Forecasts
DUBLIN, October 20, 2017 /PRNewswire/ -- The "India Outbound Tourism Market: Outbound Tourists, Purpose of Visit (Holiday, VFR (Visit Friends & Relatives), Business, Others), Tourists Spending and Forecast" report has been added to Research and Markets' offering. India...
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Global $9.3 Bn Radiotherapy Market 2017-2024 - Mergers and Acquisitions to Expand Business
DUBLIN, October 20, 2017 /PRNewswire/ -- The "Global Radiotherapy Market Analysis, Companies Profiles, Size, Share, Growth, Trends and Forecast to 2024" report has been added to Research and Markets' offering. In this report, global radiotherapy market is projected to reach USD...
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QuantumClean® and ChemTrace® to Exhibit at SEMICON Europa 2017
Validated Ultra-High Purity.  Maximum Productivity.™ QUAKERTOWN, Pennsylvania, Oct. 20, 2017 /PRNewswire/ -- Quantum Global Technologies' companies, QuantumClean and ChemTrace, will exhibit at SEMICON Europa 2017 at Munich's Messe München from November 14 - 17 (booth B1-1749).  "...
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DOVU Token Sale Raises 20,000 ETH
LONDON, October 21, 2017 /PRNewswire/ -- The blockchain mobility project will create a marketplace for data to power innovation in the transport sector. DOVU's token sale has ended. The company collected a total of 20,000 Ether (ETH), with a current value of $6.2 million. This...
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Worldwide Call for Urgent Reform of Catholic Church on Luther Anniversary
MELBOURNE, Australia, Oct. 21, 2017 /PRNewswire/ -- On the eve of 500th anniversary of the most significant reform of the Catholic Church leading to the Protestant Reformation, an Australian priest excommunicated for supporting women priests, has launched a radical program to reform the...
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A Long-term Sentence: Dermalex Skincare Survey Reveals Millions of British Adults Have Suffered With Eczema, Psoriasis, Rosacea or Acne for More Than Ten Years
LONDON, October 22, 2017 /PRNewswire/ -- ● The Dermalex skincare survey indicates that as much as  50% of the GB adult population have suffered with skin conditions in their life ● 64% have had eczema, psoriasis, rosacea or acne for over a decade ● Over a quarter (28%) hav...
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Gov UK: Press release: Chemical event at Sellafield, 21 October 2017

Press release: Chemical event at Sellafield, 21 October 2017
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Press release: UK aid provides lifeline to defenceless and wounded Syrians to help them return to a liberated Raqqa
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Press release: Government acts to improve the home buying process
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Press release: Increased security measures to give prison officers right tools for the job
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Friday, 20 October 2017

[NASA HQ News] International Space Station Crew Invites Public Along for Photographic Trip Around World

  October 20, 2017 
MEDIA ADVISORY M17-125
International Space Station Crew Invites Public Along for Photographic Trip Around World

NASA astronaut and Expedition 53 Commander Randy Bresnik will spend one full orbit photographing Earth from the International Space Station on Monday, Oct. 23, and he is inviting people around the globe to share images from their Earth-side vantage point on social media.

Bresnik, with help from fellow astronaut Joe Acaba, will begin the "photo frenzy" from the station's 360-degree Earth-facing cupola window beginning at 8:25 a.m. EDT. Traveling at about five miles per second, the station completes one orbit around Earth approximately every 90 minutes.

As part of NASA's Year of Education on Station, an initiative to inspire more students and teachers than ever before during the 2017-18 school year, students located in areas Bresnik will photograph are especially invited to join him on the journey and share their photos, including their locations and names of their schools.

"You can't look at the Earth and not be changed," Bresnik said. "You realize every experience you've ever had and every person you've ever known is down on that little blue marble."

The station's orbit will begin with a sweep from the United Kingdom across central Europe to Oman, a pass near the Maldives, sunset west of Australia and sunrise over the south Pacific Ocean before concluding with a pass over North America from Puerto Vallarta, Mexico, to Montreal, Canada. Bresnik will be posting updates of his views on his social media accounts throughout, as satellite communications coverage allows.

Regardless of where you'll be on Earth during their photo session, the astronauts are asking for your help to capture this moment in time, specifically from 8:25-9:55 a.m. EDT (12:25-13:55 GMT). They're encouraging educators, students, and the public to post a picture to social media of their surroundings from their unique vantage point using the hashtag #1World1Orbit.

Astronaut photography documents how the planet changes over time, from human-caused changes like urban growth and reservoir construction, to natural dynamic events such as hurricanes, floods and volcanic eruptions. In addition to research applications, photography is a favorite pastime of the crew, and many astronauts feel compelled to share their cosmic perspective with humanity with humanity on social media.

There are opportunities for humanity to stay in touch with our representatives off the planet every day. You can track the station and sighting opportunities in your area anytime with NASA's Spot the Station tool.

Another Earth observation from station opportunity is Sally Ride EarthKAM, which begins its next mission on Nov. 1, and allows student groups to track and analyze sections of the planet over time.

Follow Bresnik on social media at:

https://www.facebook.com/AstroKomrade/

https://twitter.com/AstroKomrade

https://www.instagram.com/astrokomrade

-end-

 

Press Contacts

Stephanie Schierholz
Headquarters, Washington
202-358-1100
stephanie.schierholz@nasa.gov

Brandi Dean
Johnson Space Center, Houston
281-483-5111
brandi.k.dean@nasa.gov

 

NASA news releases and other information are available automatically by sending an e-mail message with the subject line subscribe to hqnews-request@newsletters.nasa.gov.
To unsubscribe from the list, send an e-mail message with the subject line unsubscribe to hqnews-request@newsletters.nasa.gov.

 

 

DBV Technologies Announces Topline Results of Phase III Clinical Trial in Peanut-Allergic Patients Four to 11 Years of Age

DBV Technologies    

Published: 23:15 CEST 20-10-2017 /GlobeNewswire /Source: DBV Technologies / : DBV /ISIN: FR0010417345


  Press Release

   Montrouge, France, October 20, 2017

DBV Technologies Announces Topline

Results of Phase III Clinical Trial in Peanut-Allergic Patients Four to 11 Years of Age

 

DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT) today announced topline results from the PEPITES (Peanut EPIT Efficacy and Safety) Phase III trial evaluating the safety and efficacy of Viaskin Peanut in children four to 11 years of age. Topline results show a statistically significant response with a favorable tolerability profile, with 35.3% of patients responding to Viaskin Peanut 250 µg after 12 months of treatment as compared to 13.6% of patients in the placebo arm (difference in response rates = 21.7%; p=0.00001; 95% CI = 12.4% - 29.8%). However, the primary endpoint, which evaluates the 95% confidence interval (CI) in the difference in response rates between the active and placebo arms, did not reach the 15% lower bound of the CI that was proposed in the study's Statistical Analysis Plan (SAP) submitted to the U.S Food and Drug Administration (FDA). Following initial conversations with the FDA on these topline efficacy and safety results, DBV will continue ongoing discussions with the agency, and plans to proceed with the BLA preparation process.

 

"We believe that this preliminary analysis shows significant therapeutic promise in the peanut-allergic population, where there is a high unmet medical need and no approved treatments," said Dr. Pierre-Henri Benhamou, Chairman & Chief Executive Officer of DBV Technologies. "Viaskin Peanut has been granted both Breakthrough Therapy and Fast Track designations by the FDA for the treatment of peanut allergy. We are committed to working together with the regulatory agencies to bring forward a safe and effective treatment option for these patients."

 

Preliminary analysis of the Cumulative Reactive Dose (CRD) - a key secondary endpoint measuring threshold reactivity during the double-blind, placebo-controlled food challenge (DBPCFC) - showed that at month 12, patients treated with Viaskin Peanut 250 microg and placebo reached a mean CRD of approximately 900 mg (median 444 mg) and 360 mg (median 144 mg) of peanut protein, respectively. Mean CRD at baseline was approximately 210 mg (median 144 mg) in both groups. This increase from baseline was statistically significant compared to placebo (p<0.001), and these findings are consistent with the data observed in the Company's Phase IIb study of Viaskin Peanut. For reference, one peanut contains approximately 250 mg peanut protein.

 

Safety and tolerability data were generally in-line with prior Phase IIb results. No imbalance in serious adverse events (SAEs) was observed in the trial, with 12 cases in 10 subjects in the active arm (4.2%), and 6 cases in 6 subjects in the placebo arm (5.1%); 4 of these cases were in 3 subjects in the active arm (1.3%), and were qualified by the investigator as possibly related to treatment. None of these cases were qualified as severe anaphylaxis, and all patients responded to standard outpatient therapy. The most commonly reported adverse events were application site reactions, that were mostly mild and moderate in nature. In the 12-month treatment period, the discontinuation rate was 10.1%, which was evenly-balanced between the active and placebo arms, with a 1.1% dropout due to treatment emergent adverse events (TEAEs). Mean patient compliance was above 95% in the trial.

 

Dr. Hugh Sampson, Chief Scientific Officer of DBV Technologies and Kurt Hirschhorn Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai said, "The findings in this study underscore the potential of epicutaneous immunotherapy, and we continue to be encouraged by the response rate and clinically meaningful improvements in cumulative reactive dose that we observed. We believe the strength of all clinical data we have seen to date in over 650 patients supports the safety and efficacy profile of Viaskin Peanut, and look forward to seeing the full results from this trial." Dr. Sampson continued, "We are very grateful to all the investigators and their support staff, patients and caregivers for their participation in this important trial."

 

A full assessment of the data is ongoing, with detailed results expected to be submitted for presentation at a future medical meeting.

 

Dr. David Fleischer, Global PI for PEPITES and Associate Section Head at Children's Hospital Colorado, said, "For the past 15 years that I have been involved in food allergy research, parents of peanut-allergic patients have been asking me is there anything more we can do to manage our child's allergy besides strict avoidance. To lead the pivotal Phase III global trial has been an amazing honor, but to know I may be able to finally answer this question is even more incredible. Given the significant psychosocial and financial burdens placed on food-allergic patients and families that negatively impacts their quality of life, I am hopeful that we are one step closer to having a food allergy treatment that may improve the lives of peanut-allergic patients and families around the world."

 

The Company continues to anticipate announcing the topline results of the REALISE Phase III trial in November 2017.

 

DBV Technologies will host a conference call today, October 20, 2017, at 5:00 p.m. ET (11:00 p.m. CEST), to discuss these topline results. The conference call may be accessed by dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422 for international callers. The conference call ID number is 5556432. A replay of the call will be available for 30 days following the call, beginning at 7:00 p.m. EST (1:00 a.m. CEST). The replay number is +1 888 843 7419 for U.S. callers or +1 630 652 3042 for international callers. The conference call ID number is 5556432.

 

About PEPITES

The Peanut EPIT Efficacy and Safety Study (PEPITES) was a global, pivotal, double-blinded, placebo-controlled Phase III trial designed to evaluate the safety and efficacy of Viaskin Peanut 250 microg in children ages four to 11 years. PEPITES was conducted in 31 centers across North America (Canada and the United States), Germany, Ireland and Australia.

 

The last patient visit for PEPITES occurred in August 2017. During PEPITES, patients' response has been assessed using a double-blind, placebo controlled food challenge (DBPCFC). Patients were randomized 2:1 to receive either Viaskin Peanut 250 microg or placebo for 12 months. The primary endpoint was based on a responder analysis after 12 months of treatment with Viaskin Peanut 250 µg. For patients with a baseline peanut protein eliciting dose (ED) equal to or less than 10 mg, a responder was defined as a patient with a peanut protein ED equal to or greater than 300 mg of peanut protein after 12 months of treatment. For patients with a baseline ED greater than 10 mg, a responder was defined as a patient with a peanut protein ED equal to or greater than 1,000 mg of peanut protein after 12 months of treatment. As a secondary efficacy endpoint, Cumulative Reactive Dose (CRD), has also been used in PEPITES to establish the total quantity of peanut protein that triggers patient reactions at month 12 of active treatment versus placebo. Serological markers were also measured at baseline, 3, 6, and 12 months in order to characterize the immunological changes in patients.

 

About REALISE

REALISE is a multicenter, randomized, double-blinded, placebo-controlled Phase III study designed to generate safety data after six months of blinded treatment in patients four to 11 years of age and assess the use of Viaskin Peanut 250 microg in routine medical practice.  At the six-month time point, patients in both the placebo and active arms continue in the open-label portion of the study, which will monitor patients for a total of 36 months of active treatment. Exploratory criteria also include scores from patients' Food Allergy Quality of Life Questionnaire (FAQLQ) and the Food Allergy Independent Measure (FAIM), as well as the evolution of peanut-specific serological markers over time. The study is conducted in 32 centers in North America. No oral food challenges are required in REALISE. Patients in the study were selected based on a well-documented medical history of IgE-mediated reactions to peanut, including children with a history of severe anaphylaxis, as well as analyses of baseline peanut-specific immunological markers. During the first six months of trial, patients were randomized 3:1 active versus placebo. Key assessments of safety parameters include treatment-emergent adverse events observed in both the placebo and active treatment groups during the initial six months, which continue to be monitored during the open-label portion of the study. DBV randomized 393 patients in REALISE.

 

DBV Technologies 

DBV Technologies is developing Viaskin®, a proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT®, DBV's method of delivering biologically active compounds to the immune system through intact skin. With this new class of self-administered and non-invasive product candidates, the company is dedicated to safely transforming the care of food allergic patients, for whom there are no approved treatments. DBV's food allergies programs include ongoing clinical trials of Viaskin Peanut and Viaskin Milk, and preclinical development of Viaskin Egg. DBV is also pursuing a human proof-of-concept clinical study of Viaskin Milk for the treatment of Eosinophilic Esophagitis, and exploring potential applications of its platform in vaccines and other immune diseases. DBV Technologies has global headquarters in Montrouge, France and New York, NY. Company shares are traded on segment A of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345), part of the SBF120 index, and traded on the Nasdaq Global Select Market in the form of American Depositary Shares (each representing one-half of one ordinary share) (Ticker: DBVT). For more information on DBV Technologies, please visit our website: www.dbv-technologies.com

 

Forward Looking Statements

This press release may contain forward-looking statements and estimates, including statements regarding the potential of Viaskin Peanut and the anticipated timing of data from the REALISE clinical trial. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, the products of the Company have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals and the risk that historical clinical results in one patient population may not be predictive of future clinical trial results in different patient populations. A further list and description of these risks, uncertainties and other risks can be found in the Company's regulatory filings with the French Autorité des Marchés Financiers, the Company's Securities and Exchange Commission filings and reports, including in the Company's Annual Report on Form 20-F for the year ended December 31, 2016 and future filings and reports by the Company. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release.

 

 

DBV Investor Relations Contact

Sara Blum Sherman

Director, Investor Relations
+1 212-271-0740
sara.sherman@dbv-technologies.com

 

DBV Media Contact

Roberta Di Giorgio

Head, Corporate Communications
+1 917-612-2861
roberta.digiorgio@dbv-technologies.com

 

 

 



PDF version



This announcement is distributed by Nasdaq Corporate Solutions (One Liberty Plaza, 165 Broadway, New York, NY 10006. Tel: +1 212 401 8700. www.nasdaqomx.com) on behalf of Nasdaq Corporate Solutions clients. Source: DBV Technologies, Green Square - Bâtiment D 80/84 rue des Meuniers, Bagneux FR-92220, France
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EU Commission: Remarks by President Donald Tusk on the European Council meetings and the Leaders' Agenda

Remarks by President Donald Tusk on the European Council meetings and the Leaders' Agenda

Today we discussed the Leaders' Agenda for our work in the next two years, and I am happy to have received univocal support of all the EU leaders to go ahead with this plan. This is not an easy task, as the ambition of the Leaders' Agenda is to deal with the most contentious issues, by which I mean the Eurozone reform, migration crisis, internal security, trade and the future financing of the EU. That is why I also proposed a new work method, perhaps somewhat more direct, but at the same time more informal. It will mean confronting the areas where European cooperation does not work well and being honest about the reasons why. Confrontation is healthy as long as it is respectful and helps us move forward. And this is the spirit of our work ahead. But what I am very pleased about today is that none of the leaders questioned the fact that we must work united, hand-in-hand, with all the Member States on board.

After Prime Minister May's intervention last night, and our discussion about Brexit this morning, my impression is that the reports of the deadlock between the EU and UK have been exaggerated. And while progress is not sufficient, it doesn't mean there is no progress at all. Today the Council has agreed to start internal preparatory discussions in relation to the framework for the future relationship and on transitional arrangements. It is clear that this would not be possible without the new momentum given by the Florence speech of Prime Minister May. I would like to reassure our British friends that in our internal work we will take account of proposals presented there. So the negotiations go on, and we will continue to approach them positively and constructively. And as we are all working actively on a deal, I hope we will be able to move to the second phase of our talks in December.

Finally, as a result of our discussion last night on Turkey, we tasked the Commission to reflect on whether to cut and re-orient pre-accession funds. It was a substantive discussion, we want to keep the door open to Ankara, but the current reality in Turkey is making this difficult. It was also stressed that Turkey needs to respect all Member States in its relations with the EU, including when it comes to the implementation of the existing Customs Union agreement. And furthermore, we have listened to the concerns raised by President Anastasiades regarding Turkey's actions vis-à-vis the Greek Cypriots and Maronites.

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Letter to IFRS IC on Tentative Agenda Decisions of the IFRS IC on IFRS 3 and IAS 37

Friday 20 October 2017 13:48

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Letter to EFRAG on ED Amendments to IAS 16

Friday 20 October 2017 14:10

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Letter to IASB on ED Amendments to IAS 16

Friday 20 October 2017 14:15

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Antitrust: Commission confirms inspection in the car sector in Germany

European Commission - Statement Brussels, 20 October 2017 The European Commission can confirm that as of 16 October 2017 its officials carried out an unannounced inspection at the premises of a car manufacturer in Germany.

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Global Light Vehicle Turbochargers Market Report 2017 with Exclusive Interviews with Torotrak and Valeo

 
Global Light Vehicle Turbochargers Market Report 2017 with Exclusive Interviews with Torotrak and Valeo
DUBLIN, October 20, 2017 /PRNewswire/ -- The "Global Light Vehicle Turbochargers Market - Forecasts to 2032" report has been added to Research and Markets' offering. This report provides a comprehensive overview of the global OE turbos sector, major suppliers, top markets,...
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Global Light Vehicle Transmissions and Clutches Market to 2032
DUBLIN, October 20, 2017 /PRNewswire/ -- The "Global Light Vehicle Transmissions and Clutches Market - Forecasts to 2032" report has been added to Research and Markets' offering. This report provides a comprehensive overview of the global OE transmissions and clutches sector,...
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Global Light Vehicle Steering Market, 2032
DUBLIN, October 20, 2017 /PRNewswire/ -- The "Global Light Vehicle Steering Market - Forecasts to 2032" report has been added to Research and Markets' offering. This report provides a comprehensive overview of the global OE steering systems sector, major suppliers, top 14...
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Porsche Design and Huawei Introduce the Ultimate in Luxury and Functional Design with Porsche Design HUAWEI Mate 10
LONDON, October 20, 2017 /PRNewswire/ -- Stunning new device combines sophisticated aesthetics and high performance, powered by artificial intelligence Porsche Design extends its prestigious partnership with technology innovator Huawei to introduce the highly anticipated Porsche...
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Global Light Vehicle OE Shock Absorbers Market, 2032 - Major Suppliers, Top 14 Markets, Technology Trends and Forecasts
DUBLIN, October 20, 2017 /PRNewswire/ -- The "Global Light Vehicle OE Shock Absorbers Market - Forecasts to 2032" report has been added to Research and Markets' offering. Updated in the last quarter, this report has been extracted from motor industry information and intelligence...
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Global Commercial Vehicle Instrument Cluster Market 2017-2021: Digital Instrument Clusters are the Future of Autonomous Trucks
DUBLIN, October 20, 2017 /PRNewswire/ -- The "Global Commercial Vehicle Instrument Cluster Market 2017-2021" report has been added to Research and Markets' offering. Global Commercial Vehicle Instrument Cluster Market 2017-2021, has been prepared based on an in-depth market...
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Opportunities for 3D Printing Software 2017-2027
DUBLIN, October 20, 2017 /PRNewswire/ -- The "Opportunities for 3D Printing Software 2017" report has been added to Research and Markets' offering. Software in the 3D printing industry is often described as the 'glue' that holds together the ongoing advancements in both hardware...
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