LA ROCHELLE, France--(BUSINESS WIRE)--May 15, 2018--Regulatory News:VALBIOTIS (FR0013254851 – ALVAL / PEA/SME eligible) (Paris:ALVAL), a French Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, today announced it has received authorization from the American authorities to launch the international REVERSE-IT (Phase IIB1) clinical study of VALEDIA TM in the United States. Simultaneously, discussions are initiated with the Food and Drug Administration (FDA) for a health claim regarding the reduction of the risk of Type 2 Diabetes.“ The acceleration of our development in the United States marks the beginning of a key phase for VALBIOTIS. The authorization from the American authorities for the VALEDIATMclinical study supports our access to these markets, and in particular to the prediabetes market, which affects more than 86 million people in the United States. We are delighted with these recent breakthroughs … [Read more...] about VALBIOTIS Initiates the Clinical Development of VALEDIATM in the United-States with the REVERSE-IT Clinical Study
United states
2 Day Course: Software Risk Management (Philadelphia, PA, United States
DUBLIN--(BUSINESS WIRE)--May 15, 2018--The "Software Risk Management" conference has been added to ResearchAndMarkets.com's offering.The seminar will address the specific challenges software poses for the risk management process. Basic risk management concepts will be introduced and then applied to software specific applications.Risk Management is a regulatory and statutory requirement for medical devices. The generic procedure to perform risk management is outlined in ISO14791, however, as soon as software is used challenges arise. How to address these specific software issues and the application of FDA and IEC requirements for development of safety-critical software used in medical devices is the content of this seminar.AgendaDay 1 ScheduleLecture 1 (90 Mins)Legal and regulatory requirements for risk managementRisk management and quality systemsLecture 2 (90 Mins)Risk Management BasicsWhat are hazards / hazardous situationsHazard characteristicsRisk and risk ratingResidual … [Read more...] about 2 Day Course: Software Risk Management (Philadelphia, PA, United States
Correction: United States China-ZTE story
0 View Comments WASHINGTON (AP) — In a story May 13 about President Donald Trump's promise to help Chinese telecommunications company ZTE, The Associated Press reported erroneously that Amanda DeBusk is the chair of the international trade department at the law firm Hughes Hubbard & Reed. She is the chair of the international trade and government regulations practice at the firm Dechert, LLP. A corrected version of the story is below: Trump says US will help penalized Chinese company Trump says he will help a Chinese telecommunications company get 'back into business,' saying too many jobs in China are at stake after the U.S. government cut off access to its American suppliers WASHINGTON (AP) — In a surprising overture to China, President Donald Trump said Sunday he would help a Chinese telecommunications company get "back into business," saying too many jobs in China are at stake after the U.S. government cut off access to its American suppliers. At issue is the … [Read more...] about Correction: United States China-ZTE story
Led by Patrick Kane, United States shines at hockey worlds
By Karel Janicek Published 4:04 pm, Sunday, May 13, 2018 HERNING, Denmark — Six games, six wins. Led by Patrick Kane, the United States has impressed so far at the ice hockey world championship in Denmark. Kane scored two goals for the second straight game Sunday and added an assist to lead the United States to a 9-3 victory over Norway in Group B. The Americans finish group play Tuesday against Finland, and are assured a spot in the quarterfinals. Kane scored with a slap shot from the right circle on a power play to open the scoring and added another power play goal almost from the same spot for a 2-0 lead. “A good performance by the team tonight,” Kane said. “We had a lot of different guys contribute and chip in, which is good to see, and gives us a lot of confidence going into the next game against Finland.” Also in the group play Sunday, Finland lost to Germany 3-2 in overtime — a day after the Finns outplayed Canada. In Copenhagen, … [Read more...] about Led by Patrick Kane, United States shines at hockey worlds
ArcelorMittal makes $1.2 billion in first quarter but loses $32.4 million in the United States
ArcelorMittal made $1.2 billion in the first quarter, but ArcelorMittal USA lost $32.4 million in the United States despite the newly imposed tariffs of 25 percent on most foreign-made steel so its thousands of steelworkers in Northwest Indiana won't take home profit-sharing checks. ArcelorMittal CEO John Brett said the global steelmaker's U.S. operations achieved its target for total shipments and improved in customer delivery performance, but stumbled in quality and hurt its bottom line by missing targets for prime shipments."Increased raw material costs offset higher selling prices for the quarter. However, we expect to reverse this relationship on the improving market environment in Q2 and beyond," Brett said. "New trade remedies that were put in place the final weeks of first quarter have not yet offset or provided the intended balancing effect in combating imports. However, we believe ArcelorMittal USA is well positioned to benefit from the impact of trade remedies moving … [Read more...] about ArcelorMittal makes $1.2 billion in first quarter but loses $32.4 million in the United States