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They're called the "Apple Watch Series 2", "LG Watch", "Samsung GEAR S3" or "Moto 360 2nd Gen" but they all have the same problem. "Every new product generation has better screens, better processors, better cameras, and new sensors, but regarding input, the limitations remain," explains Srinath Sridhar, a researcher in the Graphics, Vision and Video group at the Max Planck Institute for Informatics. Together with Christian Theobalt, head of the Graphics, Vision and Video group at MPI, Anders Markussen and Sebastian Boring at the University of Copenhagen and Antti Oulasvirta at Aalto University in Finland, Srinath Sridhar has therefore developed an input method that requires only a small camera to track fingertips in mid-air, and touch and position of the fingers on the back of the hand. This combination enables more expressive interactions than any previous sensing technique. Regarding hardware, the prototype, which the researchers have named "WatchSense", requires only a depth sensor, a much smaller version of the well-known "Kinect" game controller from the Xbox 360 video game console. With WatchSense, the depth sensor is worn on the user's forearm, about 20cm from the watch. As a sort of 3D camera, it captures the movements of the thumb and index finger, not only on the back of the hand but also in the space over and above it. The software developed by the researchers recognizes the position and movement of the fingers within the 3D image, allowing the user to control apps on smartphones or other devices. "The currently available depth sensors do not fit inside a smartwatch, but from the trend it's clear that in the near future, smaller depth sensors will be integrated into smartwatches," Sridhar says. But this is not all that's required. According to Sridhar, with their software system the scientists also had to solve the challenges of handling the unevenness of the back of the hand and the fact that the fingers can occlude each other when they are moved. "The most important thing is that we can not only recognize the fingers, but also distinguish between them," explains Sridhar, "which nobody else had managed to do before in a wearable form factor. We can now do this even in real time." The software recognizes the exact positions of the thumb and index finger in the 3D image from the depth sensor, because the researchers trained it to do this via machine learning. In addition, the researchers have successfully tested their prototype in combination with several mobile devices and in various scenarios. "Smartphones can be operated with one or more fingers on the display, but they do not use the space above it. If both are combined, this enables previously impossible forms of interaction," explains Sridhar. He and his colleagues were able to show that with WatchSense, in a music program, the volume could be adjusted and a new song selected more quickly than was possible with a smartphone's Android app. The researchers also tested WatchSense for tasks in virtual and augmented reality, in a map application, and used it to control a large external screen. Preliminary studies showed that WatchSense was more satisfactory for each case than conventional touch-sensitive displays. Sridhar is confident that "we need something like WatchSense whenever we want to be productive while moving. WatchSense is the first to enable expressive input for devices while on the move." From May 6, the researchers will present WatchSense at the renowned "Conference on Human Factors in Computing," or CHI for short, which this time takes place in the city of Denver in the US. Explore further: 'Lab-on-a-glove' could bring nerve-agent detection to a wearer's fingertips


News Article | May 3, 2017
Site: www.eurekalert.org

It relies on a depth sensor that tracks movements of the thumb and index finger on and above the back of the hand. In this way, not only can smartwatches be controlled, but also smartphones, smart TVs and devices for augmented and virtual reality. They're called the "Apple Watch Series 2", "LG Watch", "Samsung GEAR S3" or "Moto 360 2nd Gen" but they all have the same problem. "Every new product generation has better screens, better processors, better cameras, and new sensors, but regarding input, the limitations remain," explains Srinath Sridhar, a researcher in the Graphics, Vision and Video group at the Max Planck Institute for Informatics. Together with Christian Theobalt, head of the Graphics, Vision and Video group at MPI, Anders Markussen and Sebastian Boring at the University of Copenhagen and Antti Oulasvirta at Aalto University in Finland, Srinath Sridhar has therefore developed an input method that requires only a small camera to track fingertips in mid-air, and touch and position of the fingers on the back of the hand. This combination enables more expressive interactions than any previous sensing technique. Regarding hardware, the prototype, which the researchers have named "WatchSense", requires only a depth sensor, a much smaller version of the well-known "Kinect" game controller from the Xbox 360 video game console. With WatchSense, the depth sensor is worn on the user's forearm, about 20cm from the watch. As a sort of 3D camera, it captures the movements of the thumb and index finger, not only on the back of the hand but also in the space over and above it. The software developed by the researchers recognizes the position and movement of the fingers within the 3D image, allowing the user to control apps on smartphones or other devices. "The currently available depth sensors do not fit inside a smartwatch, but from the trend it's clear that in the near future, smaller depth sensors will be integrated into smartwatches," Sridhar says. But this is not all that's required. According to Sridhar, with their software system the scientists also had to solve the challenges of handling the unevenness of the back of the hand and the fact that the fingers can occlude each other when they are moved. "The most important thing is that we can not only recognize the fingers, but also distinguish between them," explains Sridhar, "which nobody else had managed to do before in a wearable form factor. We can now do this even in real time." The software recognizes the exact positions of the thumb and index finger in the 3D image from the depth sensor, because the researchers trained it to do this via machine learning. In addition, the researchers have successfully tested their prototype in combination with several mobile devices and in various scenarios. "Smartphones can be operated with one or more fingers on the display, but they do not use the space above it. If both are combined, this enables previously impossible forms of interaction," explains Sridhar. He and his colleagues were able to show that with WatchSense, in a music program, the volume could be adjusted and a new song selected more quickly than was possible with a smartphone's Android app. The researchers also tested WatchSense for tasks in virtual and augmented reality, in a map application, and used it to control a large external screen. Preliminary studies showed that WatchSense was more satisfactory for each case than conventional touch-sensitive displays. Sridhar is confident that "we need something like WatchSense whenever we want to be productive while moving. WatchSense is the first to enable expressive input for devices while on the move." From May 6, the researchers will present WatchSense at the renowned "Conference on Human Factors in Computing," or CHI for short, which this time takes place in the city of Denver in the US.


News Article | May 1, 2017
Site: www.techtimes.com

Researchers at the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany, have successfully retrieved hominin DNA from cave sediments without relying on ancient bones or teeth. The newly perfected technology instead focuses on traces of mitochondrial DNA preserved in mineral sediments in the soil, and has greatly expanded the horizons of ancient DNA research. The need for stepping up the game and devising new ways to get hold of ancient human DNA stems from the scarcity of skeletal remains. Even though archaeologists have found a plethora of tools and other human-made artifacts in many prehistoric sites in Europe and Asia, not the same can be said about actual human remains. Moreover, many of the recovered fossils don't have enough DNA to be used in genetic analysis. Knowing that DNA binds to the mineral component of bones, the team, led by MPI geneticist Matthias Meyer, set out to establish if the same could happen in ancient sediments full of minerals. As Meyer explains, bits of genes from ancient humans make up just a minute fraction of the DNA floating around in the natural world. "In most excavation sites, if you find thousands of bones from animals, you're very lucky if you find one human tooth or a long-bone fragment," he said in a statement. According to Meyer, their objective was "to investigate whether hominin DNA may survive in sediments at archaeological sites known to have been occupied by ancient hominins." To test their theory, the researchers worked together with a large number of archaeologists from seven different sites in Belgium, France, Spain, Croatia, and Russia (including the Denisova Cave in Siberia) and collected 85 samples of sediment dated between 14,000 to more than 550,000 years ago. Although DNA sticks to minerals and decayed plants in soil, scientists did not know whether it would ever be possible to fish out gene fragments that were tens of thousands of years old and buried deep among other genetic debris. The team analyzed layers of sediment looking to discover if they preserved any genetic fingerprint, and was finally able to extract tiny DNA fragments that had once belonged to a variety of mammals, including our extinct human relatives. Their efforts yielded DNA traces that once belonged to extinct species such as the woolly mammoths, woolly rhinoceroses, cave bears, and cave hyenas, as well as traces of Neanderthal DNA and Denisovan DNA. "By automation-assisted screening of numerous sediment samples we detect Neanderthal DNA in eight archaeological layers from four caves in Eurasia. In Denisova Cave we retrieved Denisovan DNA in a Middle Pleistocene layer near the bottom of the stratigraphy," wrote the authors in the abstract of their paper, published April 27 in the journal Science. Mitochondrial DNA is the genetic material found in the mitochondria, the so-called "energy factories" of each cell. With only tiny amounts of material at their disposal, the scientists managed to recover and analyze mitochondrial DNA samples from twelve different mammal species. At first, the team identified the animal DNA traces and then searched for ancient hominin DNA. Initially, the gathered samples seemed to contain too much of the other mammals' DNA and the team had trouble detecting the small traces of Neanderthal and Denisovan DNA. At that point, the researchers "switched strategies and started targeting specifically DNA fragments of human origin," said study lead author Viviane Slon, a doctoral student at the German institute. They found that nine of the samples, collected from four archaeological sites, contained enough ancient hominin DNA to advance their research. In the end, the team recovered Neanderthal mitochondrial DNA — belonging to either one or several individuals — from eight sediment samples, and Denisovan DNA from only one sample. The majority of these samples came from sediment layers or sites where no hominin fossils were ever discovered. Instead, the DNA traces may have been left behind by animals that hunted the ancient humans and took shelter in the caves to eat their prey. Another possibility is that the samples are remnants of body parts or human waste. Described as "a real evolution in technology," this method, developed over the course of several years, led to the retrieval of DNA even where it seemed impossibly scarce and degraded. DNA traces were recovered even from sediment samples that had been kept at room temperature for a long period of time. "By retrieving hominin DNA from sediments, we can detect the presence of hominin groups at sites and in areas where this cannot be achieved with other methods", stated study co-author Svante Pääbo, director of the institute's Evolutionary Genetics department. "This shows that DNA analyses of sediments are a very useful archaeological procedure, which may become routine in the future," he added. © 2017 Tech Times, All rights reserved. Do not reproduce without permission.


News Article | May 3, 2017
Site: www.rdmag.com

It relies on a depth sensor that tracks movements of the thumb and index finger on and above the back of the hand. In this way, not only can smartwatches be controlled, but also smartphones, smart TVs and devices for augmented and virtual reality. They're called the "Apple Watch Series 2", "LG Watch", "Samsung GEAR S3" or "Moto 360 2nd Gen" but they all have the same problem. "Every new product generation has better screens, better processors, better cameras, and new sensors, but regarding input, the limitations remain," explains Srinath Sridhar, a researcher in the Graphics, Vision and Video group at the Max Planck Institute for Informatics. Together with Christian Theobalt, head of the Graphics, Vision and Video group at MPI, Anders Markussen and Sebastian Boring at the University of Copenhagen and Antti Oulasvirta at Aalto University in Finland, Srinath Sridhar has therefore developed an input method that requires only a small camera to track fingertips in mid-air, and touch and position of the fingers on the back of the hand. This combination enables more expressive interactions than any previous sensing technique. Regarding hardware, the prototype, which the researchers have named "WatchSense", requires only a depth sensor, a much smaller version of the well-known "Kinect" game controller from the Xbox 360 video game console. With WatchSense, the depth sensor is worn on the user's forearm, about 20cm from the watch. As a sort of 3D camera, it captures the movements of the thumb and index finger, not only on the back of the hand but also in the space over and above it. The software developed by the researchers recognizes the position and movement of the fingers within the 3D image, allowing the user to control apps on smartphones or other devices. "The currently available depth sensors do not fit inside a smartwatch, but from the trend it's clear that in the near future, smaller depth sensors will be integrated into smartwatches," Sridhar says. But this is not all that's required. According to Sridhar, with their software system the scientists also had to solve the challenges of handling the unevenness of the back of the hand and the fact that the fingers can occlude each other when they are moved. "The most important thing is that we can not only recognize the fingers, but also distinguish between them," explains Sridhar, "which nobody else had managed to do before in a wearable form factor. We can now do this even in real time." The software recognizes the exact positions of the thumb and index finger in the 3D image from the depth sensor, because the researchers trained it to do this via machine learning. In addition, the researchers have successfully tested their prototype in combination with several mobile devices and in various scenarios. "Smartphones can be operated with one or more fingers on the display, but they do not use the space above it. If both are combined, this enables previously impossible forms of interaction," explains Sridhar. He and his colleagues were able to show that with WatchSense, in a music program, the volume could be adjusted and a new song selected more quickly than was possible with a smartphone's Android app. The researchers also tested WatchSense for tasks in virtual and augmented reality, in a map application, and used it to control a large external screen. Preliminary studies showed that WatchSense was more satisfactory for each case than conventional touch-sensitive displays. Sridhar is confident that "we need something like WatchSense whenever we want to be productive while moving. WatchSense is the first to enable expressive input for devices while on the move." From May 6, the researchers will present WatchSense at the renowned "Conference on Human Factors in Computing," or CHI for short, which this time takes place in the city of Denver in the US.


News Article | April 17, 2017
Site: phys.org

Scientists have known for half a century that these two processes are coupled in bacteria, but only now have they finally had a look at the structure that makes this possible. In a paper published in Science today, biochemists from the University of Wisconsin-Madison and the Max Planck Institute (MPI) for Biophysical Chemistry in Germany have revealed the defined architecture of what is called the "expressome." The researchers say this work using the model bacteria E. coli could open numerous doors for research into how bacteria impact human health, including a better basic understanding of gene regulation and possible development of new antibiotics. "The existence of this complex in bacteria has been postulated based on evidence but nobody had ever documented that it exists," explains Robert Landick, a professor in the Department of Biochemistry at UW-Madison and author on the study. "It's the first demonstration that you can form one large super-cellular machine out of these two already pretty complicated machines." The process of transcription utilizes an enzyme called RNA polymerase to turn DNA into RNA. Following that process, another molecular machine called a ribosome translates the RNA, more specifically called messenger RNA, into proteins the bacteria can use to function. In the bacterial expressome, the polymerase and ribosome form one complex structure to carry out these two processes in a coupled manner, and this newly solved structure provides a snapshot of this taking place, says Rachel Mooney, a research scientist in Biochemistry and co-author on the paper. Transcription and translation occur in animals and humans, too, but they are not coupled like they are in bacteria. Rather, they take place in two physically different parts of the cell. If scientists can find a way to disrupt the expressome, they may be able to develop drugs that target bacteria but leave human cells unharmed, the researchers say. "Any time you find a novel interface in research like this, such as where the polymerase and ribosome come together, that interface becomes a target for drugs," Landick says. "If you can find something to disrupt that, it can work synergistically with other antibiotics or on its own." Landick adds that the finding also extends into studies of the microbiome, the community of microbes in and around the human body. Ongoing research shows how important the microbiome is for human health and understanding gene regulation in these microbial communities is a critical part of these endeavors. The expressome now provides a fundamental building block for this understanding. "We tend to think about human biology as what goes on in human cells but there's at least as many bacterial cells as human cells on and in our bodies," he says. "E. coli may not be really prevalent there, but we use it as a model to extend our research to other bacteria critical to human processes." Landick and Mooney teamed up with Rebecca Kohler and Patrick Cramer, a director at MPI. The German team's equipment helped solve the structure of the expressome, which was assembled using RNA polymerase supplied by the UW-Madison team. "It was a great example for how to do an interdisciplinary project," says Cramer. "Our work explains old observations that both processes - transcription and translation - are coupled in these cells." Researchers are also interested in the origin of this complex. Why the processes are coupled in bacteria, but not organisms like humans, is a case study in evolution. "One perspective on it is to simply appreciate that bacteria are much more evolved than we are," Landick explains. "It's counterintuitive but technically they have had many, many more generations than we have. The evolutionary pressures that bacteria face have led to the emergence of this very streamlined and efficient way to take DNA and turn it into proteins." For Landick, this work also has an important connection. The famed UW-Madison biochemist Gobind Khorana won a Nobel Prize in 1968 for his work on the molecular basis of gene action and Landick was inspired by his work to pursue a career in biochemistry and molecular biology. "In our department, Khorana did some really seminal research that defined the genetic code and how the information encoded in DNA is propagated and converted to proteins, a paradigm called the central dogma of molecular biology," he says. "So did others in the department for years after him. To be performing similar research toward the same goals is very exciting." Explore further: Atomic-scale view of bacterial proteins offers path to new tuberculosis drugs


News Article | April 20, 2017
Site: www.prnewswire.com

Zubsolv® growth in the US drives improved profitability in the commercial operations In a dynamic market environment, I am pleased to report that net sales for Zubsolv US in Q1 2017 increased with 15.9 percent from Q1 2016 and our US business continues to contribute positively to the Orexo revenues and earnings. With this growth and positive contribution from our US business, I can confirm our financial guidance of positive EBITDA for the full year. We are encouraged to see an accelerating growth in the market for treatment of opioid dependence reaching 9.7 percent in the first quarter compared to a growth of 7.6 percent in Q4 2016. This is a trend break as Q1 traditionally is weaker than Q4. The growth this year is primarily driven by the physicians certified to expand to 275 patients and most of the growth is in the public segment. The commercial segment has followed the trend from previous years with Q1 slightly below Q4 volumes. We expect the commercial segment to improve in the next quarters and we are pleased to see the growth in commercial pick-up late in the quarter. This is important for Orexo as we have better market access, market share and pay less rebates in the commercial segment. During the quarter, I have spent time in the US meeting healthcare professionals treating opioid dependence. The feedback on Zubsolv and our work in the US is positive, we have a strong brand awareness both as a company and on a product level with Zubsolv. However, market access remains an important driver of physicians' choice of medication and we need to work relentlessly to open up the market for more unrestricted access for Zubsolv. I know our message resonates well, but physicians need to move out of their comfort zone and direct their patients to get a treatment with Zubsolv versus a "drug" most patients have tried before even starting medical treatment, since they were buying it on the street as a part of their illicit opioid misuse. Another key event during the quarter was a new litigation against Actavis for infringement of our patent 8,454,996 with their generic versions of Suboxone® and Subutex®. The validity of the '996 patent was confirmed by the district court and Actavis has not appealed the decision. Actavis has been successful with the generic version of Suboxone and was the market leader the first year after launch in March 2013. The total cumulated gross sales of the generic versions of Suboxone and Subutex exceed USD 500 million and Orexo will seek compensation for damages caused by Actavis's infringement of the '996 patent. I remain confident that we will continue to see a positive development of Zubsolv and Orexo, spurred by improved market and volume growth in the US. Beyond Zubsolv in the US, our pipeline is progressing well. Zubsolv launch in Europe is anticipated early next year, we have concrete discussions with partners for OX51 and OX-MPI and we have some exciting new formulation technologies which could be ready for first clinical trials already this year. With our continued strengthening of our financial position, with six consecutive quarters with positive cash flow from operating activities, we are well positioned to capture the opportunities and continue the development of Orexo. For further information, please contact : Nikolaj Sørensen, President and CEO, or Henrik Juuel, EVP and CFO Tel +46-18-780-88 -0  E-mail ir@orexo.com CEO Nikolaj Sørensen and CFO Henrik Juuel will present the report at a teleconference on April 20, 2017, at 2:00pm CET. Please view instructions below on how to participate. Internet: https://wonderland.videosync.fi/orexo-q1-report-2017. Telephone: (SE) +46 8 566 425 09, (UK) +44 20 300 89 807 or (US) +1 855 831 5945. There will be a Q&A session and questions can also be sent in advance to ir@orexo.com at latest 11am CET. The presentation will be available at Orexo´s website one hour prior to the teleconference. This information is information that Orexo AB (publ.) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 8.00am CET on April 20, 2017. This information was brought to you by Cision http://news.cision.com http://news.cision.com/orexo/r/interim-report-q1-2017,c2242893 The following files are available for download: To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/orexo---interim-report-q1-2017-300442507.html


Encompass Compliance Corp. (OTC: ENCC) has been selected by one of the largest drug testing laboratories (Labs) to provide real time industry updates and Risk Shield Services to their respective customers. The official announcement will be made at DATIA May 16-18th. Read this and more news for Encompass Compliance at: http://marketnewsupdates.com/news/encc.html. This Lab provides products and services to over 200,000 companies. It is important to both the Lab and their customers that state specific compliance services are provided to keep up with the rapidly changing legal landscape. Millions of employers use lab based drug testing for THC, alcohol, cocaine, amphetamines, methamphetamines, opiates, benzodiazepines, propoxyphene, PCP, oxycodone, morphine, ecstasy, methadone, buprenorphine, barbiturates, to provide drug free workplaces. "Our offerings allow employers to properly follow state laws as they change and utilize our Risk Shield Service to update and maintain their compliance programs, for drug and alcohol testing in the workplace," says Encompass CEO Richard Sharp. Encompass Compliance Corp. is the most comprehensive provider of workplace drug and alcohol testing compliance services, with over 30 years of experience. We are dedicated to providing employers with the tools necessary to mitigate regulatory and compliance risk. Our solutions provide organizations with up to date policies, a comprehensive resource center and real-time monitoring for drug and alcohol testing orders. In other industry news and developments: Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, and PeaceHealth, a mission-based not-for-profit healthcare system, this week announced that they have completed a previously announced two-part agreement designed to enhance the delivery of innovative, convenient and high-value diagnostic information services to communities in Oregon, Washington and Alaska. This includes the acquisition by Quest Diagnostics of the outreach laboratory services of PeaceHealth Laboratories serving physicians and patients in Washington and Oregon. Quest also now begins to manage 11 laboratories serving PeaceHealth's medical centers in Washington, Oregon and Alaska. LabCorp® (NYSE: LH) yesterday announced a significant enhancement to its proprietary VistaSeqSM Hereditary Cancer portfolio, with ten new test panels focusing on the risk of specific hereditary cancer syndromes. The number of cancer genes that can be assessed has also increased to 59 to reflect advances in the understanding of cancer genetics since the panel was first introduced in August 2015. The VistaSeq Hereditary Cancer Panel detects inherited genetic mutations across multiple genes, which have been associated with an increased risk of developing hereditary cancers. The tests are available from LabCorp and its Integrated Genetics and Integrated Oncology specialty laboratories. Alere Inc. (NYSE: ALR), a global leader in rapid diagnostics, recently announced the launch of its Alere™ Malaria Ag P.f, a major technological breakthrough in high-sensitivity rapid testing versus currently available malaria RDTs (rapid diagnostic tests). The Alere Malaria Ag P.f offers a greater than tenfold improvement in the detection of histidine rich protein II (HRP-II) antigen of Plasmodium falciparum, which will enable better identification of individuals with very low parasitemia, many of whom may be without evident symptoms of malaria infection. Lantheus Holdings, Inc. (NASDAQ: LNTH), parent company of Lantheus Medical Imaging, Inc. (collectively, 'Lantheus'), and GE Healthcare (GE), recently announced the signing of a definitive license agreement (the 'definitive agreement') for the continued Phase III development and worldwide commercialization of flurpiridaz F 18, an investigational positron emission tomography (PET) myocardial perfusion imaging (MPI) agent that may improve the diagnosis of coronary artery disease (CAD), the most common form of heart disease. The definitive agreement follows the signing of a term sheet previously announced in late February 2017. DISCLAIMER: MarketNewsUpdates.com (MNU) is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. MNU is NOT affiliated in any manner with any company mentioned herein. MNU and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. MNU's market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. MNU is not liable for any investment decisions by its readers or subscribers.  Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed MNU has been compensated two thousand nine hundred dollars for news coverage of the current press release issued by Encompass Compliance Corp. by a non-affiliated third party. MNU HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE. 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You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and MNU undertakes no obligation to update such statements.


News Article | April 30, 2017
Site: www.businesswire.com

CAMBRIDGE, Massachusetts & OSAKA, Japon--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE: 4502) a annoncé aujourd'hui que l'ALUNBRIG™ (brigatinib) a reçu une approbation accélérée de la Food and Drug Administration (FDA) américaine pour le traitement des patients atteints d'un cancer du poumon non à petites cellules (CPNPC) métastatique à kinase positive du lymphome anaplasique (ALK+) qui ont présenté une progression avec le crizotinib ou qui y sont intolérants. Cette indication est approuvée selon la procédure accélérée sur la base du taux de réponse tumorale et la durée de la réponse. L'approbation permanente pour cette indication peut être sujette à vérification et description du bénéfice clinique lors d'un essai de confirmation. ALUNBRIG, qui avait déjà reçu une désignation de thérapie pionnière de la part de la FDA, est un traitement par voie orale à prise quotidienne unique pouvant être pris pendant ou en-dehors des repas. "Au cours des récentes années, les inhibiteurs de d'ALK à petites molécules ont révolutionné les options thérapeutiques pour les personnes atteintes d'un cancer avancé du poumon non à petites cellules ALK+. Néanmoins, il existe encore un besoin de trouver d'autres inhibiteurs ALK comme le brigatinib (ALUNBRIG), qui ont un profil d'innocuité gérable et qui peuvent répondre à des mécanismes de résistance clinique au crizotinib, y compris la progression dans le système nerveux central", déclare D. Ross Camidge (M.D., Ph.D.), directeur du service d'oncologie thoracique à l'Université du Colorado. "L'essai ALTA a montré que le brigatinib (ALUNBRIG) était hautement efficace post-crizotinib. La majorité des patients ayant reçu une dose quotidienne unique de 180 mg, avec une période préparatoire de sept jours avec une dose quotidienne unique de 90 mg, ont obtenu une réponse globale et une durée médiane de réponse supérieure à un an. L'étendue de l'activité chez les patients avec des métastases cérébrales était également un résultat notoire." "Le développement rapide de l'ALUNBRIG est un hommage au dévouement de nombreux chercheurs et cliniciens qui ont conçu et développé avec soin ce nouveau médicament pour répondre aux besoins médicaux insatisfaits chez les patients atteints de CPNPC ALK+. Avant toute chose, nous souhaitons remercier les patients et leurs familles qui ont participé aux essais cliniques", souligne Andy Plump (M.D., Ph.D.), responsable médical et scientifique chez Takeda. L'approbation par la FDA de l'ALUNBRIG s'est avant tout basée sur les résultats de l'essai pivot ALTA de Phase 2 (ALK in Lung Cancer Trial of AP26113) du brigatinib chez l'adulte. Cet essai continu, à deux groupes, ouvert et multricentrique a porté sur 222 patients atteints d'un CPNPC ALK+ localement avancé ou métastatique qui ont présenté une progression avec le crizotinib. Les patients ont reçu soit 90 mg d'ALUNBRIG en dose quotidienne unique (n=112), soit 180 mg en dose quotidienne unique après une période préparatoire de sept jours à 90 mg en dose quotidienne unique (n=110). La principale mesure d'efficacité a été la confirmation du taux de réponse globale (TRG), conformément au critère d'évaluation de réponse dans les tumeurs solides (RECIST v1.1) tel qu'évalué par un comité d'examen indépendant (IRC). Parmi les autres mesures d'efficacité, signalons le TRG évalué par les chercheurs, la durée de réponse (DR), le TRG intracrânienne et la DR intracrânienne. Les avertissements et précautions pour l'ALUNBRIG sont les suivants: maladie pulmonaire interstitielle (MPI)/pneumonite, hypertension, bradycardie, troubles visuels, élévation de la créatine phosphokinase (CPK), élévation des enzymes pancréatiques, hyperglycémie et toxicité embryonnaire et fœtale. Des réactions indésirables graves se sont produites chez 38% des patients du groupe à 90 mg et chez 40% des patients du groupe à 90→180 mg. Les réactions indésirables graves les plus communes ont été la pneumonie (5,5% au total, 3,7% dans le groupe 90 mg et 7,3% dans le groupe 90→180 mg) et MPI/pneumonite (4,6% au total, 1,8% dans le groupe 90 mg et 7,3% dans le groupe 90→180 mg). Des réactions indésirables mortelles se sont produites chez 3,7% des patients et ont pris la forme d'une pneumonie (2 patients), décès soudain, dyspnée, insuffisance respiratoire, embolie pulmonaire, méningite bactérienne et infection urinaire (1 patient pour chaque cas). ALUNBRIG est un médicament anticancéreux ciblé découvert par ARIAD Pharmaceuticals, Inc., qui a été acquis par Takeda en février 2017. ALUNBRIG a reçu la désignation de thérapie pionnière de la FDA pour le traitement des patients atteints de CPNPC ALK+ dont les tumeurs sont résistantes au crizotinib, et a reçu la désignation de médicament orphelin de la FDA pour le traitement du CPNPC ALK+, ROS1+ et CPNPC EGFR+. Une demande d'autorisation de commercialisation (DAC) pour l'ALUNBRIG a été déposée auprès de l'Agence européenne des médicaments (AEM) en février 2017. Le programme de développement clinique ALTA renforce encore l'engagement continu de Takeda en faveur du développement de thérapies innovantes pour les personnes vivant avec un CPNPC ALK+ dans le monde entier, et pour les professionnels de la santé qui les traitent. En plus de l'essai ALTA de Phase 1/2 et de Phase 2 en cours, le brigatinib est également étudié dans l'essai ALTA 1L de Phase 3 pour évaluer son efficacité et son innocuité en comparaison avec le crizotinib chez les patients atteints d'un CPNPC ALK+ localement avancé ou métastatique qui n'ont pas reçu de traitement antérieur avec un inhibiteur d'ALK. AVERTISSEMENTS ET PRÉCAUTIONS Maladie pulmonaire interstitielle (MPI)/Pneumonite: Réactions indésirables pulmonaires graves, potentiellement mortelles et mortelles liées à une maladie pulmonaire interstitielle (MPI)/pneumonite se sont produites avec l'ALUNBRIG. Dans l'essai ALTA (ALTA), une MPI/pneumonite s'est produite chez 3,7% des patients du groupe à 90 mg (90 mg en dose quotidienne unique) et chez 9,1% des patients du groupe 90→180 mg (180 mg en dose quotidienne unique avec une période préparatoire de sept jours à 90 mg en dose quotidienne unique). Des réactions indésirables liées à une possible MPI/pneumonite se sont produites de manière précoce (dans les 9 jours suivant le commencement de la prise de l'ALUNBRIG; le délai médian était de 2 jours) chez 6,4% des patients, avec des réactions de niveau 3 à 4 se produisant chez 2,7%. Surveiller les symptômes respiratoires nouveaux ou s'aggravant (ex. dyspnée, toux, etc.), tout particulièrement durant la première semaine de la prise d'ALUNBRIG. Ne pas administrer l'ALUNBRIG aux patients présentant des symptômes respiratoires nouveaux ou s'aggravant, et évaluer rapidement pour détecter une MPI/pneumonite ou d'autres causes de symptômes respiratoires (ex. embolie pulmonaire, progression tumorale et pneumonie infectieuse). Pour une MPI/pneumonite de niveau 1 ou 2, vous pouvez soit reprendre l'administration d'ALUNBRIG en réduisant la dose après récupération jusqu'au niveau de base, soit arrêter définitivement l'administration d'ALUNBRIG. Arrêter définitivement l'administration d'ALUNBRIG en cas de MPI/pneumonite de niveau 3 ou 4, ou de récurrence de MPI/pneumonite de niveau 1 ou 2. Bradycardie: Une bradycardie peut subvenir avec l'ALUNBRIG. Durant l'essai ALTA, des rythmes cardiaques inférieurs à 50 battements par minute (bpm) se sont produits chez 5,7% des patients du groupe à 90 mg et chez 7,6% des patients du groupe 90→180 mg. Une bradycardie de niveau 2 s'est produite chez 1 (0,9%) patient du groupe 90 mg. Surveiller la fréquence cardiaque et la tension artérielle durant le traitement à l'ALUNBRIG. Surveiller plus fréquemment les patients si l'utilisation concomitante d'un médicament connu pour causer de la bradycardie ne peut pas être évitée. En cas de bradycardie symptomatique, stopper l'administration d'ALUNBRIG et évaluer les médicaments concomitants qui sont connus pour causer de la bradycardie. Si un médicament concomitant connu pour causer de la bradycardie est identifié et son administration interrompue ou ajustée, reprendre l'administration d'ALUNBRIG au même dosage après la disparition de la bradycardie symptomatique; sinon, réduire la dose d'ALUNBRIG après la disparition de la bradycardie symptomatique. Arrêter l'administration d'ALUNBRIG en cas de bradycardie potentiellement mortelle si aucun médicament contribuant concomitant n'est identifié. Troubles visuels: Durant l'essai ALTA, des réactions indésirables conduisant à des troubles visuels, notamment une vision floue, une diplopie et une acuité visuelle réduite, ont été signalées chez 7,3% des patients traités à l'ALUNBRIG dans le groupe à 90 mg et chez 10% des patients dans le groupe 90→180 mg. Un œdème maculaire de niveau 3 et une cataracte se sont produits chez un patient du groupe 90→180 mg. Conseiller les patients à signaler tout symptôme visuel. Arrêter l'administration d'ALUNBRIG et demander une évaluation ophtalmologique chez les patients présentant des symptômes visuels nouveaux ou s'aggravant, de niveau 2 ou d'une gravité supérieure. Après récupération de niveau de gravité 2 ou 3 jusqu'au niveau 1 ou au niveau de base, reprendre l'administration d'ALUNBRIG en réduisant la dose. Arrêter définitivement le traitement à l'ALUNBRIG en cas de troubles visuels de niveau 4.. Élévation de la créatine phosphokinase (CPK): Durant l'essai ALTA, une élévation de la créatine phosphokinase (CPK) s'est produite chez 27% des patients recevant de l'ALUNBRIG dans le groupe à 90 mg et chez 48% des patients dans le groupe 90 mg→180 mg. L'incidence d'élévation CPK de niveau 3-4 était de 2,8% dans le groupe à 90 mg et de 12% dans le groupe de 90→180 mg. Une réduction de dosage en raison d'une élévation CPK a été réalisée chez 1,8% des patients du groupe 90 mg et chez 4,5% du groupe 90→180 mg. Conseiller les patients à signaler toute douleur, sensibilité ou faiblesse musculaire inexpliquée. Surveiller les niveaux de CPK durant le traitement à l'ALUNBRIG. Arrêter l'administration d'ALUNBRIG en cas d'élévation CPK de niveau 3 ou 4. Après résolution ou récupération de niveau 1 ou de base, reprendre l'administration d'ALUNBRIG au même dosage ou à un dosage réduit. Élévation des enzymes pancréatiques: Durant l'essai ALTA, une élévation de l'amylase s'est produite chez 27% des patients du groupe 90 mg et chez 39% des patients du groupe 90→180 mg. Une élévation de la lipase s'est produite chez 21% des patients du groupe 90 mg et chez 45% des patients du groupe 90→180 mg. Une élévation de l'amylase de niveau 3 ou 4 s'est produite chez 3,7% des patients du groupe 90 mg et chez 2,7% des patients du groupe 90→180 mg. Une élévation de la lipase de niveau 3 ou 4 s'est produite chez 4,6% des patients du groupe 90 mg et chez 5,5% des patients du groupe 90→180 mg. Surveiller la lipase et l'amylase durant le traitement à l'ALUNBRIG. Arrêter l'administration d'ALUNBRIG en cas d'élévation des enzymes pancréatiques de niveau 3 ou 4. Après résolution ou récupération du niveau 1 ou de base, reprendre l'administration d'ALUNBRIG au même dosage ou avec un dosage réduit.. Hyperglycémie: Durant l'essai ALTA, 43% des patients ayant reçu de l'ALUNBRIG ont souffert d'une hyperglycémie nouvelle et aggravante. Un hyperglycémie de niveau 3, basée sur une évaluation laboratoire des niveaux de glycémie à jeun, s'est produite chez 3,7% des patients. Deux patients sur 20 (10%) atteints de diabète ou d'intolérance au glucose au niveau de base ont eu besoin d'administration d'insuline durant l'administration d'ALUNBRIG. Évaluer la glycémie à jeun avant l'administration d'ALUNBRIG et surveiller périodiquement par la suite. Débuter ou optimiser l'administration de médicaments anti-hyperglycémiques, en fonction des besoins. Si un contrôle hyperglycémique approprié ne peut être obtenu avec une gestion médicale optimale, arrêter l'administration d'ALUNBRIG jusqu'à l'obtention d'un contrôle hyperglycémique approprié, et envisager la réduction du dosage d'ALUNBRIG ou l'arrêt définitif de l'administration d'ALUNBRIG. Toxicité embryonnaire et fœtale: Sur la base de son mécanisme d'action et des résultats obtenus sur des animaux, l'ALUNBRIG peut nuire au fœtus en cas d'administration à des femmes enceintes. Il n'existe pas de données cliniques sur l'utilisation de l'ALUNBRIG chez les femmes enceintes. Informer les femmes enceintes du risque potentiel pour le fœtus. Conseiller aux femmes en âge de procréer d'utiliser un moyen de contraception non-hormonal efficace durant le traitement à l'ALUNBRIG et pendant au moins 4 mois après l'administration de la dose finale. Conseiller aux hommes ayant des partenaires féminins en âge de procréer d'utiliser un moyen de contraception efficace durant le traitement et pendant au moins 3 mois après l'administration de la dernière dose d'ALUNBRIG.. RÉACTIONS INDÉSIRABLES Des réactions indésirables graves se sont produites chez 38% des patients du groupe 90 mg et chez 40% des patients du groupe 90→180 mg. Les réactions indésirables graves les plus communes ont été la pneumonie (5,5% au total, 3,7% dans le groupe 90 mg et 7,3% dans le groupe 90→180 mg) et MPI/pneumonite (4,6% au total, 1,8% dans le groupe 90 mg et 7,3% dans le groupe 90→180 mg). Des réactions indésirables mortelles se sont produites chez 3,7% des patients et ont pris la forme d'une pneumonie (2 patients), décès soudain, dyspnée, insuffisance respiratoire, embolie pulmonaire, méningite bactérienne et infection urinaire (1 patient pour chaque cas). Les réactions indésirables les plus communes (≥25%) dans le groupe 90 mg ont été la nausée (33%), la fatigue (29%), la céphalée (28%) et la dyspnée (27%), et dans le groupe 90→180 mg la nausée (40%), la diarrhée (38%), la fatigue (36%), la toux (34%) et la céphalée (27%). UTILISATION DANS DES POPULATIONS SPÉCIFIQUES Grossesse: ALUNBRIG peut nuire au fœtus. Informer les femmes en âge de procréer du risque potentiel pour le fœtus. Allaitement: conseiller aux femmes allaitantes de ne pas allaiter durant le traitement à l'ALUNBRIG et pendant une semaine après la dose finale. Femmes et hommes en âge de procréer: Contraception: conseiller aux femmes en âge de procréer d'utiliser un moyen de contraception non-hormonal efficace durant le traitement à l'ALUNBRIG et pendant au moins 4 mois après l'administration de la dose finale. Conseiller aux hommes ayant des partenaires féminins en âge de procréer d'utiliser un moyen de contraception efficace durant le traitement à l'ALUNBRIG et pendant au moins 3 mois après l'administration de la dernière dose. Stérilité: ALUNBRIG peut provoquer une réduction de la fertilité chez les hommes. Utilisation pédiatrique: l'innocuité et l'efficacité de l'ALUNBRIG chez des patients pédiatriques n'ont pas été établies. Utilisation gériatrique: les études cliniques de l'ALUNBRIG ne comprenaient pas un nombre suffisant de patients âgés de 65 ans et plus pour déterminer s'ils répondent différemment par rapport aux patients plus jeunes. Sur les 222 patients de l'essai ALTA, 19,4% avaient entre 65 et 74 ans et 4,1% avaient 75 ans ou plus. Aucune différence cliniquement pertinente quant à l'innocuité et l'efficacité n'a été constatée entre les patients ≥65 ans et les patients plus jeunes. Insuffisance hépatique ou rénale: aucun ajustement du dosage n'est recommandé pour les patients présentant une légère insuffisance hépatique ou une insuffisance rénale légère ou modérée. L'innocuité de l'ALUNBRIG chez les patients atteints d'une insuffisance hépatique modérée ou grave, ou une insuffisance rénale grave, n'a pas été étudiée. Takeda Pharmaceutical Company Limited est une société pharmaceutique mondiale axée sur la R&D, dont la mission est d’améliorer la santé et l’avenir des patients en traduisant la science en médicaments pionniers. Takeda concentre ses efforts de R&D sur les domaines thérapeutiques de l’oncologie, de la gastroentérologie et du système nerveux central ainsi que sur les vaccins. Les activités de R&D de Takeda ont lieu à la fois en interne et avec des partenaires, l'objectif de la société étant de se maintenir à l’avant-garde de l’innovation. De nouveaux produits innovants, notamment en oncologie et en gastroentérologie, ainsi que sa présence sur des marchés émergents, stimulent la croissance de Takeda. Les plus de 30 000 employés de Takeda se sont engagés à améliorer la qualité de vie des patients en collaborant avec les partenaires du secteur des soins de santé et répartis dans plus de 70 pays. Pour en savoir plus, visitez http://www.takeda.com/news.


"We are pleased to recognize Catherine Mott's impact on the angel investment community and her achievements on behalf of so many start-ups.  Her contributions have helped to vastly expand the reach, resources, quality, and diversity of angel investors and the startup economy nationwide," said John Huston, Chairman Emeritus of ACA and Founder and Chairman Emeritus of Ohio TechAngel Funds. As of December 2016, BlueTree Allied Angels has invested more than $42 million in 55 startup companies, and BlueTree Venture Fund has $10 million under management. Mott serves on the boards of Anglr, Figure 8, Peptilogics, Imprint, and Westmoreland Advanced Materials.  She holds a portfolio monitor seat with Cryothermics, Instream Media, Lube Holdings, Zone 2 Surgical, Thorley (4Moms), Cisse, and Rinovum Women's Health. Mott represents America's angel community to the Securities and Exchange Commission by serving as a member of the SEC Advisory Committee on Small and Emerging Companies. She is a past chairman of both ACA and the Angel Resource Institute (ARI), helping both organizations to grow and better serve the angel community.  She also has been an instructor for a variety of ARI courses all over the country and beyond. "I'm excited about Catherine's selection for the Hans Severiens Award," said Marianne Hudson, ACA's executive director.  "Not only was she a stellar leader for ACA, but she helped more women become angels.  She was one of the few who had the courage to 'invite herself' to angel investing more than ten years ago, and ensure many more broke through the doors, in a thoughtful and professional way." "I am thrilled to receive this honor.  This award is a reflection on those many individuals who helped me when I became an angel investor, and who provided guidance for managing outcomes and nurturing entrepreneurial companies on their way to success," said Mott. ACA selected Magnetic Insight as winner of the 2017 Luis Villalobos Award for ingenuity, creativity, and innovation among startups.  Magnetic Insight was selected based on competitive differentiation and progress toward bringing a product, service, or solution to market.  Based in Alameda, CA, Magnetic Insight has introduced Magnetic Particle Imaging (MPI), the first new diagnostic imaging technique since the introduction of CT, MRI, and PET over 30 years ago. MPI gives clinicians and scientists a precise and sensitive new tool for early diagnosis, for patient monitoring, and for research. Magnetic Insight has launched a research imaging scanner and is now developing the first clinical system.  The company beat out finalists DesignMedix, Inc., of Portland, OR, and Peloton Technology, Mountain View, CA, for the award. A detailed 2017 ACA Summit agenda is available here. About the Angel Capital Association (ACA) ACA is the professional association of angel investors across North America and offers education, best practices, public policy advocacy, and significant benefits and resources to its membership of more than 13,000 accredited investors, who invest individually or through its 250 angel groups, accredited platforms, and family offices. For more information, visit: www.angelcapitalassociation.org or at @ACAAngelCapital; #ACAAngelSummit. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/angel-capital-association-honors-pittsburgh-based-angel-catherine-mott-and-innovative-company-magnetic-insight-300447662.html


Vienna, Austria - 7 May 2017: A large nuclear cardiology laboratory has slashed its average radiation dose by 60% in eight years, according to new research presented today at ICNC 2017 and published in JACC: Cardiovascular Imaging.1,2 The study in over 18 000 patients shows dose reductions were achieved despite a large number of obese patients. "There has been concern amongst the medical community and the public that the radiation from medical diagnostic tests could increase the risk of cancer," said Professor Randall Thompson, a cardiologist at the Mid America Heart Institute, Kansas City, Missouri, US. He continued: "Although the risk of harm from an individual nuclear cardiology test is very low - even very conservative estimates suggest only one in 1 000 extra patients would develop cancer 20 years later - the cumulative dose from multiple medical diagnostic tests may be a concern." Medical societies advocate getting radiation doses as low as is reasonably achievable. There are ways to do this but surveys show that adoption of new technologies, which cost money, and new testing algorithms, which take more physician time, has been slow. This study assessed the impact on radiation dose of modifying protocols and introducing new hardware (cameras) and post processing software in a large nuclear cardiology laboratory network in Kansas City. The study included the 18 162 single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) studies performed at all four of the Saint Luke's Mid America Heart Institute nuclear cardiology laboratories from 1 January 2009 to 30 September 2016. SPECT MPI shows how well blood flows through the muscle of the heart and is primarily performed to diagnose the cause of chest pain or to help manage patients with known coronary artery disease.. Protocols were modified by performing stress-only tests where possible, which saves the radiotracer dose from the rest scan. Stress and rest scans are still required in some patients since shadowing from body parts can look like a lack of blood flow and two scans can clarify the findings. Technetium tracers are now used instead of thallium 100% of the time at one-third of the radiation dose. Small field of view cameras which have advanced post processing, and a new generation of camera systems which are more sensitive and need less radiotracer injected into the body, have both been introduced. These camera systems are equipped with advanced processing which enhances the nuclear pictures and need less radiation or shorter image acquisition times. Professor Thompson's laboratory focussed primarily on reducing the radiation dose. The average radiation dose fell from 17.9 mSv in 2009 to 7.2 mSv in 2016 and the median dose (the 50th percentile) dropped from 10.2 mSv to 2.5 mSv. Professor Thompson said: "There was a dramatic lowering of the radiation dose with all of these concerted efforts. The average dose fell by 60% and the median dropped by 75%." "The average dose had fallen to 5.4 mSv in 2012 but crept up as we've had more obese patients referred in whom we have to use the higher dose protocols," he added. "But more than half of patients now are tested with a low-dose, stress-only test using the new technology, which is why the median dose of radiation has fallen so dramatically." The average background dose for people living in Europe and North America from radon underground and cosmic background sources is about 3 mSv a year. Medical societies consider higher and lower dose tests to be above 10 mSv and below 3 mSv, respectively. In 2010 the American Society of Nuclear Cardiology set a target of 9 mSv or less for the majority of tests.3 Professor Thompson said: "The majority of studies were in the high dose range back in 2009 and now most tests have a radiation dose that is about a third of the target. This is despite being referred a larger number of obese patients. In the last 2.5 years, 17% of patients have needed the large field of view camera as their average body mass index was 46 kg/m2 and they were simply too big for the small cameras." He concluded: "By adopting contemporary protocols and technologies it is feasible to substantially lower radiation doses in nuclear cardiology in very large numbers of patients in real world clinical practice."

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