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News Article | April 28, 2017
Site: www.eurekalert.org

DARIEN, IL - April 28, 2017 - Several of the world's leading sleep and circadian scientists were selected as recipients of the 2017 Sleep Research Society awards, which will be presented Monday, June 5, during the plenary session of SLEEP 2017, the 31st annual meeting of the Associated Professional Sleep Societies LLC (APSS) in Boston. "The Sleep Research Society awards recognize individuals who have made significant and lasting contributions to sleep and circadian science," said SRS President Sean P.A. Drummond, PhD. "I congratulate each of the recipients of the 2017 awards and appreciate all that they have done to help the SRS achieve its mission to advance sleep and circadian science." The 2017 SRS award recipients, who were selected by the SRS board of directors, are: Distinguished Scientist Award for significant, original and sustained scientific contributions of a basic, clinical or theoretical nature to the sleep and circadian research field, made over an entire career Dr. Kilduff directs the Center for Neuroscience at SRI International in Menlo Park, California. He is co-discoverer of the neuropeptide hypocretin (orexin), a key neurotransmitter in the maintenance of wakefulness. His group at SRI has identified a cortical interneuron population that is activated during sleep in proportion to homeostatic sleep drive, and their work also focuses on therapeutic development for insomnia and narcolepsy. As the SRS Distinguished Scientist Award recipient, Dr. Kilduff also receives the honor of presenting an invited lecture at the SLEEP 2017 annual meeting. He will present the lecture, "Identifying Novel Sleep/Wake Targets: Hypocretin/Orexin, Cortical nNOS Neurons, and TAAR1," on Tuesday, June 6, at the Hynes Convention Center in Boston. Outstanding Scientific Achievement Award for novel and seminal discoveries of a basic, clinical or theoretical nature that have made a significant impact on the sleep field Dr. Rattenborg is the leader of the Avian Sleep Group at the Max Planck Institute for Ornithology (MPIO) in Seewiesen, Germany. His research, published in August 2016 in the journal Nature Communications, was the first to demonstrate sleep in flying birds. Using electroencephalogram recordings of great frigatebirds flying over the ocean for up to 10 days, his team found that the birds can sleep with either one hemisphere at a time or both hemispheres simultaneously. However, while in flight they sleep for a much smaller percentage of time than they do while on land, which challenges the dominant view that large daily amounts of sleep are required to maintain adaptive performance. Mary A. Carskadon Outstanding Educator Award for excellence in the field of education related to sleep medicine and sleep research Dr. Espie is professor of sleep medicine in the Nuffield Department of Clinical Neuroscience and a Fellow of Somerville College at the University of Oxford in England. He is research director of the Experimental and Clinical Sleep Medicine program within the Sleep & Circadian Neuroscience Institute and clinical director of the Oxford Online Program in Sleep Medicine. More information about the SRS awards is available at http://www. . Photos are available upon request. For more information, please contact Specialty Society Coordinator Barbara Hoeft at 630-737-9700, ext. 9321, or bhoeft@srsnet.org. The Sleep Research Society (SRS) is a professional membership society that advances sleep and circadian science. The SRS provides forums for the exchange of information, establishes and maintains standards of reporting and classifies data in the field of sleep research, and collaborates with other organizations to foster scientific investigation on sleep and its disorders. The SRS also publishes the peer-reviewed, scientific journal SLEEP. Learn more at http://www. .


News Article | April 28, 2017
Site: www.eurekalert.org

DARIEN, IL - April 28, 2017 - Several leaders in the field of sleep medicine and a national transportation executive were selected as recipients of the 2017 American Academy of Sleep Medicine awards, which will be presented Monday, June 5, during the plenary session of SLEEP 2017, the 31st annual meeting of the Associated Professional Sleep Societies LLC (APSS) in Boston. "I congratulate each of the 2017 award recipients, whose dedication and commitment to excellence have made a significant impact on the field of sleep medicine in the areas of administration, academic research, public policy and education," said AASM President Dr. Ronald D. Chervin. "Their contributions to the sleep field have supported the mission of the American Academy of Sleep Medicine to improve sleep health and promote high quality, patient-centered care." The 2017 AASM award recipients, who were selected by the AASM board of directors, are: Nathaniel Kleitman Distinguished Service Award for dedication to the sleep field and significant contributions in the areas of administration, public relations and government affairs Dr. Dinges is a tenured professor of psychology in psychiatry, and he serves as chief of the Division of Sleep and Chronobiology and vice chair for faculty affairs and professional development in the Department of Psychiatry at Penn's Perelman School of Medicine in Philadelphia. His laboratory has produced an extensive body of federally funded research on the acute, chronic and cumulative adverse effects of inadequate sleep on human physiological and neurobehavioral functions. William C. Dement Academic Achievement Award for exceptional initiative and progress in the areas of sleep education and academic research Dr. Redline is the Peter C. Farrell Professor of Sleep Medicine at Harvard Medical School and directs a Program in Sleep Medicine Epidemiology at Brigham and Women's Hospital and Beth Israel Deaconess Medical Center in Boston. Her research focuses on understanding the risk factors and outcomes of sleep disorders across populations, the role of sleep interventions in improving health, and use of web-based resources to enable exchange and analysis of sleep data. Mark O. Hatfield Public Policy or Advocacy Award for developing public policy that positively affects the healthy sleep of all Americans Anne Ferro was named president and CEO of the American Association of Motor Vehicle Administrators (AAMVA) in 2014 after serving five years as administrator of the U.S. Department of Transportation's Federal Motor Carrier Safety Administration (FMCSA). Under her leadership, FMCSA implemented key measures, such as limiting the risk of tired truck drivers behind the wheel and prohibiting commercial drivers from texting or talking on hand-held mobile devices while driving. Excellence in Education Award for outstanding contributions in the teaching of sleep medicine Dr. Silber is professor of neurology at the Mayo Clinic College of Medicine and Science, dean of the Mayo Clinic School of Health Sciences, and a past co-director of the Mayo Center for Sleep Medicine in Rochester, Minnesota. He served as program director of the Mayo Fellowship in Sleep Medicine for 14 years, educating 60 fellows. Dr. Silber has served as president of the AASM, president of the American Board of Sleep Medicine and chair of the Sleep Medicine Fellowship Directors Council. More information about the 2017 AASM awards is available online. Photos are available upon request. For more information, please contact Communications Coordinator Corinne Lederhouse at 630-737-9700, ext. 9366, clederhouse@aasmnet.org. Established in 1975, the American Academy of Sleep Medicine (AASM) improves sleep health and promotes high quality, patient-centered care through advocacy, education, strategic research, and practice standards. The AASM has a combined membership of 10,000 accredited member sleep centers and individual members, including physicians, scientists and other health care professionals.


Key presentations include data from the Treatment of OSA and Narcolepsy Excessive Sleepiness (TONES) Phase 3 program for JZP-110, an investigational wake-promoting agent in development for the treatment of excessive sleepiness in adult patients with narcolepsy (TONES 2) or OSA (TONES 3 and TONES 4), Phase 2/3 data from a clinical study evaluating sodium oxybate in pediatric patients aged 7-17, and new data from the Jazz-sponsored Nexus Narcolepsy Registry, the first narcolepsy-specific, web-based registry of patient-reported data. A full list of Jazz-supported oral and poster presentations follows below: Full details of the APSS annual SLEEP meeting can be found at http://www.sleepmeeting.org/. JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in late-stage development for treatment of excessive sleepiness in adult patients with narcolepsy or OSA.  In 2014, Jazz Pharmaceuticals acquired a world-wide license (except in certain countries in Asia) to develop and commercialize JZP-110 from SK Biopharmaceuticals, which discovered the compound.  Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to JZP-110, excluding certain jurisdictions in Asia.  SK Biopharmaceuticals maintains rights in Korea, Japan, China, Taiwan, Singapore, Indonesia, India, Philippines, Thailand, Malaysia, Vietnam, and Hong Kong.  JZP-110 has orphan drug designation in the United States for narcolepsy. Across the entire JZP-110 development program, over 2,000 subjects have enrolled in 20 studies. The JZP-110 Phase 3 clinical program includes one study evaluating excessive sleepiness in adult patients with narcolepsy (TONES 2), two studies evaluating excessive sleepiness in adult patients with OSA (TONES 3 and TONES 4), and an open-label, long-term safety and maintenance of efficacy study (TONES 5).  Enrollment is complete in all studies that are expected to support Jazz Pharmaceuticals' planned JZP-110 New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in late 2017. Xyrem® (sodium oxybate) oral solution, CIII, is indicated for the treatment of cataplexy in narcolepsy and for the treatment of excessive daytime sleepiness in narcolepsy.  Xyrem may only be dispensed to patients enrolled in the Xyrem REMS Program.  Xyrem was first approved in the U.S. in 2002, based on clinical trial data in adults.  The current United States Product Insert for Xyrem indicates that safety and effectiveness in pediatric patients have not been established.  Jazz plans to submit a supplemental NDA to FDA in the fourth quarter of 2017 with revised proposed labeling to include data for use in pediatric patients, consistent with the FDA's pediatric written request. Xyrem is a central nervous system (CNS) depressant. In clinical trials at recommended doses obtundation and clinically significant respiratory depression occurred in Xyrem-treated patients. Almost all of the patients who received Xyrem during clinical trials in narcolepsy were receiving central nervous system stimulants. Xyrem is the sodium salt of gamma hydroxybutyrate (GHB). Abuse of GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. Because of the risks of CNS depression, abuse, and misuse, Xyrem is available only through a restricted distribution program called the Xyrem REMS Program, using the central pharmacy that is specially certified. Prescribers and patients must enroll in the program. For further information go to www.XYREMREMS.com or call 1-866-XYREM88® (1-866- 997-3688). Xyrem is contraindicated in combination with sedative hypnotics or alcohol and in patients with succinic semialdehyde dehydrogenase deficiency. Caution should be used when considering the concurrent use of Xyrem with other CNS depressants.  Healthcare providers should caution patients against hazardous activities requiring complete mental alertness or motor coordination within the first 6 hours of dosing or after first initiating treatment until certain that Xyrem does not affect them adversely. The rapid onset of sedation, coupled with the amnestic features of Xyrem, particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (e.g. assault victim). Patients should be monitored for emergent or increased depression and suicidality and for impaired motor/cognitive function.  Episodes of sleepwalking should be fully evaluated and appropriate interventions considered.  The amount of daily sodium intake in each dose of Xyrem should be considered in patients sensitive to salt intake. The most common adverse reactions were nausea, dizziness, vomiting, somnolence, enuresis, and tremor. The Nexus Narcolepsy Registry is an effort by Wake Up Narcolepsy and the narcolepsy research and advocacy communities, in collaboration with Jazz Pharmaceuticals, to collect de-identified data from a large group of people with narcolepsy over several years in order to shed light on the impact of the condition on people's lives. To learn more about the registry, please visit www.narcolepsyregistry.com. Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs.  The company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology.  In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi) and Defitelio® (defibrotide sodium) in the U.S. and markets Erwinase® and Defitelio® (defibrotide) in countries outside the U.S.  For more information, please visit www.jazzpharmaceuticals.com. "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995 This press release contains forward-looking statements, including, but not limited to, statements related to the company's commitment to advancing meaningful treatments that address unmet needs in sleep medicine, the company's plans for submission of an NDA for JZP-110 to the FDA, the company's plans for submission of a supplemental NDA to the FDA for the use of Xyrem in pediatric patients, and other statements that are not historical facts.  These forward-looking statements are based on the company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: pharmaceutical product development and clinical success thereof; the regulatory approval process, including the risks that the company may be unable to obtain approval by the FDA  for JZP-110 or for its planned supplemental NDA for Xyrem in a timely manner or at all; effectively commercializing the company's products and product candidates; and other risks and uncertainties affecting the company and its development programs, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 and future filings and reports by the company.  Other risks and uncertainties of which the company is not currently aware may also affect the company's forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated.  The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by the company on its website or otherwise.  The company undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/jazz-pharmaceuticals-to-present-phase-3-data-on-jzp-110-an-investigational-treatment-for-excessive-sleepiness-in-patients-with-narcolepsy-and-with-obstructive-sleep-apnea-during-31st-annual-sleep-meeting-300463450.html


News Article | May 24, 2017
Site: www.prnewswire.com

"GDPR has been on the radar of European countries for a while now, but we haven't seen many organizations actively taking steps to become compliant, so now it is crunch time," said N. Robert Hammer, chairman, president and CEO, Commvault.  "You don't want to be the company in the first week of June 2018 that is used as the poster child for the harsh reality of the penalties laid out by the regulations. "There is still plenty of time for organizations to ensure compliance in time for the May 2018 deadline, but they need to move quickly and strategically, and this is where Commvault can help." Commvault can help companies meet specific articles and principles of GDPR, including the right to be forgotten, data protection by design and by default, ensuring ongoing confidentiality, integrity, availability and resilience, 72-hour data breach notification, data minimization principle, data transfers and portability, and more. To tackle these specifications from GDPR, the Commvault Data Platform indexes content from the data that it touches, uniquely providing a single point for organisations to locate Personally Identifiable Information in unstructured data, whether in backups, archives, core enterprise, private and public cloud environments, and also in Endpoint Protection. The Commvault Data Platform has been built with security in mind and provides organizations with the ability to identify, mitigate and recover from cyber attacks. Commvault utilizes sophisticated intrusion detection software to enable organizations to recognize threats such as ransomware, or the lesser-known leakware, which exposes personal customer data to the public unless a ransom is paid. By being aware of ongoing threats, companies are better able to protect Personally Identifiable Information and maintain GDPR compliance– even when vital systems are under attack. "Good data management practices are key to GDPR compliance success. Understanding where you have personal data – in which applications, on-premises or in the cloud, which processes use this data, and who owns it – is an important first step," said Carla Arend, Program Director, IDC. "If you have not started to prepare, get started now; getting GDPR compliance right takes time. Most European organizations have started preparations, but those outside the EU need to understand how this regulation applies to them as well. A good starting point is addressing unstructured data and devising data governance and management processes that cover data from edge devices to the datacenter to the cloud." The legislation includes the new "data protection officer" concept, which is a role to monitor compliance, and it can be filled by someone from the company staff or by an outsourced vendor. Likewise, companies must adapt their own systems or go for an outsourced approach. "Many SMEs will opt for the outsourcing," explains Ricardo de la Cruz, Infrastructure Director – ACENS "so they will have to depend on a reliable entity to meet their obligations and ensure confidentiality and availability for their data. In this scenario trusted suppliers like Acens and Commvault are key." Many organizations across the world are already using the Commvault Data Platform to ensure that their data management processes are robust enough to build fully GDPR compliant processes on top. "We discovered the full potential of Commvault Platform during a transformation workshop organised by the company, as part of which Commvault assessed our organization's maturity in the areas of data management and information," added Przemysław Wesołowski, IT Infrastructure Director, PGNiG SA. "The workshops resulted in recommendations that delivered greater competitive advantage to our business by making different data sets more immediately and easily visible to our executives, as well as providing greater speed and accuracy in terms of compliance – a critical factor when our business has so much commercially sensitive data and the impending GDPR legislation requirements incoming into effect in 2018." About Commvault Commvault is a leading provider of data protection and information management solutions, protecting and enabling digital business. Commvault helps enterprises worldwide activate their data to drive more value and business insight and to transform modern data environments. With solutions and services delivered directly and through a worldwide network of partners and service providers, Commvault solutions comprise one of the industry's leading portfolios in data protection and recovery, cloud, virtualisation, archive, file sync and share. Commvault has earned accolades from customers and third party influencers for its technology vision, innovation, and execution as an independent and trusted expert. Without the distraction of a hardware business or other business agenda, Commvault's sole focus on data management has led to adoption by companies of all sizes, in all industries, and for solutions deployed on premise, across mobile platforms, to and from the cloud, and provided as-a-service. Commvault employs more than 2,700 highly skilled individuals across markets worldwide, is publicly traded on NASDAQ (CVLT), and is headquartered in Tinton Falls, New Jersey in the United States. To learn more about Commvault — and how it can help make your data work for you — visit commvault.com. Safe Harbor Statement: Customers' results may differ materially from those stated herein; Commvault does not guarantee that all customers can achieve benefits similar to those stated above. This press release may contain forward-looking statements, including statements regarding financial projections, which are subject to risks and uncertainties, such as competitive factors, difficulties and delays inherent in the development, manufacturing, marketing and sale of software products and related services, general economic conditions and others. Statements regarding Commvault's beliefs, plans, expectations or intentions regarding the future are forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from anticipated results. Commvault does not undertake to update its forward-looking statements. The development and timing of any product release as well as any of its features or functionality remain at our sole discretion. ©1999-2017 Commvault Systems, Inc. All rights reserved. Commvault, Commvault and logo, the "C hexagon" logo, Commvault Systems, Solving Forward, SIM, Singular Information Management, Commvault OnePass, Commvault Galaxy, Unified Data Management, QiNetix, Quick Recovery, QR, CommNet, GridStor, Vault Tracker, InnerVault, Quick Snap, QSnap, IntelliSnap, Recovery Director, CommServe, CommCell, ROMS, APSS, Commvault Edge, Commvault GO, and CommValue are trademarks or registered trademarks of Commvault Systems, Inc. All other third party brands, products, service names, trademarks, or registered service marks are the property of and used to identify the products or services of their respective owners. All specifications are subject to change without notice. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/commvault-calls-on-businesses-to-accelerate-gdpr-compliance-preparations-300462929.html


"Developing innovative treatments for often overlooked and debilitating conditions is one of our highest priorities," said Karen Smith, M.D., Ph.D., executive vice president, research and development and chief medical officer at Jazz Pharmaceuticals.  "The breadth of data that we will be presenting at the SLEEP 2017 meeting reflects our ongoing commitment to advancing meaningful treatments that address unmet needs in sleep medicine, including for patients living with narcolepsy and obstructive sleep apnea (OSA)." Key presentations include data from the Treatment of OSA and Narcolepsy Excessive Sleepiness (TONES) Phase 3 program for JZP-110, an investigational wake-promoting agent in development for the treatment of excessive sleepiness in adult patients with narcolepsy (TONES 2) or OSA (TONES 3 and TONES 4), Phase 2/3 data from a clinical study evaluating sodium oxybate in pediatric patients aged 7-17, and new data from the Jazz-sponsored Nexus Narcolepsy Registry, the first narcolepsy-specific, web-based registry of patient-reported data. A full list of Jazz-supported oral and poster presentations follows below: Full details of the APSS annual SLEEP meeting can be found at http://www.sleepmeeting.org/. JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in late-stage development for treatment of excessive sleepiness in adult patients with narcolepsy or OSA.  In 2014, Jazz Pharmaceuticals acquired a world-wide license (except in certain countries in Asia) to develop and commercialize JZP-110 from SK Biopharmaceuticals, which discovered the compound.  Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to JZP-110, excluding certain jurisdictions in Asia.  SK Biopharmaceuticals maintains rights in Korea, Japan, China, Taiwan, Singapore, Indonesia, India, Philippines, Thailand, Malaysia, Vietnam, and Hong Kong.  JZP-110 has orphan drug designation in the United States for narcolepsy. Across the entire JZP-110 development program, over 2,000 subjects have enrolled in 20 studies. The JZP-110 Phase 3 clinical program includes one study evaluating excessive sleepiness in adult patients with narcolepsy (TONES 2), two studies evaluating excessive sleepiness in adult patients with OSA (TONES 3 and TONES 4), and an open-label, long-term safety and maintenance of efficacy study (TONES 5).  Enrollment is complete in all studies that are expected to support Jazz Pharmaceuticals' planned JZP-110 New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in late 2017. Xyrem® (sodium oxybate) oral solution, CIII, is indicated for the treatment of cataplexy in narcolepsy and for the treatment of excessive daytime sleepiness in narcolepsy.  Xyrem may only be dispensed to patients enrolled in the Xyrem REMS Program.  Xyrem was first approved in the U.S. in 2002, based on clinical trial data in adults.  The current United States Product Insert for Xyrem indicates that safety and effectiveness in pediatric patients have not been established.  Jazz plans to submit a supplemental NDA to FDA in the fourth quarter of 2017 with revised proposed labeling to include data for use in pediatric patients, consistent with the FDA's pediatric written request. Xyrem is a central nervous system (CNS) depressant. In clinical trials at recommended doses obtundation and clinically significant respiratory depression occurred in Xyrem-treated patients. Almost all of the patients who received Xyrem during clinical trials in narcolepsy were receiving central nervous system stimulants. Xyrem is the sodium salt of gamma hydroxybutyrate (GHB). Abuse of GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. Because of the risks of CNS depression, abuse, and misuse, Xyrem is available only through a restricted distribution program called the Xyrem REMS Program, using the central pharmacy that is specially certified. Prescribers and patients must enroll in the program. For further information go to www.XYREMREMS.com or call 1-866-XYREM88® (1-866- 997-3688). Xyrem is contraindicated in combination with sedative hypnotics or alcohol and in patients with succinic semialdehyde dehydrogenase deficiency. Caution should be used when considering the concurrent use of Xyrem with other CNS depressants.  Healthcare providers should caution patients against hazardous activities requiring complete mental alertness or motor coordination within the first 6 hours of dosing or after first initiating treatment until certain that Xyrem does not affect them adversely. The rapid onset of sedation, coupled with the amnestic features of Xyrem, particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (e.g. assault victim). Patients should be monitored for emergent or increased depression and suicidality and for impaired motor/cognitive function.  Episodes of sleepwalking should be fully evaluated and appropriate interventions considered.  The amount of daily sodium intake in each dose of Xyrem should be considered in patients sensitive to salt intake. The most common adverse reactions were nausea, dizziness, vomiting, somnolence, enuresis, and tremor. The Nexus Narcolepsy Registry is an effort by Wake Up Narcolepsy and the narcolepsy research and advocacy communities, in collaboration with Jazz Pharmaceuticals, to collect de-identified data from a large group of people with narcolepsy over several years in order to shed light on the impact of the condition on people's lives. To learn more about the registry, please visit www.narcolepsyregistry.com. Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs.  The company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology.  In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi) and Defitelio® (defibrotide sodium) in the U.S. and markets Erwinase® and Defitelio® (defibrotide) in countries outside the U.S.  For more information, please visit www.jazzpharmaceuticals.com. "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995 This press release contains forward-looking statements, including, but not limited to, statements related to the company's commitment to advancing meaningful treatments that address unmet needs in sleep medicine, the company's plans for submission of an NDA for JZP-110 to the FDA, the company's plans for submission of a supplemental NDA to the FDA for the use of Xyrem in pediatric patients, and other statements that are not historical facts.  These forward-looking statements are based on the company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: pharmaceutical product development and clinical success thereof; the regulatory approval process, including the risks that the company may be unable to obtain approval by the FDA  for JZP-110 or for its planned supplemental NDA for Xyrem in a timely manner or at all; effectively commercializing the company's products and product candidates; and other risks and uncertainties affecting the company and its development programs, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 and future filings and reports by the company.  Other risks and uncertainties of which the company is not currently aware may also affect the company's forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated.  The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by the company on its website or otherwise.  The company undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.


News Article | May 24, 2017
Site: www.prnewswire.co.uk

DUBLIN, May 24, 2017 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company will host a webcast to discuss data to be presented on JZP-110 and Xyrem® (sodium oxybate) oral solution during the Associated Professional Sleep Societies (APSS) Annual Meeting taking place from June 3-7, 2017 in Boston, MA. The live webcast will begin at 7:00 p.m. EDT on June 6, 2017. The webcast may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.


News Article | May 24, 2017
Site: www.prnewswire.com

DUBLIN, May 24, 2017 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company will host a webcast to discuss data to be presented on JZP-110 and Xyrem® (sodium oxybate) oral solution during the Associated Professional Sleep Societies (APSS) Annual Meeting taking place from June 3-7, 2017 in Boston, MA. The live webcast will begin at 7:00 p.m. EDT on June 6, 2017. The webcast may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.


News Article | February 15, 2017
Site: www.businesswire.com

IRVINE, Calif.--(BUSINESS WIRE)--Dr. Javier Dávila Torres, along with 11 officials from Mexico announced at the Patient Safety Movement Foundation’s (PSMF) World Patient Safety, Science & Technology Summit that 25 hospitals signed a commitment to implement processes to eliminate preventable patient deaths. In addition, Mexico’s Academy of Surgery, Federation of Anesthesiologists and College of Health Quality Professionals of the West, Guadalajara and Jalisco have joined the Foundation as "Committed Partners" that share the PSMF’s mission. By signing the commitment, the hospitals commit to implementing processes, such as Actionable Patient Safety Solutions (APSS), designed to help eliminate preventable patient deaths in hospitals. To date, there are 13 easy to implement APSS available for download. To view each hospital’s commitment, please visit http://patientsafetymovement.org/challenges-solutions/commitments-pledges/. “Our Patient Safety Movement began in the United States, but its vision for protecting patient lives has always been global. We are very excited to see patient safety commitments representing 33 hospitals and 3 healthcare organizations in Mexico, protecting our neighbors from preventable deaths,” said Joe Kiani, Founder of the Patient Safety Movement Foundation. “Patient safety in hospitals is a global concern, and we hope all countries will join us.” “We appreciate all of the physicians, nurses and multi-disciplinary teams that have stepped forward to make a commitment to the Patient Safety Movement,” said Dr. Javier Davila, Patient Safety Movement’s Regional Chairman for Mexico and Former Medical Director of the Social Security Mexican Institute. “This is just the beginning for Mexico and we need every hospital to participate if we want to eliminate medical errors and preventable deaths.” “We are looking forward to working closely with the Patient Safety Movement. Our Institute aims to promote the comprehensive education of patient safety, and to eliminate the serious infections associated with health care,” said Dr. David Kershenobich, General Director of the National Institute of Medical Sciences and Nutrition and former President of the National Academy of Medicine of Mexico. “We were pleased to see mental health as one of the challenges addressed at this year’s Summit, said Dr. María Elena Medina-Mora, General Director of the National Institute of Mental Health. “The people who suffer with mental health conditions live much of their life without access to proper care. Our mission is to try to provide them with quality of life and safety in their care. We are excited to work with the Patient Safety Movement.” “The Mexican Academy of Surgery, in conjunction with the Public Health sector of the Mexican Federal Government, will provide continuous medical education in different surgical specialties to academic organizations and Universities,” said Dr. Jesús Tapia, President of the Mexican Academy of Surgery. “It is our hope that all of our members commit to making zero preventable patient deaths by the year 2020 their safety goal.” To date, the following organizations representing 33 hospitals in Mexico have committed to one or more Actionable Patient Safety Solutions (APSS): More than 200,000 people die every year in U.S. hospitals and 3 million worldwide in ways that could have been prevented. The Patient Safety Movement Foundation was established through the support of the Masimo Foundation for Ethics, Innovation, and Competition in Healthcare, to reduce that number of preventable deaths to 0 by 2020 (0X2020). Improving patient safety will require a collaborative effort from all stakeholders, including patients, healthcare providers, medical technology companies, government, employers, and private payers. The Patient Safety Movement Foundation works with all stakeholders to address the problems with actionable solutions for patient safety. The Foundation also convenes the World Patient Safety, Science and Technology summit. The Summit brings together some of the world’s best minds for thought-provoking discussions and new ideas to challenge the status quo. By presenting specific, high-impact solutions to meet patient safety challenges, called Actionable Patient Safety Solutions, encouraging medical technology companies to share the data their products are purchased for, and asking hospitals to make commitments to implement Actionable Patient Safety Solutions, Patient Safety Movement is working toward zero preventable deaths by 2020. Visit http://patientsafetymovement.org/.


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News Article | February 16, 2017
Site: www.businesswire.com

加州爾灣--(BUSINESS WIRE)--(美國商業資訊) -- Javier Dávila Torres博士與11位墨西哥官員一起,在病人安全運動基金會(Patient Safety Movement Foundation, PSMF)的世界病人安全與科技高峰會上宣佈,25家醫院已簽署承諾以落實流程,杜絕可預防的病人死亡。此外,墨西哥外科學會、麻醉師聯盟,以及西部、瓜達拉哈拉市和哈利斯科州衛生品質專業人員學會亦加入基金會成為「承諾合作夥伴」,共同承擔PSMF的使命。 簽署承諾即表示上述醫院承諾落實旨在幫助杜絕可預防之病人院內死亡的各項流程,例如可付諸行動的病人安全解決方案(APSS)。迄今為止,已有13項易於落實的APSS可供下載。欲瀏覽各家醫院的承諾,請造訪http://patientsafetymovement.org/challenges-solutions/commitments-pledges/。 病人安全運動基金會創辦人Joe Kiani表示:「病人安全運動雖然開始於美國,但其保護病人生命的願景一直都適用於全球。看到我們的鄰國墨西哥有33家醫院和3家醫療保健機構簽署


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News Article | February 17, 2017
Site: www.businesswire.com

米カリフォルニア州アーバイン--(BUSINESS WIRE)--(ビジネスワイヤ) -- 患者安全運動財団(PSMF)の世界患者安全・科学・技術サミットにて、Dr. Javier Dávila Torresはメキシコ当局者11人と共に、予防可能な患者死亡を根絶するプロセス導入のための誓約書に25軒の病院が署名したと発表しました。また、メキシコの外科学会、麻酔科医協会、西部地域医療品質専門家協会(ハリスコ州グアダラハラ)が、PSMFの使命を共有する「誓約パートナー」として当財団に加わりました。 各病院は誓約書に署名することで、予防可能な死亡を病院で根絶する上で役立つように作った「実施可能な患者安全ソリューション」(APSS)などのプロセスを導入することを誓約します。現在、導入・実施が容易なAPSSは13項目に上り、ダウンロード可能となっています。各病院の誓約内容は、http://patientsafetymovement.org/challenges-solutions/commitments-pledges/から確認できます。 患者安全運動財団創設者のジョー・キアニは、次のように述

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