PRNews

Boston University Research Shows RayVio UVB LED is 2.4 Times More Efficient Than Sunlight for Producing Vitamin D3 in Human Skin

Breakthrough research will lead to new photopharmacology applications to help treat and prevent chronic illnesses

HAYWARD, Calif., Sept. 13, 2017 /PRNewswire/ — Research published today in Scientific Reports shows that light from RayVio’s 293nm ultraviolet (UV) LED is more efficient than sunlight at producing vitamin D3 in skin samples. Tyler Kalajian and his research team, led by Dr. Michael F. Holick, Ph.D., M.D., and supported by Boston University School of Medicine and a Boston University Ignition Award, found that skin samples exposed to RayVio’s UV LED for just 0.52 minutes produced more than twice as much vitamin D3 as samples exposed to 32.5 minutes of sunlight.

“We tested ultraviolet LEDs from different sources and at different wavelengths. RayVio’s 293nm LED showed the most significant potential for vitamin D3 production in the shortest amount of time,” said Dr. Holick, a Professor of Medicine, Physiology and Biophysics at Boston University School of Medicine, and endocrinologist at Boston Medical Center. “This study will lead to a new generation of technology that can be labeled as photopharmacology in which the use of LEDs with targeted wavelengths can cause specific biologic effects in human skin to help treat and prevent chronic illnesses.”

Vitamin D deficiency is associated with osteoporosis, rickets and other metabolic bone diseases and is more prevalent in northern and southern latitudes where sunlight is limited for a significant part of the year. This device for making vitamin D is ideally suited for patients with fat malabsorption syndromes including inflammatory bowel disease and gastric bypass surgery. The research shows that RayVio’s UV LEDs could be used for treating patients that are vitamin D deficient.

A vitamin D3 producing UV LED device could be used on skin areas that experience less exposure to sunlight such as upper legs and arms and abdomen and back thus minimizing risk for developing non-melanoma skin cancer. The UV LED device also emits a much narrower band of UVB light and thereby decreasing likelihood of skin damage that can occur when the skin is exposed to higher wavelengths of UV radiation.

“The potential of digital UV technology for phototherapy is enormous,” said Dr. Robert C. Walker, RayVio’s CEO. “Dr. Holick’s research with our UVB LEDs demonstrates the potential for new applications that can potentially improve and save hundreds of thousands of lives. In the U.S. alone, seventy-five percent of teens and adults are vitamin D deficient. Thanks to the work of the research team and the pioneering work of the Boston University Photonics Center on UV LEDs, we may soon see innovative treatment options like simple integration with a wearable device could aid millions of people.”

About Vitamin D3
Two forms of vitamin D are important to humans: vitamin D2 produced by plants, yeast and mushrooms, and vitamin D3 produced by skin when exposed to sunlight or the appropriate wavelength of ultraviolet light.

Co-authors on the paper, all from Boston University, are T.A. Kalajian, A. Aldoukhi, A.J. Veronikis, K. Persons, and M.F. Holick.

About Boston University School of Medicine
Originally established in 1848 as the New England Female Medical College, and incorporated into Boston University in 1873, Boston University School of Medicine (BUSM) today is a leading academic medical center with an enrollment of more than 700 medical students and 950 students pursuing degrees in graduate medical sciences. BUSM faculty contribute to more than 950 active grants and contracts, with total anticipated awards valued at more than $693 million in amyloidosis, arthritis, cardiovascular disease, cancer, infectious diseases, pulmonary disease and dermatology, among other areas. The School’s teaching affiliates include Boston Medical Center, its primary teaching hospital, the Boston VA Healthcare System, Kaiser Permanente in northern California, as well as Boston HealthNet, a network of 15 community health centers. For more information, please visit http://www.bumc.bu.edu/busm/

About RayVio Corp.
RayVio Corp. is an advanced health and hygiene company that delivers clean water and environments. RayVio helps protect billions from germs and creates new markets and revenue streams by enabling a new class of products. Its powerful and efficient UV LED technology can be integrated into a variety of applications, powering versatile on-demand solutions that give consumers control over health without chemicals or costly consumables. To learn more, please visit www.rayvio.com.

PRNews

Frost & Sullivan Commends Philips for Revolutionizing Respiratory Care Through Its Innovative Trilogy Series of Home Care Ventilators

Philips’ Trilogy offer multiple ventilation modes, real time data sharing capabilities and a long battery life that allows patients to have a near normal quality of life.

SANTA CLARA, California, Sept. 13, 2017 /PRNewswire/ — Based on its recent analysis of the home ventilation market, Frost & Sullivan recognizes Philips with the 2017 North American Home Ventilation Product Leadership Award for its Trilogy series of home care ventilators. Trilogy ventilators are cost-effective, invasive and non-invasive, with multi-mode capabilities providing easy-to-view and -share data for near-real-time patient care.

According to the Center for Disease Control and Prevention (CDC), chronic lower respiratory disease is the third-leading cause of death in the United States. The prevalence of respiratory disease creates pressure on care providers and vendors to create population health management solutions to replace existing episodic care protocols. With reimbursements shifting away from traditional fee-for-service models to value-based care, hospitals are increasingly required to demonstrate improvements in care provision to qualify for reimbursements, including faster discharge rates, lower inpatient bed days, lower readmission rates, and better follow-up care and post-treatment management. To address these issues, ventilator manufacturers need to look at a combination of products and solutions to appeal to patients with chronic diseases, both at home and in sub-acute facilities. To help prevent hospitalization, the best ventilation products will be able to share ventilation data seamlessly with care providers.

Philips offers the Trilogy 100 and Trilogy 200 ventilators as part of its extensive sleep and respiratory care solutions. Both of these products are compact, portable, and have multiple circuit choices to help clinicians caring for patients with different chronic respiratory conditions and ventilation requirements.

“It’s worth noting that, in the United States, clinicians are using Trilogy 100 and Trilogy 200 ventilator units to treat hundreds of thousands of patients with different respiratory conditions,” said Senior Research Analyst, Tanvir Jaikishen. “Philips’ extensive experience in IT really strengthens and distinguishes it from competitors in the home ventilation space.”

Philips’ Trilogy products have a number of standout features:

  • Digital Auto-Trak, available on both the Trilogy 100 and Trilogy 200, is an algorithm that can detect inspiration and expiration to react and respond to every breath, with a Sensitive Auto-Trak setting for an enhanced triggering response for patients all while compensating for leak.
  • DirectView reporting software stores and analyzes data and streamline reporting to allow care providers to make adjustments using different ventilation modes as required.
  • Care Orchestrator, a patient management application, delivers data wirelessly from Bluetooth-enabled Trilogy devices directly to the tablets, mobile devices or desktops of care providers multiple times per day, enabling early intervention if needed.
  • The Trilogy 100 and Trilogy 200 ventilators display pressure and flow graphically in a waveform format using the Waveform screen. This format enables fast synchronization between the patient and the ventilator, thus allowing for an expeditious transfer from the hospital to a sub-acute or home care setting.

“Philips’ Trilogy ventilation products provide hospitals with improvements in care provision, including faster discharge rates, lower inpatient bed days, lower readmission rates, and better follow-up care and post-treatment management,” said Jaikishen. “This really helps hospitals to better adapt to the emergence of quality-based care payment models in the healthcare industry.”

The Trilogy Series ventilators allow for ease of viewing patient data, the ability to quickly and easily share data, and data analytics on large patient data sets. Philips is a pioneer in the IT and analytics industry and these products’ interplay between data management and patient management is why Frost & Sullivan is recognizing Philip with the 2017 Award for North American Home Ventilation Product Leadership.

Each year, Frost & Sullivan presents this award to the company that has developed a product with innovative features and functionality, gaining rapid acceptance in the market. The award recognizes the quality of the solution and the customer value enhancements it enables.

Frost & Sullivan Best Practices awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research to identify best practices in the industry.

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips’ health technology portfolio generated 2016 sales of EUR 17.4 billion and employs approximately 70,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

About Frost & Sullivan

Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants. For more than 50 years, we have been developing growth strategies for the global 1000, emerging businesses, the public sector and the investment community. Contact us: Start the discussion.

Contact:

Claudia Toscano
P: 210.277.8417
F: 210.348.1003
E: claudia.toscano@frost.com

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PRNews

Merck Expands Celonic’s Upstream Capabilities with Mobius® Single-use Bioreactors

DARMSTADT, Germany, Sept. 13, 2017 /PRNewswire/ —

  • Sizes range from 50-liter to 2,000-liter manufacturing scale
  • Industry-leading design offers flexibility, scalability and ease-of-use

Merck, a leading science and technology company, today announced that Celonic AG, a Swiss contract development and manufacturing organization (CDMO), is upgrading its manufacturing facility with five of Merck’s Mobius® single-use bioreactors.

Celonic, which produces biosimilars and also offers a cell line development platform, will add 50-, 200- and 2,000-liter bioreactors to its development and manufacturing facility in Basel, Switzerland. The upgrade will expand Celonic’s upstream capabilities, improving flexibility and scalability.

“Our extensive portfolio of single-use technologies allows us to support CDMO customers like Celonic as they adopt new technologies and expand their capabilities,” said Andrew Bulpin, Head of the Process Solutions business unit, Life Science at Merck. “Our new Mobius® single-use bioreactors will help Celonic streamline its processes and expand its capacity to better serve clients.”

“For our biotech customers, each step towards market authorization boosts the valuation of their assets, and that’s where Celonic’s breadth of services has been instrumental in creating tremendous value for our partners,” said Konstantin Matentzoglu, CEO, Celonic. “Merck’s Mobius® single-use bioreactors offer a flexible, scalable system that addresses our needs and those of our clients. With the addition of the 2,000-liter bioreactor, we are moving a step closer to our objective of serving customers with commercial manufacturing needs.”

Single-use, disposable equipment and systems have increased in popularity in the biopharmaceutical industry, as they offer many advantages over conventional stainless steel systems, such as improved batch success rates, less cross-contamination risk, decreased water and waste water requirements, shortened project duration and reduced project costs.

At the same time, biopharmaceutical manufacturers are moving toward end-to-end solutions — from process development and scale-up through to manufacturing for pre-clinical, clinical and commercial supply — as they seek to cut costs while increasing quality and efficiency.

Merck’s portfolio of 3- to 2,000-liter Mobius® single-use bioreactors delivers greater flexibility and continuity for scale-up, reducing the need for retraining operators. These are some of the multiple reasons that CDMOs such as Celonic have become early adopters of Merck’s technologies.

Merck is a premier supplier of process development and clinical-stage manufacturing solutions, materials and services needed for the production of biopharmaceutical drugs. The company is committed to delivering superior bioreactor technology to manufacturers, several of which are already collaborating with the company in that space in North America, Europe and Asia.

About Celonic
 Celonic AG is a privately owned CDMO based in Basel, Switzerland. Celonic offers include comprehensive GMP development and manufacturing services for New Biological Entities (NBEs) and Biosimilars worldwide. Applying empathy, efficiency and excellence, Celonic goes one step beyond expectations in all business aspects in order to help its clients attain their goals more efficiently and reliably. Celonic’s services include the development of cell lines, production processes, as well as the GMP and non-GMP manufacturing of biopharmaceutical drug substances. In addition, Celonic licenses its proprietary CHOvolution™ cell line technology to clients, drug developer and service provider. Visit www.celonic.com to learn more.

All Merck news releases are distributed by email at the same time they become available on the Merck website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

About Merck
 Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of €15 billion in 66 countries.

Founded in 1668, Merck is the world’s oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the “Merck” name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

PRNews

Report depicts global challenge of psoriasis, need for database to document the disease’s worldwide prevalence

ST. LOUIS, Sept. 13, 2017 /PRNewswire/ — In 2016, the World Health Organization issued a report recognizing psoriasis as a chronic, disfiguring, disabling, non-communicable disease that deserves global attention. Yet, the report noted, knowledge regarding the global burden of psoriasis is limited. Psoriasis affects approximately 125 million people worldwide; however, little is known regarding prevalence or incidence of the disease in regions outside of the U.S. and Europe.


Paper authors (Back Left to Right) Luigi Naldi, Chris Griffiths, Carsten Flohr, Darren Ashcroft, (Front) Matthias Augustin, and Tamar Nijsten at the conclusion of the symposium, “The Epidemiology of Psoriasis: Towards a Global Psoriasis Atlas,” held during the European Society for Dermatological Research (ESDR) meeting in Rotterdam, the Netherlands.

A new scientific report, entitled “Global State of Psoriasis Epidemiology: A Workshop Report,” recently published in the British Journal of Dermatology, chronicles the global health challenges in psoriasis epidemiology and highlights the ambitious plan for a web-based Global Psoriasis Atlas (GPA) database that will document the prevalence and incidence of psoriasis worldwide.

This report resulted from a workshop held by the International Psoriasis Council (IPC), a U.S.-based nonprofit organization composed of psoriasis experts from around the world, which examined the current state of psoriasis epidemiology and introduced the vision and development of the GPA. Professor Christopher Griffiths of the University of Manchester, United Kingdom, corresponding and first author of the report, IPC immediate past-president and GPA director, led a panel of key experts who identified the challenges associated with assessing psoriasis epidemiology and described resources (eg, registries, country-specific databases) that can be used to understand trends and patterns of psoriasis epidemiology.

The panel discussed the need to view the overall health burden of psoriasis at the patient level and beyond the level of the skin. In this approach, the increased risk of inflammatory conditions, including psoriatic arthritis, cardiovascular disease, depression, metabolic syndrome, and liver disease, can be recognized and treated. The structure and development of the GPA were introduced as a rigorous and standardized approach and as a leading resource for estimating the true burden of disease in all countries.

“The data collected by the GPA will demonstrate to health care providers and policymakers around the world that psoriasis is not an inconsequential condition,” Griffiths said. “The GPA will be a resource that will help improve treatment and patients’ access to care worldwide and to recognize psoriasis as a health care priority.”

The IPC has joined with two other global organizations – the International League of Dermatological Societies (ILDS) and the International Federation of Psoriasis Associations (IFPA) – to develop the atlas. The project’s first phase, which will begin this year, will be to comprehensively review current psoriasis literature and gather data on psoriasis from as many countries as possible. Once the database is established, the project’s second phase will be to establish a core set of rigorous methods for collecting data throughout the world.

Ultimately, the GPA is expected to spur improvement in, and equality of, health care planning for psoriasis in every country.

The article is available online at http://bit.ly/psoriasisatlas.

CONTACT: Christy Langan, CEO, christy.langan@psoriasiscouncil.org

About IPC:
Founded in 2004, the International Psoriasis Council (IPC) is a dermatology-led, voluntary, global nonprofit organization dedicated to innovation across the full spectrum of psoriasis through research, education and patient care.

Global Psoriasis Leadership:
With more than one hundred board members and councilors from thirty countries, IPC embodies the global expertise of multi-specialty psoriasis key opinion leaders. These leaders include representatives from dermatology, basic science, translational research, genetics, epidemiology, cardiology, psychology, international clinical trials, and direct patient care.

Mission:
IPC’s mission is to advance the care of people with psoriasis worldwide, through education, research and advocacy.

Learn more about the International Psoriasis Council at www.psoriasiscouncil.org and follow us on Facebook and Twitter.

PRNews

Fitness kingpin from Downunder shares secrets to success

LAS VEGAS, Sept. 13, 2017 /PRNewswire/ — Josef Rakich, a world’s leading online personal trainer and founder of Josef Rakich Fitness (JRF) arrived in the US today.


Josef Rakich, founder of Josef Rakich Fitness (JRF)

His whirlwind tour includes meeting US fans in person while training at the renowned Gold’s Gym in Venice Beach, and speaking at Brandon Carter’s ‘Influencer Domination Tour’ being held at the Mr Olympia Expo in Las Vegas, where he will be sharing insider tips on how to upscale their business using social media to an audience of fitness entrepreneurs.

“There’s huge potential in the fitness industry for growing sales using only social media channels.  We’ve seen a massive revenue increase from Snapchat alone,” says Josef. “I’ll share many specific insights and what it takes to deliver seven figure results.”        

Based in Auckland, New Zealand, Josef Rakich (27) is a pioneer in the online fitness training industry with over 4 million followers and more than 50,000 clients in over 69 countries.

While stateside Josef will also launch his Keto Diet Meal Plan, the latest of his trademark personalised fitness and nutrition programs, based on the popular Keto diet. 

Josef’s company JRF recently pledged all profits from September to the Houston Food Bank to support the Texas flood victims.

Josef is available for interviews and photo opportunities during his eleven day tour.

Please contact him at +64 210 227 3820 or email josef@josefrakichfitness.co.nz.    

View original content with multimedia:http://www.prnewswire.com/news-releases/fitness-kingpin-from-downunder-shares-secrets-to-success-300517677.html

AFT Features, PRNews, Travel & Wellness

adidas and Wanderlust Break the GUINNESS WORLD RECORDS(TM) Title for Most people doing yoga in pairs

NEW YORK, Sept. 12, 2017 /PRNewswire/ — On Sunday, September 10th adidas and Wanderlust broke the official GUINNESS WORLD RECORDS Title for Most people doing yoga in pairs at the Wanderlust 108 Brooklyn event in Prospect Park. Led by yoga instructors Elena Brower and Lauren Imparato, over 2500 people participated in the record breaking attempt that lasted approximately 10 minutes. The partner flow included three poses — Thick Tree, Supported Chair and Supported Seat Twist.


adidas and Wanderlust Break the GUINNESS WORLD RECORDS Title for Most People Doing Yoga in Pairs – Sept 10, 2017

adidas and Wanderlust Break the GUINNESS WORLD RECORDS Title for Most People Doing Yoga in Pairs – Sept 10, 2017

“The partnership with Wanderlust allows us to create new and exciting opportunities. Breaking a GUINNESS WORLD RECORDS title was a unique way for us to bring people together and celebrate the largest Wanderlust event in the world,” said Alison Stewart, Senior Director for adidas Women’s.

adidas and Wanderlust share a vision of holistic, high-touch experiences that create community around sport and mindful living. Wanderlust’s transformative events attract some of the world’s most versatile and committed fitness and healthy-lifestyle devotees, including trainers, instructors and attendees. A Wanderlust 108 is full day celebration in support of the mindful movement, featuring a triathlon of three intentional activities in a local park: a 5K run, an outdoor yoga flow class and a guided meditation.

“Wanderlust’s mission is to help people to find their true north, and part of that is making yoga, meditation and mindfulness practice something that’s accessible, attainable, community-focused and fun. The idea of getting grounded while also setting a world record with a friend was immediately appealing, and we’re thrilled to be working with adidas and Guinness to make it happen,” said Sean Hoess, co-CEO of Wanderlust.

For additional images and information, please refer to the media contacts above.  For more information about Wanderlust events please visit www.wanderlust.com. To shop the adidas x Wanderlust Co-Branded apparel collection please visit www.adidas.com.  

About the adidas Group
 adidas is a global leader in the sporting goods industry. A designer and developer of athletic and lifestyle footwear, apparel and accessories, adidas has the mission to be the best sports brand in the world. Headquartered in Herzogenaurach, Germany and Portland, Ore., adidas employs more than 60,000 people across the globe and generated sales of EUR19 billion in 2016.

About Wanderlust:
Wanderlust Holdings, LLC is a global yoga lifestyle company founded in 2009. Our mission is to help you find your true north — to live a healthy and inspired live.  Wanderlust’s events encompass Wanderlust Festival, the largest multi-day yoga and music festivals in the world and Wanderlust 108, a one-day “mindful triathlon” taking place in urban parks across the world. In 2012, we opened the first Wanderlust Yoga studio, a re-imagination of the yoga studio experience and began offering Wanderlust Teacher Training, a yoga teacher-training program inspired by the Wanderlust festival experience. In 2015, we launched Wanderlust TV, a media platform connecting viewers with inspirational teachers and wellness experts and Wanderlust Hollywood, a 10,000 square foot center in Los Angeles, CA offering yoga and meditation classes, a world-class organic restaurant, and a full-featured performance venue.

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PRNews

Fiasp(R) Significantly Improved Overall Blood Sugar Control in Type 1 Diabetes Long-term

LISBON, Portugal, Sept. 12, 2017 /PRNewswire/ — Fiasp® (fast-acting insulin aspart), the only approved, new-generation, ultra-fast acting[1]–[3] mealtime insulin, improved overall blood sugar (HbA1c) and post-meal sugar (postprandial glucose or PPG) control over 52 weeks, compared to conventional insulin aspart (NovoRapid®), in new study findings[4].

The findings were presented today at the 53rd European Association for the Study of Diabetes (EASD) Annual Meeting, and showed that Fiasp® maintained the significant improvement in overall blood sugar control that was seen in a shorter-term (26 weeks) study period[1]. The results also reconfirmed the safety profile of Fiasp®, showing comparable overall numbers of severe or blood-sugar confirmed hypoglycaemia (low blood sugar levels)[4].

“These results provide reassurance of the meaningful long-term benefits of Fiasp® versus conventional insulin aspart,” said Professor Chantal Mathieu, study investigator, chair of Endocrinology and professor of Medicine at Katholieke Universiteit Leuven, Belgium. “Accordingly, for people with diabetes who struggle to control their post-meal sugar levels, Fiasp® might offer a better option to meet their needs.”

After eating, blood sugar levels rise rapidly. In diabetes, the body either cannot bring these high sugar levels down, or struggles to do so. Sustained high post-meal sugar levels are associated with an increased risk of cardiovascular disease and other diabetes-related complications, including damage to eyes and kidneys and cancer[5],[6]. High post-meal sugar levels also contribute to inadequate overall blood sugar control[2],[5],[7].

While mealtime insulins aim to bring post-meal sugar levels down, conventional rapid-acting insulins are not as fast as the speed of the natural physiological insulin response. Due to this slower response, people with diabetes can remain in an elevated post-meal sugar state for an extended period[2].

“Compared to conventional insulin aspart, Fiasp® is a closer match to the natural physiological insulin response, leading to better long-term blood sugar control,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “Fiasp® delivers benefits for people with diabetes, helping them to achieve better post-meal and overall blood sugar control.”

About the study 

The onset 1 trial (1,143 people randomised) was a phase 3a, partially double-blind, basal-bolus, treat-to-target trial, evaluating the efficacy and safety of Fiasp® compared with conventional insulin aspart in type 1 diabetes over 52 weeks, in two 26 week treatment periods. The findings from the 52 week study period were presented at the EASD Annual Meeting 2017.

In the 52 week study period, Fiasp® demonstrated a statistically significantly greater overall blood sugar reduction of -0.10% in adults with type 1 diabetes, in comparison to conventional insulin aspart. Fiasp® also showed a statistically significant reduction in 1-hour post-meal sugar increment of -0.91 mmol/L; no significant difference was seen in 2-hour post-meal sugar increment, compared with conventional insulin aspart. These results were achieved with a comparable overall rate of severe or blood-sugar confirmed hypoglycaemia between the two treatments[4].

About Fiasp® 

Fiasp® is the only approved, new-generation, ultra-fast acting[1]–[3] mealtime insulin. Fiasp® is insulin aspart in an innovative formulation, in which two excipients have been added: Vitamin B3 (niacinamide) to increase the speed of absorption and a naturally occurring amino acid (L-Arginine) for stability[8].

Fiasp® received marketing authorisation from the European Commission on 9 January, from Health Canada on 6 January, from Swissmedic on 7 June and from the Australian Government Department of Health on 28 June 2017. It is currently under regulatory review in over 10 countries.

After receiving a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) in October 2016, Novo Nordisk resubmitted the fast-acting insulin aspart new drug application (NDA) as a class II resubmission on 29 March 2017 and FDA approval is expected at the end of Q3 2017.

About Novo Nordisk 

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 41,400 people in 77 countries and markets its products in more than 165 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube 

References 

  1. Russell-Jones D, et al. Fast-acting insulin aspart improves glycemic control in basal-bolus treatment for type 1 diabetes: results of a 26-week multicenter, active-controlled, treat-to-target, randomized, parallel-group trial (onset 1). Diabetes Care 2017; 40(7):943-50.
  2. Heinemann L and Muchmore DB. Ultrafast-acting insulins: state of the art. Journal of Diabetes Science and Technology 2012; 6(4):728-42.
  3. Cengiz E, et al. Moving toward the ideal insulin for insulin pumps. Expert Review of Medical Devices 2016; 13(1):57-69.
  4. Mathieu C, et al. Efficacy and safety of fast-acting insulin aspart are maintained over 52 weeks: comparison with insulin aspart in onset 1. Poster presentation at the 53rd EASD Annual Meeting. 11-15 September 2017; Lisbon, Portugal.
  5. Madsbad S. Impact of postprandial glucose control on diabetes-related complications: how is the evidence evolving? Journal of Diabetes and Its Complications 2016; 30(2):374-85.
  6. International Diabetes Federation (IDF). Guideline for management of postmeal glucose in diabetes. 2011.
  7. Monnier L, et al. Postprandial and basal glucose in type 2 diabetes: assessment and respective impacts. Diabetes Technology & Therapeutics 2011; 13(Suppl.1):25-32.
  8. Heise T, et al. A pooled analysis of clinical pharmacology trials investigating the pharmacokinetic and pharmacodynamic characteristics of fast-acting insulin aspart in adults with type 1 diabetes. Clinical Pharmacokinetics 2017; 56(5):551-9.

Further information
Media:        
Katrine Sperling
+45-3079-6718    
krsp@novonordisk.com

Åsa Josefsson
+45-3079-7708
aajf@novonordisk.com

Investors:        
Peter Hugreffe Ankersen  
+45-3075-9085
phak@novonordisk.com

Hanna Ögren
+45-3079-8519
haoe@novonordisk.com

Anders Mikkelsen
+45-3079-4461  
arm@novonordisk.com

Christina Jensen
+45-3079-3009  
cnje@novonordisk.com

Kasper Veje (US)
+1-609-235-8567  
kpvj@novonordisk.com 

ZINC#: HQMMA/FA/0717/0218

Date of preparation: August 2017

PRNews

Unleashing the Power of the Latest Pharmaceutical Research for Simplified Global Healthcare Solutions through Conference Series Pharma meetings

Conference Series has scheduled 300 more Pharma meetings for 2018 in 30+ countries

LONDON, and SINGAPORE, Sept. 12, 2017 /PRNewswire/ — Associated with over 1000 scientific societies and organizations, Conference Series is scheduled to organize pharmaceutical conferences in Europe, USA, and Asia Pacific with a view to unleash precious scientific findings for the benefit of humanity.

With the changing face of pharmaceutical markets around the world, the industry exhibits enormous potential exponential growth. In the US, healthcare spending is in the range of $3.12 trillion with pharmaceutical sales of around $333 billion. Of this, $244 billion comes from patented sales and $70 billion from generic sales. Considering this vast economy in the pharmaceutical field, we at Conference Series are organizing some of our best conferences in the USA, Europe and Asia-Pacific regions on the current topics, which are instrumental in the changing landscape of the pharmaceutical market.

Our pharmaceutical conferences scheduled during 2018 span all over the world and feature several pharmaceutical topics like drug delivery systems, drug discovery, drug designing, pharmacology, neuropharmacology, bioavailability bioequivalence studies, biopharmaceutical drug discovery, antibiotics, toxicology, clinical trials, best compliance methods, regulatory frameworks and other related topics. Conference Series Pharmaceutical meetings promote extended networking between experts and address all such challenges, which require early troubleshooting. Attendees of the conferences witness several hours of pharmaceutical knowledge exchange and sharing that would inevitably boost scientific research and developments in the pharmaceutical sciences.

ConferenceSeries and its partnered companies organise 3000+ conferences across the USA, Europe & Asia and publish 1000+ Peer Reviewed Journals, which attract over 50 million readers and feature over 50,000 eminent personalities and reputed scientists as editorial board members.

During these conferences we have also partnered with some of the best pharmaceutical and healthcare companies around the globe who are not only pioneers in drug discovery, but also the market leaders in terms of revenue, to unveil their latest discoveries. Reputed universities across the USA, UK, Europe and Asia grace these conferences with a view to promote industry-academia collaborations. These pharma conferences witness a web traffic total of one million visits, whereas the total page views are 4 million (analyzed twice a year).

For a glimpse of our conferences and testimonials visit our Conference Gallery & Meetings Experts Outlook

For assistances on registrations/exhibitions and other details Contact:

T: +1-650-889-4686
E: contact@conferenceseries.com

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PRNews

Merck Set to Join Forces with Project Data Sphere to Pioneer Global Oncology Big Data Alliance

DARMSTADT, Germany, Sept. 11, 2017 /PRNewswire/ —

Not intended for U.K./U.S. based media 

  • Big data platform to help accelerate innovative discovery, development and delivery of new approaches in cancer care  
  • Enhanced analytical capabilities to better define personalized treatment options and help predict treatment outcomes 
  • Focused on areas of high unmet need to help enhance advancement in understanding, and empower and connect oncology community  

Merck, a leading science and technology company has announced that it will enter into a strategic collaboration with Project Data Sphere LLC, an independent, not-for-profit initiative of the CEO Roundtable on Cancer’s Life Sciences Consortium, to jointly lead the Global Oncology Big Data Alliance (GOBDA). This was announced at the signing of a Memorandum of Understanding yesterday, to coincide with Merck’s Award Ceremony announcing the recipients of its 2017 Grant for Oncology Innovation, held during the annual European Society for Medical Oncology Congress (ESMO 2017) in Madrid, Spain.

“The ultimate goal of our alliance with Project Data Sphere is to unleash the power of big data to bring value to cancer patients,” said Belen Garijo, Member of the Executive Board of Merck and CEO Healthcare. “Merck is deeply committed to investing in initiatives that push the boundaries of cancer research, that we hope will accelerate the discovery, development and delivery of innovative treatments to all who need it.”

The GOBDA initiative has been formed to expand the open-access of de-identified patient data sets to further enhance analytical capabilities, by building on Project Data Sphere’s innovative digital platform. The current platform contains historical clinical trial data from almost 100,000 patients provided by multiple organizations, and access to this information has already led to new and potentially practice-changing findings. GOBDA will expand this platform to include rare tumor trial, experimental arm and real-world patient data. Leveraging these data with big data analytics will help to optimize clinical trials, build a registry of data and help to enable advancement in the understanding of cancer treatment globally, with the mission to address the significant unmet needs in this field. In addition, by unleashing analytical power and big data to study and learn how to better manage rare but serious immune-mediated adverse events, institutes and industry will be able to assist regulators to adapt these new learnings into treatment guidelines. As well as establishing models to help enable early adverse event identification and improved patient outcomes.

“Big data is changing the face of healthcare as we know it, and advances in our ability to collect data, share and analyze it has already led to ground-breaking work,” said Dr Martin J. Murphy, CEO of Project Data Sphere LLC. “The joint force of Merck and Project Data Sphere will aim to connect and empower a truly global oncology community with these big data and analytical capabilities. We are excited about the Global Oncology Big Data Alliance initiative and the continuing engagement of a diverse community focused on finding solutions for cancer patients.”

Investment in the initiative builds on Merck’s commitment to rewarding innovation and creative thinking that could further advance the field of medicine, and begins a new chapter for global oncology innovation. Since 2014, the company has awarded a total of €4 million to further research in oncology through the Grant for Oncology Innovation award, which has engaged over 1,000 investigators worldwide, generated 12 winning research proposals from leading academic institutions, and generated seven high impact manuscripts. More information about the program can be found online at: http://www.grantforoncologyinnovation.org

About Project Data Sphere, LLC 

Project Data Sphere, LLC is an independent, not-for-profit initiative of the CEO Roundtable on Cancer Inc.’s Life Sciences Consortium. The CEO Roundtable on Cancer is a 501(c)(3) nonprofit corporation founded by President George H.W. Bush in 2001 to develop and implement initiatives that reduce the risk of cancer, enable early diagnosis, facilitate access to the best available treatments, and hasten the discovery of novel and more effective anti-cancer therapies.

For more information, visit http://www.ProjectDataSphere.org, or follow the Project Data Sphere initiative on Twitter at https://twitter.com/ProjDataSphere.

About the Global Oncology Big Data Alliance (GOBDA) 

The Global Oncology Big Data Alliance (GOBDA) will be a joint alliance, co-led by Merck and Project Data Sphere with the shared vision to connect and empower the oncology community with big data and advanced analytical capabilities. It is the goal of the initiative that by unleashing these data capabilities, this platform will help accelerate discovery, development and delivery of innovative treatment approaches for cancer patients, and address current significant unmet needs in this field.

A joint steering committee will monitor the initial progress of the collaboration including expansion of the PDS database with new data sets provided by the National Cancer Institute and other parties, designing the first FDA/Industry immuno-related adverse event Safety Meeting on December 15, 2017. The anticipated overall term of the GOBDA project and strategic collaboration shall be from 2018-2021.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

About Merck 

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of EUR 15.0 billion in 66 countries.

Founded in 1668, Merck is the world’s oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

Your Contact: Martina Brunner +49-6151-72-43959

PRNews

Galderma: Combined Use of Rosacea Therapies Ivermectin 1% Cream and Brimonidine 0.33% Gel Evaluated in MOSAIC Study

LAUSANNE, Switzerland, Sept. 11, 2017 /PRNewswire/ — Today, the results of a study evaluating the combined use of topical rosacea treatments ivermectin 1% cream and brimonidine 0.33% gel were published in the Journal of Drugs in Dermatology.

“This is the first study evaluating the benefit of using both ivermectin 1% and brimonidine 0.33% in combination to effectively target the multiple features of rosacea,“ commented study author Linda Stein Gold, Henry Ford Hospital, Detroit, MI. “This study develops a comprehensive and early treatment approach to this complex disease.“

“The visible signs of rosacea can significantly impact patients‘ quality of life,“ said Gregor Schaefer, Medical Lead at Galderma. “Galderma is committed to supporting patients through the development of practical treatment options.“

Reference:  

Stein Gold L, et al. J Drugs Dermatol. 2017;16(9):909-916.

About Rosacea 

Rosacea is a common inflammatory skin disease that presents variable clinical characteristics, of which the most common are flushing, permanent erythema, and inflammatory lesions. It mainly affects the central areas of the face, such as the cheeks and nose. The disease can affect both adult men and women, usually after the age of 30. Additionally, symptoms such as stinging, burning and increased sensitivity of the skin are common. The eyes are often affected, and might present as red, dry or itchy.

Although the cause of the disease is still under debate, various trigger factors are known, including spicy foods, alcohol, emotional stress, sun/UV-exposure, hot baths and beverages. Demodex, generally harmless mites, can also be found in the skin in an elevated quantity in people with rosacea.

Rosacea may worsen over time if left untreated. People that suspect they suffer from rosacea should visit their dermatologist or healthcare provider for diagnosis and discuss what treatment is right for them. Because rosacea is a highly visible disease, it is known to cause embarrassment and anxiety in some patients, which in turn may cause frustration and have a negative impact on their social life.

About Galderma 

Galderma, Nestle Skin Health’s medical solutions business, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically defined and medically proven solutions for the skin, hair and nails. For more information, please visit http://www.galderma.com

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