healthcare innovation summit 2016

Global Hospital & Healthcare Management




Jun 30th
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Teva Pharmaceutical Receives Positive CHMP Opinion on CINQAERO (23.06.2016)
Teva Pharmaceutical Industries Ltd announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for CINQAERO® (reslizumab), a humanized interleukin 5 antagonist monoclonal antibody for add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

“As a company committed to providing medicines and solutions for people around the world living with respiratory disease, Teva is very pleased to report a positive opinion by CHMP for the first intravenous anti-IL-5 biologic therapy for severe eosinophilic asthma,” said Rob Koremans, MD, President and CEO of Teva Global Specialty Medicines. “In clinical trials, reslizumab was effective in reducing asthma exacerbations, improving lung function and improving asthma-related quality of life measures. It is our hope that we can expand the availability of reslizumab globally and soon bring this important treatment option to a specific group of severe eosinophilic asthma patients in Europe who struggle to control their symptoms despite today’s standard of care.”

The CHMP opinion is based on review of a Marketing Authorization Application (MAA) containing efficacy and safety data from Teva’s global development program in asthma. The clinical trial program consisted of five placebo-controlled studies which demonstrated the efficacy and/or safety profile in a population of 1,028 adult and adolescent asthma patients treated with reslizumab 3 mg/kg that were inadequately controlled with inhaled corticosteroid (ICS)-based therapies. Three of these studies constituted the Phase III program in patients with asthma and elevated blood eosinophils greater than 400 cells/mcL, where reslizumab was administered for up to 52 weeks. 

They demonstrated that treatment with reslizumab reduced the annual rate of asthma exacerbations in the two 52-week trials by 50 and 59 percent, respectively. In addition, reslizumab was associated with significant improvement in lung function, patient-reported asthma control and asthma-related quality of life measures. The most commonly reported adverse reaction during treatment was increased blood creatinine phosphokinase, which occurred in approximately two percent of patients. These were mostly mild, transient, asymptomatic and did not lead to treatment discontinuation. Adverse reactions of myalgia and anaphylactic reaction were uncommon and occurred in less than one percent of patients.

The CHMP positive opinion is a formal recommendation to grant marketing authorization for reslizumab. The recommendation will now be reviewed by the European Commission, which has authority to approve medicines for use in the 28 countries of the European Union along with Norway, Liechtenstein and Iceland. The final decision by the European Commission is expected in the second half of 2016.

About Teva Respiratory
Teva Respiratory develops and delivers high-quality treatment options for respiratory conditions, including asthma, COPD and allergic rhinitis. The Teva Respiratory portfolio is centered on optimizing respiratory treatment for patients and healthcare providers through the development of novel delivery systems and therapies that help address unmet needs. The company’s respiratory pipeline and clinical trial program are based on drug molecules delivered in proprietary dry powder formulations and breath-actuated device technologies, as well as a targeted biologic treatment for severe asthma. Through research and clinical development, Teva Respiratory continually works to expand, strengthen and build upon its treatment portfolio to positively impact the lives of the millions of patients living with respiratory disease.

About Teva
Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2015 amounted to $19.7 billion. For more information, visit .
Teva Pharmaceutical Industries Ltd.
United States
Kevin C. Mannix, 215-591-8912
Ran Meir, 215-591-3033

Tomer Amitai, 972 (3) 926-7656

Iris Beck Codner, 972 (3) 926-7687

United States
Denise Bradley, 215-591-8974
Nancy Leone, 215-284-0213

March of Dimes, UHG Launch Prenatal Care Program to Help Improve Health Outcomes  (22.06.2016)

UnitedHealth Group contributes $700,000 to help launch and evaluate new group prenatal care program for pregnant women
New program aims to reduce nation's preterm birth rate to 5.5 percent by 2030 from the 2015 rate of 9.6 percent
March of Dimes and UnitedHealth Group are launching a new group prenatal care program designed to help improve mothers' and babies' health during pregnancy, birth and infancy.
March of Dimes supportive pregnancy care enables expectant mothers to access prenatal care on a monthly basis in a supportive group setting with women who are of similar gestational ages. During each visit, expectant mothers will have more time with their care providers than they would during their standard individual prenatal checkups, and benefit from prenatal care education and vital social and emotional support from other mothers. This environment can empower women to take control of their pregnancy care and fosters relationships that can last throughout their pregnancies and beyond.
Funded by $700,000 from UnitedHealth Group, March of Dimes and UnitedHealth Group will collaborate to develop the program's content and curriculum, and make it available to participating care providers. The curriculum will adhere to the prenatal care standards of the American College of Obstetricians and Gynecologists.
March of Dimes will operate the program in Tennessee beginning fourth-quarter 2016. The program will include web-based tools and a social media platform to enable mothers to connect and socialize with each other online outside the group sessions and access helpful information on healthy pregnancies. The program will be open to any expecting mother interested in participating, regardless of insurance coverage.
March of Dimes and UnitedHealth Group will evaluate the program's performance over the coming months to build a case study with a goal to expand the model to more care providers and health systems across the country.
"Preterm birth takes a devastating toll on the health of families in the United States and costs the health care system billions," said March of Dimes President Dr. Jennifer L. Howse. "And for the first time in eight years, the national preterm birth rate has increased rather than decreased. Preterm birth continues to be the No. 1 killer of babies. We must redouble our efforts to prevent the serious lifelong health consequences that many babies suffer from being born too soon. Our enhanced group prenatal care program could help change this dynamic, one mother and child at a time. We are pleased to work with UnitedHealth Group to accelerate the adoption of group prenatal care that can make a positive difference in so many lives."
Dr. Deneen Vojta, a pediatrician and executive vice president at UnitedHealth Group's Enterprise Research and Development, said: "group prenatal care is part of the future of care for expecting mothers and their babies because it's about creating emotional and social support, motivation and education to have a healthy birth and baby. We are grateful for the opportunity to collaborate with March of Dimes to put mothers and babies on the path to better health and reduce health care costs."
The Toll of Preterm Births in the United States
According to the National Center for Health Statistics (NCHS), nearly 10 percent of all births in the United States are preterm, meaning these babies are born before 37 weeks of pregnancy. That represents one of the highest prematurity rates of any developed country in the world. The March of Dimes 2015 Premature Birth Report Card shows serious disparities continue to exist among communities and among racial and ethnic groups in the United States, with African-American infants more than twice as likely to be born preterm as white infants.
The economic costs of preterm births reached $26.2 billion in 2006 – the most recent data available from the Institute of Medicine – accounting for more than one-third of all U.S. health care spending for infants, according to the Institute of Medicine. A premature birth costs employers about 10 times more than a healthy, full-term birth in the first year of life ($55,393 vs. $5,085), according to a 2014 analysis by Truven Health Analytics commissioned by the March of Dimes.
Babies who survive an early birth often have lifelong health issues such as cerebral palsy, vision and hearing loss, and intellectual disabilities. Even infants born just a few weeks early have a greater risk of respiratory distress syndrome (RDS), feeding difficulties, temperature instability (hypothermia), jaundice and delayed brain development.
Group prenatal care has gained momentum in recent years and has shown promising evidence that it can lead to healthier pregnancies and births, and lay the foundation for better lifelong health. In addition to providing substantially more contact with health care providers, prenatal care delivered in a group setting can motivate pregnant women to be more actively engaged in their health care, offer support services, and meet the needs of pregnant women and their families more effectively.
Research from the National Institutes of Health (NIH) found that a group setting for prenatal care was associated with fewer preterm births, reduced incidence of low-birth-weight infants, and shorter neonatal intensive care unit (NICU) stays after birth. States and the federal government bear a substantial share of the costs of preterm birth through the Medicaid program, which covers roughly half of all births. The potential net savings to the Medicaid program over a five-year period would equal roughly $12 billion if half the pregnant women enrolled in Medicaid were to receive care through a group model, according to research from the UnitedHealth
Center for Health Reform & Modernization.
Successfully scaling this program is expected to improve population health outcomes, reduce disparities and decrease systemwide costs. March of Dimes' goal for the program is to reduce the nation's preterm birth rate to 5.5 percent by 2030 from the 2015 preliminary NCHS rate of 9.6 percent.
About March of Dimes
The March of Dimes is the leading nonprofit organization for pregnancy and baby health. For more than 75 years, moms and babies have benefited from March of Dimes research, education, vaccines, and breakthroughs. For the latest resources and health information, visit our websites and If you have been affected by prematurity or birth defects, visit our community to find comfort and support. For detailed national, state and local perinatal statistics, visit You can also find us onFacebook or follow us on Twitter.
About UnitedHealth Group
UnitedHealth Group is a diversified health and well-being company dedicated to helping people live healthier lives and helping to make the health system work better for everyone. UnitedHealth Group offers a broad spectrum of products and services through two distinct platforms: UnitedHealthcare, which provides health care coverage and benefits services; and Optum, which provides information and technology-enabled health services. For more information, visit UnitedHealth Group at .

Astellas Pharma Inc Ties Up with University of Tokyo on Rice-Based Vaccine (22.06.2016)
The Institute of Medical Science, the University of Tokyo and Astellas Pharma Inc. announced that they have signed a new collaborative development agreement on the rice-based oral vaccine “MucoRice-CTB” (“MucoRice”) against cholera*1 and enterotoxigenicEscherichia coli (E coli) *2 caused diarrheal diseases.
MucoRice is a rice-based oral vaccine expressing cholera toxin B subunit (CTB)*3 in the intrinsic storage protein of rice using genetic engineering, which was developed by Prof. Hiroshi Kiyono, Project researcher Yoshikazu Yuki and their colleagues at International Research Development Center for Mucosal Vaccines (IMSUT).
In developing countries, diarrhea caused by pathogenic bacteria such as Vibrio cholerae and enterotoxigenic E coli, is one of the major causes of death among infants. At present, the challenges of the cholera vaccines used in developing countries are the need for the cold chain*4 and the ineffectiveness against enterotoxigenic E coli.MucoRice is stable at room temperature and easily produced, therefore it is expected to meet the unmet medical needs of existing cholera vaccines.
Under the MEXT (Ministry of Education, Culture, Sports, Science and Technology) and the AMED (Japan Agency for Medical Research and Development) Translational Research Network Program, an investigator-initiated phase 1 trial of this vaccine is nearing completion at IMSUT hospital (Principal investigator, Assoc. Prof. Osamu Hosono) in Japan. Data from this trial is now being analyzed.
Under the contract, IMSUT provides clinical trial materials and trial data, etc. which are necessary for the phase 1 and phase 2 trials of MucoRice for cholera and enterotoxigenic E coli., and Astellas is responsible for conducting and managing the clinical trials.
Through the collaborative development, IMSUT and Astellas will develop vaccines against infectious diseases affecting developing countries and hope we can address Access to Health issues.
Cholera is an acute gastroenteritis by Vibrio cholera which produce cholera toxin causing severe diarrhea. It is spread through contaminated food or water, therefore it is more common in developing countries.
*2Enterotoxigenic Escherichia coli:
Enterotoxigenic E coli is the E coli which produces a toxin that causes diarrhea and abdominal pain in humans. Severe diarrhea is caused by ingesting food or water contaminated by it. It is common in areas that lacks an adequate environmental sanitation, responsible for diarrhea in infants, and is also known to be a major cause of diarrhea in tourists who visit these areas.
*3Cholera toxin B subunit (CTB):
Cholera toxin consists of 2 types of subunits, CTA (chorea toxin A subunit) is toxic, and CTB pentamer adheres to epithelial cells and delivers CTA into the cell.
*4The cold chain:
The cold chain is a system to store and transport vaccine at a constant low temperature to maintain its effect.
About Access to Health issues:
There are many people with insufficient access to healthcare they need due to the lack of available treatments, poverty, challenges in healthcare systems and limited healthcare information. Astellas recognizes this problem as “Access to Health” issue and works to improve “Access to Health” by engaging in various initiatives.
About the Institute of Medical Science, the University of Tokyo
The Institute of Medical science, the University of Tokyo (IMSUT) was founded by Prof. Shibasaburo Kitasato in 1892 as “The Institute of Infectious Disease”. IMSUT with its own affiliated hospital is Japan's foremost university-associated research institute for medical and life science. Focusing on infectious disease, cancer and immunological diseases, our mission is to translate basic research findings directly to novel medical therapies. Thus, research environment of IMSUT is represented by the "bed to bench and bench to bed" inheriting the Kitasato’s DNA of “Wisdom and Practice” for medical science leading to the next generation of Genome-based medicine, Antibody-drugs, .Mucosal Vaccines, Gene-therapy and Regenerative medicine.
About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at




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