Monthly Archives: January 2013



First new IUD (intrauterine device) to enter market in more than a decade 
Approval of Skyla expands Bayer’s IUD portfolio

Wayne, NJ, January 29, 2013 - Bayer HealthCare Pharmaceuticals Inc. recently announced that the U.S. Food and Drug Administration (FDA) approved Skyla™ (levonorgestrel-releasing intrauterine system) 13.5 mg, a new hormone-releasing system that is placed in the uterus for the prevention of pregnancy for up to three years.1

“Research shows that nearly 50 percent of pregnancies in the U.S. are unintended,2 which emphasizes the need for increased education and access to effective birth control options,” said Anita L. Nelson, M.D., Professor of Obstetrics and Gynecology at Harbor-UCLA Medical Center, Torrance, CA. “Skyla is more than 99 percent effective at preventing pregnancy and may be appropriate for women who want a birth control method that they do not have to take daily. Further, Skyla may be used by women whether or not they have ever had a child, representing an important new choice for women who don’t want to become pregnant for up to three years.”

Skyla is a small, flexible plastic T-shaped device containing 13.5 mg of a progestin hormone called levonorgestrel. The size of the Skyla T-body is 28mm x 30mm and the outer diameter of the placement tube is 3.8mm. Because Skyla slowly releases levonorgestrel into the uterus, only small amounts of the hormone enter the blood. During the first three to six months of using Skyla, women may experience irregular periods and an increase in the number of bleeding days. Women may also have frequent spotting or light bleeding. Some women may have heavy bleeding during this time. After using Skyla for a while, the number of bleeding and spotting days is likely to lessen, and there is a small chance that periods may stop altogether.1,3

Women can have Skyla placed by a healthcare provider during an in-office visit. Skyla is intended for long-term use for up to three years but may be removed by a healthcare provider at any time. Women could become pregnant as soon as Skyla is removed, so they should use another method of birth control if they do not want to become pregnant. About 77% of women who want to become pregnant will become pregnant sometime in the first year after Skyla is removed.3

“The approval of Skyla expands Bayer’s IUD portfolio and highlights our continued commitment to empower women with a variety of birth control options at different reproductive stages of their lives,” said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. “We are pleased to bring the first new IUD to market in the U.S. in 12 years, and to provide women who are seeking contraception with an important new and effective option to consider with their healthcare providers.”

Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg will be available by prescription the week of February 11.

About the Clinical Trial for Skyla1

The approval of Skyla is supported by data from a Phase 3 trial that included 1,432 women aged 18-35 who received Skyla, of which 38.8% (556) had not yet had a child. The trial was a multicenter, multinational, randomized open-label study conducted in 11 countries in Europe, Latin America, the U.S. and Canada. Women less than six weeks postpartum, with a history of ectopic pregnancy, with clinically significant ovarian cysts or with HIV or otherwise at high risk for sexually transmitted infections were excluded from the trial.

The pregnancy rate calculated as the Pearl Index (PI) in women aged 18-35 years was the primary efficacy endpoint used to assess contraceptive reliability. The PI was calculated based on 28-day equivalent exposure cycles; evaluable cycles excluded those in which back-up contraception was used unless a pregnancy occurred in that cycle. Skyla-treated women provided 15,763 evaluable 28-day cycle equivalents in the first year and 39,368 evaluable cycles over the three-year treatment period. The PI estimate for the first year of use based on the five pregnancies that occurred after the onset of treatment and within seven days after Skyla removal or expulsion was 0.41 with a 95% upper confidence limit of 0.96. The cumulative three-year pregnancy rate, based on 10 pregnancies, estimated by the Kaplan-Meier method was 0.9 per 100 women or 0.9%, with a 95% upper confidence limit of 1.7%.

Of Skyla-treated women, 21.9% discontinued the study treatment due to an adverse event. Most common adverse reactions (occurring in 5% users) were vulvovaginitis (20.2%), abdominal/pelvic pain (18.9%), acne/seborrhea (15.0%), ovarian cyst (13.2%), headache (12.4%), dysmenorrhea (8.6%), breast pain/discomfort (8.6%), increased bleeding (7.8%) and nausea (5.5%).

Other serious adverse reactions were also observed, including ectopic/intrauterine pregnancy, life-threatening infections, pelvic inflammatory disease (PID), perforation and expulsion.

Important Safety Information for Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg

If you have a pelvic infection, get infections easily, or have certain cancers, don’t use Skyla. Less than 1% of users get a serious infection called pelvic inflammatory disease.

If you have persistent pelvic or stomach pain or if Skyla comes out, tell your doctor. If Skyla comes out, use back-up birth control. Skyla may attach to or go through the uterus and cause other problems.

Pregnancy while using Skyla is uncommon but can be life threatening and may result in loss of pregnancy or fertility. Ovarian cysts may occur but usually disappear.

Bleeding and spotting may increase in the first few months, and remain irregular. Over time, periods are likely to become shorter and lighter, or may stop.

Skyla does not protect against HIV or STDs.

Only you and your healthcare provider can decide if Skyla is right for you. Skyla is available by prescription only.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit, or call 1-800-FDA-1088.

For additional information about Skyla, please see full prescribing information at

About Bayer HealthCare Pharmaceuticals Inc. 

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world’s leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare Pharmaceuticals provides products for Diagnostic Imaging, General Medicine, Hematology, Neurology, Oncology and Women’s Healthcare. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

# # #

BAYER® and the Bayer Cross® are registered trademarks of Bayer. Skyla is a trademark of Bayer.

Media Contact:

Marcy Funk, Tel. +1 (973) 305 5385

Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

1 Skyla Prescribing Information, January 2013

2 Mosher WD, Jones J. Use of contraception in the United States: 1982–2008. National Center for Health Statistics. Vital Health Stat 23(29). 2010. “Introduction” Available at Accessed on 1/2/13.

3 Skyla Patient Prescribing Information, January 2013

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EVANSTON, ILL., January 22, 2013 - What is a MOOC? What were the top jobs offered to graduates last year? Who earns more college degrees: men or women? Find answers to these questions and more at, a comprehensive new website that provides easy access to thousands of the best online higher-education resources for students, counselors, professors and lifetime learners.

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First umbrella that enables texting and e-mailing in the rain

CHICAGO, May 23 – Rainy days just became fun with the introduction of the Brolly™, a very affordable (less than $20 retail) small umbrella, that hopes to supplant the bigger and behemoth-sized umbrellas with a very unique finger hole grip.

The grip literally removes the danger of losing control of the umbrella in really foul weather, which can be prevalent in the Windy City.  At the same time, it (grip) allows the holder to text/e-mail on your mobile phone in the rain with a certain degree of security and sturdiness.  The Brolly, available in blue and black and green and black — is compact, stylish and comfortable to hold onto.

“We wanted to create a rain umbrella that was easy to hold and offered a superior level of durability. Rain umbrellas do a decent job of keeping people dry in the rain, but they are often uncomfortable to hold and fall apart after a few uses,” said Greg Edson, president of Brollytime Inc., the Chicago-based company that created and built The Brolly.

With its patent-pending finger hole grip, the Brolly puts your hand in full control of the rain umbrella, making it nearly impossible for you to lose your grip or grasp. Durability is the keystone of the umbrella. Its ribs are reinforced with fiberglass to handle strong winds and the frame consists of steel and aluminum. Even little things, like plastic around the umbrella tips, were incorporated to prevent people from being poked in the eye with metal tips.

You can buy the Brolly rain umbrella online and at select local retailers throughout the U.S.  The price-tag alone makes it affordable for anyone to own and it’s anything but another low-priced rain umbrella.

“It’s time to redefine the rain umbrella industry by offering  a high quality, low cost rain umbrella that is a conversation starter no matter where you go,” said Edson. “The Brolly gives you an extra hand to do things that are impossible to do with traditional rain umbrellas.

“We are excited to release the Brolly rain umbrella to the world and hope consumers enjoy using it, as much as we enjoyed bringing it from concept to life. We have put our best hand forward with this rain umbrella invention — literally.”

About Brollytime Inc.

Brollytime Inc. is a Chicago, IL-based business that developed The Brolly rain umbrella to create the most comfortable, fashion-forward and durable rain umbrella. The Brolly rain umbrella has a patent pending finger hole grip design to make the umbrella easy to hold and enable people to multi-task even when standing in the rain. For more information, please visit


Andrew Edson & Associates, Inc.
Andrew Edson, 516.850.3195


Students at Over Half of US Colleges Embrace Boundless Open Textbooks

BOSTON, January 10, 2013 - Boundless — the free alternative to traditional textbooks — announces major additions to its free textbooks library and improved study tools for the new collegiate semester. Using free, openly-licensed content Boundless creates digital books that align to students’ assigned readings — making education more affordable, accessible and effective.

“I’m proud to announce that students at over half the colleges in the US have used Boundless,” said Ariel Diaz, co-founder and CEO of Boundless. “This year, we expect that number to continue to grow, as we’ve more than doubled the number of subjects that we offer and built a suite of features that go way beyond traditional textbooks. Most importantly, 88% of students who used our textbooks last semester are likely to go Boundless again and 95% of our users achieved the grade they expected — or did better!”

Textbooks remain the core content for most courses in higher education, with over 80% of the market controlled by the top four publishers. These publishers have continued to raise prices for this stagnant product in the face of innovation in every other information related industry, growing at a rate of 3 times inflation.

The Boundless free textbooks not only save students money, but go far beyond what traditional textbooks offer. Boundless creates a beautiful e-reading experience that makes it easy to highlight and make notes directly on its digital content. As students make annotations on their readings, they are aggregated into an interactive notebook. Key features of the Boundless textbook that go beyond traditional textbooks include:

  • Shareable Study Guides for individual and group study sessions
  • Notebooks that are autogenerated as students highlight important text and figures
  • Boundless SmartNotes that summarize important topics, perfect for exam prep or studying in a flash
  • Self-assessment tools, like pre-made flashcards and quizzes, for students to test their knowledge before exams and classes
  • New, unaligned textbooks, combining the best the web has to offer in subjects such as biology, history and marketing
  • Mobile, HTML 5, website optimized for studying on any device so students can study anywhere.

Students at more than 2,000 colleges in the U.S. are turning to Boundless for free, effective tools for learning. See why students are ditching their textbooks and saving hundreds of dollars by visiting

About Boundless
Boundless is the only free alternative to expensive textbooks. Boundless creates free online textbooks and study tools for students using the wealth of high quality, openly licensed educational content available online. Learn more at


Ariel Diaz, CEO,
Phone: 617-500-7225

Submit a Short Video on Grand Challenges for Engineering and Enter to Win a Trip to London

WASHINGTON, January 9, 2013 – The Global Grand Challenges Summit is a major new initiative by the national academies of engineering in the UK, the US, and China. The summit will bring together leading international thinkers and innovators to explore new approaches to solving some of the most pressing challenges of the 21st century, on themes ranging from sustainability to health care, from driving growth and employment to protecting our planet.

In conjunction with the Global Grand Challenges Summit, each of the academies is running a short video competition for entrants 18-27 years old in the US, the UK, and China. Each competition will have its own judging process and prizes. Each academy will select its own competition winner to be screened at the Global Grand Challenges Summit in London, UK on March 12-13 2013. The winning contestants (maximum of two representatives per video) will be invited as guests to the Summit.

This short video competition is calling for creative entrants to produce a video highlighting the importance of engineering and how engineers can collaborate with other professions to solve (a) one of the challenges articulated by the National Academy of Engineering in its NAE Grand Challenges for Engineering program or (b) a challenge within one of the related Summit themes: Sustainability, Education, Enriching Life, Technology and Growth, Resilience.

The video should include data that supports ideas presented.

The competition is open to short videos (no longer than two minutes) of all production techniques and genres, such as drama, animation, documentary, experimental or artist video, and hybrid work. The video may be shot with a full crew or with a mobile phone, it may be serious or amusing. However you choose to produce your video, it should be thought provoking.

Eligible entries, whether selected as a winner or not, may be made available through the Global Grand Challenges Summit’s dedicated YouTube/Vimeo channel.

Deadline for submissions is midnight February 3, 2013, EST.

The National Academy of Engineering is an independent, nonprofit institution. Its members consist of the nation’s premier engineers, who are elected by their peers for seminal contributions to engineering. The academy provides leadership and guidance to government on the application of engineering resources to social, economic, and security problems. Established in 1964, NAE operates under the congressional charter granted to the National Academy of Sciences in 1863.


‘Go Viral To Improve Health,” Win Up to $10,000

WASHINGTON, January 9, 2013 – Students pursuing degrees toward careers in health, engineering, and computer science could earn a distinctive addition to their resumes by participating in “Go Viral to Improve Health,” a contest that challenges undergraduate and graduate students to create innovative health-related apps and offers $18,000 in prizes.

“Go Viral to Improve Health” is the third annual collegiate challenge sponsored by the Institute of Medicine and National Academy of Engineering to inspire students to work in interdisciplinary teams and transform health data into mobile apps, online tools or games, or other innovative products that solve vexing health problems.

The top prize is $10,000, sponsored by Heritage Provider Network. The second and third place teams will receive awards of $5,000 and $3,000, respectively. Entries will be assessed on their design, usability, and how well they integrate public health data.

Participating teams must consist of between two and five undergraduate and/or graduate students. Multidisciplinary teams including students in health-related fields and computer science/engineering are especially encouraged. Teams must use at least one publicly available, de-identified data set to develop their app. Additional eligibility criteria and terms are spelled out at

Students must register their teams for the challenge by Feb. 27, 2013. Once registered, teams have until 5 p.m. EST on April 17 to submit their apps. Further details about “Go Viral to Improve Health” can be found at and on Facebook at Questions can be directed to

The Institute of Medicine and National Academy of Engineering along with the National Academy of Sciences and National Research Council make up the National Academies. They are private and independent nonprofit institutions that provide science, technology, and health policy advice under a congressional charter granted to NAS in 1863. For more information, visit

Heritage Provider Network Inc. is one of the largest physicians’ groups in the United States, providing medical care to approximately 700,000 individuals. It is on the cutting edge of the accountable care model of health care delivery and is dedicated to quality, affordable health care and putting patients’ wellness first. For more information, visit