Sunday, February 7, 2010

FDA Issues Complete Response Letter for Ceftobiprole

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) today announced it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for ceftobiprole. The New Drug Application (NDA) was originally submitted to the FDA in May 2007 for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections.


The FDA has requested additional information and recommended additional clinical studies be conducted in order to consider a future approval of ceftobiprole in this indication. J&JPRD intends to discuss the best path forward with the FDA as soon as possible.

Ceftobiprole was licensed from Swiss-based Basilea Pharmaceutica Ltd. in February 2005. In March 2008, J&JPRD received an Approvable Letter regarding the ceftobiprole filing. J&JPRD responded to the FDA's Approvable Letter in August 2008. In November 2008, J&JPRD received a Complete Response letter,

which recommended additional site audits be conducted. The Company completed those audits through a third party and included the results in its June 2009 response to the FDA's Complete Response letter.
About Ceftobiprole

Ceftobiprole is a novel, broad-spectrum, anti-MRSA cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA), penicillin-resistant Streptococcus pneumonia and many clinically important Gram-negative bacteria, including Pseudomonas.

The regulatory review process is ongoing in Europe and other countries for the use of ceftobiprole in adults for the treatment of complicated skin and skin structure infections. Ceftobiprole is approved in Canada,
Switzerland, Russia, Azerbaijan, Ukraine and Hong Kong.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) J&JPRD is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Asia, Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

[This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from J&JPRD or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and

governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2008. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. Neither J&JPRD nor Johnson & Johnson undertakes to update any forward-looking statements as a result of new information or future events or developments.

Friday, February 5, 2010

WHO HAILS NEW GATES FOUNDATION SUPPORT FOR DECADE OF VACCINES

The World Health Organization welcomes the Bill & Melinda Gates Foundation pledge of US$ 10 billion over the next ten years to accelerate global vaccine efforts.


"The Gates Foundation’s commitment to vaccines is unprecedented, but needs to be matched by unprecedented action. It’s absolutely crucial that both governments and the private sector step up efforts to provide life-saving vaccines to children who need them most," said Dr Margaret Chan, WHO Director-General.

Vaccines and immunization have played a major role since the last century in overall health gains. Smallpox has been eradicated, polio is on the verge of being eradicated and more than 2 million deaths are averted each year.

"Building on these achievements, we can take immunization to the next level, with the expanded uptake of new vaccines against major killers such as pneumonia and rotavirus diarrhoea," said Dr Chan. "An additional two million deaths in children under five years could be prevented by 2015 through widespread use of new vaccines and a 10% increase in global vaccination coverage."

Vaccines join other proven measures, such as micronutrient supplements, oral rehydration therapy, and community delivery of antibiotics, that form an integrated approach to child health and have already brought much progress.

The Bill & Melinda Gates Foundation announcement comes on the tenth anniversary of the establishment of the Global Alliance for Vaccines and Immunization (GAVI). Dr Chan also congratulated the GAVI Alliance on their accomplishment of reaching 257 million additional children with new and underused vaccines.

Friday, January 29, 2010

Counsyl Test to Prevent Diseases Like Those in 'Extraordinary Measures' Now at 100+ Medical Centers

Free with Insurance, New Pre-Pregnancy Test Saves Lives While Dramatically Cutting Health Care Costs


Genetic diseases like those seen in the new Harrison Ford movie "Extraordinary Measures" can now be prevented with a simple saliva test which is free with insurance for more than 100 million Americans.

The movie centers on the real-life efforts of the Crowleys, a family trying to find a cure for a rare genetic disease affecting two of the family’s three children. The condition wasn’t detected until after their children were born.

Now, couples can take a Universal Genetic Test before pregnancy to determine whether their baby is at risk for more than 100 life-threatening genetic diseases. At-risk couples may then use a well-understood procedure called IVF/PGD to protect their child from genetic disease and ensure a healthy pregnancy.

This Universal Genetic Test was invented by scientists and social entrepreneurs from Stanford and Harvard and brought to the public via a Stanford startup named Counsyl (counsyl.com). As Newsweek recently reported:

“What is the secret to improving public health while cutting costs? The question has consumed Washington, but it's being answered elsewhere, by doctors offering a new test for more than 100 rare recessive genes, some of which cause fatal diseases. The test, [offered by] Counsyl, lets potential parents assess their genomes to see if their future kids are at risk. ... This is as preventive as medicine gets: the test could eliminate all single-recessive-gene diseases.”

The test is now offered by physicians at more than 100 prestigious medical centers across the United States, including Yale Fertility Center (see counsyl.com/map), and has attracted the support of prominent academics, bioethicists,

religious leaders, families with genetic disease, and doctors from America’s largest hospitals.

Broad Support among Prominent Physicians for Universal Genetic TestingDr. Steven Ory, Past President of the American Society for Reproductive Medicine: "After 30 years in reproductive medicine, I am more optimistic about this development in genetic disease prevention than I've ever been before. The vast majority of babies born with genetic disease have no family history. That's why it's so critically important for all parents to get the Universal Genetic Test before pregnancy."

Dr. Pasquale Patrizio, Director of the Yale Fertility Center: "Every adult of reproductive age needs the Counsyl test. It is unusual in that it benefits all three parts of the health care triad: patients, doctors, and insurers. A child stricken by

preventable genetic disease often dies in infancy and costs the bereaved parents millions in medical bills. A five minute saliva test that prevents this is a money saver, a time saver, and most importantly a life saver; it really is a no-brainer."

Dr. Thomas Walsh, Director of the Male Fertility Laboratory at the University of Washington: "Genetic testing has been recommended for all adults before pregnancy since 2001, but like many topics related to planning a pregnancy, awareness of this

issue continues to lag. This test covers several key genetic diseases, including cystic fibrosis, spinal muscular atrophy, sickle cell, Tay-Sachs, and many others. The results of testing enable couples to make an informed decision before conceiving a child.”

Dr. John Marshall, Former Chairman of Ob/Gyn at Harbor-UCLA Medical Center: "Because the test can be taken in the privacy of one's home as well as in a clinical setting, it reminds me of the first 'at home pregnancy test'. This 'at home carrier test' is very similar in that the healthy adults who take it generally

test negative, with those who test positive referred for medical followup. It thus completely reshapes the debate over so-called direct-to-consumer or 'DTC' testing. Offering this test over the web as well as in a clinical setting is simply a moral imperative, as it is the only way to get needed care to people in rural areas who may be far away from large hospitals."

Dr. Michael Levy, Clinical Professor of Ob/Gyn at Georgetown & Director of IVF at Shady Grove Fertility, America's largest IVF center: "Parents who know their carrier status before pregnancy can take preventive measures to have a healthy

child. Because new techniques like PGD are used before pregnancy, they avoid the ethical dilemma of termination that was previously a roadblock to wider adoption of carrier testing."

The New Standard of Care at the Nation's Largest Fertility CentersDr. Angeline Beltsos, Medical Director of the Fertility Centers of Illinois: "Every doctor and patient wants to avoid a high-risk pregnancy. Yet many people don't know that

single gene disorders now account for more than 10% of infant deaths. The Universal Genetic Test is the next ultrasound: a non-invasive early warning system for couples to know if their baby is at risk."

Dr. Arthur Wisot, Medical Director of Reproductive Partners Medical Group in Los Angeles: "The Counsyl test is appropriate for everyone trying to conceive because it is the first test that makes it both practical and economical to screen for so

many genetic diseases. Couples can now protect their baby from developing any one of over a hundred debilitating and lethal genetic diseases with just a saliva sample. This test is the future of genetic screening."

Dr. Ian Hardy, Medical Director of Fertility Centers of New England: "We have been offering the Counsyl test to our incoming patients as part of their standard

evaluation with exceptional results. It is an easy-to-use saliva test which is covered by most insurance plans and allows couples to be screened for both common genetic diseases (like CF, SMA, PKU, and beta thalassemia) as well as dozens of rare conditions."

Dr. Kaylen Silverberg, Medical Director of Texas Fertility: "The Counsyl test replaces a battery of more expensive blood tests. It provides a couple and their physician with much more information for a fraction of the cost. Counsyl testing

represents a quantum leap forward in pre-pregnancy planning for couples — especially those concerned about having a child with a genetic disease — as it is safe, affordable, and easy to use."

Dr. Michael Soules, Medical Director of Seattle Reproductive Medicine: "The new Counsyl test is the simplest and most cost-effective way to do genetic screening as it checks for over 100 significant disorders with a single saliva sample. Enlightened insurance carriers are paying for this test as it saves them the major future expenses of covering a chronically sick child."

An Advance for Women, Minorities, and Families with Genetic Disease Professor Henry Louis Gates of Harvard University: "As the first genetic test for all ethnic groups, the Counsyl test represents a genuine breakthrough for minority health. With

one test for diverse communities, African Americans and Hispanics can benefit from a new technology that actually reduces health care disparities."

Elena Ashkinadze, Program Supervisor in Genetics, UMDNJ-Robert Wood Johnson Medical School: "Because Counsyl's test simultaneously covers diseases from many ethnic groups at a considerably lower cost than standard blood tests, it promises to make carrier testing affordable for previously underserved patient populations, including African Americans and Hispanics. The current practice is mostly to screen once a woman gets pregnant. With Counsyl's test, we can change the emphasis to pre-pregnancy screening when more options, including preimplantation genetic diagnosis, are available. Ideally, women should understand that having carrier testing before
pregnancy is as important as refraining from alcohol during pregnancy."

David Brenner, Director of the Dysautonomia Foundation: "As a parent of a child with a genetic disease, I wouldn't want another child to suffer from what my son has

endured. Nothing is more important than safeguarding the health of our children, and this test is such a simple and powerful way to prevent terrible suffering."

Rabbi David Wolpe of the Sinai Temple in Los Angeles: "Several years ago, a mother whose son was born with Tay-Sachs said to me sadly ‘The Rabbi made sure to tell us not to play Wagner's march at our wedding, but said nothing about being genetically tested.’ Ensuring that Jewish couples — and others — are offered genetic
testing is a critical task."

Professor Steven Pinker of Harvard University: "Universal genetic testing can drastically reduce the incidence of genetic diseases, and may very well eliminate many of them." Last year, Professor Pinker took the test with his wife, the novelist Rebecca Goldstein. To raise awareness of preventable genetic disease, they are now publicly announcing for the first time that both of them tested positive as carriers for familial dysautonomia. While they themselves are healthy, their children would have been at risk for this life-threatening genetic disease — underscoring that the value of genetic testing is far from hypothetical.
About Counsyl

The Universal Genetic Test was developed by Counsyl, a Stanford startup founded by social entrepreneurs and philanthropists. Counsyl's mission is to end the needless suffering of preventable genetic disease.

To ensure that every ounce of prevention enables a pound of cure, each test taken helps Counsyl fund treatments for children living with genetic disease. More than $50,000 has already been donated to nonprofits over the course of 2009. For the next month, donations will go to the John F. and Aileen A. Crowley Foundation in honor of John Crowley, the Harvard Business School graduate whose life is the basis

Sunday, January 24, 2010

Stimulus for Thailand’s hospitality industry

The Office of Small and Medium Enterprises Promotion (OSMEP), Impact Exhibition Management and Thailand Restaurant News magazine are inviting local and international players in the hospitality business, and entrepreneurs interested in this sector, to Thailand International Restaurant and Bar 2010 at Impact Muang Thong Thani in June 2010.


This international expo is designed to raise the standard of Thailand’s hospitality industry and giving encouragement and support to new entrepreneurs now that the economy is recovering.

Yuthasak Supasorn, OSMEP’s Director-General pointed out that the restaurant and service industry was one of Thailand’s vital sectors, with a value of two hundred thousand million baht each year, and that new business ventures were continually opening.

“As the economy continues to improve, everyone involved in this sector needs to be ready to take advantage of emerging opportunities,” he said.

“However, sustainable success in this business depends on many factors, such as location, financial support, market insight, product and service quality, customer base and network of business alliances. The Thailand International Restaurant and Bar 2010 has been organised to give players in this sector, whether they’re actual or potential, the support they need to go for that success.”

Pornphan Bulner, Assistant Director Exhibition Project of Impact Exhibition Management, explained that the expo would integrate products, services and technologies relating to restaurants, hotels, bars, coffee shops and catering to meet the needs of entrepreneurs.

“It will showcase raw materials, equipment and machinery, as well as new techniques and skill trainings for all roles in the hospitality industry. At the same time it will provide a platform for negotiation, networking and exchanging information,” she said.

“At least 150 local and international companies will exhibit their products and services on a combined space of 10,000 square meters. We’re expecting to receive more than 10,000 Thai and foreign visitors -- owners, managers, suppliers and business consultants, as well as people who are interested in running their own business.”

Thailand International Restaurant and Bar 2010 will be arranged in three zones: Cuisine for Change, World of Wine & Spirits, and Coffee (Tea & Bakery) Culture. It will also include seminars, demonstrations of recipes and cooking techniques, competitions for chefs, sommeliers and bartenders and an Asian barista championship.

Chatthaporn Yolao, Managing Director of Thailand Restaurant News magazine, said that the event would present new food trends and the latest technologies as business opportunities, and marketing information from experts. Thai SME’s would also benefit from the new relationships they make with other entrepreneurs and service providers.

“We are hoping that Thailand International Restaurant and Bar 2010 will be instrumental in raising the standard of the food and beverage and hospitality industries in Thailand, and in doing so benefit the Thai economy,” she said.

International Diabetes Federation Reports Diabetes Burden Shifting to Developing Countries

International Diabetes Federation calls for increased funding for essential medicines and for governments to make diabetes a priority in national healthcare plans


Four out of every five people with diabetes now live in developing countries, with most affected men and women being of working age.

This is according to the latest data published by the International Diabetes Federation (IDF) in the fourth edition of the IDF Diabetes Atlas. (www.diabetesatlas.org)

"It is dismal news that some 285 million people live with diabetes today. Even worse, low and middle-income countries are bearing the brunt of the disease," said IDF President Jean Claude Mbanya.

According to World Health Organization estimates, India and China will lose national income to the tune of nearly US$900 billion between 2005 and 2015 to diabetes and cardiovascular disease. IDF predicts that diabetes will cost the world economy US$376 billion in 2010 and a hundred billion more within a generation.

"Families are losing breadwinners, parents are losing children, children are losing mothers. Much of this tragic loss of life is preventable," said Prof Mbanya, who features in a BBC documentary showcasing the burden of diabetes in the developing world.

The half-hour documentary - titled Bittersweet - is being aired this week as part of BBC World's Kill or Cure series. Set in Nairobi, Kenya and Pune, India, the film shows how the South Asian subcontinent is facing a type 2 diabetes pandemic, while in Africa many countries struggle to put insulin within reach of people with type 1 diabetes.

"It's an outrage that while treatment and technology exists for people with diabetes to manage their disease, the reality is that for millions of people in low and middle-income countries, modern treatment and technology is still a dream," added Prof Mbanya.

"IDF calls for increased funding for essential medicines and for governments to make diabetes a priority in national healthcare plans."

Bittersweet will air on BBC World at 11:30GMT on 13 January (Asia Pacific only), 15:30GMT on 14 January and 02.30GMT on 15 January. The documentary can also be viewed online at http://www.rockhopper.tv/programmes/311/
About IDF

The International Diabetes Federation (IDF) is an umbrella organization of 212 member associations in 163 countries and territories, representing over 285 million people with diabetes, their families, and their healthcare providers. The mission of IDF is to promote diabetes care, prevention and a cure worldwide. Its main activities include education for people with diabetes and healthcare professionals, public awareness campaigns and the promotion and exchange of information. IDF is a non-governmental organization in official relations with WHO and associated to the United Nations' Department of Public Information. For more information, please visit www.idf.org and follow us at twitter.com/IntDiabetesFed

Thursday, January 21, 2010

Thailand to host 17th International Training Course for Full-Endoscopic Operations

Bumrungrad International; the Faculty of Science at Mahidol University; the Faculty of Medicine at Ramathibodi Hospital, Mahidol University; and the Department of Spine Surgery and Pain Therapy Center of Orthopaedics and Traumatology, St. Anna-Hospital in Herne, Germany, will host the 17th International Training Course for Full-Endoscopic Operations of the Lumbar, Thoracic and Cervical Spine, on

- Friday 22 January, at the Conference Center, Bumrungrad International hospital, Sukhumvit Soi 3, and
- Saturday 23 January, at the Faculty of Science, Mahidol University.

Endoscopic spine surgery has been gaining more popularity for the past decade. Today, it is regarded as a standard treatment for early disc pathology. This course is designed for both neurosurgeons and orthopaedic surgeons from domestic and international hospitals, who have a strong interest in developing the endoscopic lumbar discectomy technique for patient selection.

Sunday, January 17, 2010

First Non-Invasive Technology for Treatment of Uterine Fibroids Awarded MHLW Approval in Japan

InSightec's ExAblate System Uses Magnetic Resonance-Guided Focused Ultrasound to Perform Uterine Procedures Without Incisions


InSightec Ltd. announced today that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the company’s ExAblate® MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with uterine fibroids. “We are very pleased that the Japanese Ministry of Health has approved the

ExAblate system and that women in Japan will now have access to a noninvasive treatment option for uterine fibroids,” said Dr. Kobi Vortman, President and Chief Executive Officer of InSightec. “The approval was based on a growing body of evidence showing that ExAblate is a safe, effective, and durable treatment for this widespread, life-impacting condition. ExAblate is an outpatient procedure and patients normally return home the same day and to work within one to two days compared to lengthy hospitalizations and recovery times associated with more invasive procedures such as hysterectomy, myomectomy or UAE.”

ExAblate is currently the only noninvasive treatment for uterine fibroids approved for use in Japan. Approximately 25% Japanese women will develop symptomatic uterine fibroids, primarily during childbearing years. These benign tumors can significantly impair functionality and degrade quality of life resulting in significant work absences.

Using the ExAblate system, the physician uses the Magnetic Resonance Imaging (MRI) to visualize the patient's anatomy and then aims focused ultrasound waves at the targeted tissue to thermally ablate, or

destroy it. The MRI allows the physician to monitor and continuously adjust the treatment in real time. The patient is consciously sedated to alleviate pain and minimize motion.

A growing body of evidence supports the system's safety and efficacy, including the results of a study published in the August 2007 edition of Obstetrics and Gynecology. The study showed that ExAblate offered

women sustained relief from uterine fibroid symptoms for up to two years, with a low incidence of side effects. The 359-patient Mayo Clinic-led collaborative study also showed that destroying as much of the fibroid as possible leads to the most durable symptom relief with 85% of the participants experiencing symptom improvement after one year. Studies conducted in Japan indicate similar results.

The ExAblate system received the CE Mark for uterine fibroids in October 2002 and US Food and Drug Administration (FDA) approval in 2004. Over 5,500 women around the world have chosen to undergo the non-invasive ExAblate treatment for their symptomatic uterine fibroids over invasive surgery.
GE Healthcare is the distributor of ExAblate in Japan.
About InSightec

InSightec Ltd. is a privately held company owned by Elbit Imaging, General Electric, MediTech Advisors, LLC and employees. It was founded in 1999 to develop the breakthrough MR guided Focused Ultrasound technology and transform it into the next generation operating room. Headquartered near Haifa, Israel, the company has over 160 employees and has invested more than $130 million in research, development, and clinical investigations. Its U.S. headquarters are located in Dallas, Texas. For more information, please go to:
http://www.insightec.com/
About GE Healthcare Japan

GE Healthcare Japan Corporation provides cutting edge medical technologies and healthcare services that design the next-generation patient care model by utilizing its expertise across a wide range of areas such as medical diagnostic imaging systems and healthcare IT equipments such as CT (Computerized Tomography) systems and MR (Magnetic Resonance) imaging systems, medical diagnostic drugs, biological information monitors, drug discovery, biotechnology-based drugs, and providing support for the management of

healthcare institutes. GE Healthcare Japan Corporation was established as the core site in Japan for the healthcare business section within the General Electric Company (GE, based in the U.S.)