Monthly Archives: September 2012

Stiefel receives US FDA approval of Sorilux™ Foam, 0.005% for topical treatment of plaque psoriasis of the scalp

Posted: September 30, 2012 at 6:13 pm

RESEARCH TRIANGLE PARK, N.C., Sept.28, 2012 /PRNewswire/ --Stiefel, a GSK (GSK) company, today announced that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Sorilux (calcipotriene) Foam, 0.005%. The sNDA expands the indication for Sorilux Foam to include the topical treatment of plaque psoriasis of the scalp in patients aged 18 years and older. It is not known if the product is safe and effective in people under 18 years old.

"Studies have shown that in at least 50 percent of psoriasis cases, the scalp is involved," said Susan Learned, PharmD, MD, PhD, Medicines Development Leader, Dermatology Research and Development, Stiefel. "We believe this additional indication for Sorilux Foam will help meet the needs of both patients and physicians."

The approval of Sorilux Foam for treatment of plaque psoriasis of the scalp was based on a multi-center, randomized, double-blind, vehicle-controlled pivotal Phase 3b study of patients with moderate scalp and body psoriasis. The most common side effects of Sorilux Foam were redness and pain of the treated skin areas. The incidence of these adverse reactions was similar between the body and scalp. It is for use on the skin only. It is not for facial, oral, ophthalmic, or intravaginal use. More information about the clinical trial results can be found in the Full US Prescribing Information at http://www.stiefel.com/content/dam/stiefel/globals/documents/pdf/US_Sorilux_Foam.pdf.

About Plaque Psoriasis

Psoriasis is a chronic (life-long) skin disease. It occurs when the immune system "speeds up" the growth cycle of skin cells. A normal skin cell matures and falls off the body in about a month. For people with plaque psoriasis, it can take only three or four days for new skin cells to develop. Instead of falling off, the cells remain on the skin and form thickened patches (lesions or plaques). While plaque psoriasis is a chronic condition, many patients experience times when their symptoms improve or worsen.

Plaque psoriasis is the most common form of psoriasis. It typically causes raised, red lesions covered with silvery white scales. Plaque psoriasis can occur on any part of the body, but most commonly on the scalp, knees, elbows, and torso. Sometimes, the lesions can appear in the same place on the left and right sides of the body.

Important Safety Information

Patients should not use Sorilux Foam if they have been told by their doctor that they have a high level of calcium in their blood (hypercalcemia). The medicine in Sorilux Foam has been shown to cause hypercalcemia. If hypercalcemia occurs, patients are advised to stop using Sorilux Foam until calcium levels return to normal.

Sorilux Foam is flammable. Patients should avoid fire, flame, or smoking during and right after applying Sorilux Foam to the skin.

Patients should avoid excessive exposure of the treated skin to natural or artificial sunlight (including tanning booths and sun lamps). Patients are advised to wear a hat and clothes that cover the treated areas of the skin if they have to be in sunlight.

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Stiefel receives US FDA approval of Sorilux™ Foam, 0.005% for topical treatment of plaque psoriasis of the scalp

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Research and Markets: Psoriasis (Event Driven)

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DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/sn7nsz/psoriasis_event) has announced the addition of Decision Resources, Inc's new report "Psoriasis (Event Driven)" to their offering.

Despite the major impact psoriasis has on patients' quality of life, physicians believe many patients are untreated or undertreated, offering important commercial opportunities for current and emerging agents targeting this indication. During our ten-year forecast period, intense competition between the TNF-a inhibitors etanercept and adalimumab and the interleukin inhibitor ustekinumab has the potential to transform current treatment algorithms and define new market leaders. These current therapies will vie for share with several emerging agents with novel mechanisms of action and distinct risk-benefit profiles.

Key Topics Covered:

Executive Summary

What are the key parameters of the psoriasis market?

What factors are driving the market for psoriasis therapies?

What factors are constraining the market for psoriasis therapies?

What are the drug development activities of note in psoriasis?

What do the experts say?

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Research and Markets: Psoriasis (Event Driven)

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International Study Highlights Need to Support Patients With Psoriasis Suffering Feelings of Isolation, Stigmatisation …

Posted: at 6:13 pm

COPENHAGEN, Denmark, September 30, 2012 /PRNewswire/ --

Data from the Burden of Psoriasis patient research were presented this weekend at the 21st EADV Congress in Prague, Czech Republic. The results from the research, which included a quantitative online survey completed by 3,822 patients with psoriasis, showed 73% of patients surveyed scored their psoriasis as having a moderate to high impact on their lives[1].

To view the Multimedia News Release, please click:

http://multivu.prnewswire.com/mnr/prne/leo-pharma/56611

People living with psoriasis experience flare-ups that can result in the appearance of thick, red, scaly skin lesions on any part of their body[2]. The skin is often sore and itchy[2],[3], but the current study emphasizes that the psychological impact of psoriasis can have an even greater impact on patients' everyday lives[1].

Factors analysed in the research included the influence of symptom burden, healthcare professional (HCP) relationships, patient factors and the psychosocial impact of psoriasis on how much the patient's psoriasis "dictates how they live their life"[1]. Factors that were most strongly associated dealt with daily activities, stigmatisation, isolation and anxiety. However, diagnosed symptom severity was not a significant indicator[1].

Commenting on the research Dr Anthony Bewley, Whipps Cross University Hospital & Barts & the London NHS Trust, UK, said, "The reality for patients is that the reactions of other people, real or perceived, can make life a real struggle. We need to ensure that we actively question our patients about these issues, and modify management accordingly. We plan further analysis of this comprehensive data set, which we believe will help to individualise care".

"The physical, psychological and social effects of psoriasis can have a serious impact on people's lives," said LEO Pharma President and CEO Gitte P. Aabo. "To give people with psoriasis the best chance of improving their quality of life, we need to address the issues that affect them individually. The Burden of Psoriasis patient research will help healthcare professionals learn more about the impact that psoriasis has on peoples' lives and hence inform and help evolve the way the disease is treated."

References

1. Bewley A, Ersser S, Hansen M, Pevac C. Psychosocial and symptomatic burden of psoriasis for patients in Europe, the USA and Canada. Abstract presented at: EADV Congress, Prague, 27 - 30 September 2012 (ID number PRA12-0920).

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Gene clues offer new hope for treating breast cancer

Posted: at 6:13 pm

NEW YORK Scientists reported Sunday that they have completed a major analysis of the genetics of breast cancer, finding four major classes of the disease. They hope their work will lead to more effective treatments, perhaps with some drugs already in use.

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Trampolines are too dangerous for children to use, the American Academy of Pediatrics warned Monday. There were nearly 100,000 trampoline injuries in 2009 -- and safety nets don't offer much protection, doctors say.

The new finding offers hints that one type of breast cancer might be vulnerable to drugs that already work against ovarian cancer.

The study, published online Sunday by the journal Nature, is the latest example of research into the biological details of tumors, rather than focusing primarily on where cancer arises in the body.

The hope is that such research can reveal cancer's genetic weaknesses for better drug targeting.

"With this study, we're one giant step closer to understanding the genetic origins of the four major subtypes of breast cancer," Dr. Matthew Ellis of the Washington University School of Medicine said in a statement. He is a co-leader of the research.

"Now we can investigate which drugs work best for patients based on the genetic profiles of their tumors," he said.

The researchers analyzed DNA of breast cancer tumors from 825 patients, looking for abnormalities. Altogether, they reported, breast cancers appear to fall into four main classes when viewed in this way.

One class showed similarities to ovarian cancers, suggesting it may be driven by similar biological developments.

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Gene clues offer new hope for treating breast cancer

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Gene key to chemotherapy efficacy

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19 September 2012 Last updated at 01:39 ET

Dundee University researchers believe they have found a way to predict the effectiveness of chemotherapy drugs in fighting ovarian cancer.

Scientists have discovered a gene called FGF1 was highly active in aggressive, advanced ovarian cancers.

They observed it was present at higher levels in cancer cells that were resistant to a common treatment for the disease.

The team hope the findings help to develop new cancer treatments.

Researchers measured amounts of a variety of genes in 187 ovarian cancer patients and found each cancer had a unique range of active genes.

However, FGF1 appeared to playing the greatest role in determining how cancers behave.

The team, based at the University's School of Medicine, found the gene called FGF1 was found at higher levels in cancer cells that are resistant to platinum chemotherapy treatments, such as carboplatin and cisplatin.

As a result, women with high levels of FGF1 are less likely to respond to these drugs and have a poorer prognosis.

The scientist believe measuring how active the gene is could predict which women with ovarian cancer will benefit from the drugs.

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Gene Study Yields New Clues to Breast Cancer

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SUNDAY, Sept. 23 (HealthDay News) -- A comprehensive look at the genetic blueprint of breast cancer has revealed new insights into the disease -- including the discovery that certain breast and ovarian tumors may be closely related.

Basal-like breast tumors -- one of the most deadly subtypes of breast cancer -- are genetically more similar to ovarian cancer than to other breast cancers, the new research found.

In this study, the scientists used six different technologies to analyze 348 tumors from women with breast cancer. They looked for defects in DNA, RNA and proteins in the tumors.

They confirmed the existence of four main subtypes of breast cancer -- luminol A, luminal B, HER2 and basal-like -- and found unique genetic and molecular signatures within each of the subtypes.

The findings add to growing evidence suggesting that tumors should be catalogued and treated based on the genes that are disrupted rather than their location in the body, the researchers said.

"With this study, we're one giant step closer to understanding the genetic origins of the four major subtypes of breast cancer," study co-leader Dr. Matthew Ellis, chair of medical oncology at Washington University School of Medicine in St. Louis, said in a university news release.

One oncologist said the findings on breast cancer's diversity echo her own experience in treating patients.

"The diversity of breast cancer is instinctual to a practicing breast surgeon who has seen women with breast cancer, presumably the same stage, have differing outcomes with respect to recurrence and survival," said Dr. Donna-Marie Manasseh, director of breast surgery at the Maimonides Breast Cancer Center in New York City. "This research validates what we have suspected."

According to Ellis, the new study suggests that most basal-like breast tumors and ovarian tumors have similar genetic origins and potentially could be treated with the same drugs.

Basal-like tumors account for about 10 percent of all breast cancers and disproportionately affect younger and black women in the United States. Basal-like tumors include most triple-negative breast tumors, which are often aggressive and do not respond to therapies that target hormone receptors or to standard chemotherapies.

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Researchers discover gene that causes deafness

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Public release date: 30-Sep-2012 [ | E-mail | Share ]

Contact: Katie Pence katie.pence@uc.edu 513-558-4561 University of Cincinnati Academic Health Center

CINCINNATIResearchers at the University of Cincinnati (UC) and Cincinnati Children's Hospital Medical Center have found a new genetic mutation responsible for deafness and hearing loss associated with Usher syndrome type 1.

These findings, published in the Sept. 30 advance online edition of the journal Nature Genetics, could help researchers develop new therapeutic targets for those at risk for this syndrome.

Partners in the study included the National Institute on Deafness and other Communication Disorders (NIDCD), Baylor College of Medicine and the University of Kentucky.

Usher syndrome is a genetic defect that causes deafness, night-blindness and a loss of peripheral vision through the progressive degeneration of the retina.

"In this study, researchers were able to pinpoint the gene which caused deafness in Usher syndrome type 1 as well as deafness that is not associated with the syndrome through the genetic analysis of 57 humans from Pakistan and Turkey," says Zubair Ahmed, PhD, assistant professor of ophthalmology who conducts research at Cincinnati Children's and is the lead investigator on this study.

Ahmed says that a protein, called CIB2, which binds to calcium within a cell, is associated with deafness in Usher syndrome type 1 and non-syndromic hearing loss.

"To date, mutations affecting CIB2 are the most common and prevalent genetic cause of non-syndromic hearing loss in Pakistan," he says. "However, we have also found another mutation of the protein that contributes to deafness in Turkish populations.

"In animal models, CIB2 is found in the mechanosensory stereocilia of the inner earhair cells, which respond to fluid motion and allow hearing and balance, and in retinal photoreceptor cells, which convert light into electrical signals in the eye, making it possible to see," says Saima Riazuddin, PhD, assistant professor in UC's department of otolaryngology who conducts research at Cincinnati Children's and is co-lead investigator on the study.

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Colon Cancer Gene Database May Assist Research Efforts

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WEDNESDAY, Sept. 26 (HealthDay News) -- A colorectal gene database will help further research into the disease, a new study suggests.

The CRCgene database gathers all genetic association studies on colorectal cancer. It allows researchers to accurately interpret the risk factors of the disease and provides insight into the direction of further research, according to Julian Little, with the department of epidemiology and community medicine at the University of Ottawa, and colleagues.

To determine the genetic factors associated with colorectal cancer, they analyzed data from all published genetic association studies on colorectal cancer.

The researchers identified 16 independent gene variants with the strongest links to colorectal cancer, among 23 variants, a number lower than expected. Unfortunately, the researchers say, this reduces the feasibility of combining variants as a profile in a prediction tool to identity people who are at increased risk for colorectal cancer and who should be screened for the disease.

Even so, the analysis "provides a resource for mining available data and puts into context the sample sizes required for the identification of true associations," the researchers wrote in the Sept. 27 issue of the Journal of the National Cancer Institute.

About 950,000 new cases of colorectal cancer are diagnosed each year, according to a journal news release. Risk factors for the disease include age, diet, lifestyle and possibly genetics.

-- Robert Preidt

Copyright 2012 HealthDay. All rights reserved.

SOURCE: Journal of the National Cancer Institute, news release, Sept. 27, 2012

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National banned book week sheds light on censorship

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When it comes to censorship, librarians sit at ground zero.

"Librarians are on the front line in protecting our freedom to read," said Trisha Noack, supervisor of public relations for the Peoria Public Library.

Almost every day in the U.S. someone challenges a book and asks that it be removed from the shelf of a public or school library.

"They don't want you to read anything from 'Harry Potter' to 'Captain Underpants,' " said Noack. "People are still trying to keep you from reading 'To Kill a Mockingbird' - it gets challenged every year. If everyone backed down, there would be nothing on the shelves to read."

To draw attention to the issue, libraries all over the country will be participating in the American Library Association's Banned Book Week Sept. 30 through Oct. 6.

"It's a freedom we enjoy. You have to protect it," said Noack.

Books are not challenged often in Peoria. In the nine years Noack has been working at the library she has seen only onechallenge.

"The last challenge we had was to 'It's Perfectly Normal' by Robie Harris," said Noack. Meant for ages 10 and up, the book, whose full title is "It's Perfectly Normal: Changing Bodies, Growing Up, Sex, and Sexual Health," describes puberty and human sexuality in a light, kid-friendly way.

"People seemed to object to the drawings, which are line drawings and somewhat humorous at times," Noack said. "They also objected to the practices described as 'perfectly normal.' "

The challenge was instigated by a national group protesting the book all over the country, Noack said.

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National banned book week sheds light on censorship

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Big Brother still watching: Internet censorship up, report says

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Draconian laws, brutal attacks against bloggers and politically motivated surveillance are among the biggest threats to Internet freedom emerging in the last two years, according to a new report from free speech advocates, Freedom House.

"Freedom on the Net 2012: A Global Assessment of Internet and Digital Media," looked at barriers to access, limits on content, and violations of user rights in 47 countries across the globe. Estonia was rated as having the greatest degree of Internet freedom, while Iran, Cuba and China were viewed as the most restrictive.

While social media was key in the uprising in Egypt, censorship there continues apace, says Freedom House, a U.S.-based independent watchdog organization.

Although online activism is increasing, the report said authoritarian regimes were employing a wider and increasingly sophisticated arsenal of countermeasures.

According to Freedom House, China has the world's largest population of Internet users, yet the authorities operate the most sophisticated system of censorship. Its "great firewall" has become notorious for literally shutting down Internet "chatter" it views as sensitive. Earlier this year, censors blocked related search terms to prevent the public from obtaining news on prominent human rights activist Chen Guangcheng, who caused a diplomatic storm when he escaped house arrest to seek refuge in the U.S. Embassy in Beijing.

Major web portals and social networking sites, though not state-owned, have had to comply with strict government censorship rules -- or risk being shut down. After launching a campaign to clean up "rampant online rumors," Chinese authorities in March ordered the country's leading micro-blogging sites -- including Sina Weibo -- to disable their comment function for three days. In China, bloggers are also required to register their real names -- though it's not clear how many have complied with the rules.

"It's a typical response by officials and quite a successful strategy in making it extremely difficult to spread information beyond some small circles of activists," Jeremy Goldkorn, a leading commentator on China's social media, told CNN at the time.

Freedom House claims Beijing's influence as an "incubator for sophisticated restrictions" has not gone unnoticed, with governments such as Belarus, Uzbekistan, and Iran using China as a model for their own Internet controls.

Unrest across the Middle East prompted increased censorship, arrests, and violence against bloggers as authoritarian regimes look to quell calls for reform. Social media was widely accepted to have played a key role in popular uprisings in Egypt and Tunisia. Fearing a similar "revolution" in Saudi Arabia, the authorities there took immediate steps to respond to what they regarded as a national security threat.

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