This study found that the relation between fluid intake and kidney stones may be dependent on the type of beverage consumed. The higher consumption of sugar-sweetened drinks was associated with a higher incidence of kidney stones.

The researchers analyzed data from three ongoing cohorts, the Health Professionals Follow-Up Study (HPFS), and both the Nurses’ Health Study I (NHS I) and II (NHS II). The total analysis involved 194,095 participants over a median follow-up of more than 8 years. Participants in all the three cohorts had been asked to complete biennial questionnaires with information on medical history, lifestyle, and medication. Questions on diet were updated every four years.

The researchers found that participants who consumed one or more sugar-sweetened cola servings per day had a 23 percent higher risk of developing kidney stones compared with those participants consuming less than one serving per week. This was true for consuming sugar-sweetened non cola as well, such as punch. They also found that some beverages, such as coffee, tea and orange juice, were associated with a lower risk of stone formation.

This prospective study confirms that some beverages are associated with a lower risk of kidney stone formation, whereas others are associated with a higher risk. Although higher total fluid intake reduces the risk of stone formation, this information about individual beverages may be useful for general practitioners seeking to implement strategies to reduce stone formation in their patients.

SIMPONI is the first and only subcutaneously administered anti-tumor necrosis factor (TNF)-alpha therapy approved to induce and maintain clinical response and improve endoscopic appearance of the mucosa during induction. In addition, SIMPONI is indicated to induce clinical remission and achieve and sustain clinical remission in induction responders. As many as 700,000 people in the United States are affected by UC, a chronic inflammatory bowel disease (IBD) marked by inflammation and ulceration of the innermost lining of the colon.

The FDA approval of SIMPONI brings an important, new subcutaneous therapeutic option to adults living with moderate to severe ulcerative colitis, a disease where treatment options have been limited. SIMPONI has demonstrated significant benefits in the treatment of ulcerative colitis, a chronic inflammatory bowel disease, and represents a meaningful addition to the treatment armamentaria for gastroenterologists.

For the treatment of UC, the SIMPONI dose regimen consists of 200 mg subcutaneously injected at week 0, followed by 100 mg at week 2 and then 100 mg every 4 weeks, thereafter.

The approval is supported by data from the Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT) clinical trials, evaluating patients with moderately to severely active UC who had previously failed or were intolerant to conventional treatments. Significantly greater proportions of patients who received SIMPONI 200 mg/100 mg achieved clinical response, clinical remission and improvement of the endoscopic appearance of the mucosa at week 6 compared with patients receiving placebo. Through week 54, significantly greater proportions of patients in the SIMPONI 100 mg group maintained clinical response compared with the placebo group. The proportion of patients in clinical response following SIMPONI induction treatment who went on to demonstrate clinical remission at both weeks 30 and 54, without demonstrating a loss of response at any time point through week 54, were significantly greater in the SIMPONI 100 mg group compared with the placebo group.

SIMPONI is also approved by the FDA for the treatment of moderately to severely active rheumatoid arthritis (RA) with the medicine methotrexate, active psoriatic arthritis alone or with the medicine methotrexate and active ankylosing spondylitis.

The Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT) included Phase 3 multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of subcutaneous induction and every-four-week maintenance regimens of SIMPONI in adults with moderately to severely active UC. All trial patients had failed to respond to or tolerate treatment with 6-mercaptopurine (6-MP), azathioprine (AZA), corticosteroids and/or 5-aminosalicylate (5-ASA), or were corticosteroid dependent. Study participants were naive to treatment with TNF inhibitors and had a baseline Mayo score between 6 and 12 and an endoscopic subscore of 2 or more. The Mayo score is a 12-point clinical assessment and colonoscopy-based measure of disease activity, which assesses improvement in symptoms based on rectal bleeding, endoscopic findings, stool frequency and a physician’s global assessment.

The induction trial (PURSUIT-SC) had an adaptive design with a Phase 2 dose-finding portion followed by a Phase 3 dose-confirming component. The primary endpoint was clinical response at week 6. Secondary endpoints at week 6 included clinical remission and mucosal healing (improvement of endoscopic appearance of mucosa) – Mayo endoscopy score of 0 or 1. Overall, 1,065 patients were treated in the study; 774 of these patients were randomized into the Phase 3 component of the study.

Patients responding to induction treatment with SIMPONI were eligible to be randomized in the Phase 3 PURSUIT-Maintenance study. The primary endpoint in this study was maintenance of clinical response through week 54, and secondary endpoints included clinical remission and mucosal healing (improvement of endoscopic appearance of mucosa) – Mayo endoscopy score of 0 or 1 – at both weeks 30 and 54.

The safety results of SIMPONI observed in the PURSUIT studies were consistent with the known safety profile of SIMPONI in labeled rheumatologic indications

Ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD) affecting as many as 700,000 individuals in the United States is marked by the inflammation and ulceration of the colonic mucosa, or innermost lining, which may lead to bloody stools, severe diarrhea and frequent abdominal pain.¹ Tiny open sores, or ulcers, form on the surface of the lining, where they bleed and produce pus and mucus.¹ Symptoms of the disease may lead to loss of appetite, subsequent weight loss and fatigue.¹ On average, people are diagnosed with UC in their mid-30s, but the disease can occur at any age. As many as 30 percent of people living with UC will require surgery at some point in their life.² UC is a chronic disease, and there is no cure. Although progress has been made in IBD research, researchers do not know what causes this disease.³

SIMPONI is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. SIMPONI is approved for the treatment of moderately to severely active rheumatoid arthritis (RA) with the medicine methotrexate, active psoriatic arthritis alone or with the medicine methotrexate, active ankylosing spondylitis and moderately to severely active ulcerative colitis.

Bone is the most common site in the body to be affected by metastatic cancer, and bone metastases are particularly prevalent in patients with prostate cancer.Approximately 90% of patients with metastatic prostate cancer show evidence of bone metastases.Bone metastases can lead to an increase in frequency of skeletal events and are shown to be the main cause of morbidity and death in patients with CRPC.

The approval of Xofigo is based on data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. At the interim analysis, Xofigo significantly improved overall survival (OS) [HR=0.695 (95% CI 0.552-0.875), p=0.00185]; median OS was 14.0 months with Xofigo plus best standard of care vs. 11.2 months with placebo plus best standard of care.¹ Additionally, at the interim analysis there was a delay in time to first symptomatic skeletal event (SSE) for patients treated with Xofigo vs. placebo.

An updated analysis, conducted after the study was unblinded, showed improvement in overall survival (OS), with a median OS of 14.9 months vs. 11.3 months; HR=0.695 (95% CI 0.581-0.832).

The most common adverse reactions (greater than or equal to 10%) in patients receiving Xofigo in the ALSYMPCA trial were nausea, diarrhea, vomiting and peripheral edema. The most common hematologic laboratory abnormalities (greater than or equal to 10%) were anemia, lymphocytopenia, leukopenia, thrombocytopenia and neutropenia.

The vaccine, Rotavac, against the deadly Rotavirus is actually the culmination of 25 years of work, involving multi-institution and multi-country collaboration. However, it is yet to be approved by Indian drug authorities for mass production of the vaccine.

“This is an important scientific breakthrough against rotavirus infections, the most severe and lethal cause of childhood diarrhoea, responsible for approximately 100,000 deaths of small children in India each year,” K. Vijaraghavan, the Secretary of India’s Department of Biotechnology, told the media in the national capital Tuesday.

As per the clinical results of the vaccine, if licensed, could save the lives of thousands of children each year in India. The official said that it costs one U.S. dollar per oral vaccine which is ready for production. International pharma giants like GlaxoSmithKline and Merck produce similar vaccines but each costs around 1,000 Indian rupees.

The vaccine will be produced by Bharat Biotech Ltd, based in the southern Indian city of Hyderabad. Sheela Panicker, a company spokeswoman, said the oral vaccine will also be made available to other developing countries. “We have pledged it to the government and the vaccine will be also be supplied to developing countries through a UN agency,” she was quoted as saying.

A University of Arizona research team has made a novel discovery in brain cells being treated with statin drugs: unusual swellings within neurons, which the team has termed the “beads-on-a-string” effect.

The team is not entirely sure why the beads form, said UA neuroscientist Linda L. Restifo, who leads the investigation. However, the team believes that further investigation of the beads will help inform why some people experience cognitive declines while taking statins.

Restifo and her team’s co-authored study and findings recently were published in Disease Models & Mechanisms, a peer-reviewed journal. Robert Kraft, a former research associate in the department of neuroscience, is lead author on the article.

Restifo and Kraft cite clinical reports noting that statin users often are told by physicians that cognitive disturbances experienced while taking statins were likely due to aging or other effects. However, the UA team’s research offers additional evidence that the cause for such declines in cognition is likely due to a negative response to statins.

The team also has found that removing statins results in a disappearance of the beads-on-a-string, and also a restoration of normal growth. With research continuing, the UA team intends to investigate how genetics may be involved in the bead formation and, thus, could cause hypersensitivity to the drugs in people. Team members believe that genetic differences could involve neurons directly, or the statin interaction with the blood-brain barrier.

“This is a great first step on the road toward more personalized medication and therapy,” said David M. Labiner, who heads the UA department of neurology. “If we can figure out a way to identify patients who will have certain side effects, we can improve therapeutic outcomes.”

India alone accounts 26.4 per cent of all women dying of cervical cancer globally, with China, Bangladesh, Pakistan, Indonesia and Thailand also showing high death incidence.  According to the report card, cervical cancer kills an estimated 275,000 women every year and 500,000 new cases reported worldwide. This entirely preventable disease is the second largest cancer killer of women in low and middle-income countries, with most women dying in the prime of life.

India, China, Brazil, Bangladesh and Nigeria represent more than half of the “global burden of cervical cancer deaths. Australia has the lowest cervical cancer mortality rate, which is due to the successful rollout of a comprehensive package of HPV vaccines, treatment and prevention.

The Crisis Card report also highlighted the startling disparities between women in the developed and developing world personified by cervical cancer.

A woman in Zambia is 25 times more likely to die from cervical cancer than a woman in Australia and India, has 750 times more deaths than Norway. The data released by India’s Health Ministry based on the National Cancer Registry Programme (NCRP) report in 2009 the number of cervical cancer cases were 101938 which has increased to 107690 in 2012.

Cervical cancer can happen to anyone. Certain women are at greater risk. These include women who started sexual activity at an early age, had multiple pregnancies, had multiple partners themselves, or their partners have multiple partners,” said Dr Neerja Bhatla, Professor, Department of Obstetrics and Gynaecology at All India Institute of Medical Sciences (AIIMS).

Women with STIs like chlamydia, gonorrhoea, herpes simplex, women with immune suppression, for example, HIV or transplant recipients, smokers and prolonged use of oral contraceptives have a higher risk. There is thought to be a small element of genetic predisposition as well.

It is being estimated that the number of cervical cancer cases and deaths are estimated to increase by 2025 to 203,757 and 115,171, respectively.

Cervical cancer is caused by the human papillomavirus (HPV), a fairly ubiquitous virus that will be acquired by about 80 per cent of women some time during their lives. Most women clear this virus by their immune system, but in about 8-10 percent of cases the infection remains persistent.

These women are at risk of the disease and in the presence of certain co-factors, risk factors; they can go on to develop precancerous lesions called CIN (cervical intraepithelial neoplasia). Again, if left untreated, some of these women will develop cervical cancer. The main spread of HPV is by sexual contact, but spread by fomites and mother to child transmission are reported.

Cervical cancer, like all cancers, may be asymptomatic in its precancerous phase and while it is an early cancer. Symptoms that point to the cancer include inter menstrual and post coital bleeding, postmenopausal bleeding and persistent vaginal discharge.

Data of the Indian Council of Medical Research (ICMR) of the number of breast and cervical cancer cases among women has increased in the country. At present the Government of India is looking for alternative techniques and affordability to implement test to be used for detection of cervical cancer. Although,  health is a state subject, the Centre has launched the national programme for prevention and control of cancer, diabetes, cardiovascular disease and stroke (NPCDCS) in 2010 in 100 districts across 21 states.

BREO ELLIPTA is a combination of the inhaled corticosteroid (ICS), fluticasone furoate “FF”, and the long-acting beta2 agonist (LABA), vilanterol “VI” (FF/VI 100/25 mcg).

Following this approval by the FDA, it is anticipated that BREO ELLIPTA will be available in the US during the third quarter of 2013. Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment of $30 million (USD) to GSK following FDA approval of BREO ELLIPTA.

The data submitted to the FDA to support the regulatory review of FF/VI included data from a comprehensive programme of non-clinical studies, 52 clinical pharmacology studies in 1,406 patients, and 11 clinical studies in 7,851 patients with COPD. There were four primary COPD studies: two 6-month lung-function studies and two 1-year replicate exacerbation studies.

Chronic obstructive pulmonary disease (COPD) is a term referring to two lung diseases, chronic bronchitis and emphysema, that are characterized by obstruction to airflow that interferes with normal breathing. The National Heart, Lung and Blood Institute (NHLBI) estimates that as many as 27 million people in the US alone are affected by COPD, a number that is predicted to increase.

According to the NHLBI, long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. In the United States, the most common irritant that causes COPD is cigarette smoke. Breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace also can contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin. COPD-related exacerbations are typically defined as a worsening of symptoms that require medical intervention.

This approval was based on two Phase III trials in SJIA patients, aged 219, showing significant improvement in the majority of Ilaris-treated patients. Study 1 showed that 84% of patients treated with one subcutaneous dose of Ilaris achieved the primary endpoint of the adapted pediatric American College of Rheumatology 30 (ACR30), compared to 10% achievement of ACR30 for placebo at Day 15. In the open-label part of Study 2, 92 of 128 patients attempted corticosteroid tapering. Of those 92 patients, 62% were able to substantially reduce their use of corticosteroids, and 46% completely discontinued corticosteroids. In the controlled portion of Study 2, there was a 64% relative reduction in the risk of flare for patients in the Ilaris group as compared to those in the placebo group (hazard ratio of 0.36; 95% CI: 0.17 to 0.75).

“The efficacy of Ilaris, along with its monthly subcutaneous dosing, makes it an exciting new option for children who are living with this debilitating disease,” said Daniel Lovell, MD, MPH, study investigator and Joseph E. Levinson Professor of Pediatrics at the Cincinnati Children’s Hospital Medical Center. “Additionally, the potential to reduce corticosteroid use is particularly beneficial in this patient population given the side effects associated with long-term use of corticosteroids in children.”

SJIA affects 5-15 children per 100,000 in the United States,and is the most severe subtype of juvenile idiopathic arthritis. Although the disease can be life-threatening, treatment options are limited. Corticosteroids are often used to treat symptoms and pain despite their association with potentially serious adverse effects, including Cushing syndrome, growth suppression and osteoporosis.

Ilaris is a selective, fully human, monoclonal antibody that inhibits IL-1 beta, which is an important part of the body’s immune system defenses. Excessive production of IL-1 beta plays a prominent role in certain inflammatory diseases. Ilaris works by neutralizing IL-1 beta for a sustained period of time, therefore inhibiting inflammation.

In addition to its approval for SJIA in the US, Ilaris is approved in more than 60 countries, including in the EU, US, Switzerland and Japan for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), a rare, lifelong, genetic disorder with debilitating symptoms. The approved indication may vary depending upon the individual country..

Ilaris can cause serious side effects, including increased risk of serious infections. Ilaris can lower the ability of your immune system to fight infections.

Tell your healthcare provider right away if you have any symptoms of an infection such as fever, sweats or chills, cough, flu-like symptoms, weight loss, shortness of breath, blood in your phlegm, sores on your body, warm or painful areas on your body, diarrhea or stomach pain, or feeling very tired.

You should not receive Ilaris if you are allergic to canakinumab or any of the ingredients in Ilaris.

The lead author of the study and a researcher, Neil Campbell, at Pfizer, which sells Viagra, said that it is pretty scary situation. These products are not herbal at all, they’re adulterated. The U.S. Food and Drug Administration, which is in charge of regulating herbal supplements, posted 11 warnings to consumers in 2013 alerting them of unlabeled pharmaceuticals being found in these products.

Campbell and his colleagues analyzed 91 samples from 58 products.They sent undercover consumers into convenience stores and gas stations in the Atlanta and Baltimore areas, and bought products such as Rize 2 The Occasion, Stiff 4 Hours, and Man King. Although 57 of the products claimed to be “all natural,” 81 percent of them contained the tadalafil or sildenafil (marketed as Cialis and Viagra, respectively) or similar ingredients that are not approved by the FDA.

The products also had labeling problems, indicating poor quality production, according to the authors. In some cases, expiration dates or lot numbers were missing, manufacturers could not be identified, or samples of the same product had different appearances.

Campbell said given the potential side effects and health risks associated with prescription erectile dysfunction drugs, men are “risking their lives” taking herbal sex enhancement drugs. Seven samples that Campbell’s group analyzed contained only unknown substances.

It’s unclear where the ingredients are coming from. Patients often turn to these products because they are cheap – costing between $2.99 and $17.99, according to Campbell’s study, published in the Journal of Sexual Medicine.

But they are taking a health risk in doing so. Erectile dysfunction medicines can be unsafe for men taking nitrates for chest pain, but only 14 of the samples in the study included a warning against combining the drugs. Unfortunately, to an unwitting patient they think they’re taking an herbal product. It really poses a really scary threat for patient health and safety.

The QIDP designation for ceftolozane/tazobactam allows Cubist to benefit from certain incentives for the development of new antibiotics, including Priority Review, the Fast Track status designation provided, and if ceftolozane/tazobactam is ultimately approved by the FDA, a five year extension of Hatch-Waxman exclusivity. These incentives are provided under the Generating Antibiotic Incentives Now Act (GAIN Act), which received strong bipartisan support in Congress and was signed into law by President Obama in July 2012 as part of the FDA Safety and Innovation Act (FDASIA), the fifth authorization of the Prescription Drug User Fee Act.

Ceftolozane/tazobactam is currently being studied in pivotal Phase 3 trials as a potential intravenous therapy for the treatment of cIAI and cUTI caused by Gram-negative pathogens, including those caused by multi-drug resistant Pseudomonas aeruginosa. Cubist expects to initiate a Phase 3 VABP program for ceftolozane/tazobactam by mid-year.