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Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design.  Shruti brings to you some highlights from current pharma and clinical research news, views and data.


Canada Approves Seasonal Flu Nasal Vaccine.
Health Canada for the first time "granted approval for a nasal vaccine FluMist, designed to protect against seasonal flu." The nasal vaccine which is marketed by AstraZeneca Canada, is attractive to many who have a fear of needles. Another benefit of the nasal vaccine is that research finds it is "more effective in children age 2 to 17 than the traditional injectable flu vaccine." 

Extended Stroke Treatment Window Appears To Be A Safe Option For Saving Lives.
Extending the time window to treat stroke patients with the clot-dissolving drug tPA from three hours to up to 4.5 hours after the onset of stroke doesn't result in any significant delays in treatment and appears to be a safe option for saving lives," according to a new paper in The Lancet Neurology. The "three-hour post-stroke time limit was set because of fears that use of the clot-dissolving drug beyond that period might cause dangerous bleeding or other complications," but after the "publication of two landmark studies, the American Heart Association, the American Stroke Association and the European Stroke Association revised their guidelines in October 2008 to recommend that tPA be used up to 4.5 hours after the onset of an ischemic stroke." Still, "experts have been worried."

So, researchers at the Karolinska Institute "analyzed data from 23,942 patients with ischemic stroke who were included in SITS-ISTR [the Safe Implementation of Treatment in Stroke-International Stroke Thrombolysis Registry] between December 2002 and February 2010," and  reported that "although the rate of symptomatic hemorrhage and death was higher among those treated beyond three hours -- and the rate of functional independence was lower -- the benefits of treatment in that window outweighed the risks," the researchers explained. In fact, "safety and functional outcomes are less favorable after three hours, but the wider time window now offers an opportunity for treatment of those patients who cannot be treated earlier." 

FDA Adds Boxed Warning To Plavix.
FDA "is adding its strongest warning to the label for Plavix [clopidogrel bisulfate], cautioning that some patients do not respond to the blockbuster blood thinner." The "warning indicates that the drug is dangerous only in the sense that it doesn't work in" certain "patients and thus may leave them unprotected against heart attacks and strokes." Specifically, some patients have a difference in a liver enzyme known as CYP2C19, which helps to convert Plavix to a form that the body can use, Notably, FDA officials said CYP2C19 tests typically cost less than $500. Robert Temple, deputy director for clinical science at the FDA's Center for Drug Evaluation and Research, said, "What there hasn't been is a clear test of whether you can take people who are poor metabolizers, double their dose and do just as well. 

Reovirus May Hold Promise As Nontoxic Prostate Cancer Treatment.
The respiratory, enteric, orphan virus, or 'reovirus' is widespread," but those who are exposed to it tend to "suffer, at most, mild flu-like respiratory symptoms or diarrhea." More interestingly, the "reovirus has 'oncolytic' potential," as there "is already some evidence of its effect against lymphoid, ovarian, breast, pancreatic, and high grade glioma brain cancers."  

With that in mind, researchers in Canada "recruited six men with early-stage prostate cancer that had not yet started to spread. Each was given a single injection of the virus into their tumor, guided by ultrasound." After three weeks, "patients had their prostate glands removed as part of their normal treatment." Investigators were then able to see that the virus "triggered the cancer cells' self-destruct program. All around the injection site, the reovirus -- a product from Oncolytics Biotech Inc. called Reolysin -- made cancer cells go away" without harming normal cells. The only flaw was that "the virus did not spread throughout the prostate," meaning "cancer cells not in the immediate area of the injection were spared.

Research Team Finds Q Fever Demands 18 Months Or More Of Treatment.
Researchers based in France have outlined treatment for Q fever, and "the findings have relevance because of the current -- and unusual -- outbreak of Q fever in the Netherlands, where 3,483 cases have been diagnosed since 2007 and six people have died." Dr. Didier Raoult, of the University of the Mediterranean and colleagues, published results of their study of 104 patients in the journal Lancet Infectious Diseases. The team said that "at least" 18 months of treatment are necessary to "cure an infection of the heart lining or valves resulting from Q fever, and an additional six months will most likely be required if the patient has a prosthetic valve."  

Read more at-
http://www.latimes.com/news/health/la-heb-q-fever-20100714,0,2951263.story 
http://www.theglobeandmail.com/life/health/nasal-vaccine-against-flu-gets-green-light-in-canada/article1640399/  http://consumer.healthday.com/Article.asp?AID=641489 
http://www.medpagetoday.com/Cardiology/Strokes/21395 
http://www.pharm-education.com/2010/07/extended-stroke-treatment-window.html 

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 

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FDA Approves Three-In-One Blood Pressure Drug.  
"Daiichi Sankyo Inc. stated that regulators have approved the sale of its three-in-one high blood pressure drug Tribenzor [hydrochlorothiazide, amlodipine, olmesartan medoxomil]." 

The drug product is intended "to treat patients whose blood pressure is not controlled on angiotensin receptor blockers, calcium channel blockers, or diuretics." The FDA issued several warnings regarding the use of the drug, including that "pregnant patients should not take the new combination drug," and "those who become pregnant while on the polypill should discontinue therapy immediately." The drug also "may increase the risk of angina and myocardial infarction once calcium channel blocker therapy has started or after a dose increase, particularly in patients with severe obstructive coronary artery disease." The most common adverse reactions seen in clinical trials of the combo drug were dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper-respiratory-tract infection, diarrhea, urinary-tract infection, and joint swelling."  

New "Smart Bomb" invented to target cancer cells.
A team of researchers from Australia and India are hard at work developing a new "smart bomb" to target tumors. The investigators are developing an antibody that binds to cancer stem cells, delivering a lipid particle containing an anti-cancer therapy coupled with RNAi gene silencing tech. 

"While current treatments kill the bulk of the cancer cell, the cancer root escapes the therapy and can regenerate into a new cancer mass," says Wei Duan, an associate professor at Deakin University, who is collaborating with colleagues in India on the project. "The aim of our research is to develop a smart bomb that can penetrate the cell and release the drugs within the cells, rather than from the outside, and kills the whole tumor, root and all."

Indian Institute of Science in Bangalore, Barwon Health's Andrew Love Cancer Centre and ChemGenex Pharmaceuticals are all collaborating on the program, which has been funded in part by the Indian and Australian governments. And the scientists say the delivery technology isn't restricted to the cancer field. The same approach could also work for Alzheimer's, heart disease and diabetes.

"This system would also be very human compatible and human degradable meaning it would not be toxic to other cells in the body and would cause very limited side-effects," says Duan. The molecular drug delivery system would use a technique known as RNA interference, or gene silencing, which enables control over the genes inside cells.First, the scientists are developing a chemical antibody that will bind specifically to cancer cells. This "guided missile" will have a purpose-built lipid particle - carrying an anti-cancer drug as well as anti-cancer genes - as its payload. Combined, they create a treatment that will actively seek and penetrate the cells in a tumour, killing those vital for a cancer to spread. 

The working of the ‘smart bomb’: According to the scientists, the mechanism is aimed at killing the root of the cells that play a vital role in generating the lethal cells in body. 

The process involves a molecular drug delivery system which will pick out the active cells of the cancer before they can develop into a full blown lethal disease. 

Researchers are designing a chemical antibody that will bind the cancer cells, which together with the technique known as 'RNA interference', or gene silencing, will penetrate and destroys mutated cells that cause the occurrence and reoccurrence of cancer. 

Dr Duan stated, "Our precision-guided cancer therapy will afford reduced side-effects, decreased toxicity to normal cells. We will probably still be using existing drugs but the way we use them will be much more specific.

"We're not saying we will have a cure cancer in 10 years but at least these people will live longer and importantly enjoy a higher quality of life."

The researchers are optimistic that the clinical trials of the treatment will soon be on the way.

Dr Duan said there was also potential to use the same technique to tackle neurodegenerative diseases such as Alzheimer's disease, heart disease and diabetes.

The project is a collaboration with the Indian Institute of Science in Bangalore, Barwon Health's Andrew Love Cancer Centre and ChemGenex Pharmaceuticals.It has received $400,000 funding over three years from the federal government's Australia-India Strategic Research Fund, with reciprocal support from the Indian government. 

"This system would also be very human compatible and human degradable meaning it would not be toxic to other cells in the body and would cause very limited side-effects, that professes to slash the grim but inevitable effects of conventional treatment such as hair loss, vomiting, and irritated mucous membrane.

"The success of this project will bring us a step forward in significantly improving the survival rate and quality of life of cancer patients."

AIDS Vaginal Gel Considered Promising, But More Work Remains.
 "The best AIDS-prevention news in years was released...last week at a world conference on the disease: a vaginal gel, called a microbicide, that can be used without a man knowing it, gave women a 39 percent chance of avoiding infection with the deadly virus." The Times adds, "After more than a dozen microbicide failures," these findings were "a huge relief." Dr. Anthony S. Fauci, director of the NIH's NIAID, said, "There's a certain feeling of ease and pleasure for me as a scientist that any way you slice the data, it's statistically significant." Still, researchers must address many questions before the treatment can be submitted for regulatory approval. 

http://www.pharm-education.com/2010/07/new-smart-bomb-tech-used-to-target.html  

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. 

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10
 
 
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Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design.  Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Large Drugmakers Placing New Emphasis On Targeted Cancer Treatments.
Increasingly, large pharmaceutical companies are restructuring their business models so that they can collaborate with small biotech firms to develop medications which target small groups, rather than large populations. This move is influenced in part by a new emphasis on personalized medicine and the need for targeted therapies. For instance, Pfizer has partnered with Abbott Molecular to develop a treatment called crizotinib, which would only benefit four percent of lung cancer patients. Meanwhile, AstraZeneca is seeking FDA approval so that its drug Iressa [gefitinib] can be used to treat EGFR-positive lung cancer patients.
http://www.ft.com/cms/s/2/72803d54-9046-11df-ad26-00144feab49a,dwp_uuid=e8477cc4-c820-11db-b0dc-000b5df10621.html  

Experts Warn Absence Of Clinical Trials For Biosimilar Drugs Could Hurt Safety, Effectiveness.
Medical experts warned that the absence of mandatory clinical trials for biosimilar drugs could compromise their safety and effectiveness." That provision was "designed to get biosimilars – and the cost savings that accompany them – to the marketplace more quickly" by allowing FDA to base its approval, "in part, on the safety and efficacy record of the original breakthrough drug." The provision, however, is "vague," according to critics, and "leaves FDA with a great deal of leeway to okay those drugs – including the flexibility to decide whether clinical trials are necessary at all." The "difference in manufacturing processes" between companies "can alter the drugs 'in ways that technology can't detect.'" http://thehill.com/blogs/healthwatch/health-reform-implementation/109647-experts-concerned-about-lack-of-clinical-trials-for-biosimilar-drugs

Number Of HIV-Positive Patients Receiving Antiretroviral Drugs Increased By More Than A Quarter In 2009.
The number of HIV-positive people receiving antiretroviral drugs for their infections jumped by more than a quarter in 2009, growing from four million to 5.2 million, the World Health Organization disclosed at the International AIDS Conference in Vienna." The organization's Dr. Hiroki Nakatani said, "This is the largest increase in people accessing treatment in a single year." But "unfortunately, that still leaves 10 million who need therapy." http://www.latimes.com/news/health/boostershots/la-heb-aids-treatment-20100719,0,3111390.story 

Bosentan May Not Improve Exercise Capacity In Patients With Systemic Sclerosis.
"Treatment with the endothelin receptor antagonist bosentan (Tracleer) failed to improve exercise capacity in patients with systemic sclerosis, a randomized trial found." James R. Seibold, MD, of the University of Connecticut in Farmington, and colleagues said that after one year of treatment, "there was a nonsignificant mean change in the six-minute walk test in the bosentan-treated patients (−12 meters) compared with the change in the placebo group (9 meters)." In addition, the study found bosentan "had no effect on time to death or worsening pulmonary function test scores."
http://www.medpagetoday.com/Rheumatology/GeneralRheumatology/21082

Clinical Trials To Continue For Potential Hemophilia Drug.
"Biogen Idec Inc. and Swedish Orphan Biovitrum stated they will continue clinical testing of a potential hemophilia drug based on promising results from an early trial." The companies "are testing a form of a protein called factor VIII," which "is involved in the formation of blood clots, and people with hemophilia A have little or none of it." Biogen and Biovitrum also "said that in an early study on 16 patients, their drug was safe and had 'a prolonged half-life' compared an older drug, Advate."
http://www.businessweek.com/ap/financialnews/D9GRJQP00.htm 

Vaccine May Help Shrink The Most Deadly Cancers.
"An injection to help kill off the most deadly cancers...has been created by scientists" in the UK. The "Middlesex University vaccine capitalizes on the finding that some of the most vicious tumors produce a hormone normally only found in pregnancy," that is, human chorionic gonadotropin. In fact, "a form of hCG is...made by around half of bladder and pancreatic cancers," and "some breast, bowel, ovarian, and cervical tumors also pump it out." The vaccine, however, "which is being developed in conjunction with US firm Celldex Therapeutics, revs up the immune system, directing it to destroy hCG." This "shrinks tumors -- and, crucially, stops them from spreading, or metastasizing." http://www.dailymail.co.uk/health/article-1293927/Jab-halt-deadly-forms-cancer.html 
http://www.pharm-education.com/2010/07/vaccine-may-help-shrink-most-deadly.html  

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10Do you have questions for the author?
 
 
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Tea Tree Oil May Help Treat Some Skin Cancers- new opportunities of  cancer therapy...calls f

"Tea tree oil may provide a fast, cheap and effective treatments for some skin cancers, according to researchers." A team of researchers from the University of Western Australia found that the common remedy was able "to shrink non-melanoma skin cancers in mice in just one day and wiped them out within three days." Study leader Dr. Sara Greay said, "We are very excited about these results and are hoping to find funding for a small clinical trial of about 50 people with pre-cancerous lesions, with the aim of preventing the development of skin cancers." Non-melanoma skin cancer is one of the most common types of cancer in the UK, with around 100,000 new cases diagnosed every year. Scientists believe a tea tree oil formulation could be an effective treatment

Read more: http://www.dailymail.co.uk/health/article-1292074/Tea-tree-oil-offers-hope-new-effective-treatment-skin-cancer.html#ixzz0t2gOdtiK
http://www.dailymail.co.uk/health/article-1292074/Tea-tree-oil-offers-hope-new-effective-treatment-skin-cancer.html  

More pharmaceutical research updates at http://www.pharm-education.com/2010/07/dengue-returns-to-us-sanofi-sees-phase.html  
 
 
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EU Approves Chewable Form Of Lipitor For Children.
The European Union has approved a new chewable form of cholesterol blockbuster Lipitor for children 10 and up with high levels of bad cholesterol and triglycerides...Pfizer said Tuesday.This "approval includes children whose high blood fats are due to...familial hypercholesterolemia.
http://www.google.com/hostednews/ap/article/ALeqM5j7lgaYrKYwRcQCtKT0Y2jSQstyNQD9GPLL480

Doctors Identify Two Therapies That May Slow Progress Of Diabetic Retinopathy.
The Los Angeles Times blog reported that, according to data published June 29 in the New England Journal of Medicine and presented at the American Diabetes Association meeting, "doctors said they have identified two therapies that may slow the progress of" diabetic retinopathy. After examining data on a subset of 2,856 people from the ACCORD study, researchers found that "people with type 2 diabetes who adhere to intensive blood sugar control, compared with standard blood sugar control, have reduced progression of retinopathy. In addition, patients treated with a combination of a cholesterol-lowering statin and fibrate drugs also had a lower rate of progression compared with patients taking statins alone."
http://latimesblogs.latimes.com/booster_shots/2010/06/diabetes-retinopathy-glucose-control.html http://content.nejm.org/cgi/content/full/NEJMoa1001288 http://www.nhlbi.nih.gov/health/prof/heart/other/accord/index.htm  

Weight-Loss Supplement Contains Potentially Dangerous, Undeclared Drug Ingredients, FDA Warns.
MedPage Today reported, "The FDA warned customers about several potentially dangerous and undeclared drug ingredients in Que She, a pill sold as an herbal weight-loss supplement." Specifically, the "supplement contains fenfluramine, a stimulant drug withdrawn from the market because it may cause serious heart valve damage; propranolol, a prescription beta-blocker that may be hazardous to patients with bronchial asthma or certain heart conditions; sibutramine, a controlled, prescription weight-loss drug that studies have shown may increase heart attack and stroke risk; and ephedrine, a stimulant that is sold over-the-counter for temporary asthma relief but may have adverse cardiovascular effects.
http://www.medpagetoday.com/ProductAlert/OTC/21087

Two Studies Suggest Diabetes Drug Avandia Increases Risk Of Heart Problems.
ABC World News reported, "Two major studies have found the medicine called Avandia [rosiglitazone] could create a significant new risk of heart attack and other serious problems." 

The CBS Evening News reported, "FDA experts meet in two weeks to decide whether or not to pull Avandia off the market." NBC Nightly News reported, however, that the drug's maker, GlaxoSmithKline, "said today the drug is effective and safe."  

The Washington Post reported that one study, "involving more than 35,500 people, found that Avandia significantly raises the chances of a heart attack." A separate study "of more than 227,500 Medicare patients -- the largest such study to date -- found that the drug boosts the risk for strokes, heart failure, and death."  The Los Angeles Times reported that the first study "found Avandia raised the risk of heart attacks by 28% to 39% as compared with other diabetes medications. The study was published online in the Archives of Internal Medicine."  

Bloomberg News quoted "I think we've got more than enough evidence to say this drug should not be used." USA Today reported that in the second study, published in the Journal of the American Medical Association, "scientists from the Center for Drug Evaluation and Research at the Food and Drug Administration evaluated data from 227,571 Medicare beneficiaries taking either Avandia or Actos [pioglitazone hydrochloride]." The investigators found "no differences in the risk for heart attack between the two drugs, but the study found that compared with Actos, Avandia was associated with a 25% increased risk of heart failure, a 27% increased risk of stroke and a 14% increased risk of death." The Boston Globe quoted the study's coauthor Dr. David Graham, the FDA's associate director for science and medicine, as saying, "Look at our study, and then ask yourself, 'Why would you want to take Avandia?'"        

The New York Times reported that "the studies were made public in hopes of influencing an expert panel to offer advice to the Food and Drug Administration about whether Avandia should be removed from the market." According to Dr. Joshua M. Sharfstein, the FDA's principal deputy commissioner, the studies "will be part of the discussion that FDA has as we consider the important question of Avandia's safety." The AP reports that "at the FDA's request, Glaxo began a big study last year comparing heart and stroke risks in patients on Avandia or Actos, made by Japan's Takeda Pharmaceuticals. It aims to enroll thousands of patients, but an editorial in JAMA about the Medicare study says it would be unethical to let the study continue."        

The NPR blog reported that "Glaxo, for its part, defended the medicine, saying in a statement that randomized clinical trials have shown 'Avandia does not increase the overall risk of heart attack, stroke or death.'" 

http://www.washingtonpost.com/wp-dyn/content/article/2010/06/28/AR2010062802089.html?hpid=moreheadlines http://www.latimes.com/news/science/la-sci-diabetes-avandia-20100629,0,6076476.story?track=rss
http://archinte.ama-assn.org/cgi/content/abstract/2010.207v1?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=Avandia&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT http://www.bloomberg.com/news/2010-06-28/glaxo-diabetes-drug-avandia-harms-patients-should-be-pulled-doctors-say.html http://www.usatoday.com/news/health/2010-06-28-Avandiaheartrisks-diabetes_N.htm http://jama.ama-assn.org/cgi/content/full/jama.2010.920 http://www.boston.com/business/healthcare/articles/2010/06/29/new_studies_add_to_avandia_concerns/ http://www.nytimes.com/2010/06/29/health/research/29drug.html?_r=1&ref=health http://www.forbes.com/feeds/ap/2010/06/28/business-health-care-us-med-diabetes-drugs_7726225.html
http://jama.ama-assn.org/cgi/content/full/jama.2010.954
http://www.npr.org/blogs/health/2010/06/28/128161946/diabetes-avandia-heart-risks http://www.medpagetoday.com/MeetingCoverage/ADA/20933
http://www.washingtontimes.com/news/2010/jun/28/study-finds-diabetes-drug-risky-health/ http://online.wsj.com/article/SB10001424052748703964104575334570859778764.html?mod=googlenews_wsj http://www.washingtontimes.com/news/2010/jun/28/study-finds-diabetes-drug-risky-health/ http://www.reuters.com/article/idUSN2826887120100628
http://www.google.com/hostednews/afp/article/ALeqM5gk-BsMFSQxxxAoQBhSkWMTivx9fA
http://consumer.healthday.com/Article.asp?AID=640571
http://diabetes.webmd.com/news/20100628/new-study-avandia-riskier-than-actos
http://www.pharm-education.com/2010/07/eu-approves-chewable-form-of-lipitor.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
 
 
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Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations and quality-by-design.  Shruti brings to you some highlights from current pharma and clinical research news, views and data. 

The U.S. Food and Drug Administration yesterday announced it has approved the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage age-related macular degeneration (AMD).  

Surgically implanted in one eye, the IMT is a small telescope that replaces the natural lens and provides an image that has been magnified more than two times. AMD, a condition that mainly affects older people, damages the center of the retina (macula) and results in a loss of vision in the center of the visual field. About 8 million people in the United States have AMD and nearly 2 million of them already have significant vision loss, according to the National Eye Institute. AMD can make it difficult or impossible to recognize faces or perform daily tasks such as reading or watching television.

"This innovation has the potential to provide many people with an improved quality of life," said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. 

The IMT is available in two models: one that provides 2.2 times magnification and another 2.7 times magnification. The IMT is designed to magnify and project images onto a healthy portion of the retina. The IMT is intended to be implanted in only one eye; the non-implanted eye is used for peripheral vision.

The IMT is used in patients ages 75 years and older with stable severe to profound vision impairment (when vision impairment has not changed over time) caused by blind spots (bilateral central scotoma) associated with end-stage AMD. These patients also have evidence of a visually significant cataract. 

Patients agree to undergo training with an external telescope with a low vision specialist prior to implantation to determine whether adequate improvement in vision with the external telescope can be obtained and to verify if the patient has adequate peripheral vision in the eye that would not be implanted. Patients also agree to participate in a post-operative visual training program. 

In a 219-patient, multi-center clinical study of the IMT, 90 percent of patients achieved at least a 2-line gain in either their distance or best-corrected visual acuity, and 75 percent of patients improved their level of vision from severe or profound impairment to moderate impairment. 

Because the IMT is a large device, implantation can lead to extensive loss of corneal endothelial cells (ECD), the layer of cells essential for maintaining the clarity of the cornea, and chronic endothelial cell loss. The chronic rate of endothelial cell loss is about 5 percent per year. Significant losses in ECD may lead to corneal edema, corneal decompensation, and the need for corneal transplant. In the study, 10 eyes had unresolved corneal edema, with five resulting in corneal transplants. The calculated five-year risk for unresolved corneal edema, corneal decompensation, and corneal transplant are 9.2 percent, 6.8 percent and 4.1 percent, respectively. 

To ensure that the risks of IMT implantation are sufficiently and consistently communicated to patients, the FDA and the manufacturer created detailed labeling, including an Acceptance of Risk and Informed Decision Agreement, which patients must complete prior to IMT implantation. The agreement provides a guide for patients and their physicians to discuss the risks associated with IMT implantation. Patients should be given adequate time to review all of the information regarding the IMT. 

As a condition of FDA approval, the manufacturer, VisionCare Ophthalmic Technologies Inc. of Saratoga, Calif., must conduct two post-approval studies. In one study, VisionCare must continue follow-up on the subjects from its long-term follow-up cohort for an additional two years. Another study of 770 newly enrolled subjects will include an evaluation of the endothelial cell density and related adverse events for five years after implantation. 

http://www.pharm-education.com/2010/07/fda-approves-first-implantable.html 

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. 

Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

Introducing ! A new blog- Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.
 
 
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Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moeities, brings to you some highlights from current pharma and clinical research news, views and data.

Resveratrol May Help Prevent Age-Related Deterioration Of Eyesight.
Resveratrol, found in particularly high levels in grape skin (and consequently red wine)," may help prevent age-related deterioration of eyesight, according to a study published in the American Journal of Pathology. "The substance...is believed to work because it protects against abnormal angiogenesis -- the formation of damaged or mutated blood vessels," a condition which "is linked to cancer, heart disease, and eye diseases, such as age-related macular degeneration."
http://www.telegraph.co.uk/health/healthnews/7851772/Drinking-wine-could-protect-your-eyes.html

Pfizer Suspends Clinical Trials Of Tanezumab As Potential Osteoarthritis Treatment.
Pfizer Inc. Spokesperson said Wednesday it has suspended clinical trials of its drug tanezumab as a potential osteoarthritis treatment, after some patients' conditions worsened." The drugmaker "said it halted the worldwide program following a request by the Food and Drug Administration after reports of a 'small number' of patients experiencing more severe osteoarthritis that led to joint replacement."  

FDA has also asked the company to show data on potential effects in clinical studies of the drug among patients with cancer pain, interstitial cystitis, chronic low back pain and painful diabetic peripheral neuropathy, Pfizer said." The FDA "will then decide whether to halt Pfizer's remaining trials of tanezumab after reviewing company data." However, "trials for other conditions haven't reported similar adverse events, MacKay Jimeson, a Pfizer spokesman, said."

The drugmaker recently reported that patients using the drug for knee pain related to osteoarthritis had positive responses.
http://www.forbes.com/feeds/ap/2010/06/23/business-health-care-us-pfizer-halts-study_7714952.html
http://www.bloomberg.com/news/2010-06-23/pfizer-suspends-trial-of-tanezumab-for-osteoarthritis-pain-at-u-s-request.html
http://online.wsj.com/article/SB10001424052748703900004575325320800502744.html
 
Glucosamine, Chondroitin Sales Remain Strong Despite Evidence They May Be Ineffective.
Despite a 2006 study published in the New England Journal of Medicine that suggested that "for most people, glucosamine and chondroitin do not soothe knee pain much better than a placebo," Americans nevertheless "spent $838 million on glucosamine and chondroitin in 2008," according to the Nutrition Business Journal. Rheumatologist Sean Whelton, MD, who "attended the American College of Rheumatology meeting where" results of the NEJM study were presented, tells his osteoarthritis patients that the products are safe, but also points out that they may not be "particularly effective."

SSRI Antidepressant Use Associated With Cataracts.
According to a study published online in the journal Ophthalmology, "SSRI antidepressants raise the risk of cataracts by about 15% -- enough to cause 22,000 extra cataract cases in the US each year." After analyzing "data collected from 18,784 cataract patients and 187,840 comparison patients between 1995 and 2004," researchers found that risk for cataracts was associated with the antidepressants Luvox (fluvoxamine, 39%), Effexor (venlafaxine, 33%), and Paxil (paroxetine, 23%), while overall "use of any SSRI antidepressant raised cataract risk by 15%." The authors theorized that SSRI antidepressants may cause more serotonin to be deposited into receptors in the lens of eye, over time making the lens more opaque. 

http://www.pharm-education.com/2010/06/resveratrol-seems-to-be-promising-drug.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 
Introducing ! A new blog- Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.

Do you have questions for the author? 
 
 
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Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moeities, brings to you some highlights from current pharma and clinical research news, views and data.

Antiretroviral Therapy Treatment May Reduce Perinatal AIDS Transmission.
According to studies published June 17 in the New England Journal of Medicine, "AIDS transmission to babies was blocked in 99 percent of cases when breastfeeding mothers infected with the HIV virus took triple-drug combinations." In fact, one study in Botswana of 730 pregnant women with HIV found that "virus transmission fell to 1.1 percent when mothers were assigned to one of three combination regimens initiated before birth and continued through six months of pregnancy." But, "without the drugs, the infection rate would be at least 25 percent."  

The second study, which took place in Malawi, "found that giving babies an antiretroviral drug once a day during their first six months of life reduced the transmission rate to 1.7 percent." Researchers came to that conclusion after giving 2,369 "HIV-positive mothers...either antiretrovirals after delivery and while breast-feeding, or" instructing them "to give their babies a single vial of the drug nevirapine daily." Meanwhile, "infants in a third control group received a single dose of nevirapine and seven days of two other antiretroviral drugs."

According to accompanying editorial "debate over which regimen is best 'should not be used to justify inaction.'" Rather, "the choice of regimen is secondary to identifying, caring for, and treating HIV-positive women and their infants."
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aTKRE8oVsUVg
http://consumer.healthday.com/Article.asp?AID=640176
http://content.nejm.org/cgi/content/full/362/24/2271
http://www.medpagetoday.com/HIVAIDS/HIVAIDS/20717

Experimental Colon Cancer Treatment Fails To Meet Goal In Midstage Study.
A potential colon cancer treatment failed to meet its goal in a midstage study." The research "was conducted by Curis' partner Roche and that company's Genentech unit." A drug, a so-called hedgehog-pathway inhibitor, combined with the Avastin [bevacizumab] tumor drug and chemotherapy didn't keep the disease at bay or extend lives of patients compared with those given standard treatment." This "study of 199 patients was the biggest yet for the hedgehog treatment," known as GDC-0449.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aJxiB1BIwgUM
http://www.forbes.com/feeds/ap/2010/06/16/business-health-care-us-curis-mover_7694092.html
http://www.reuters.com/article/idUSSGE65F0G020100616 

After 12 Months, Aspirin OK Without Plavix For Patients With Stents.
Giving aspirin alone to patients who have had stents implanted seems just as good as giving aspirin along with the blood thinner Plavix [clopidogrel]," according to a study presented at the American College of Cardiology annual meeting. Researchers discovered that, after an initial year receiving the dual anti-clotting therapy, patients who went off Plavix and just took aspirin had the same rate of heart attacks and death as those patients continuing on the two drugs together. Dr. Gurpreet Sandhu, an interventional cardiologist with the Mayo Clinic, cited ACC guidelines, saying, "In general, this fits with current guidelines, so it's not going to be practice-changing, per se." 

Investigational Implantable Sensor May Reduce Risk Of Hospitalizations For Heart Failure.
A study being called the start of a revolution in the management of heart failure." Among heart failure patients with moderate to severe disease, six months of monitoring with an investigational implantable sensor that measures pulmonary artery pressure was associated with a 30% relative risk reduction in hospitalizations for heart failure," according to the research, presented at the Heart Failure Congress. Investigators found that, "after six months there were 83 hospitalizations for heart failure among the 270 patients randomized to treatment guided by hemodynamic measurements from the CardioMems Heart Sensor, compared with 120 heart failure hospitalizations in the 280-patient control arm." One of the researchers "said the data suggests that using the pulmonary monitoring device to guide treatment in just eight heart failure patients for six months would result in one less hospitalization for heart failure." 

FDA Seeks More Information On Inhaled Insulin Drug.
MannKind Corp.allegedly "failed to win approval from US regulators to market its inhaled insulin drug, Afrezza, for people with diabetes." The FDA "asked for more information about the medication and the inhaler patients will use, MannKind said today in a statement," and although the agency "didn't cite any safety concerns, they requested updated safety data." The FDA questioned whether the inhaler used in clinical trials was similar to another one the company created and wants to market with Afrezza. 
Related links-
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm215515.htm http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm216214.htm http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm216218.htm http://www.medscape.com/viewarticle/723988
http://www.pharm-education.com/2010/06/investigational-implantable-sensor-may.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Introducing a new blog Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.
Do you have questions for the author? 
 
 
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Teva Announces Positive Results from a Study Assessing a New Formulation of Copaxone(R). Significantly less pain and fewer injection site reactions were reported by patients receiving the new lower volume injection. Teva Pharmaceutical Industries Ltd. announced positive results from a study assessing a new lower-volume injection of Copaxone(R) (glatiramer acetate) containing the currently approved dose in half the injection volume.  

The SONG study ('Study of New Glatiramer Acetate Formulation') explored the safety and tolerability of a 20mg/0.5mL injection of Copaxone(R) versus the current formulation of 20 mg/1.0mL. These findings were presented at the 24th Annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in San Antonio, Texas. 

"Copaxone(R) has proven long-term efficacy, safety and tolerability with more than one million patient years of treatment," said Dr. Ronald Murray, FAAN, a lead study investigator and Director of the MS Clinic of Colorado. "We are encouraged by these data as they suggest that a 0.5mL dose of glatiramer acetate may enhance patients' experience with the most frequently prescribed MS therapy." 
http://www.marketwatch.com/story/teva-announces-positive-results-from-a-study-assessing-a-new-formulation-of-copaxoner-2010-06-04?reflink=MW_news_stmp  

Starpharma Plans Effectiveness Studies On Herpes-Killing Gel For Women.
Bloomberg News  reported, "The world's first herpes-killing vaginal gel may go on sale within two years, said its developer Starpharma Holdings Ltd., which plans to start patient studies on its effectiveness." Starpharma CEO Jackie Fairley said her company is discussing the trials of VivaGel with "a number of groups," noting that it's the only microbicide designed to stop herpes from spreading. The company also "plans to study the product's effectiveness against bacterial vaginosis, the most common vaginal infection in women of childbearing age, later this year, it said" in March.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aqEEau5hBC6Q

Bevacizumab May Improve Some Outcomes In Advanced Gastric Cancers.MedPage Today  reported that "bevacizumab (Avastin) may improve some outcomes in advanced gastric cancers, but it did not benefit overall survival, according to a major international clinical trial reported" at the American Society of Clinical Oncology annual meeting. Researchers found, "in the phase III AVAGAST clinical trial, conducted among more than 770 patients," that "adding the monoclonal antibody bevacizumab to standard chemotherapy tended to be associated with a 13% reduction in risk of death from any cause, but the two-month survival advantage was not significant compared with chemotherapy alone." But, "bevacizumab produced significant benefits in progression-free survival and response rates," the researchers reported.
http://www.medpagetoday.com/MeetingCoverage/ASCO/20582

 
Erlotinib May Prolong Survival In Older Women With Advanced Non-Small Cell Lung Cancer.
MedPage Today  reported that "the targeted agent erlotinib (Tarceva) prolonged survival by 26% in older women with advanced non-small cell lung cancer, but did not benefit men with the disease," according to research presented at the American Society of Clinical Oncology annual meeting. Investigators found, "in the randomized clinical trial, conducted among 670 patients (median age 77)," that "erlotinib also markedly extended the time before relapse in women." However, "men in the study saw no benefit either in overall survival or progression-free survival."
http://www.medpagetoday.com/MeetingCoverage/ASCO/20581

 
Mapatumumab Fails In Midstage Study.
"Human Genome Sciences's potential cancer drug mapatumumab failed in a midstage study. The company found "no difference in disease response or progression-free survival rates between patients receiving the drug for multiple myeloma and the control group. The drug was studied in combination with bortezomib for the study.
http://www.forbes.com/feeds/ap/2010/06/09/business-health-care-us-human-genome-sciences-study_7672784.html http://www.reuters.com/article/idUSSGE6580FL20100609 


Rosiglitazone, Metformin Low-Dose Combination May Reduce Progression To Type 2 Diabetes.
The Los Angeles Times  reported, "A combination of low doses of the diabetes drugs Avandia [rosiglitazone] and metformin can reduce the progression to type 2 diabetes by two-thirds in people who are at high risk of developing the disease," according to a study published online  in The Lancet. In fact, "the benefit is greater than with either of the drugs used alone, and the combination has fewer side effects." For the study, researchers at the University of Toronto "enrolled 207 patients with impaired glucose tolerance, randomly assigning half to take the combination and half to take a placebo," then followed them for almost four years.  

HealthDay  reported that not only did the study find "that the risk of developing type 2 diabetes was reduced by two-thirds in those taking the drug combo compared to those on placebo," but also that "using half of the maximum dose was extremely effective for preventing type 2 diabetes." Moreover, "the drug combination appeared to counteract the weight gain that's common with Avandia therapy alone," and with relatively few side effects.  

"The dosages used in the study were 2 milligrams of Avandia plus 500 milligrams of metformin. There is no evidence whatsoever that lower doses of [Avandia] are 'safe’. Any suggestion that serious cardiovascular toxicity can be avoided by using a small dose represents pure speculation at best." According to MedPage Today , an accompanying editorial also "cautioned that the 'larger issues that have cast doubt on use of drugs to prevent diabetes are not addressed by the'" study.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.pharm-education.com/2010/06/rosiglitazone-metformin-low-dose.html 
Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 

Shruti has initiated a new blog Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.

Do you have questions for the author? 
 
 
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Researchers have scored the first big win against melanoma, the deadliest form of skin cancer. An experimental drug significantly improved survival in a major study of people with very advanced disease.

The results, reported Saturday at a cancer conference, left doctors elated. 

“We have not had any therapy that has prolonged survival” until now, said Dr. Lynn Schuchter of the Abramson Cancer Center at the University of Pennsylvania, a skin cancer specialist with no role in the study or ties to the drug’s maker.

The drug, ipilimumab, (ip-ee-LIM-uh-mab), works by helping the immune system fight tumors. The federal Food and Drug Administration has pledged a quick review, and doctors think the drug could be available by the end of this year. 

“People are going to have a lot of hope and want this drug, and it’s not on their doctors’ shelves,” although some may be able to get it through special programs directly from its maker, Bristol-Myers Squibb Co., Schuchter said. 

Melanoma is the most serious form of skin cancer. Last year in the United States, there were about 68,720 new cases and 8,650 deaths from the disease. Worldwide, more than 50,000 people die of melanoma each year. 

“The incidence is rising faster than any other cancer,” said one of the study’s leaders, Dr. Stephen Hodi of Dana-Farber Cancer Institute in Boston. “When it spreads to vital organs, it’s almost always fatal.” 

Doctors also reported Saturday at the conference that an experimental drug for lung cancer patients with a certain gene showed extraordinary promise in early testing. The drug, Pfizer Inc.’s crizotinib, (crih-ZAH-tin-ib) targets a gene that promotes tumor growth and is found in about 4 percent of lung cancers, especially among younger, non-smokers. 

Nearly 220,000 new cases of lung cancer are diagnosed each year in the United States alone, and it is the world’s top cancer killer. Two other gene-targeted treatments, Tarceva and Iressa, help about 20,000 lung cancer patients annually in the U.S. 

The skin cancer study involved 676 people around the world with advanced, inoperable melanoma who had already tried other treatments — a very grim situation. They were given one of three treatments: ipilimumab by itself, with another immune-stimulating treatment, or the immune-stimulating treatment alone. 

After two years, 24 percent of those given the drug alone or in combination were alive, versus 14 percent of those given just the immune-stimulating treatment. 

Average survival was 10 months with ipilimumab versus just more than six months for the others, which worked out to a 67 percent improvement in survival for those on the drug, said one of the study’s leaders, Dr. Steven O’Day of the Angeles Clinic and Research Institute in Los Angeles. 

Doctors hope the drug can provide more benefit if given earlier in the course of the disease and to less sick patients. 

Ten percent to 15 percent of patients on ipilimumab had serious side effects related to the drug’s actions on the immune system. Most were treatable with high doses of steroids, but 14 deaths were thought to be related to the treatment. That’s still far fewer than deaths due to the cancer. 

The study was funded by Bristol-Myers and Medarex Inc., a company that co-developed the drug and was bought by Bristol-Myers last year. A spokeswoman said Bristol-Myers has not yet set a price for the drug, but similar treatments for other cancers cost several thousand dollars a month or more. 

Results were reported at the American Society of Clinical Oncology’s annual conference in Chicago and published online by the New England Journal of Medicine. 

References Online:

Cancer meeting: www.asco.org
National Cancer Institute: www.cancer.gov
New England Journal of Medicine: www.nejm.org
http://www.pharm-education.com/2010/06/first-big-win-against-skin-cancer-drug.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. 

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 

Shruti has initiated a new blog Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.

Do you have questions for the author?