 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. FDA To Decide On Therapeutic Cancer Vaccine. Prostate cancer strikes more American men than any other cancer. In fact, "just last year there were nearly 200,000 new cases" and "more than 27,000 deaths." But, Dendreon Corp. scientists have been hard at work on a new vaccine that may "extend the lives of" patients with an advanced form of the disease. More importantly, the FDA this week is expected to decide "whether to approve" the nation's "first therapeutic cancer vaccine." What makes Provenge so novel is the fact that it "uses the patient's own blood cells to trick the tumor cells in to stimulating the body's own immune system to attack that tumor" without inducing "widespread toxicity," Dr. Jennifer Ashton explained in an article posted on the outlet's website. "She said these are personalized vaccines, so it's not one size or one-size fits all." And "that makes the" vaccine "more complicated and expensive to make, but the patient will reap the benefits in treatment." Accordingly, "many cancer patients were disappointed when the FDA failed to approve the treatment in 2007, even though the agency's own advisory panel had voted overwhelmingly in favor of it." However, officials "appear poised to approve" the new treatment, which "may cost as much as $75,000." Notably, the "science behind the vaccine could also have applications for other kinds of cancers." Concurrent Use Of PPIs, Clopidogrel In Heart Disease Linked To Fewer Gastroduodenal Bleeding Hospitalizations. Concurrent use of proton pump inhibitors (PPIs) in patients with serious coronary heart disease treated with clopidogrel is associated with fewer hospitalizations for gastroduodenal bleeding," Vanderbilt researchers found after reviewing data on "20,596 patients (including 7,593 concurrent users of clopidogrel and PPIs) who received clopidogrel between 1999 and 2005." According to the paper in the Annals of Internal Medicine, "compared with nonusers of PPIs, concurrent PPI users had a 50% lower adjusted incidence of hospitalization for gastroduodenal bleeding." PPI use was also "associated with an absolute reduction of 28.5 (95% CI, 11.7 - 36.9) hospitalizations for gastroduodenal bleeding per 1000 person-years, for those patients at highest risk of bleeding." Metformin May Improve Ability Of Bicalutamide To Slow Proliferation In Hormone-Resistant Prostate Cancer Cell Lines.
The commonly prescribed anti-diabetes drug metformin appears to improve the ability of bicalutamide (Casodex), an androgen ablation drug, to slow proliferation in hormone-resistant prostate cancer cell lines," according to a study presented at the annual meeting of the American Association for Cancer Research. Researchers said that "combining metformin with bicalutamide significantly reduces prostate cancer cell colony formation rates more effectively than either drug in monotherapy." The researchers also said that "this combination regimen may potentially improve prostate cancer specific survival through a direct anti-proliferation mechanism." NSAID Use May Not Reduce Risk Of Ovarian Cancer.
Regular use of anti-inflammatory drugs did not reduce the risk of ovarian cancer," according to a study presented at the American Association for Cancer Research meeting. Researchers found that "neither weekly nor daily use of aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) influenced the relative risk of ovarian cancer." However, "self-reported daily use of acetaminophen almost doubled the risk of ovarian cancer." References- http://www.pharm-education.com/2010/04/pharmaceutical-research-updates.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?
 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. Scientists and engineers have used uniform magnetic fields to drive iron-bearing nanoparticles to metal stents in injured blood vessels, where the particles deliver a drug payload that successfully prevents blockages in those vessels. In this animal study, the novel technique achieved better results at a lower dose than conventional non-magnetic stent therapy.
Conducted in cell cultures and rats, the research is the latest in a series of studies at The Children's Hospital of Philadelphia demonstrating the feasibility of magnetically guided nanoparticles as a new delivery platform for a variety of possible therapeutic cargos: DNA, cells and drugs. The findings may set the stage for a new medical tool, called vascular magnetic intervention.
"This can become a major platform technology for delivering drugs and other agents to specific sites where they can produce benefits in diseased or injured blood vessels," said study leader Robert J. Levy, M.D., the William J. Rashkind Endowed Chair in Pediatric Cardiology at The Children's Hospital of Philadelphia.
The research appears in the Proceedings of the National Academy of Sciences, published online, Levy's group from Children's Hospital collaborated with engineers and scientists from Drexel University, Northeastern University and Duke University.
Levy's work introduces a new delivery system to an existing medical technology—catheter-deployed stents. Patients with heart disease commonly receive such stents, narrow metal scaffolds that widen a partly clogged blood vessel. These stents are often coated with antiproliferative drugs such as paclitaxel. Paclitaxel inhibits the accumulation of smooth muscle cells within the stent that cause an obstruction.
However, current drug-eluting stents have their limitations. They contain a fixed dose of medication, good for just one release. In a significant number of patients, reobstruction occurs. Levy's magnetically guided system broadens the possibilities for stents, since magnetic targeting permits using higher doses, redosing if problems recur and using more than one type of agent to treat a blood vessel with a stent.
Levy made use of nanotechnology—the application of extremely small materials. His lab team created nanoparticles, approximately 290 nanometers across, made of a biodegradable polymer and impregnated with magnetite, an iron oxide. (A nanometer is one millionth of a millimeter; these nanoparticles are ten to 100 times smaller than red blood cells.). The magnetite in the particles responds strongly to a magnetic field. Being biodegradable, the particles break down safely in the body after releasing their payload.
Levy's team first implanted stainless steel stents into the carotid arteries of live rats. After injecting paclitaxel-loaded nanoparticles into the rat's arteries through a catheter, they produced a uniform magnetic field around each rat for five minutes. The magnetic field, comparable to that produced by existing MRI machines, but one-tenth as strong, magnetized both the stents and the nanoparticles, and drove the particles into the stents and the nearby arterial tissue.
The researchers inserted stents and nanoparticles into a group of control rats, but without using a magnetic field. Five days after receiving the nanoparticle infusion, the magnetically treated animals had four to 10 times as many particles in their stented arteries as the control animals.
Moreover, using magnetic fields to concentrate the treatment had a lasting effect. Fourteen days after using the magnetic field and a single dose of magnetic nanoparticle-encapsulated paclitaxel, the researchers found the rat arteries had significantly lower restenosis than found in arteries of control rats that had no magnetic treatment.
Over the past several years, Levy and colleagues have shown similar proofs of concept in other animal studies, using magnetically guided nanoparticles to deliver gene therapy and therapeutic endothelial cells to arterial stents. The technique is versatile, Levy says, adding that it could also deliver a broad range of effective therapeutic agents.
Stents and magnetic fields might also deliver combination therapies. Nanoparticles could carry different agents simultaneously or at different times. Since the stents remain in place, physicians could retreat patients, delivering therapeutic agents through catheters under magnetic guidance. Because the magnetic effect concentrates its delivery package at the specific site of a stent, physicians could achieve stronger effects with lower overall doses of a given agent. Contributing to the technique's efficiency, the polymer-based nanoparticles provided sustained drug release over the 14-day course of the study.
Levy envisions a future therapy called vascular magnetic intervention, in which a patient would receive regular treatments from a vascular surgeon or interventional cardiologist who delivers doses of therapeutic nanoparticles under a low-level, uniform magnetic field.
Although currently stents are primarily used for heart patients, Levy cited a great unmet need among the millions of patients with chronic peripheral artery disease. In diabetes patients with poor circulation, for example, drug-eluting stents have had "disappointing results," Levy says, because leg arteries are larger than coronary arteries, and insufficient drug doses are included in the stent coating. "Our technique offers opportunities for a novel approach in which we can vary doses and repeat the treatments," he adds.
In children, stents are used to mechanically enlarge anatomic structures for conditions such as peripheral pulmonary artery stenosis, the heart defect coarctation of the aorta, and atrial septal defects created by interventional techniques to provide oxygenated blood. Levy suggests the magnetically guided nanoparticles might deliver drugs that could improve the outcomes in each of these settings, as well as a number of other stent-based interventions used in pediatric cardiology.
For the magnetically-guided nanoparticles that Levy studies, potential clinical applications are still in the future, but possibly not too distant. He expects to partner with clinical researchers in the next few years to bring vascular magnetic intervention closer to clinical reality. "This technique is poised to become a new platform for interventional therapies that could be safer and more effective than the current treatments," he said. References- http://www.labspaces.net/103231/Magnetic_fields_drive_drug_loaded_nanoparticles_to_reduce_blood_vessel_blockages http://www.pharm-education.com/2010/04/nanotechnology-in-pharmaceutical.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
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 Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in 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. Who's regulating nanotechnology? Nanotechnology and its applications are so small that it can be hard to get your head around, but there are more than 1,000 products with nanomaterials already on the market, so we'd better get a handle on this quick. Nanoscale science and technology manipulate matter at the level of 1-300 nanometers (or billionths of a meter) and claim a seemingly amazing array of applications for medicine, technology, energy and food. Pulitzer Prize-winning reporter Andrew Sheider's recent investigative series "The Nanotech Gamble" lays bare the potential health and environmental risks and extent to which largely unregulated nanotech products are already on the market, and in the food supply, without our knowledge.Given the risks and speed with which nanotechnology is entering the marketplace, U.S. states are starting to explore what they can do in light of federal inaction. In testimony before the Minnesota state legislature, IATP's Steve Suppan outlines the regulatory holes at the Food and Drug Administration and the Environmental Protection Agency, which thus far have largely given nanotechnology a free ride. On April 15, the University of Minnesota hosted Governing Nanobiotechnology: Reinventing Oversight in the 21st Century. Academics, private industry, public interest representatives and government regulators grappled with the particular regulatory challenges posed by nanotechnology (videos of presentations coming soon).As Steve points out in his testimony to state legislators, traditional regulation targets pollutants partially in terms of volume: that approach won't work for nanotechnology. "The quantity of nanomaterials that may cause environmental and/or public health harm will be much smaller in volume than what [...] has traditionally been inventoried. Prioritizing when and where to monitor pollutants will be a difficult task because potential risks of nanomaterials are not indicated simply by their size but also by their configuration and shape."When scientific advancement overtakes our ability to regulate it's time to take a step back. The U.S. government's National Nanotechnology Initiative spent an estimated $1.8 billion developing new nanotech products in 2009. Little more than one percent of that taxpayer investment is dedicated to research to protect consumers and nanotechnology workers from potential environental, health and safety hazards of nanotechnology products. This is an unacceptably nano-sized start to a huge regulatory challenge.Nanopatch tipped to replace syringe : Researchers have used nanotechnology to discover a far more effective and less painful vaccination technique than the syringe. University of Queensland Professor Mark Kendall's bio engineering and nanotechnology team have developed the Nanopatch - which uses 100 times less vaccine than a syringe and is smaller than a postal stamp. The patch is tipped to revolutionise vaccination programs in both industrialised and developing nations, which must overcome issues with vaccine shortages and distribution. Prof Kendall said being both painless and needle-free, the Nanopatch offers hope for those with needle-phobia, as well as improving the vaccination experience for young children. "The Nanopatch targeted specific antigen-presenting cells found in a narrow layer just beneath the skin surface and as a result we used less than one-hundredth of the dose used by a needle while stimulating a comparable immune response," Prof Kendall said, "Our result is 10 times better than the best results achieved by other delivery methods and does not require the use of other immune stimulants, called adjuvants, or multiple vaccinations." He said developing nations would particularly benefit as it does not need refrigeration and can be administered by non-professionals. Despite its small size, the Nanopatch comprises several thousand densely packed projections invisible to the human eye. The influenza vaccine was dry coated onto these projections and has already been tested on the skin of mice. "By using far less vaccine we believe that the Nanopatch will enable the vaccination of many more people, Prof Kendall said, "A government might provide vaccinations for a pandemic such as swine flu to be collected from a chemist or sent in the mail." Prof Kendalls team includes researchers from UQ's Diamantina Institute for Cancer, Immunology and Metabolic Medicine and Faculty of Health Sciences, as well as the University of Melbourne. He said after about five years worth of work the project was at about the halfway point of hitting the market, with the next stage to be human clinical trials. "To the public this might seem like a long time, but in the vaccine world this is quite quick," he said. References-http://news.smh.com.au/breaking-news-national/nanopatch-tipped-to-replace-syringe-20100424-tjsl.htmlhttp://www.tcdailyplanet.net/blog/iatp/whos-regulating-nanotechnologyhttp://www.pharm-education.com/2010/04/nanotechnology-new-tool-in.htmlDisclaimer- 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?
 Dr.Shruti Bhat, an Leader, Pharmaceutical R&D and expert in product development for 35 different theraoeutic class of drugs moeities, brings to you some highlights from current pharma and clinical research news, views and data. Results From First Progeria Drug Trial Expected Soon.The Pittsburgh Tribune-Review reported that only 16 "children in the United States" are currently battling progeria, but the majority of those "kids live only to age 13; almost all die from heart attacks or strokes." In 2003, the "National Institutes of Health announced" that a "gene that causes progeria" had been identified, a discovery that led to the "first progeria drug trial." Started in 2007, the study, which "involves 28 children, ages three to 18, from 16 countries," concluded in December, with investigators now ready to reveal findings regarding FTI, a drug that was "initially intended to treat cancer." Meanwhile, researchers are also conducting a "triple-drug trial" that focuses on "two a dditional drugs" -- pravastatin and zoledronate. Brain Cancer Vaccine May Benefit Patients Who Are Not Newly Diagnosed. The Cleveland Plain Dealer reported on a brain cancer "vaccine was designed by Dr. Andrew Parsa, principal investigator of the Brain Tumor Research Center at the University of California, San Francisco." Should research on the vaccine prove "successful, patients could conceivably control the disease and prevent a recurrence with regular vaccine booster shots." According to the Plain Dealer, "What makes this vaccine different from other vaccines developed for brain-tumor patients is that this is one of the few immune therapies designed specifically for patients who are not newly diagnosed." FDA Warns Companies Against Claiming Dietary Supplements Can Prevent, Treat H1N1. The Food and Drug Administration is warning four companies, including two in Florida, to stop marketing dietary supplements they claimed can prevent or treat the...swine flu virus, as officials said the products are not drugs approved for that use. The products, "being sold online," include "creams, hand sanitizers and pills." One company is even "marketing a 'miracle mineral supplement' it claimed could treat malaria, colds, flu and pneumonia; and several dietary products" said to "prevent cancer or 'attack cancer cells.'" FDA Says Highest Available Dose Of Zocor May Cause Muscle Damage. The FDA "said Friday the highest available dose of Zocor [simvastatin]...can cause muscle damage as well as severe and potentially lethal kidney damage”, in a statement, said, "Although muscle injury ... is a known side effect with all statins, the warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of this drug." The "Booster Shots" blog reported that "the risk is highest in patients of Chinese descent and is also high when Zocor...is combined with certain other medications, including amiodarone, niacin, and diltiazem." One study "comparing 6,031 patients taking 80 mg daily with 6,033 patients taking 20 mg. found 52 cases of myopathy in the 80-mg group and only one in the 20-mg group." That study also found that "11 patients taking the 80 mg dose developed rhabdomyolysis, the most serious form of myopathy which can lead to kidney failure and death, where as none of those on the 20mg dose developed the condition". More at http://www.pharm-education.com/2010/04/results-from-first-progeria-drug-trial.htmlDisclaimer- 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?
 Dr.Shruti Bhat, an Leader,Pharmaceutical R&D and expert in oncology product development, brings to you some highlights from current pharma and clinical research news, views and data. Many Oncologists Say Drugs Aimed At Disabling Proteins Are The Future Of Cancer Therapies. The New York Times reported that "drugs aimed at disabling proteins that spur cancer are, many oncologists say, the future of cancer therapies." However, "these so-called targeted therapies are only as good as tests to find their protein targets." The article also discusses HER2 tests and the "HER2 testing guidelines by the College of American Pathology and the American Society of Clinical Oncology," which dictate "criteria for declaring a test positive or negative and requiring proficiency testing, among other things." Diabetes Drug May Help Reduce Lung Tumors. The Los Angeles Times "Booster Shots" blog reported, "Metformin, a safe and inexpensive drug widely used to lower blood glucose in type 2 diabetics, may have a variety of other uses, researchers are finding." For example, "at an American Society of Clinical Oncology meeting on genitourinary cancers last month, Dr. Cristiano Ferrario, of McGill University in Montreal, Canada, reported that metformin could inhibit the growth of prostate cancer cells in the laboratory." The latest discovery involved lung cancer prevention and researchers at the National Cancer Institute. The group "treated mice with metformin for 13 weeks after exposing them to a chemical derived from nicotine," HealthDay reported. "The drug reduced lung tumors by 40 percent to 50 percent when given by mouth and by 72 percent when given by injection." Lead Researcher Dr. Phillip A. Dennis "said the levels of the drug given to mice would be easy to reach in humans." Statins May Not Lower Risk Of Colorectal Cancer.
HealthDay reported that "statins don't lower the risk of colorectal cancer, and may even increase the chances of developing precancerous polyps," according to a study published in the journal Cancer Prevention Research. The investigators "found that patients who had been in the placebo group and who used statins at any time were no less likely to develop adenomas over a five-year period, compared with those patients who never used statins." Among "those who took statins for three years or longer, the chances of developing the adenomas were nearly 40 percent higher than those not on statins." Tailored Treatment Based On Tumor's Molecular Traits May Improve Lung Cancer Survival. The Wall Street Journal reports that tailoring treatment based on a tumor's molecular features may improve survival in lung cancer patients, according to a study called Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) presented at the annual meeting of the American Association for Cancer Research. The patients' "tumor samples were tested for cancer biomarkers, including mutations to a gene called KRAS and EGFR, or epidermal growth factor receptor, a cell-signaling protein that causes cancer cells to grow and divide." Some patients were "assigned to one of four drugs without regard to their biomarkers." Other patients "were assigned to drugs based on their particular tumor biomarkers, taking into consideration how people in the first group with similar biomarkers were faring." The Houston Chronicle reports that altogether, the University of Texas MD Anderson Cancer Center researchers "found 46 percent of patients gained 'disease control,' nonprogression of a tumor seen as an indicator of survival, after two months of targeted treatment, compared with untargeted therapy's 30 percent disease control rate in advanced lung cancer patients historically." Certain drug-tumor match-ups seemed especially effective. One of the best -- and somewhat surprising -- results came when Nexavar [sorafenib] was used in conjunction with a KRAS mutation. In that case, 61 percent of patients treated had disease control at two months. Meanwhile, "the rate for patients with a KRAS mutation who got one of the other drugs was just 32 percent." FDA Okays Tarceva As Initial Maintenance Treatment For Most Common Form Of Lung Cancer. OSI Pharmaceuticals Inc. won approval from US regulators to expand the use of its Tarceva [erlotinib] drug as an initial maintenance treatment for the most common form of lung cancer. In 2004, the drug "was approved...for patients whose non-small lung cancer...gets worse after chemotherapy." Yet, "Tarceva received a positive opinion in March for use as first-line maintenance from the European Union's Committee for Medicinal Products for Human Use." Notably, a panel of outside advisers voted against approving the drug for such use, because they maintained patients experienced moderate gains, Other Gene Mutations May Inhibit Colon Cancer Drug's Effectiveness. Amgen Inc.'s Vectibix [panitumumab], a drug for colon cancer, may be useful to even fewer patients who suffer from that illness than scientists previously found," according to a new study. "Previous research showed that Vectibix doesn't work in about 40 percent of colon cancer patients who have certain mutations in a gene called K-RAS." The new company-funded analysis, however, "found that an additional 14 percent have other gene variations that also keep them from being helped by the drug." Those who carry a mutated version of NRAS failed to benefit from the drug. Investigators also implicated a second gene -- BRAF -- but further study is warranted. Now, says Amgen's Dr. David Reese, "We have to identify the patient population that will benefit from the drug." http://www.pharm-education.com/2010/04/many-oncologists-say-drugs-aimed-at.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.TouTube Channel : Http://www.youtube.com/user/ShrutiBhat10Do you have questions for the author?
 Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data. Development of a pharmaceutical product involves several inter-related steps with multiple decisions requiring iterative improvements. Large amounts of information, including the properties of a drug substance, interactions of additives, packing materials, unit operations, equipment, administration modes, environmental impact on product intergrity, logistics etc, have to be gathered and used for decision making during pharmaceutical formulation development.Hence, a systematic model of the associated information is thus needed to streamline the product development process and provide a common foundation to support the information. Following the information-centric tool to enable efficient drug discovery and development research is the buzz for today’s pharmaceutical R&D. Dr. Shruti Bhat, an expert with pharmaceutical formulation development and patenting, through her white paper releases, touching this topic, demonstrates benefit of using an information model through a case study for managing information generated from the preformulation stage of pharmaceutical product development.http://www.pharm-education.com/2010/04/information-modeling-for-pharmaceutical.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.TouTube Channel : Http://www.youtube.com/user/ShrutiBhat10Do you have questions for the author?
 Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data.
Gonorrhea Becoming Increasingly Resistant To Many Antibiotics.
"Gonorrhea may soon reach superbug status, thanks to growing antibiotic resistance," researchers in the UK say. "Choosing an effective antibiotic can be a challenge, because the organism that causes gonorrhea is very versatile and develops resistance to antibiotics very quickly," according to a presentation given at the Society for General Microbiology Spring Meeting this week. Prof. Catherine Ison, of the Health Protection Agency Centre for Infections, added, "The current drugs of choice, ceftriaxone and cefixime, are still very effective, but there are signs that resistance, particularly to cefixime, is emerging, and soon these drugs may not be a good choice." Guidelines Call For Pediatric Drug Studies To Focus On Safety. Drug studies involving children must have a strong emphasis on safety, according to new guidelines issued by the American Academy of Pediatrics.The guidelines call for a "robust plan to monitor safety" and suggest "that a data- and safety-monitoring committee should be in place for all phase III trials, as well as for some phase I and II trials, especially if they involve blinding." In addition, the guideline authors maintain that "investigators should often defer pediatric studies until a drug is in the phase III stage in adults." Glaxo To Offer Free Vaccines To Uninsured Americans. GlaxoSmithKline PLC said Monday it is launching a program in the US to provide free vaccines to adults who don't have health insurance." The vaccines will include "shots for hepatitis A and B, tetanus, diphtheria and whooping cough," and its cervical cancer vaccine Cervarix "also will be included for women between the ages of 19 and 25." The GSK Vaccine Access program "is open to adults ages 19 and up whose income totals no more than $27,075 for a single person or $36,425 for a couple." Pharmaceutical Company To Collaborate With NCI On Nanotechnology Research. Cranbury-based Cornerstone Pharmaceuticals said it has entered into an agreement with the National Cancer Institute to collaborate on research involving the company's proprietary nanotechnology." Notably, "as part of the collaboration, Cornerstone will apply its novel lipid oil nanoemulsion to a class of anti-cancer agents developed by the NCI's Center for Cancer Research Nanobiology Program." Basal Insulin Requirements May Be Less On Day After Dialysis In Type 2 Diabetes Patients With ESRD. According to a study published March 9 in the journal Diabetes Care, "basal insulin requirements may be less on the day after maintenance hemodialysis in type 2 diabetic patients with end-stage renal disease (ESRD)." After studying 10 such type 2 diabetic patients in whom "intravenous insulin was adjusted every 30 minutes to achieve 5.5 ± 1.1-mmol/L glycemia during the 24-hour period preceding hemodialysis, during the hemodialysis session, and during the 24-hour period after hemodialysis," researchers found "a significant 25% reduction in basal insulin requirements the day after dialysis compared to the day before." Carboplatin May Be Better-Tolerated Alternative For Treating Advanced Ovarian Cancer.
Intraperitoneal (IP) carboplatin might offer a better-tolerated alternative to intraperitoneal cisplatin for treatment of advanced ovarian cancer, results of a preliminary clinical study suggest." Administered "to an AUC of 6 over multiple cycles, IP carboplatin plus intravenous paclitaxel was well tolerated, and three-fourths of patients completed six cycles of therapy, researchers reported at the Society of Gynecologic Oncologists meeting." A second study "reported at the meeting demonstrated the feasibility of combining IP carboplatin with IV carboplatin and IP paclitaxel." Vitamin B6 Appears To Play Role In Preventing Colon Cancer. Vitamin B6 appears to play a beneficial role in preventing colon cancer," according to a paper in the Journal of American Medical Association. After reviewing data from 13 studies, researchers in Sweden "traced the beneficial effects to pyridoxal-phosphate (PLP), the main active coenzyme form of vitamin B6." Although "taking vitamin B6 supplements did not appear to reduce the risk of colorectal cancer, increases in the level of PLP in the bloodstream were associated with an inversely lower risk of colorectal cancer." Once-Daily Treatment Of Itraconazole May Help Treat Onychomycosis. According to a poster presentation at the American Academy of Dermatology meeting, "once-daily treatment with a single 200-mg tablet of the oral antifungal itraconazole (Sporanox) demonstrated noninferiority to conventional treatment with two 100-mg tablets daily" in treating patients with onychomycosis, but "both active therapies resulted in significantly higher rates of complete cure and clinical improvement compared with placebo." Researchers reached this conclusion after randomizing "1,381 patients with culture-proven onychomycosis at a ratio of 3:3:1 to a single 200-mg tablet of itraconazole, two 100-mg tablets, or a single placebo tablet" for 12 weeks of daily treatment, followed by 40 weeks of additional follow-up. More at http://www.pharm-education.com/2010/04/vitamin-b6-appears-to-play-role-in.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.TouTube Channel : Http://www.youtube.com/user/ShrutiBhat10Do you have questions for the author?
 Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data. Scientists Move Closer To Creating Equivalent Of Male Viagra For Women. The Los Angeles Times blog reported that "when Viagra [sildenafil] was first marketed, some sexual health experts suggested that it might work in women as well as men, providing a pharmacological aid for women with low levels of arousal (sometimes termed 'female sexual dysfunction' or 'female sexual arousal disorder')." Women haven't had great success with the little blue pill, however, which suggests "there's something about arousal in male versus female parts that differs physiologically." Now, however, researchers at Pfizer say they've made headway in finding a drug that could help some women with FSAD. According to the article, the breakthrough came courtesy of rabbits. Researchers administered a drug known as UK-414,495 to female rabbits and it appeared to "mimic the human body's natural processes in bolstering" excitement". By specifically blocking the enzyme in the body that checks blood flow to" female genitalia, "the drug could allow for greater blood flow and greater physiological arousal, said Chris Wayman, the lead researcher on the project" that is detailed in the British Journal of Pharmacology. The "drug would not create arousal out of nowhere," but it will "boost blood flow when accompanied by desire and sexual stimulation." What's more, it "will not affect desire, mood, or emotional problems," the UK's Daily Mail (4/14, Ellicott) reported. In short, "this is the first pill that claims to be an equivalent of the male Viagra." Pfizer, however, "will not develop the drug and has said the chemical may not work in the same way in humans,while the particular chemical compound studied in this research did not prove appropriate for further development, the implications of the research could lead to the development of a product in future." Blood Cancer Drug Campath May Help Patients With Multiple Sclerosis. According to research presented at an American Academy of Neurology meeting.reports that "Genzyme Corp.'s blood cancer drug Campath [alemtuzumab] helped patients with multiple sclerosis," The drug "halted the development of disease-related disabilities and prevented relapses in 71 percent of patients in a four-year study, compared with 35 percent with Merck KGaA's competing product Rebif [interferon beta 1a]." InterMune Adds Ritonavir To Second Part Of Hepatitis C Treatment Study.
InterMune Inc. said Wednesday researchers will add a new drug that promises an increased safety margin to a midstage study of a potential hepatitis C treatment after analyzing preliminary results." The company "said the first part of the study paired the experimental treatment, labeled ITMN-191 [danoprevir], with the drugs Pegasys [Peginterferon alfa-2a] and Copegus [ribavirin]," and the "second part of the study will include those drugs and the virus-fighting drug ritonavir." InterMune Chairman and CEO Dan Welch said the combination with ritonavir "appears to deliver strong efficacy and offer attractive advantages of dosing convenience and increased safety margin." Rituximab May Benefit Patients With Myasthenia Gravis. According to a study presented at an American Academy of Neurology meeting, "Rituximab (Rituxan), the anti-CD20 antibody that decreases B-cell activation, slashed autoantibody titers and improved symptoms in patients with myasthenia gravis (MG) refractory to standard therapies," Researchers said that "thirteen MG patients whose disease was not well controlled with moderate steroid doses were able to do better symptomatically and could reduce conventional treatments when rituximab was added to their therapy." High-Dose Aspirin May Provide Acute Migraine Relief. MedPage Today reported, "High-dose aspirin matched a triptan drug for relief of acute migraine," Oxford researchers found after reviewing 13 studies in which 4,222 people received either "aspirin with or without an antiemetic, placebo, or an active comparator, most often sumatriptan 50 mg or 100 mg." A "fourth of patients treated with 900 to 1,000 mg of aspirin, with or without an antiemetic, were pain free after two hours, and half of patients had no more than mild residual pain," according to a paper in The Cochrane Library. "Results for most outcomes were similar for patients treated with sumatriptan." Fidaxomicin May Be As Effective As Vancomycin In Patients With Clostridium Difficile Infection.
Medscape reported, "Phase 3 clinical trial results...show that fidaxomicin is at least as effective as vancomycin (equivalent cure rates) in patients with Clostridium difficile infection (CDI)." The drug was also "associated with significantly lower recurrence rates, particularly in patients infected with the emerging hypervirulent BI/NAP1/027 subtype of C difficile that has proven especially difficult to treat," researchers in Canada explained. Notably, the drug's manufacturer, Optimer Pharmaceuticals, "plans to submit a New Drug Application for fidaxomicin to the US Food and Drug Administration later this year, according to the company website." 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.More at http://www.pharm-education.com/2010/04/blood-cancer-drug-campath-may-help.htmlHttp://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
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 Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data.I've done extensive work within the healthcare sector over the last many years; this is one industry where the rapidity of scientific driven change is simply unprecedented. Think about what is really happening around us, and about what needs to be done:A transformative shift - Personalized medicine drives the agenda: the big picture item is that we are in the midst of a fundamental, significant shift in healthcare philosophy and medical research: from a world in which we “react” to disease and illness after it has happened, to one in which we will be doing far more to “prevent” health care problems through highly personalized medicine. This is primarily coming about because of furious rates of discovery related to genomics. This more than anything will dominate the health care / pharmaceutical research / delivery agenda through the next years.Knowledge growth becomes exponential; pace of innovation / discovery picks up: medical knowledge is now doubling every eight years. Expect it to be doubling every two years by 2010 -- with the result that medical professionals will be struggling to an even greater degree in keeping up than they are today. Research taps out practical results faster than ever before. The key for everyone is tapping into global collaborative discoveries / keeping up / developing agility for rapid innovation, response, development, and implementation. For pharmaceutical and health care suppliers, it's about rapid development and rapid time to market.Discovery moves offshore: for a good chunk of the pharmaceutical industry, the proces of R&D, approval and application will increasingly move offshore, particularly to China / India, due to different regulatory requirements (or lack thereof). Also, such things as stem-cell research limitations, US visa policies and other factors play a factor in the diminishing role of the US as a pharmaceutical industry hub. The pharmaceutical industry will continue to spend a huge amount of time learning to work within the new shifting zones of influence in the world of research.Theory into practice becomes the primary focus; operational excellence is key: already, health care can’t keep up with the rate of scientific discovery: “Because of the rapid discovery of new medical knowledge, you'll get the most up to date treatment today only 50% of the time” is one key stat to remember. Tomorrow, the prime focus in the medical community will be how to ingest and incorporate this new knowledge into practice. In terms of the pharmaceutical industry, the key goal will be “operational excellence,” i.e. ….from the Financial Times 6 Jun article on Roche, “…the Avastin story also highlights a central issue for innovation-led companies: how to make sure advances in the laboratory are brought to market quickly and efficiently.” There’s a whole line of thinking emerging in that article and elsewhere that puts into perspective that collaborative excellence in managing complex teams is quickly becoming a key and critical success factor. Skills fragment and a battle for skills drives decisions: hyper-growth in knowledge and new medical discoveries means that every medical profession is becoming more specialized, leading to a greater degree of niche-oriented medical skills than we see today. In the pharmaceutical industry, small biotech companies will continue to dominate the research agenda over big-pharma, by focusing on ever tighter niche markets, as well as by discovering disease-oriented drugs based on specific genetic markers. Skills fragmentation results in challenges, but so does the looming baby boomer retirement wave. A war for medical talent drives much of the agenda of the industry by 2010, and the battleground is global in scope. Complexity partnerships take on an increasing role: because of the skills crisis, rapid discovery, need for operational excellence, knowledge growth and discovery, big/medium the pharmaceutical industry will continue to look to shed additional component pieces of the discovery / regulatory approval process; outsourcing takes on a whole new meaning.Bio-informatics emerges, core competence becomes critical: Microsoft estimates that at least 50,000 people worldwide are working in the field of bio-informatics – the folks who are developing the highly sophisticated computer databases and computational methodologies that can do the billions of measurements on an individual patient that is leading us into the era of personalized medicine. Bio-connectivity becomes the next big thing: a new generation of intelligent, Internet-connected medical devices flood the industry, providing new opportunities for monitoring and management of difficult health care conditions. Furious pace of innovation occurs here as consumer tech trends (collapsing product lifecycles) come to medical devices and medical technology. Hospitals get “de-physical”, customer service comes to the industry: today, a health care institution is thought of as the building or campus that makes up its constituent parts. Tomorrow, it will be defined by the reach of its virtual network, and the hospital will be thought of as the extended community network by which a good portion of its services are provided. Walmart is coming to health care; the Minute-Clinic business model and others like it mean that we are seeing a revolution in customer service come to the industry.Generational attitude transforms the system: the entrance of Gen-Y -- kids who are in 2005 aged 15 -- into the health care system -- will bring a flood of new ideas, innovation and new ways of thinking helping to break some of the organizational sclerosis that has clogged up the opportunity for change in the world of health care. http://www.pharm-education.com/2010/03/walmart-coming-to-healthcare-how-do-we.html
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 Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data. Thalidomide May Help Treat HHT. A team from the National Institute of Health and Medical Research (Inserm) reported in the journal Nature Medicine, that, Thalidomide, the sedative blamed for tragic birth defects half a century ago, treated a rare inherited blood disorder," called hereditary hemorrhagic telangiectasia, or HHT, "according to lab experiments reported on Sunday." The researchers, "experimenting on mice genetically engineered to have HHT, found that thalidomide reduced the risk of haemorrhage and stabilised blood vessels. The drug works by boosting a protein called PDGF-B. Some Tumor Cells May Develop Transient, Non-Genetic Form Of Drug Resistance. Researchers have discovered that tumor cells under treatment can develop a transient and non-genetic form of drug resistance," according to a study appearing in the journal Cell. They examined "a mutant cell line of non-small cell lung cancer that is very sensitive to tyrosine kinase inhibitors that target the epidermal growth factor receptor," finding that "a small fraction" of cells "remained quiescent, but alive" when "exposed to...a drug at high concentrations." But, the study showed that "the drug-resistant cells had elevated expression of the gene for a chromatin-modifying enzyme called KDM5A." The researchers concluded that "blocking the activity of the protein might offer a pharmacological opportunity to improve cancer therapy." Aspirin May Reduce Migraine Pain Within Two Hours. "Taking an aspirin can reduce the pain of a migraine headache within two hours for over 50% of people," a paper in the Cochrane Library Review revealed. After looking at data culled from 13 studies, researchers in Oxford "found that a single dose of aspirin also reduces nausea, vomiting, and sensitivity to light or sound -- other symptoms of a migraine." The study co-author Sheena Derry reported that, "My advice for sufferers would be to try aspirin or other over the counter medicines as a first choice and then go on to more migraine specific drugs if these do not work." She added, "We are also planning to carry out similar studies on other painkillers, such as ibuprofen and paracetamol [acetaminophen], because we still do not know how affective they are at treating migraine." FDA Phasing Out Production, Sale Of CFC Asthma Inhalers. The Los Angeles Times "Booster Shots" blog reported, "The Food and Drug Administration said Tuesday it is taking a long-expected step and phasing out the production and sale of asthma inhalers using chlorofluorocarbons as a propellant." Indeed, "four of the seven devices using CFCs are no longer being made, but they are being banned to prevent their reintroduction," and the "rest will be forbidden after the end of 2013." Notably, "most uses of the chemicals have already been abandoned," because they "have been shown to damage the Earth's ozone layer." Certain Painkillers May Help Reduce Ovarian, Breast Cancer Risk.
A study published in the April issue of Cancer Epidemiology, Biomarkers & Prevention found that "postmenopausal women who regularly take" nonsteroidal anti-inflammatory "painkillers have lower estrogen levels than nonusers...which might explain a decreased risk of breast or ovarian cancer among these women." Examining 740 postmenopausal women who participated in the Nurses' Health Study, researchers found the level of estrogen was reduced "12 percent to 15 percent, depending on which estrogen form was evaluated." Margaret Gates, a research fellow at the Channing Laboratory at Brigham and Women's Hospital and Harvard Medical School, Boston, speculated that this may be due to the painkillers inhibiting the expression of aromatase, which converts testosterone to a form of estrogen. TB Treatments Called Outdated. Reports on the 28th World TB Day stated that, methods for treating the disease are very outdated, and tuberculosis still kills far too many people. The Times positively notes recent discussions by the FDA to start testing innovative treatments simultaneously, but points out that TB does not have the advocacy other diseases have. NIAID Director Dr. Anthony Fauci laments the lack of new researchers entering the specialty, saying, "More than a sea change, we need a storm." Statin Treatment Linked To Lower Cardiovascular Mortality In Very Elderly Patients After MI. According to research published in the Journal of the American College of Cardiology. "statin treatment is linked to lower cardiovascular mortality rates in very elderly patients after myocardial infarction, but without an increased risk for cancer mortality," According to the study's authors, "These observations suggest that the protective effect of statin treatment in very elderly patients' post-myocardial infarction is of a similar relative magnitude as that demonstrated in randomized clinical trial for middle-age subjects and that it may in absolute terms be even greater." 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. More at http://www.pharm-education.com/2010/04/are-tb-treatments-outdated-more-than.htmlHttp://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
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