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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. Presented below are updates in Pharmaceutical and clinical research- 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... 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 ... 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 ... 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 ... 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 ... 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 ... More at http://www.pharm-education.com/2010/06/rosiglitazone-metformin-low-dose.html Http://www.drshrutibhat.comExpert 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? Add Comment  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. Presented below are updates in Pharmaceutical and clinical research- Experimental Drug Appears To Shrink Tumors In Lung Cancer Patients With A Certain Genetic Variation. Lung cancer is one of the "hardest cancers to treat," but scientists in South Korea "have made progress in taming" one form. In fact, using a "focused approach," the researchers were able to significantly shrink "tumors...in a majority of patients with ... Investigational Drug May Help Improve Survival In Patients With Advanced Breast Cancer. Eribulin, a chemotherapy drug being developed by Eisai Co. Ltd., may help improve survival in patients with advanced breast cancer, according to a study scheduled to be ... Avastin May Extend Progression-Free Survival In Ovarian Cancer Patients. The cancer drug Avastin [bevacizumab] extends progression-free survival by 39% in ovarian cancer patients." This "study, reported Sunday at a Chicago meeting of the American Society of Clinical Oncology, is also the first to use the drug as first-line therapy for ovarian cancer." The "trial involved 1,873 women with newly diagnosed Stage 3 or Stage 4 ovarian cancer who had undergone surgery to remove as much cancer ... Data Suggest Two Drugs May Be Better Than Gleevec For Patients With Newly Diagnosed CML. Research presented at the American Society of Clinical Oncology meeting and published online in the New England Journal of Medicine suggests that Bristol-Myers Squibb Co.'s Sprycel (dasatinib) and Novartis's Tasigna (nilotinib) may be better than Novartis AG's Gleevec ... Drug Shows Promise In Treating Drug-Resistant Medulloblastomas. An experimental drug, currently called GDC-0449, "has shown promise in treating" drug-resistant medulloblastomas, "a small study unveiled at ... Ipilimumab Nearly Doubles Number Of Late-Stage Melanoma Patients Surviving One Year. An experimental immune therapy may provide a new way to fight advanced melanoma." Specifically, "in a study of two novel treatments -- a therapeutic vaccine called gp100 and an immune stimulator called ipilimumab -- ipilimumab nearly doubled the number of patients surviving one year, found ... . Erbitux Provides No Benefit Among Patients With Early-Stage Colon Cancer. For the second time in a year, researchers have found that a drug that has proved useful in treating advanced colon cancer provides no benefit in the early stages of the disease. It is well known that "cancer drugs are typically tested first in the most advanced cases for ... Adding Everolimus To Herceptin May Benefit Some Patients With Metastatic Breast Cancer. Adding the targeted agent everolimus (Afinitor) to therapy for women with metastatic breast cancer resistant to trastuzumab (Herceptin) results in clinical benefit for ... More at ... http://www.pharm-education.com/2010/06/experimental-drug-appears-to-shrink.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?  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. Presented below are updates in Pharmaceutical and clinical research- Experimental Prostate Cancer Drug Combined With Prednisone/Prednisolone Appears To Reduce Mortality Risk. Bloomberg News reported, "Sanofi-Aventis SA said new data from the late-stage Tropic trial showed that the experimental prostate cancer medicine cabazitaxel combined with prednisone/prednisolone reduced the risk of death by 28 percent, in an emailed statement today." In fact... Drugmaker Proposing Shortened Research Path For Cholesterol Drug. Bloomberg News reported that Karo Bio AB, "a Swedish pharmaceutical company with no products on the market," is currently "hatching a drug-testing shortcut to catapult its experimental cholesterol pill," called eprotirome, "into a potential $1.3 billion-a-year ... FDA Warned At Least 43 Drug Plants In Recent Months Over Manufacturing Practices. USA Today reported that, "At least 43 drug factories supplying medication to thousands of US consumers have received government warnings in recent months for failing to correct shoddy manufacturing practices that may have exposed patients to health risks... Lamotrigine May Be Most Effective Antiepileptic Drug For Older Adults. Medscape reported, "Lamotrigine is the most effective antiepileptic drug (AED) in older adults with epilepsy, with levetiracetam a close second, according to the results of a retrospective review of 10 AEDs reported in the April issue of the Archives of Neurology." The study compared ... Investigational Drug May Suppress Appetite, Lower Blood Pressure. WebMD reported that "an experimental weight loss/blood pressure pill may pack a one-two punch against hunger and high blood pressure...according to new research presented at ... FDA Grants Orphan Drug Status To Potential Type-1 Diabetes Treatment. Dow Jones Newswire reports that the FDA granted Osiris Therapeutics Inc. orphan-drug designation for its stem cell therapy Prochymal as a treatment for type-1 diabetes. The drug is currently in midstage trials, and Osiris is seeking approval for multiple indications. Shingles Vaccine Appears To Be Well-Tolerated, But Not Widely Used. MedPage Today reported, "The vaccine against shingles, already shown to be effective, is both safe and well-tolerated, researchers" at the Veterans Affairs New York Harbor Healthcare System "found ... Vitamin A May Improve Response To Standard HCV Treatment. MedPage Today reported, "Early and sustained virologic responses to standard treatment for hepatitis C virus (HCV) infection were markedly improved when patients also received high doses of vitamin A," according to a Japanese study that included 42 participants... More at http://www.pharm-education.com/2010/05/pharmaceutical-r-updates-fda-grants.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 Note : 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?  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.... More at 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 Expert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Do you have questions for the author?  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 ... 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 ... More at http://www.pharm-education.com/2010/04/nanotechnology-new-tool-in.html References- http://news.smh.com.au/breaking-news-national/nanopatch-tipped-to-replace-syringe-20100424-tjsl.html http://www.tcdailyplanet.net/blog/iatp/whos-regulating-nanotechnology 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 Do 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... 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 ... 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 ... 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 ... More at http://www.pharm-education.com/2010/04/results-from-first-progeria-drug-trial.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 Do 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... Dr. Shruti Bhat, an expert with pharmaceutical formulation development and patenting, through her white paper releases... 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.com Expert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. TouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Do 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... 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 ... 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 ... 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... 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... 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... 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 ... 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 ... 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.com Expert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. TouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Do 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'... 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... 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... 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... 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... 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... 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.html Http://www.drshrutibhat.com Expert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. TouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Do 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. 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 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. Do you have questions for the author? | AuthorShruti is a visionary leader,a result-oriented professional and a pharmaceutical scientist targeting path- breaking research and technologies of future.  ArchivesAugust 2010 CategoriesAll |
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