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 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." ... 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... 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... 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... 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... 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... More at 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.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? Add Comment  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," ... 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. ... 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."... 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... 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... 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... 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... 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.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?  What efforts go behind the scene till a new drug hits the market? Do patients benefit? Are they cured? How do we control health care costs? What are the new drugs in the making? To know more, visit http://www.drugsinthemaking.com Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you titles from current pharma and clinical research. Heartburn Drug Renamed To Avoid Medicinal Mix-Ups... Cabazitaxel May Improve Metastatic Prostate Cancer Survival... Hydroxychloroquine May Help Delay Skin Damage In SLE Patients... FDA Approves Pre-Filled Injection Pens Of Somatropin... FDA Approves Weekly Immune-Replacement Therapy... Details of above topics/ data at http://www.pharm-education.com/2010/03/cabazitaxel-may-improve-metastatic.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?  Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data. FDA warns against using four asthma drugs as stand-alones or for extended periods. The Los Angeles Times reported that the FDA "on Thursday called for putting new limits on powerful and long-lasting bronchial drugs" containing both long-acting beta agonists, commonly called LABAs, and inhaled corticosteroids, in "a move designed to lower the risk of complications leading to hospitalization or even death." The agency "said patients should use products containing only the corticosteroids or other asthma-relieving medication whenever possible." Meanwhile, "patients who cannot control asthma symptoms any other way should use LABAs for the shortest possible time, but the drugs should never be used alone in treating asthma in adults or children, the agency said." FDA Clears Drug To Treat Respiratory Symptoms Of Cystic Fibrosis. The Food and Drug Administration has approved for marketing Gilead Sciences, Inc.'s "drug Cayston [aztreonam for inhalation solution] as a treatment for respiratory symptoms of cystic fibrosis, the company said Tuesday." The company "said it plans to make the drug available by the end of next week." The San Francisco Business Times reported that "Cayston, administered three times a day over a 28-day period, treats the bacteria Pseudomonas aeruginosa, which causes mucus to build up in the lungs and digestive tract of cystic fibrosis patients," and which is also "the single greatest cause of death for CF patients." FDA Panel Recommends Approval Of Xifaxan To Treat Hepatic Encephalopathy. A Food and Drug Administration panel "recommended Salix Pharmaceutical's drug Xifaxan [rifaximin] be approved to treat" hepatic encephalopathy, which is "brain damage caused by liver failure." In a 14-to-4 vote, the panel found that "the drug's benefits warrant its approval. In a separate vote, the panel also voted 14-4 in favor of the drug's safety." The agency will consider its panel's vote when it makes a final decision anticipated by Mar. 24. Reuters also noted that the FDA has already approved Xifaxan to treat travel-related diarrhea. Three Major US Drugmakers Create Asian Cancer Research Group. Three major US drugmakers, Eli Lilly and Co., Merck & Co., and Pfizer Inc., said Tuesday they have formed a not-for-profit company in Asia to focus on cancer research and treatments." The Asian Cancer Research Group will "focus on the most commonly diagnosed cancers in Asia, including lung and gastric cancers." The companies aim to "create an extensive database that will be made available to researchers." 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. Also at http://www.pharm-education.com/2010/02/three-major-us-drugmakers-create-asian.html http://www.drshrutibhat.com Expert at leading Pharmaceutical R&D. Translates innovative concepts to PROFITS. Do you have questions for the author?  The pharmaceutical business is yet another dynamic venture, present globally and extremely important to research scientists, investors and the entire community at large. As in any other business, the success of any pharma company lies on 2 factors- investment potential and risk taking ability. In addition, the R&D portfolio becomes a huge numerator to ensure successful profit quotient. So what efforts go behind the scene till a new drug hits the market? Do patients benefit ? Are they cured? How do we control health care costs? What are the new drugs in the making? Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data. Aspirin may boost survival, cut risk of recurrence in breast cancer survivors. A new study says breast cancer survivors who take aspirin regularly may be less likely to die or have their cancer return." The researchers found that "women who had been diagnosed with early breast cancer and who just happen to be taking aspirin, somewhere between two and five days, had a 50% reduction in dying of the breast cancer." In women who took "aspirin just once a week, there was no benefit," but, those who took "aspirin two to five times a week" experienced a 71 percent reduction in dying from a return of the cancer. ... Discovery Laboratories to run additional preclinical trials for respiratory stress syndrome drug. Following discussions with the FDA, "Discovery Laboratories Inc. said Tuesday it won't have to run new clinical trials of its respiratory stress syndrome treatment Surfaxin [lucinactant], which could save the company money and help get the drug approved sooner." ... Additional trials may underscore prostate cancer drug's early successes. Further tests have underlined abiraterone's "potential" as a prostate cancer drug, and "larger trials are underway." ... Statins may increase diabetes risk. According to a study published online Feb. 17 in The Lancet, statins may increase the risk of developing diabetes. After analyzing 13 studies of statins encompassing "more than 90,000 patients," researchers found that "the risk" for developing diabetes is "tied to the entire class of medications, and the danger increases with age." ... Botox may help prevent some types of migraines. Allergan Inc.'s Botox [botulinum toxin type A], given in the doses used to reduce facial wrinkles, may stop certain kinds of migraines that patients describe as crushing or 'eye-popping' more than other types," according to research published in the Archives of Dermatology. .... Details at- http://www.pharm-education.com/2010/02/aspirin-may-boost-survival-cut-risk-of.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. Clinical research updates on new drugs 02/12/2010
FDA does not approve Ofirmev due to manufacturing site issues. Reuter’s reported, "A pain and fever drug," called Ofirmev (intravenous acetaminophen), "being developed by Cadence Pharmaceuticals was not approved by federal regulators because of manufacturing problems at a facility where the drug is made, the company said Thursday." The FDA said it will not approve the drug until the issues are resolved. "Cadence said the FDA inspected a third party manufacturing facility on Friday," and the company "plans to meet with the FDA to make sure the problems have been addressed." It is stated further that, the FDA did not cite any safety or efficacy issues for the drug or require any additional studies to be conducted prior to approval. FDA approves heat-stable version of Norvir. Abbott Laboratories reported that it received Food and Drug Administration approval for a heat-stable version of the HIV treatment Norvir [ritonavir]." The approval is for a new formulation of the drug that "allows it to be stored at room temperature rather than in a refrigerator." Taspoglutide may reduce sugar levels when compared with or added to other treatments. Roche Holding AG declared results from five late-stage clinical trials show that its experimental diabetes drug taspoglutide reduced blood sugar levels when compared with or added to widely prescribed treatments." Roche said in a statement that the drug met the main goal of studies comparing it to Lantus (insulin glargine injection), Byetta (exenatide injection) and Januvia (sitagliptin), as well as trials where it was combined with metformin and against placebo. Additionally, taspoglutide was found to be generally well tolerated in all five trials, and the most frequently reported side effects were nausea and vomiting. Few women taking tamoxifen for breast cancer prevention. A study, appearing in the February 2010 edition of Cancer Epidemiology, Biomarkers & Prevention,Gardner) reported that, "despite the fact that experts have known since 1998 that tamoxifen can cut the risk of developing breast cancer by almost 50 percent," a recent study found that "only a tiny fraction of women at high risk of developing breast cancer take tamoxifen to prevent the disease." Looking at data on about 10,000 women from 2000 and 2005,. Researchers found that "only about 0.2 percent of US women aged 40 to 79 took tamoxifen to prevent breast cancer" in 2000. "In 2005, the prevalence was even lower -- only 0.08 percent." Researchers "did not say specifically how many of the women taking tamoxifen were at high risk for breast tumors." Tamoxifen use linked to lower cognitive test scores. According to a study appearing in the February Journal of Clinical Oncology, tamoxifen appears to affect cognitive abilities, including some types of memory. After a year of taking tamoxifen (Nolvadex), women in the study scored lower on tests of verbal memory functioning and other cognitive skills than did women taking another breast cancer drug, exemestane (Aromasin). Still, researchers "emphasized that it's important to keep the study results in perspective, noting the life-saving benefits of tamoxifen. Statin users may continue to suffer muscle pains long after stopping the drugs. According to a study published in the New England Journal of Medicine. Researchers found that patients experiencing muscle pain and weakness as a result of statin treatment may continue to suffer symptoms long after stopping the drugs. Nearly a third of patients who stopped statin treatment because of neuromuscular symptoms still showed myalgia six months later, and creatine kinase levels above 200 units/L persisted in 17%. The researchers suggested that creatine kinase measurements at the start of statin therapy could help identify patients with underlying neuromuscular diseases." Twice weekly etanercept may provide benefits for skin but not joints. According to a study published Feb. 2 in the BMJ, "twice weekly treatment with 50 mg of etanercept appears to be superior to once weekly treatment for the clearance of skin lesions in patients with psoriasis and psoriatic arthritis," but "there was no significant difference between the two etanercept regimens in the treatment of joint symptoms." Researchers arrived at those conclusions after studying "752 patients with both psoriasis and psoriatic arthritis who were randomly assigned to receive etanercept 50 mg twice weekly (n=379) or 50 mg once weekly (n=373) for 12 weeks by subcutaneous injection." Also at http://www.pharm-education.com/2010/02/clinical-research-updates-on-new-drugs.html Disclaimer- The information posted here is for knowledge purpose only and should not be considered as medical advise. Expert opinion should be sought for individual case matter. February 10, 2010 news room bring Bad news for GSK and generics manufacturers of Paxil ! A report appeared of a new study published in BMJ (the British Medical Journal) linking antidepressant paroxetine (marketed by GSK as Paxil) with increased mortality rates in breast cancer patients over the age of 66. The observational study, conducted by a team at the Sunnybrook Health Sciences Centre in Toronto, looked at data on 2,430 patients treated with tamoxifen for breast cancer along with a single SSRI (selective serotonin reuptake inhibitor) for depression. The women were all 66 or older, and all were from the province of Ontario. Those taking paroxetine for 25 percent of the duration of their tamoxifen treatment had a 24 percent increase in risk of death from breast cancer. Patients taking paroxetine for 75 percent of the duration saw their risk jump to 91 percent. The researchers report that these percentages were confined to paroxetine; other SSRIs, like fluoxetine (Prozac) and sertraline (Zoloft) had no effect on mortality rate. David Juurlink, a member of the research team, explained that the discrepancy comes from paroxetine’s method of reuptake inhibition. While the other SSRIs settle for temporarily inhibiting a particular enzyme (CYP2D6), paroxetine’s effect is not reversible. Unfortunately, CYP2D6 is essential for metabolizing tamoxifen, so with paroxetine permanently inactivating this enzyme, the cancer-fighting drug is essentially neutralized. “There’s been a suspicion for years about possible negative effects of paroxetine on drugs like these,” Juurlink said. “This is the first study to actually quantify it.” The data excluded women younger than 66 for the simple reason that data sets are much less complete—or nonexistent—for those populations in Canada. However, Juurlink believes physicians will (and should) discontinue using paroxetine for all patients being treated with tamoxifen, and is confident that further studies on younger populations will yield similar results. “You’ll soon see warnings from the FDA and Health Canada, which have already been sniffing around this for a while,” he predicted. Also at http://www.pharm-education.com/2010/02/study-links-paxil-to-breast-cancer.html Disclaimer – This information is for knowledge purposes only and should not be considered as medical or legal advise. Expert consultation should be sought for your individual query related to this topic. Stevioside associated with inhibited artherosclerosis in obese, insulin-resistant mice. According to a study published online in the International Journal of Obesity, "stevioside treatment was associated with increased adiponectin and insulin sensitivity and improved antioxidant defense in both the adipose tissue and the vascular wall, leading to inhibition of atherosclerotic plaque development and inducing plaque stabilization." After treating "14 mice...with 10 mg/kg stevioside and 20 with placebo for 12 weeks," researchers found that "stevioside treatment...lowered levels of glucose and insulin, improved adipose tissue maturation, and increased glucose transport, insulin signaling and antioxidant defense in white visceral adipose tissue, compared with placebo," and "reduced plaque volume in the aortic arch. "Shire Plc's Replagal [agalsidase alfa] provided 'substantial and sustained' benefits to patients with a rare condition called" Fabry disease "after five years taking the enzyme replacement therapy, according to" data collected on 181 multinational patients. In fact, the "drug improved all areas studied, including heart mass and function, kidney function, pain, and quality of life," investigators noted in their paper in The Lancet. However, "advanced complications of Fabry disease do not appear to be fully reversible with treatment and that future studies [should] examine whether early initiation of treatment can improve long-term outcomes more than was evident in the current study." Specific drug combination may be more effective in patient with high HIV viral load. "In patients with a high HIV viral load at the start of initial therapy, regimens based on tenofovir/emtricitabine (Truvada) were more effective than those based on abacavir/lamivudine (Epzicom)," Brigham and Women's Hospital researchers found after evaluating 1,858 patients. "Current guidelines for initial HIV therapy suggest a regimen based on two nucleoside reverse transcriptase inhibitors (NRTIs) and either a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor." While such combinations are "potent," it has "not been clear if they differ in antiviral activity, tolerability, and safety." The new "surprise finding," however, "suggests that physicians should be aware of the difference when prescribing initial treatment for patients with a high level of HIV-1 RNA in their blood," according to the paper in the New England Journal of Medicine. Roche says experimental diabetes drug works better than Januvia. In a clinical trial, Roche Holding AG's experimental diabetes treatment, taspoglutide, worked better than Merck & Co. Inc.'s Januvia [sitagliptin]. In a phase III trial for treatment of type 2 diabetes, the drug met its primary endpoints. Researchers found that the drug lowered blood-glucose levels more than Januvia, and showed superior HbA1c reduction compared to placebo. Pharmaxis says Bronchitol improved lung function in patients with cystic fibrosis. Drugmaker Pharmaxis Ltd. said "its Bronchitol [mannitol] drug improved patients' lung function" in "a study of 170 patients with cystic fibrosis." Researchers found that patients "who switched to the drug after taking a placebo for six months improved by 10.3 percent." FDA rejects approval of Merck's cladribine to treat Multiple Sclerosis. Merck KGaA announced that the FDA rejected approval of its cladribine drug to treat multiple sclerosis. The company sought approval of cladribine as a potential short-course treatment for the condition, but the agency said Merck's application is not adequately complete. Merck intends "to request a meeting with the FDA" to discuss the agency's "concerns with its application for approval," according to a spokesperson. Also at http://www.pharm-education.com/2010/01/clinical-research-updates-on-new-drugs.html Disclaimer – This information is presented for knowledge purpose only and should not be interpreted as medical advise. Post Title. 01/18/2010
Sanofi fails to win preliminary NICE backing for its Multaq heart drug. Sanofi-Aventis SA failed to win the preliminary backing of the UK's health-cost panel for its Multaq [dronedarone] heart medicine after a committee said the medicine isn't more beneficial than standard therapies." The UK's "National Institute for Health and Clinical Excellence's [NICE] independent appraisal committee found that the drug doesn't work as well and costs more than medicines already on the market, NICE said today in an emailed statement and added that "NICE will make a final recommendation on whether the UK's National Health Service should pay for the medicine after a consultation period that ends on Jan. 28 2010. MedImmune responds to FDA inquiry regarding motavizumab. AstraZeneca PLC, the London pharmaceutical that owns MedImmune, said the local subsidiary has filed its formal responses to the Food and Drug Administration's questions about motavizumab, an enhanced version of MedImmune's blockbuster drug Synagis." According to the Business Journal, the drug, which treats respiratory syncytial virus disease in infants, "has hit its share of delays to market." Combination therapy with mirtazapine may be more effective than fluoxetine alone. According to a study published online Dec. 15 in the American Journal of Psychiatry, "mirtazapine used in combination with fluoxetine, venlafaxine, or bupropion is more effective and as well tolerated in treating major depressive disorder (MDD) as fluoxetine alone." After treating "a total of 105 patients meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, criteria for MDD," researchers found that "patients treated with these combinations had mean differences of 4.5 to 4.8 points on the Hamilton Depression Rating Scale (HAM-D) by day 42, compared with those treated with monotherapy." FDA says Aridol cannot be approved in present form. Pharmaxis, Ltd. reported that it has received a so-called complete response letter from the US Food and Drug Administration saying the application for its lung-function test Aridol [mannitol dry powder for inhalation] couldn't be approved in the present form." The agency "cited deficiencies at three manufacturing and testing subcontractors, a labeling issue, and post-marketing requirements, Pharmaxis said in a statement." The company plans to "address the issues and seek approval as soon as possible," Pharmaxis CEO Alan Robertson said. Aridol, which is already "approved for sale in Australia, major European countries, and Korea," is "a lung function test designed to help doctors diagnose and manage asthma by detecting active airway inflammation through measuring airway hyper-responsiveness." Monoclonal antibody may be promising in Ewing's sarcoma. A monoclonal antibody that targets an insulin-like growth-factor receptor (IGF-1R) was well tolerated and demonstrated antitumor activity in refractory Ewing's sarcoma," according to research appearing online in Lancet Oncology. In a study of "29 patients with advanced sarcomas treated with figitumumab," researchers assessed "tumor response...every six to eight weeks by CT, MRI, or both." The study showed that "two patients...had confirmed responses," and eight "had disease stabilization." Researchers found "no cardiac toxicity," and "no substantial change in cardiac valve function or left ventricular ejection fraction," which they said "was noteworthy...because IGF-1R is expressed on cardiac myocytes, and three-quarters of the patients had previously received potentially cardiotoxic anthracyclines." Patients with MDD taking paroxetine may undergo greater personality change. According to a study published in the Dec. issue of the Archives of General Psychiatry, "patients with major depressive disorder (MDD) taking paroxetine underwent greater personality change than those taking placebo, including a significant reduction in neuroticism and a marked increase in extraversion, even after controlling for depression improvement." Researchers arrived at that conclusion after randomizing "240 MDD patients aged 18 to 70 years to receive paroxetine (n = 120), placebo (n = 60), or cognitive therapy (n = 60)," then following them for a year. Notably, paroxetine "appears to have a positive effect on personality that is separate and distinct from its antidepressant effects." Also at http://www.pharm-education.com/2010/01/drug-clinical-research-updates_18.html Disclaimer : The information presented here is for knowledge purpose only and should not be interpreted as medical advise. Cancer drugs : clinical research updates 01/09/2010
Researchers increasingly targeting cellular environments in cancer research. NewYork Times reports that "more and more researchers are studying tumors in their cellular environments," a "major shift in thinking about why cancer occurs and how to stop it." The approach is rooted in the idea "that cancer cells cannot turn into a lethal tumor without the cooperation of other cells nearby," which implies that "cancer might be kept under control by preventing healthy cells around it from crumbling." Drugmakers are also "investigating the way some skin, ovarian, colon, and brain cancers signal surrounding cells to promote cancer growth." Dr. Barnett Kramer, associate director for disease prevention at the National Institutes of Health, noted, however, that such ideas are not new, pointing to a 1962 study in The Lancet that suggested "cancer may be a disorder of cellular organization." Compugen confirms development of cancer treatment target. Israeli drug developer Compugen Ltd. said that it has discovered a potential cancer treatment target using its RNA sequence technology." The company claims to have validated CGEN-671, which "can be used to better tailor treatments to target a wide range of cancers." According to Compugen's research, CGEN-671 "is expressed in more than 75 percent of colorectal and breast cancers, and 50 percent in lung cancers." Teva seeks approval for copy of Amgen's Neupogen. Teva Pharmaceutical "has tired of waiting for the U.S. government to establish a pathway for approval of generic versions of biologic drugs," and has instead decided to seek approval "for its copy of Amgen's Neupogen under the normal branded-drug process." Teva has recently submitted a Biologic License Application "for XM02, its copycat of Neupogen - a drug that stimulates the production of a type of white blood cells in cancer patients." However, "it doesn't mention having tested XM02 in acute myeloid leukemia or severe chronic neutropenia," and is "likely settling for fewer patients in exchange for a more restrictive label." Synta Pharmaceuticals begins mid-stage trial of treatment for gastrointestinal stromal tumors. Synta Pharmaceuticals Corp. Reported that it has started a mid-stage trial of a cancer drug candidate as a treatment for cancers of the digestive tract." The drugmaker will examine STA-9090 in patients with gastrointestinal stromal tumors "who have not responded to treatment with two other cancer drugs, Novartis AG's Gleevec [imatinib] and Pfizer Inc.'s Sutent [sunitinib]." The drug works by inhibiting a protein, Hsp90, which "activates other proteins that cancer cells need to grow. Gefitinib may improve survival among lung cancer patients with EGFR mutations. According to research appearing online Dec. 21 in Lancet Oncology, "Asian patients with lung cancer and epidermal growth-factor receptor (EGFR) mutations respond well to initial treatment with gefitinib." In a study of 177 patients, researchers found that "gefitinib conferred superior progression-free survival time vs. standard treatment with platinum-based combination chemotherapy." The study also showed that "the objective response rate in patients with measurable disease was significantly higher among patients receiving gefitinib," and "the disease control rate was also higher." Findings may help researchers understand how cordycepin inhibits cancer cell growth. According to findings published in the Journal of Biological Chemistry, "scientists have discovered how a promising cancer drug, first discovered in a wild mushroom, works." Researchers found that the drug cordycepin "inhibits the uncontrolled growth and division of the cells" at low doses by interfering "with the production of mRNA, the molecule that gives instructions on how to assemble a protein." Meanwhile, "at high doses it stops cells from sticking together, which also inhibits growth." The results may help investigators determine which cancers may be treated with cordycepin. Also at http://www.pharm-education.com/2010/01/cancer-drugs-clinical-research-updates.html Disclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise. | The pharmaceutical business is yet another dynamic venture, present globally and extremely important to research scientists, investors and the entire community at large.  ArchivesAugust 2010 Categories |
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