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			Regulatory Consultants Brand Institute is the premier full-service branding agency dedicated to strategic and innovative brand naming and identity solutions. We strive to exceed the expectations of every client by combining leading-edge market research with the highest levels of client service, integrity and brand management FDA updates labeling for Ortho-McNeil's Ortho Evra birth control patch The Food and Drug Administration updated labeling for Ortho-McNeil Pharmaceutical Inc.'s Ortho Evra (norelgestromin/ethinyl estradiol) contraceptive patch, warning women that they are being exposed to approximately 60 percent more estrogen than with a typical birth control pill, which could put them at higher risk for blood clots. The FDA said the new labeling includes information about the higher levels of estrogen, but that it was not clear whether women who use the once-a-week product are at a higher risk of serious side effects than women who use the typical 35-mcg estrogen pills. The FDA added that women and health care professionals should weigh the increased exposure to estrogen against the chance of pregnancy if doses are missed with a daily birth control pill. The patch releases ethinyl estradiol, an estrogen hormone, and norelgestromin, a progestin hormone, through the skin into the bloodstream. The patch's manufacturer is conducting studies comparing the risk of developing blood clots in women who use Ortho Evra with the risk in women who use typical birth control pills. The company has submitted results from the initial analysis to the FDA, The Wall Street Journal reported. Since its launch in 2002, the patch has been prescribed to more than five million women and remains safe and effective when used according to the product's label, according to Ortho-McNeil Pharmaceutical. Regulatory Consultants Viventia's Proxinium granted fast track status for head, neck cancer Viventia Biotech Inc.'s Proxinium was granted fast track status by the Food and Drug Administration for the treatment of patients with recurrent squamous cell carcinoma of the head and neck. "Recurrent, refractory head and neck cancer is a devastating and aggressive disease for which there are limited treatment options," said Dr. Nick Glover, chief executive officer of Viventia. "We look forward to working with the FDA to further advance our clinical strategy for Proxinium, which has shown promising early-stage efficacy results in patients with this form of cancer." Viventia noted that most drugs which receive fast track status also receive priority review after a New Drug Application is filed. Last February, Proxinium received orphan drug status for advanced, recurrent head and neck cancer. The drug, which combines a cytotoxic protein payload with a monoclonal antibody's tumor-targeting characteristics, will also be studied in chemotherapy-refractory head and neck cancer. Viventia said its Phase II trial for this indication has been cleared by the FDA and Health Canada. The firm plans to begin the trial by the end of the year. Regulatory Consultants Nexium more effective than Protonix as maintenance therapy following healing of erosive esophagitis AstraZeneca Plc's Nexium (esomeprazole magnesium) is clinically more effective than Wyeth's Protonix (pantoprazole sodium) for healing erosive esophagitis (EE) and maintaining this healing, as well as for providing relief of gastroesophageal reflux disease symptoms, data indicate. Researchers conducted a two-phase, double-blind, randomized study. To enroll in the first phase of the study, patients were required to have EE within the seven days before study randomization, GERD symptoms for at least six months immediately preceding randomization and moderate or severe heartburn at least four days in the week prior to randomization. A group of 3,170 patients with GERD symptoms and endoscopically confirmed EE were randomized to receive Nexium 40 mg or Protonix 40 mg daily for up to eight weeks for the first phase of the study. They were then eligible to enter the second phase of the study, a six-month maintenance phase, if they met the following criteria: they had no EE confirmed at the final endoscopy (four or eight weeks) during the healing phase of the study, they were free of moderate to severe heartburn and acid regurgitation for seven days immediately before entering into the maintenance phase and they had no dysplasia in biopsies. Overall, 2,813 patients were both healed and asymptomatic during the last seven days of the healing phase and continued into the next phase. In this phase, patients were re-randomized with either treatment, regardless of which drug the patients received during the first phase. A total of 2,766 patients comprised the intent-to-treat population, of whom 1,377 patients received 20 mg of Nexium and 1,389 received 20 mg of Protonix each day during the second phase. The percentage of patients in endoscopic and symptomatic remission was significantly greater for patients who received Nexium 20 mg (87 percent) as compared with those who received Protonix 20 mg (74.9 percent) for maintenance. Similarly, the treatment group that received Nexium 20 mg also had a higher proportion of patients free of moderate to severe GERD symptoms and fewer discontinuations because of symptoms as compared with those who received Protonix 20 mg (92.2 percent vs. 88.5 percent). "The results reported here, from the maintenance phase of the large comparative EXPO study, show for the first time that [Nexium] 20 mg is clinically more effective than [Protonix] 20 mg in keeping patients with healed EE in endoscopic and symptomatic remission at six months of treatment irrespective of whether EE was initially healed during therapy with [Nexium] or [Protonix]," the researchers concluded. "In addition, higher healing and subsequent remission rates were also observed for patients who were treated with [Nexium] during both the healing and subsequent maintenance phase (reported here) than for patients who were treated with [Protonix] during both phases of the trial." This study appeared in the first November issue of the journal Alimentary Pharmacology & Therapeutics. Regulatory Consultants Preliminary results suggest Pegasys with Copegus reduces viral levels in patients with HCV who failed previous treatment F. Hoffmann-La Roche Ltd. said preliminary study results show re-treatment with Pegasys (peginterferon alpha-2a) in combination with Copegus (ribavirin) reduced viral levels patients with hepatitis C for whom treatment with Peg-Intron (peginterferon alpha-2b) plus Rebetol (ribavirin) failed. Pegasys and Copegus are both market by Roche; Schering AG markets Peg-Intron and Rebetol. The study assessed the efficacy and safety of different regimens of Pegasys and Copegus combination therapy in 950 patients with HCV who did not generate a sustained virologic response when treated with Peg-Intron and Rebetol. For the first 12 weeks, patients received either a standard weekly dose of Pegasys 180 mcg plus Copegus or a high fixed-dose induction of Pegasys 360 mcg plus Copegus weekly. Since the initial 12-week treatment period, all patients have been receiving the standard dose of Pegasys and Copegus. Forty-five percent of patients treated with the standard dose of Pegasys in combination with Copegus achieved an early viral response (EVR), defined as a significant drop in viral load or no detectable virus. Among the group of patients treated with the higher induction dose, 62 percent achieved an EVR after 12 weeks. "The interim results from this study suggest that previous nonresponders to treatment can still be re-treated with some success, particularly in those treated with the higher dose of Pegasys with [Copegus]," said Dr. Donald Jensen, director of the Center for Liver Diseases at the University of Chicago. "In addition, the interim data show that the high dose of Pegasys is generally well tolerated by patients." These interim study results will be presented on Nov. 14 at the 56th annual meeting of the American Association for the Study of Liver Diseases in San Francisco. Regulatory Consultants Mortality risk among hemodialysis patients lower with Hectorol, Zemplar than with calcitriol, analysis finds Treatment of secondary hyperparathyroidism with Genzyme Corp.'s Hectorol (doxercalciferol ciferol) or Abbott's Zemplar (paricalcitol) is associated with a lower mortality risk than is treatment with calcitriol, new data suggest. Researchers conducted a retrospective analysis of hemodialysis patients at Dialysis Clinic Inc. facilities who initiated treatment with Hectorol (n=2,432), Zemplar (n=2,087) or calcitriol (n=3,212) between 1999 and 2004. Findings demonstrated that the mortality rate, defined as the number of deaths per 100 patient-years at risk, was higher among patients who received calcitriol (19.6) as compared with those who received Zemplar (15.3) or Hectorol (15.4). Results of Cox proportional hazard models indicated that patients who received Hectorol or Zemplar were 18 percent less likely to die than patients who received calcitriol. No difference in survival was observed between patients who received Hectorol and those who received Zemplar. Patients who received treatment with any of the three vitamin D analogues had a survival advantage as compared with those who did not receive any type of vitamin D therapy. "The magnitude of the observed effects of vitamin D type on survival is small," the investigators stated. "Due to a potential survival advantage, the use of either [Hectorol] or [Zemplar] in the treatment of secondary hyperparathyroidism among hemodialysis patients may be preferable to calcitriol. "However, the safety and efficacy of [Hectorol] and [Zemplar] appear to be similar. A randomized control trial is needed to confirm these findings," they concluded. These data were presented as a poster at the American Society of Nephrology's annual meeting in Philadelphia. Regulatory Consultants Seniors uncertain about benefits of Medicare prescription drug program, study shows Many seniors are uncertain how the new Medicare prescription drug benefit program will affect them and are unsure about whether they will enroll, according to a new survey by the Kaiser Family Foundation and the Harvard School of Public Health. The study was conducted between Oct. 13 and Oct. 31 among a nationally representative sample of 802 participants aged 65 years or older. Sixty-one percent of seniors surveyed said they did not understand the drug benefit "too well" or "at all," while 35 percent said they understood it "very well" or "somewhat well." Forty-nine percent said the Medicare drug benefit would not help them personally compared with 39 percent who said it would. Overall, 37 percent of the seniors polled said they do not plan to enroll in a Medicare drug plan for 2006, 20 percent said they plan to enroll and 43 percent said they were uncertain. The survey found that seniors are almost equally divided in their overall views of the drug benefit; 37 percent have an unfavorable view, 31 percent have a favorable view and 31 percent are undecided. Those who reported that they understand the benefit well were more likely to report favorable views. Specifically, 47 percent of those who said they understand the program are in favor of it compared with 21 percent of those who said they do not understand it well. Many seniors who may qualify for additional low-income assistance do not realize it, the findings suggest. Also, most seniors substantially underestimate the number of drug plan choices that will be available. U.S. health officials said the greater number of plans being offered provides seniors with a range of options at affordable prices. "The reason that we have better benefits and lower cost is because of choice," said Dr. Mark McClellan, administrator of the Centers for Medicare & Medicaid Services, Reuters reported. The study's results underline the importance of ongoing education efforts to successful implementation of the new program, according to the Kaiser Family Foundation. Wall Street analysts expect approximately 29 million of the nation's 42 million Medicare beneficiaries to sign up, but some analysts have expressed doubts. Goldman Sachs investment researchers said "enrollment may be disappointing," Reuters reported. Enrollment begins Nov. 15 for the voluntary benefit, which will go into effect Jan. 1, 2006. Regulatory Consultants Regulatory Consultants The Centers for Medicare & Medicaid Services The Centers for Medicare & Medicaid Services announced increased payments that will take effect in 2006. Projected payments to more than 4,200 hospitals for Medicare outpatient services increased 5.2 percent to $27.6 billion in 2006 compared with projected payments of $26.2 billion in 2005. CMS also increased the reimbursement amount for most screening tests performed at hospitals that are aimed at preventive health and early detection of disease. Part B drugs and biologics administered in the hospital outpatient setting will be covered by Medicare payments under the rule. The payment rate for these drugs will be based on 106 percent of the manufacturer's average sales price. Regulatory Consultants Regulatory Consultants Merck & Co. Inc. Merck & Co. Inc.'s next several Vioxx (rofecoxib) trials may involve only patients who took the drug for at least 18 months, according to The Wall Street Journal. The newspaper said that Carol Higbee, the judge who is overseeing 3,500 Vioxx trials in New Jersey, told lawyers "that she wants the next 10 or so trials in her courtroom to involve plaintiffs who took the drug for 18 months or longer." The Journal noted that this would make the company's defense more difficult, as Merck has acknowledged that Vioxx may increase the risk of myocardial infarction when taken daily for at least 18 months. Regulatory Consultants Regulatory Consultants ImClone Systems Inc. ImClone Systems Inc.'s Chief Executive Officer Daniel Lynch resigned "by mutual agreement with the company's board of directors." Dr. Philip Frost, who is currently the firm's chief scientific officer, will serve as interim CEO while the board searches for an external candidate. Frost will continue serving as chief scientific officer as well. Regulatory Consultants Regulatory Consultants Advancis Pharmaceutical Corp. Advancis Pharmaceutical Corp. began its Phase III trial for Amoxicillin PULSYS in adults and adolescents with pharyngitis/tonsillitis due to Group A streptococcal infections. Advancis plans to enroll at least 600 patients and expects to announce the trial's results in the third quarter of 2006. The double-blind, double-dummy, noninferiority trial will compare Amoxicillin PULSYS to the standard comparator therapy of penicillin VK. If the trial is successful, Advancis plans to file a New Drug Application late next year. In September, the company said it would conduct this 10-day trial because earlier seven-day trials had been unsuccessful. Regulatory Consultants


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