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			Online Research 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 Advisory panel recommends approval of ADHD patch, with restrictions, warnings An advisory panel of the Food and Drug Administration recommended approval of Shire Pharmaceuticals Group Plc and Noven Pharmaceuticals Inc.'s investigational skin patch to treat attention-deficit/hyperactivity disorder, but with certain restrictions and warnings. Panelists said the drug's packaging should include a restriction asking physicians not to consider the patch as a first-line treatment if pills are a feasible alternative. In addition, the patch should carry a warning about the risk of children who use the patch becoming desensitized to methylphenidate. The panel's recommendations came a day after a key FDA staff reviewer said he was against the patch's approval. Reversing his opinion, Dr. Robert Levin said that although he still has some safety concerns, he now is in favor of the patch being approved. "I have reconsidered this (earlier) recommendation for a number of reasons. I think some of the safety concerns remain, but they seem to occur to a lesser degree," Levin said, according to Reuters. The FDA is expected to make a decision regarding the patch later this month, Reuters reported. The once-daily patch, known as the methylphenidate transdermal system, is intended for use in children aged 6 to 12 years. It contains the same active ingredient as Novartis AG's Ritalin (methylphenidate hydrochloride) and several other ADHD drugs. Online Research New safety data added to prescribing information for Epogen, Aranesp, Procrit The prescribing information for Amgen Inc.'s Epogen (epoetin alfa) and Aranesp (darbepoetin alfa) and Ortho Biotech Products LP's Procrit (epoetin alfa) has been updated to include new safety information. "The revised labeling provides updated safety information on reports of pure red cell aplasia and severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin in patients treated with these products," according to the Food and Drug Administration. In letters to health care professionals, Amgen and Ortho Biotech both said the risk-benefit profile of the anemia treatments "continues to be favorable" when they are used "in accordance with the approved prescribing information." The prescribing information for all three erythropoietic proteins now says that if a patient has a sudden loss of response that is accompanied by a low reticulocyte count and severe anemia, "an evaluation for causative factors should be undertaken." If a patient is suspected to have anti-erythropoietin antibody-associated anemia, erythropoietic protein treatment should be suspended. The patients' physicians should then contact Amgen or Ortho Biotech so the companies may "perform assays for binding and neutralizing antibodies." The prescribing information also states that patients who have antibody-mediated anemia should permanently discontinue these therapies and that patients should not be switched to other erythropoietic proteins, "as there is a potential for the antibodies to cross-react." The drugs' dosage and administration sections for patients with chronic renal failure were updated to recommend intravenous, rather than subcutaneous, injection for patients on hemodialysis. According to the FDA, cases of pure red cell aplasia and severe anemia associated with neutralizing antibodies to erythropoietin have predominately been reported in patients with chronic renal failure who received the drugs subcutaneously. Online Research FDA asks for more data on Inspires dry eye treatment Inspire Pharmaceuticals Inc. received a second approvable letter from the Food and Drug Administration for its investigational dry eye treatment, diquafosol tetrasodium ophthalmic solution. In the letter, the agency said the studies submitted by Inspire "fail to demonstrate adequate replication of results for the efficacy endpoints and therefore are insufficient to establish efficacy." The agency added that "consistent findings of corneal clearing need to be demonstrated to support the efficacy of the drug product." Inspire plans to meet with Allergan Inc., who is slated to co-promote the product, and the FDA to discuss the options for its New Drug Application, according to Christy Shaffer, Inspire's chief executive officer. After these meetings, the firm will provide an update, she added. Inspire is currently co-promoting Allergan's Restasis (cyclosporine) ophthalmic emulsion, the only product approved in the United States for dry eye treatment. According to Reuters, Allergan had wanted to include diquafosol in its product line. "We are committed to supporting Inspire's effort to secure approval for diquafosol," said Dr. Scott Whitcup, executive vice president of research and development at Allergan. "Though the development of pharmaceuticals to treat dry eye disease is challenging, we still believe that diquafosol could potentially provide a valuable addition to the spectrum of treatments available to patients suffering from dry eye." Inspire shares closed at $4.90, down $2.53, or 34.1 percent, in heavy trading on the Nasdaq. Online Research Taxotere sNDA for advanced gastric cancer granted priority review Sanofi-aventis Group's supplemental New Drug Application for the use of Taxotere (docetaxel) injection concentrate in combination with cisplatin and 5-fluorouracil in the treatment of advanced gastric cancer was granted priority review by the Food and Drug Administration. The sNDA includes data from the Phase III TAX 325 study, which included 457 patients with advanced gastric cancer. Patients who were treated with Taxotere plus cisplatin and 5-fluorouracil had significantly improved overall survival as compared with those treated with the standard treatment of cisplatin and 5-fluorouracil (median survival, 9.2 months vs. 8.6 months, respectively), sanofi-aventis said. Furthermore, patients in the Taxotere arm had a two-year survival of 18 percent while those in the standard treatment arm had a two-year survival of 9 percent. "Doctors treating patients with gastric cancer urgently need new and more effective therapeutic strategies and better treatment options to help patients with this devastating disease," said Dr. Jaffer Ajani, principal investigator of the TAX 325 study. "If approved, the incorporation of Taxotere into a commonly used chemotherapy regimen may be the most important development in the treatment of advanced gastric cancer in more than a decade." Gastric cancer is the second most common cause of cancer death throughout the world, sanofi-aventis said. The firm added that approximately 870,000 new cases of the disease are diagnosed each year. Once diagnosed, most patients with gastric cancer have advanced disease and are expected to live only six to nine months. In the United States, Taxotere currently is approved to treat breast cancer, non-small cell lung cancer and prostate cancer. Online Research Enzon seeks approval for first-line use of Oncaspar in acute lymphoblastic leukemia Enzon Pharmaceuticals Inc.'s supplemental Biologics License Application for an expanded label for its pediatric oncology product Oncaspar (pegaspargase) was accepted for review by the Food and Drug Administration. The sNDA seeks approval of the drug as a first-line therapy for patients with acute lymphoblastic leukemia. Currently, Oncaspar is approved to treat patients with ALL who require L-asparaginase as part of their treatment regimen, but who have developed hypersensitivity to the native forms of the enzyme. Enzon's sNDA includes data from two randomized studies. The first study, CCG-1962, compared Oncaspar with Merck & Co. Inc.'s Elspar (asparaginase), a native form of L-asparaginase, in the first-line treatment of 118 pediatric patients with ALL. According to Enzon, Oncaspar was associated with a more convenient dosing schedule as well as a lower incidence of neutralizing antibodies and more rapid clearing of lymphoblasts from the bone marrow. The observed advantages of the drug in this study led to its use in the multi-arm CCG-1991 study. Interim safety data from this study, which involves more than 2,000 patients, is included in Enzon's application. Enzon expects the FDA to take action on its sBLA in the third quarter of next year. Online Research Lunesta effective, well tolerated as long-term treatment for insomnia Sepracor Inc.'s Lunesta (eszopiclone) 3 mg appears to provide significant improvements in sleep and daytime function after 12 months of treatment among patients with insomnia, according to a recent trial. In the study, researchers conducted a six-month, open-label extension phase of a prior six-month, double-blind study among subjects with a sleep duration of less than 6.5 hours per night or sleep latency of more than 30 minutes each night. During the initial six-month, double-blind period, 788 subjects received either Lunesta 3 mg/day or placebo. A total of 471 subjects continued to the open-label period, and 382 subjects (81 percent) completed this phase; of these patients, 86 were randomized to placebo and 296 were randomized to Lunesta in the original double-blind study. In the open-label phase, all patients received Lunesta 3 mg/d. The last month of the double-blind period was used as the baseline for the open-label period, and all participants were followed during monthly clinic visits. Between months six and 12, patients initially randomized to placebo experienced a significant decrease in sleep latency, wake time after sleep onset (WASO), number of awakenings and number of nights with an awakening at each monthly follow-up as compared with the baseline month. The researchers also noted significantly increased scores for sleep quality and total sleep time at all monthly time points. Within this group, median sleep latency decreased 47 percent, median WASO decreased 52 percent, median number of awakenings decreased 25 percent and median total sleep time increased 15 percent between months six and 12. Comparable findings were observed for the number of nights awakened per week and sleep quality. The authors observed similar improvements in patients who had originally been randomized to Lunesta. Between months six and 12, median sleep latency decreased 8 percent, median WASO decreased 29 percent, median number of awakenings decreased 19 percent and median total sleep time increased 4 percent. Compared with the pre-study baseline (i.e., prior to the double-blind trial), median sleep latency decreased 55 percent, median WASO decreased 75 percent, median number of awakenings decreased 57 percent and total sleep time increased 33 percent in these patients. "Although the initial response to active treatment appeared to be slightly larger in the [placebo-Lunesta] group versus the [Lunesta-Lunesta] group, these differences were not statistically significant," they noted. With regard to daytime variables, both groups demonstrated significant improvements in daytime alertness, ability to function and a sense of physical well-being at month six and month 12. The study results appeared in the November issue of the journal Sleep Medicine. Online Research Online Research Schering-Plough Corp. Schering-Plough Corp. and Alder Biopharmaceuticals Inc. entered into an alliance under which Alder will use its proprietary yeast production system and high throughput antibody selection system on up to 10 antibody products from Schering-Plough. Alder is eligible for milestone payments, research funds and future royalties on each of the 10 products developed under the alliance. "We believe this alliance will be a model for how Alder can positively impact other companies that are looking for solutions to their antibody manufacturing challenges and ways to identify antibodies where traditional methods have failed," said Dr. Randall Schatzman, chief executive officer of Alder. Online Research Online Research Teva Pharmaceutical Industries Ltd. Teva Pharmaceutical Industries Ltd. said the Federal Trade Commission will not object to the company's proposed settlement with Wyeth regarding Teva's application to market a generic version of Wyeth's Effexor XR (venlafaxine hydrochloride), an extended-release antidepressant. Wyeth and Teva will file motions to request court approval of the settlement, which the two companies agreed on in October. Terms of the settlement were not disclosed. Online Research Online Research Barr Pharmaceuticals Inc. Barr Pharmaceuticals Inc. agreed to pay $139 million to Akzo Nobel NV's human health care business, Organon, to settle a patent dispute and to acquire all rights to Organon's Mircette (desogestrel/ethinyl estradiol) oral contraceptive, which Barr markets a generic version of as Kariva. Barr said its Duramed Pharmaceuticals Inc. subsidiary will promote the oral contraceptive. Savient Pharmaceuticals Inc., which acquired the patents for Mircette, said it also reached a settlement with Barr and Organon in that it received an approximately $13.8 million payment from Barr. Online Research Online Research Idenix Pharmaceuticals Inc. Idenix Pharmaceuticals Inc. said the Food and Drug Administration requested more information from its two ongoing Phase IIb trials studying valopicitabine, formerly know as NM283, in the treatment of hepatitis C. Idenix plans to provide the agency with more data in January. The firm then plans to meet with the FDA to review the data and to discuss the proposed protocol for its Phase III trial. Based on the FDA's request, Idenix expects to finalize the design of a Phase III trial in treatment-refractory patients by the end of the first quarter of next year; it will then being enrolling patients. "We are pleased with the interaction we have had with the FDA to date regarding valopicitabine development," said Jean-Pierre Sommadossi, chief executive officer of Idenix. "We are optimistic that we will continue to advance the valopicitabine clinical program, particularly in view of the serious unmet need in the treatment-refractory patient population in hepatitis C." Online Research


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