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			USAN INN Name 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 Remicade approved as first biologic to treat ulcerative colitis Centocor Inc.'s Remicade (infliximab) was approved by the Food and Drug Administration to treat ulcerative colitis (UC), making it the only biologic drug approved to treat this chronic inflammatory bowel disease, Centocor said. Remicade's new indication includes reducing symptoms and signs, achieving clinical remission and mucosal healing and eliminating the use of corticosteroids in patients with moderately to severely active UC who have inadequately responded to conventional therapy. "This is an unprecedented milestone in the treatment of moderate to severe UC; to date, no therapy has ever been indicated for mucosal healing and eliminating the use of corticosteroids," Centocor said. Remicade is also indicated to treat rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis and is the only anti-tumor necrosis factor therapy indicated to treat Crohn's disease, another IBD, Centocor noted. Remicade's approval for its latest indication was based on data from two Phase III trials, each involving 346 patients with active UC who did not respond to standard therapy. The two randomized, placebo-controlled trials, ACT I and ACT 2, showed that Remicade 5 mg/kg of body weight and Remicade 10 mg/kg met primary and secondary endpoints. According to Centocor, 62 percent to 69 percent of patients in the Remicade groups showed significant improvement in their symptoms at week eight, with similar results reported for both the 5 mg/kg and 10 mg/kg arms. "Not only did many patients in clinical trials experience a significant reduction in the occurrence of symptom flare-ups with Remicade, some achieved clinical remission and mucosal healing as well," said Dr. William Sandborn, director of the IBD Clinical Research Unit at Mayo Medical Center. "This is welcome news for these patients whose only option otherwise may have been surgery to remove their colons." UC affects more than 500,000 Americans, Centocor said, noting that there is no medical cure for this chronic and debilitating condition. Centocor, which discovered Remicade, has exclusive marketing rights to the product in the United States, while Schering-Plough Corp. has the rights to market the drug in the rest of world, except in Japan and in parts of Asia. USAN INN Name Dosing suspended in trial of Genzyme, Schering's MS drug Campath Although a scheduled interim analysis of a Phase II trial of Genzyme Corp. and Schering AG's Campath (alemtuzumab) revealed significantly positive results in patients with multiple sclerosis, the companies suspended dosing of the drug after three patients developed idiopathic thrombocytopenic purpura (ITP). One of the cases was fatal. The open-label trial, which is intended to run for three years and includes 334 patients with active relapsing-remitting MS, is designed to compare the safety and efficacy of Campath, a humanized monoclonal antibody, with that of Serono SA and Pfizer Inc.'s Rebif (interferon beta-1a). Patients have been randomized to receive once-a-year infusion regimens of either low-dose or high-dose Campath or Rebif three times a week. Researchers are investigating two primary endpoints: the rate of relapse of MS symptoms and the time to progression of clinically significant disability. The one-year analysis showed that, compared with patients in the Rebif group, patients in both dosage groups of Campath experienced a minimum 75 percent reduction in the risk for relapse and at least a 60 percent reduction in the risk for clinically significant disability. While results for the first endpoint reached statistical significance, those for the second endpoint did not. To date, 11 patients have experienced serious adverse events; two of the patients were in the Rebif group, four were in the group that received the lower dose of Campath and five were in the high-dose Campath group. The three cases of ITP, which is a condition that results in lower counts of blood platelets, occurred only in patients who were treated with Campath. The two surviving patients with ITP have responded to treatment for the condition. Genzyme and Schering plan to collect data from the Phase II trial and initiate a Phase III trial. Distributed in the United States by Berlex Inc., Campath is already approved in the United States to treat patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and who have not responded to fludarabine therapy. Genzyme and Schering are co-developing Campath for indications in oncology; Schering holds exclusive marketing and distribution rights to the drug. An analyst for Sal. Oppenheimer predicted that the interim results could delay Campath's launch for the MS indication beyond 2010. A spokesman for Schering said the company is not issuing an anticipated launch date or potential sales figures at this time. USAN INN Name BMS' investigational drug Orencia shows benefit in patients with RA Bristol-Myers Squibb Co.'s investigational drug Orencia (abatacept) showed significant clinical and functional benefits in a Phase III trial of patients with rheumatoid arthritis who had inadequately responded to at least three months of anti-tumor necrosis factor (TNF) therapy. Researchers randomized patients, who were stratified according to the use of anti-TNF therapy at enrollment (current vs. former), to Orencia (n=258) or placebo (n=133) in a 2:1 ratio. A total of 99 patients in the placebo group and 223 in the Orencia group completed 24 weeks of therapy. The study's primary endpoints were proportion of patients with an American College of Rheumatology (ACR) 20 response and proportion of patients with a clinically meaningful improvement in physical function, defined as at least a 0.3 improvement from baseline in the Health Assessment Questionnaire (HAQ) disability index, at six months. Patients stopped anti-TNF therapy and then received a fixed dose of approximately 10 mg/kg of body weight of Orencia or placebo in 30-minute intravenous infusions on days one, 15 and 29. Every 28 days after that, up to and including day 141, they received another dose. After six months, 50.4 percent of patients who had received Orencia and 19.5 percent of patients who had received placebo had an ACR20 response, defined as a decrease of at least 20 percent in the number of swollen and tender joints and a 20 percent improvement in at least three specified measures. ACR50 and ACR70 responses were also significantly higher in the patients who took Orencia compared with those who took placebo (20.3 percent vs. 3.8 percent and 10.2 percent vs. 1.5 percent, respectively). The rates of ACR20 response were significantly higher in the Orencia group among current and former users of anti-TNF therapy, the researchers noted. Furthermore, at six months, significantly more patients in the Orencia group (47.3 percent) showed at least a 0.3 improvement from baseline on the HAQ disability index than those in the placebo group (23.3 percent). "Our results provide evidence that [Orencia] is clinically efficacious and has an acceptable safety profile in patients with RA and an inadequate response to anti-TNF therapy," the researchers concluded. The study appeared in the Sept. 15 issue of The New England Journal of Medicine. Earlier this month, a Food and Drug Administration advisory committee recommended that Orencia be approved for certain patients with RA. USAN INN Name Javelins Dyloject superior to Voltarol in patients with postsurgical pain, study shows Final results from a Phase II/III study show Javelin Pharmaceuticals Inc.'s Dyloject (diclofenac) injection demonstrated superior pain relief, faster onset and lower incidence and severity of phlebitis compared with Voltarol (diclofenac), which is marketed by Novartis AG in the United Kingdom, in patients with postsurgical pain. Study data were reported in a press release issued by Javelin. The randomized, head-to-head study, which included a total of 155 patients with postsurgical moderate to severe pain, compared a single dose of Dyloject 75 mg, Voltarol 75 mg or placebo. According to Javelin, Dyloject uses the same active ingredient as Voltarol, but it is given in a single, brief injection as opposed to the 30-minute infusion required for Voltarol. The study met its primary endpoints of total pain relief through four hours and non-inferiority to Voltarol. Secondary endpoint results showed statistically significant superior pain relief during the first two hours compared with Voltarol. Dyloject demonstrated faster onset of analgesia within 15 minutes based on pain intensity and pain relief measures compared with Voltarol, and a significantly greater proportion of patients treated with Dyloject achieved a 30 percent decrease in pain intensity. Also, patients in the Dyloject arm had a lower incidence and severity of phlebitis at the intravenous administration site compared with those who received Voltarol. "Dyloject was less irritating to veins than Voltarol, which translates into convenience and cost savings for postoperative patients whose intravenous sites risk being inflamed or clotted. With growing concerns about the safety of selective COX-2 inhibitors, the nonselective nonsteroidal anti-inflammatory drug Dyloject is a promising alternative based upon an active pharmaceutical ingredient with a large and well-established safety database," said Dr. Daniel Carr, chief executive officer of Javelin. Novartis also markets versions of diclofenac as Voltaren and Cataflam in the United States. USAN INN Name Cardinal Health merges units to improve customer focus Cardinal Health Inc. plans to combine its pharmaceutical distribution, medical products distribution and nuclear pharmacy services businesses into a single operating unit in order to improve customer service and efficiency in their supply chains. The merged units, with more than $70 billion in annual sales, control one-third of all pharmaceutical, medical and laboratory products in the industry that move from drug and medical supply manufacturers to health care providers. The company said it expects that by aligning distribution and supply chain services they will serve the approximately $300 billion U.S. market more efficiently, adding that "[t]he new business also complements Cardinal Health's Integrated Provider Solutions organization, which was formed earlier this year to align the company's sales and marketing resources for hospitals and health-system customers." According to Cardinal Health, the businesses in the new unit represented more than 60 percent of its fiscal 2005 operating earnings. USAN INN Name ICD malfunction rate rising, FDA study suggests The malfunction replacement rate for implantable cardioverter defibrillators appears to be rising, according to a study released by the Food and Drug Administration in an effort "to improve the safety monitoring of implantable cardiac devices and provide earlier notice to doctors and patients of potential problems." Researchers reviewed ICD and pacemaker annual reports, which give the number of devices implanted along with information on malfunctions, submitted to the FDA between 1990 and 2002. A device was considered to have malfunctioned if it was removed due to malfunction, returned to the manufacturer and confirmed by the manufacturer to be functioning incorrectly. Approximately 2.3 million pacemakers and approximately 416,000 ICDs were implanted between 1990 and 2002 in the United States. Of these devices, 8,834 pacemakers and 8,489 ICDs were taken out because of confirmed malfunction. The annual ICD malfunction replacement rate, which was calculated assuming the malfunctioning devices were taken from living patients and replaced with new devices, was significantly higher than the pacemaker malfunction replacement rate (20.7 vs. 4.6 replacements per 1,000 implants, respectively). Additionally, the pacemaker malfunction replacement rate decreased significantly during the study period, while the ICD rate increased markedly toward the end of the study. More than 50 percent of ICD malfunctions occurred in the last three years of the study. In total, ICD or pacemaker malfunctions were directly responsible for the confirmed deaths of 61 patients. "It is important for patients to understand that there is no action that they need to take as a result of this report," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health (CDRH). "It does alert [the] FDA that there is a trend that needs to be addressed and points out the need for our agency to improve the way it regulates these products, and we are doing just that." The FDA said its goals include improving CDRH's ability to get information on device failures and to be able to clearly and quickly present this information to physicians and the public. The agency also hopes to better coordinate the review of information from companies' annual reports and to form task groups to improve communication on problems with these devices, especially ICDs, within CDRH. Other changes are being considered as well and are outlined on the FDA's Web site. Study data were presented at the Heart Rhythm Society "Policy Conference on Pacemaker and ICD Performance," in Washington, D.C. The complete study will be submitted for publication in a medical journal, the FDA said. USAN INN Name USAN INN Name Amgen Inc. Amgen Inc. received approval from the Food and Drug Administration to update the prescribing information for Neulasta (pegfilgrastim). The label now includes data from a Phase III study that demonstrated the white blood cell booster helps protect patients with most types of cancer undergoing moderately myelosuppressive chemotherapy from infection, such as febrile neutropenia, a low white blood cell count with fever. Previously, Neulasta was indicated for patients who receive myelosuppressive chemotherapy associated with a more than 30 percent to 40 percent risk of febrile neutropenia, but now it is indicated for patients who receive chemotherapy associated with at least a 17 percent risk of the condition. "The Phase III study demonstrated that administering Neulasta beginning in the first chemotherapy cycle reduced the incidence of febrile neutropenia by 94 percent," said Dr. Willard Dere, chief medical officer at Amgen. USAN INN Name USAN INN Name Bristol-Myers Squibb Co. Bristol-Myers Squibb Co. and Ventiv Health Inc. expanded their service agreement for BMS' Tequin (gatifloxacin), an antibiotic for the treatment of lung, sinus, skin and urinary tract infections and certain sexually transmitted diseases. Under the agreement, Ventiv will provide medical science liaisons to educate infectious disease specialists and other audiences on the latest Tequin data. Financial terms of the agreement were not disclosed. USAN INN Name USAN INN Name Ranbaxy Laboratories Ltd. Ranbaxy Laboratories Ltd. received tentative approval from the Food and Drug Administration for the company's 1 mg and 2 mg tablet generic formulations of Pfizer Inc.'s Detrol (tolterodine tartrate), a drug indicated for patients who have overactive bladders with symptoms of urge urinary incontinence, urgency and frequency. According to Ranbaxy, a recent IMS Health report places total annual sales of tolterodine tartrate at $98 million. USAN INN Name USAN INN Name Boston Scientific Corp. Boston Scientific Corp. received approval from the Food and Drug Administration to market its Flextome Cutting Balloon dilatation device for the treatment of coronary artery blockages that resist conventional balloon angioplasty. The device is composed of a balloon with three to four microsurgical blades. When the balloon is inflated, the blades cut the plague by severing the elastic and fibrotic continuity of the vessel. This procedure allows for expansion of the target lesion with less pressure on the vessel wall, possibly reducing trauma compared with standard balloon angioplasty, according to Boston Scientific. The company hopes to launch the product in the United States immediately. USAN INN Name USAN INN Name


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