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USAN NamingBrand 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 GSK's Arranon chemotherapy receives accelerated approval GlaxoSmithKline Plc's Arranon (nelarabine) injection, a chemotherapy agent, received accelerated approval from the Food and Drug Administration.The drug is indicated for T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in pediatric and adult patients whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. The approval was based on two Phase II trials that involved 151 children and 39 adult patients with T-ALL or T-LBL. The primary efficacy results came from 39 children and 28 adults who were refractory to, or had multiple relapses after, at least two standard treatment regimens. After receiving Arranon, 21 percent of these adults and 23 percent of these children achieved a complete response or a complete response without full hematological recovery, GSK said, adding that the median survival was 21 weeks for adults and 13 weeks for children. Post-marketing Phase III trials will be conducted to assess the drug's event-free survival at four years and minimal residual disease in the post-consolidation phase for patients who are receiving standard therapy either with or without Arranon. GSK shares closed at $52.39, up $1.05, or 2.1 percent, in heavy trading on the New York Stock Exchange. USAN Naming FDA approves Galderma's Clobex psoriasis treatment The Food and Drug Administration approved Galderma Laboratories LP's Clobex (clobetasol propionate) 0.05% spray for the treatment of moderate to severe plaque psoriasis. Clobex spray imitates the clinical profiles of Clobex lotion and shampoo, which have been available by prescription since September 2003 and June 2004, respectively. Currently, Clobex spray is the only super-high potency corticosteroid formulation that combines clobetasol in a convenient, non-aerosol spray formulation. A pair of randomized, double-blind clinical trials that included 209 patients with moderate to severe psoriasis showed Clobex spray to be safe and effective. In the first clinical study, 82 percent of patients were clear or almost clear of psoriasis after four weeks of treatment, with 47 percent of these subjects deemed clear or almost clear after two weeks of treatment. In a second study, 78 percent of patients were clear or almost clear after four weeks of treatment. "The product's vehicle has been specifically designed to efficiently deliver clobetasol propionate to the skin," said Albert Draaijer, president of Galderma Laboratories. "Above and beyond its unsurpassed efficacy, the easy application of this advanced vehicle will allow even the most active psoriasis patients to remain compliant with their therapy." USAN Naming FDA delays decision on Exubera inhaled insulin The Food and Drug Administration is extending its review period for Pfizer Inc. and sanofi-aventis Group's inhaled insulin powder, Exubera (rDNA origin), by three months so it can review the additional "technical chemistry data" that the companies submitted. In September, an FDA advisory committee voted in favor of approving Exubera, which is inhaled using a device developed by Nektar Therapeutics and is intended to treat adults with type 1 or type 2 diabetes. Concerns have arisen regarding the drug's pulmonary safety, as clinical studies have shown that some individuals experience a slight decline in lung function and are more likely to experience coughing when taking the drug. Pfizer and sanofi-aventis said they will "continue to work closely with the FDA so that this important medicine can be made available for patients." USAN Naming Lilly, Centocor permanently discontinue patient enrollment in Phase III trial of Reopro Eli Lilly and Co. and Centocor Inc. permanently discontinued patient enrollment in the Phase III trial of Reopro (abciximab) for the treatment of acute ischemic stroke. The companies reached this decision after the trial's independent safety and efficacy monitoring committee (SEMC) recommended that the study not resume enrollment. Earlier this month, the companies temporarily suspended enrollment in the AbESTT-II trial, a randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of Reopro as a treatment for patients who have had an acute ischemic stroke. The SEMC issued the new recommendation after it "reviewed additional efficacy and safety data on most of the 808 enrolled patients to help determine if the benefit-risk profile warranted continuing the study," according to Centocor. Reopro is currently approved as an adjunct to percutaneous coronary intervention to prevent cardiac ischemic complications in patients undergoing PCI and in patients with unstable angina when PCI is planned within 24 hours. The companies reiterated that they were not aware of any new data that would alter the product profile of Reopro in the drug's approved indications, noting that these indications "are supported by more than 14 randomized clinical trials and a decade of clinical experience." USAN Naming Schering-Plough discontinues vicriviroc study Schering-Plough Corp. discontinued a Phase II study of vicriviroc, its investigational CCR5 receptor antagonist, which was administered in combination with GlaxoSmithKline Plc's Combivir (lamivudine/zidovudine) in treatment-naive patients with HIV. The study was discontinued following a recommendation from the independent data safety monitoring board, which assessed the trial's safety and efficacy data. An increased incidence of detectable virus was observed in some patients late in therapy compared with the trial's control regimen of Combivir and Bristol-Myers Squibb Co.'s Sustiva (efavirenz). The company pointed out that the decision was not based on hepatotoxicity or other significant safety issues and a second Phase II study in treatment-experienced patients with HIV will continue. The vicriviroc study in treatment-naive patients with HIV had been under way since spring 2004 and 92 patients had enrolled. Patients currently participating in the study will continue to receive vicriviroc until they consult with their physician and are switched to an alternative treatment. "We will continue to evaluate the potential use of vicriviroc in combination with other treatment regimens, including those used in the treatment-naive patient population," said Robert Spiegel, chief medical officer of Schering-Plough Research Institute. USAN Naming Discovery's Surfaxin granted orphan drug status for chronic lung disease in premature infants Discovery Laboratories Inc.'s Surfaxin (lucinactant) was granted orphan drug designation by the Food and Drug Administration for the treatment of bronchopulmonary dysplasia, or chronic lung disease, in premature infants. "Market exclusivity under this designation would mean that Surfaxin, as a precision-engineered surfactant, has the potential to become the dominant engineered surfactant for the next decade," said Robert Capetola, chief executive officer of Discovery. Surfaxin has already been deemed approvable for the prevention of respiratory distress syndrome in premature infants, and the FDA is expected to finish reviewing the New Drug Application for this indication by April 2006. Currently, no drugs are approved to treat chronic lung disease, Discovery said, adding that the condition is usually associated with a premature infant being treated for respiratory distress syndrome. Discovery is in the process of enrolling up to 210 premature infants of very low birth weight who are at risk of chronic lung disease in a double-blind, Phase II trial. The study will assess the safety and tolerability of up to five doses of the drug in the first 10 days of life. The trial is intended to find out if this treatment can reduce the incidence of death or chronic lung disease and if it can reduce the number of infants who need oxygen or mechanical ventilation. Infants with chronic lung disease usually need respiratory assistance for several months and may also need years of comprehensive care, Discovery said. USAN Naming Net earnings rise, sales flat for BMS in third quarter For the third quarter ended Sept. 30, Bristol-Myers Squibb Co. reported an increase in net earnings but flat quarterly sales, missing analysts' projections. Net earnings were $964 million, or $0.49 per share, up from $758 million, or $0.38 per share, in the third quarter of 2004. Excluding items, BMS earned $0.31 per share, which is $0.02 below a consensus projection, Reuters reported. Net sales were $4.77 billion compared with $4.78 billion in the previous year's quarter. Revenue related to the company's global sales of prescription drugs fell 2 percent to $3.8 billion; sales fell 3 percent in the United States. Declining sales have been attributed to generic competition for cancer drug Paraplatin (carboplantin) and HIV treatment Videx (didanosine). Paraplatin sales plummeted 76 percent to $42 million and Videx sales dropped 39 percent to $41 million. However, sales of the company's other HIV treatment drug Reyataz (atazanavir sulfate) jumped 66 percent to $176 million. Sales of the company's blood clot prevention drug, Plavix (clopidogrel bisulfate), rose 9 percent to $980 million. Also, the company expects earnings for 2005 to be in the middle of its previously announced $1.35 to $1.45 per share range, excluding special items. However, this is less than the average forecast by analysts polled by Reuters Estimates of $1.44 per share, Reuters reported. "Our strategy remains on track and our newer products delivered solid global sales performance during the quarter," said Peter R. Dolan, chief executive officer of BMS. "The company's full-year expectations remain within our range and include our decision to make incremental, targeted investments, in addition to the spending programs we identified at mid year, to further support key products and pipeline priorities. And, our robust portfolio sets the stage for sustained growth for the future, with four new products launched in three years, three drugs currently under U.S. regulatory consideration and another possible filing within the next three months." BMS shares closed at $21.14, down $0.53, or 2.5 percent, in heavy trading on the New York Stock Exchange. USAN Naming USAN Naming The Centers for Medicare & Medicaid Services The Centers for Medicare & Medicaid Services and the American College of Cardiology will work together to collect nationwide data on the use of implantable cardioverter defibrillators among Medicare beneficiaries. Effective April 1, 2006, the American College of Cardiology's National Cardiovascular Data Registry will be used in more than 1,300 U.S. hospitals to gather evidence on ICDs in order "to improve care for Medicare beneficiaries who may be at risk of sudden cardiac death," CMS said. USAN Naming USAN Naming Schering AG Schering AG and Sonus Pharmaceuticals Inc. signed an agreement granting Schering an exclusive worldwide license to Sonus' Tocosol paclitaxel cancer drug. Sonus' Tocosol technology uses vitamin E and its derivatives to solubilize, stabilize and formulate drugs to enhance delivery, safety and efficacy. According to the terms of the agreement, Schering will make an approximately 15 percent equity investment in Sonus. Sonus will receive an up-front fee, milestone payments and royalties. The drug is currently in Phase III testing for the treatment of metastatic breast cancer and the companies expect to submit a New Drug Application to the Food and Drug Administration for this indication by the end of 2007. USAN Naming USAN Naming Eisai Co. Ltd. Eisai Co. Ltd. and Eisai Inc.'s supplemental New Drug Application for Aricept (donepezil hydrochloride) tablets for the treatment of severe Alzheimer's disease was not accepted by the Food and Drug Administration due to deficiencies in the format of the application. The sNDA was submitted on Aug. 31. The companies plan to resolve the formatting issues and resubmit the sNDA in mid-December. Aricept is co-promoted in the United States by Eisai Inc. and Pfizer Inc. and is currently approved for the treatment of mild to moderate AD. USAN Naming USAN Naming Biogen Idec Inc. Biogen Idec Inc. updated the prescribing information for lymphoma drug Zevalin (ibritumomab tiuxetan) to include a boxed warning regarding the skin reactions. Zevalin has been reported to cause severe cutaneous or mucocutaneous reactions that can sometimes be fatal. Biogen Idec advises patients who experience a severe skin reaction to stop treatment with Zevalin and seek medical evaluation. USAN Naming USAN Naming Cellegy Pharmaceuticals Inc. Cellegy Pharmaceuticals Inc.'s Phase III trial for Savvy (C31G) vaginal gel as a prevention for HIV can continue as planned, based on the first interim analysis of the trial's data monitoring committee. However, since sero-conversions are currently lower than expected, additional analyses will be done and presented to the committee in the next several weeks. The committee will then decide if protocol modifications are required for the Ghana-based trial, which involves a total of 2,142 patients. Shares of Cellegy closed at $1.20, up $0.16, or 15.4 percent, in moderate trading on the Nasdaq. USAN Naming
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