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Product NamesBrand 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 UNITEDHEALTH, WALGREEN TO PARTNER ON MEDICARE DRUG PLANOvations, a business unit of UnitedHealth Group, chose to partner with Walgreen Co. and its Walgreens Health Initiatives subsidiary for Ovations' Medicare Part D Prescription Drug Plan offering. "Importantly, this combination enables consumers to seamlessly access the most appropriate and cost-effective fulfillment channels for their particular needs--whether that be traditional mail order, online order or in person at a retail pharmacy," the firms said. The partners expect to offer a "highly customized" plan to the Medicare population in all states, the District of Columbia and U.S. territories, including those patients who are enrolled in Medicare Advantage prescription drug plans, Special Needs Plans and employer-sponsored plans. The decision by UnitedHealth was unusual, according to The Wall Street Journal, because the health insurer chose not to ally with other traditional, independent pharmacy benefit managers. UnitedHealth contracts with Medco Health Solutions Inc. for administering drug benefits to its employer health plans business, and some analysts had expected they would work together for UnitedHealth's Medicare business. "Our partnership with Medco is an excellent relationship and will continue to be an excellent relationship," said John Penshorn, senior vice president of UnitedHealth. The Journal further reported that a Medco spokeswomen said the firm had conducted preliminary talks with Ovations, but that UnitedHealth realized it needed to work with a partner who had a large retail presence and consumer brand. "Walgreens brings to the partnership an outstanding reputation for quality and customer service, and includes one of the largest networks of retail drug store locations in the nation, comprehensive prescription drug fulfillment capabilities and state-of-the-art mail order services, all using unique technology capabilities that span these channels," the companies said. Ovations provides senior citizens access to prescription drugs through a network of more than 54,000 retail pharmacies throughout the Untied States and U.S. territories. -=- MANUFACTURING COMPLIANCE WOES MAY LEAD TO FINE FOR GSK GlaxoSmithKline Plc may face a formal consent decree from the Food and Drug Administration, following the agency's seizure of supplies of its antidepressant Paxil CR (paroxetine hydrochloride) and diabetes drug Avandamet (rosiglitazone maleate/metformin hydrochloride) from its Puerto Rican plant earlier this month, Reuters reported. A consent decree could result in a fine of up to $1.4 billion and require greater compliance requirements from the company by the FDA, Reuters said. A GSK spokesman said that although a consent decree is sometimes used to resolve issues such as the manufacturing problems the company is facing, it has not yet discussed this with the agency. FDA regional director Gary Dykstra, however, said at an industry conference that a consent decree was being discussed with GSK, Reuters reported. If a consent decree is signed, the FDA could potentially stop all manufacturing at the Puerto Rican facility, which has had other compliance problems in the past, Reuters stated. Regulators might, however, allow production to continue for other drugs that have shown no quality problems. -=- SENATE BLOCKS PROPOSED MEDICAID CUTS The U.S. Senate passed an amendment Thursday that removed all $14 billion of the proposed Medicaid cuts from the Senate's $2.6 trillion budget for 2006, setting up a potential deadlock with the House of Representatives, which passed its version of the budget containing up to $20 billion in Medicaid cuts, The Associated Press reported. The amendment, proposed by Gordon Smith (R-Ore.) and co-sponsored by Jeff Bingaman (D-N.M.) and other senators, passed 52-48 with all 44 Democratic senators voting for it as well as one independent senator and seven Republican senators. In addition to restoring the money to Medicaid, the amendment proposes appointing a 23-member bipartisan commission to study the program for a year and issue a report of its findings, Knight Ridder news service reported. "We shouldn't risk the health of millions for the sake of expediency," Smith said in a news release from his office. "A short delay will allow a full study and ensure that any changes improve Medicaid's sustainability while maintaining access to care." Senate Budget Committee Chairman Judd Gregg (R-N.H.) told AP that suggestions that the Medicaid cuts would harm people are "absurd, misleading" and "just scare tactics." The final budget was passed 51-49 and included the Medicaid funding. Overall, the Senate's budget contains $17 billion in mandatory spending reductions over five years, according to Knight Ridder. Shortly after the Senate's budget was passed, the House passed its version 218-214. The House budget proposes $69 million in spending cuts over five years, Knight Ridder said, and includes a reduction in Medicaid spending of up to $20 billion, according to AP. The differing budgets set the stage for a potential stalemate as Senate and House leaders meet next month to reconcile differences in the bills. Similar deadlocks have stopped Congress from adopting a budget in the last two years. -=- CERTAIN DRUG COMBINATION COMPARABLE TO PROTEASE-INHIBITOR--BASED REGIMEN FOR CONTINUED VIROLOGIC SUPPRESSION IN PATIENTS WITH HIV, NEW STUDY SHOWS Substituting a once-daily combination of Gilead Sciences Inc.'s Emtriva (emtricitabine) and Bristol-Myers Squibb Co.'s drugs Videx (didanosine) and Sustiva (efavirenz) for a protease-inhibitor (PI)-based regimen appeared to be safe and effective in sustaining virologic suppression in patients with HIV during one study. The trial enrolled 355 patients who had HIV, a CD4 cell count of at least 100 cells/mm3, were receiving at least one PI plus two nucleoside reverse-transcriptase inhibitors, were naive to non-nucleoside reverse-transcriptase inhibitors and had plasma HIV-1 RNA levels of less than 400 copies/mL for at least six months. During the open-label, 48-week study, patients were randomized to either maintain their PI-based regimens or switch to a combination of 200 mg of Emtriva, 250 mg or 400 mg of Videx (depending on body weight) and 600 mg of Sustiva once daily. At week 48, 77 percent of the PI arm and 85 percent of the combination arm completed therapy. The proportion of patients who sustained virologic suppression (less than 400 copies/mL) was 87.6 percent in the PI group and 90.5 percent in the combination arm, according to the intention-to-treat analysis. The treatment difference was -2.9 percent. In the receiving-study-drug analysis, virologic suppression was sustained by 93.1 percent and 96 percent of the PI- and combination-treated patients, respectively, resulting in a treatment difference of -2.8 percent. For both analyses, missing plasma viral load data were considered treatment failure, and both treatment differences were below the predefined noninferiority threshold of 15 percent. Furthermore, the number of patients who discontinued the study due to adverse events was similar between the combination group and the PI group (9 percent and 10 percent, respectively). But self-reported adherence indicated the proportion of patients who fully adhered to the study drug through week 48 was significantly higher in the combination arm than the PI group (82 percent vs. 63 percent). "This [combination] regimen offers the advantage of simplicity and low pill burden and, therefore, represents a new and attractive therapeutic option for HIV-1-infected patients," the researchers concluded. This study was published in the March 15 edition of the Journal of Infectious Diseases. -=- LAMICTAL APPEARS EFFECTIVE, WELL TOLERATED AS ADJUNCT THERAPY IN CHILDREN WITH REFRACTORY EPILEPSY, LONG-TERM DATA SUGGEST; MAY BE SUPERIOR TO VIGABATRIN, GABAPENTIN, PARTICULARLY FOR PATIENTS WITH EPILEPTIC ENCEPHALOPATHY GlaxoSmithKline Plc's Lamictal (lamotrigine) appears to be both effective and well tolerated as an add-on therapy in children with treatment-resistant epilepsy, according to the results of a retrospective study. Additionally, the authors suggested that Lamictal may be more effective than vigabatrin or gabapentin at reducing seizure frequency and maintaining a sustained benefit, particularly among patients with epileptic encephalopathy. Gabapentin is marketed by Pfizer Inc. as Neurontin and is also available in generic formulations. Vigabatrin has not been approved by the Food and Drug Administration, but the drug is marketed by sanofi-aventis Group in most other countries under the brand name Sabril. Investigators reviewed data for 176 pediatric patients with refractory epilepsy. Eligible patients were those who received Lamictal (n=132), vigabatrin (n=80) or gabapentin (n=39) as an add-on therapy between September 1990 and February 1996. Of these patients, 73 had experienced partial seizures, 42 had experienced generalized seizures and 61 patients with multiple seizure syndromes were characterized as having epileptic encephalopathy. Adjunct treatment with Lamictal, vigabatrin or gabapentin was considered effective if a patient became seizure-free or responded to treatment (at least a 50 percent reduction in seizure frequency) within six months. Patients who maintained this reduction after six months were considered to have a sustained benefit. Among patients with partial seizures, 20 percent of the Lamictal group, 15 percent of the vigabatrin group and 8 percent of the gabapentin group achieved seizure freedom within six months of initiating add-on therapy; 13 percent, 22 percent and 23 percent, respectively, were considered responders to treatment. A sustained benefit was observed in 33 percent of Lamictal-treated patients, 26 percent of vigabatrin-treated patients and 27 percent of gabapentin-treated patients within this subgroup. Among patients with generalized seizures, 10 percent of Lamictal-treated patients, 11 percent of vigabatrin-treated patients and 0 percent of gabapentin-treated patients achieved seizure freedom; 30 percent, 5 percent and 0 percent, respectively, were considered responders to treatment. Those exhibiting a sustained benefit included 37 percent of the Lamictal-treated patients, 11 percent of the vigabatrin-treated patients and 0 percent of the gabapentin-treated patients. Among children with epileptic encephalopathy, 20 percent of Lamictal-treated patients, 6 percent of vigabatrin-treated patients and 0 percent of gabapentin-treated patients achieved seizure freedom; 16 percent, 6 percent and 0 percent, respectively, were considered responders to treatment. Of these patients, 32 percent in the Lamictal group, 6 percent of those in the vigabatrin group and 0 percent of those in the gabapentin group exhibited a sustained benefit. The authors also noted that, among patients who continued add-on therapy, survival rates were better with Lamictal as compared with vigabatrin or gabapentin. The primary reason for withdrawal in the Lamictal group was development of a rash; primary reasons for withdrawal in the vigabatrin and gabapentin groups were a lack of efficacy and an apparent worsening of seizures, respectively. The overall incidence of adverse events, excluding lack of efficacy, was 14.5 percent in the Lamictal group, 25 percent in the vigabatrin group and 62 percent in the gabapentin group. "Our study spanning a 10-year period documents a significant sustained benefit from [Lamictal], which also appears to have the lowest adverse-event profile of the three anticonvulsants," the authors concluded. Complete results of this study were published in the March issue of the journal Seizure. -=- CO-ADMINISTRATION OF INTRANASAL DRUG WITH VIAGRA HAS POSITIVE EFFECTS ON ERECTILE DYSFUNCTION PATIENTS, NEW STUDY REVEALS Results of a new study indicate Palatin Technologies Inc. and King Pharmaceuticals Inc.'s intranasal PT-141, a melanocortin receptor agonist, when co-administered with Pfizer Inc.'s Viagra (sildenafil citrate), a peripheral vasodilator, has more positive effects in patients with erectile dysfunction than Viagra alone. The study randomized 32 men with erectile dysfunction to receive doses of either 50 mg or 100 mg of Viagra with or without nasally administered PT-141 (7.5 mg or 10 mg). Researchers measured the level of erectile activity for six hours using a RigiScan device in the absence of visual sexual stimulation. The data showed patients who received both Viagra and PT-141 had significantly greater duration of erectile activity when compared to patients who received the relevant dose of Viagra alone. Results showed statistically significant enhancement in three of four comparisons. Palatin said the co-administration of the drugs did not produce any serious or adverse events. In addition, the company said PT-141 may have an advantage over other erectile dysfunction drugs because it works through a different mechanism rather than acting directly on the vascular system. In February, a Phase IIa pilot clinical study of PT-141 in premenopausal women conducted by Palatin and King also showed positive results for women with female sexual dysfunction, The Wall Street Journal reported. -=- Product Names THE FOOD AND DRUG ADMINISTRATION Acting Food and Drug Administration Commissioner Lester Crawford told the Senate Committee on Health Education, Labor and Pensions that the agency plans to change its process for disclosing any potential conflicts of interest among advisory committee members, according to The Wall Street Journal. Speaking at his confirmation hearing to be the permanent head of the FDA, Crawford said the disclosure procedures should be simplified. An FDA spokeswoman later told The Journal the agency is "reviewing ways to make our current process for providing disclosures more transparent and readily available to the public." -=- Product Names BIOGEN IDEC INC. Biogen Idec Inc. extended for 15 days the filing of its 10-K with the Securities and Exchange Commission, as it "has been diligently assessing the impact of the suspension of Tysabri (natalizumab) . . . and related matters on the company's 2004 financial statements." As a result of the withdrawal of the multiple sclerosis drug, Biogen Idec expects audited financial statements for the fiscal year ended Dec. 31, 2004 to reflect a decrease in income before income taxes of no more than $15 million, resulting in income before income taxes of at least $78 million. -=- Product Names MERCK & CO. INC. Merck & Co. Inc. said in papers filed with a federal court in Louisiana that it has been served with 1,357 product liability lawsuits relating to its COX-2 inhibitor, Vioxx (rofecoxib), as of March 9, 2005, The Associated Press reported. Drug industry analysts have estimated that Merck's potential liability in the cases could total between $4 billion and $30 billion, AP added. Excluding possible class action members, Reuters said, the cases represent 3,128 plaintiffs, but more cases are expected. -=- Product Names SIEMENS AG Siemens AG entered a merger agreement to acquire all businesses of CTI Molecular Imaging Inc. in a transaction valued at approximately $1 billion. Siemens Medical Solutions USA Inc. will begin a cash tender offer within 10 business days to acquire all outstanding shares of CTI stock at $20.50 per share. The board of directors of each company have approved the transaction. Siemens said the transaction is expected to close in the second quarter of 2005. -=- Product Names TORREYPINES THERAPEUTICS INC. TorreyPines Therapeutics Inc., formerly Neurogenetics Inc., signed a research agreement with Eisai Co. Ltd. for Alzheimer's disease drug discovery. The agreement will give Eisai exclusive rights of first negotiation and refusal for validated compounds. The companies said they may enter drug development agreements involving certain compounds that meet a set of criteria established by the agreement. Other terms of the transaction were not disclosed. -=- Product Names
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