USAN INN Naming - Brand Institute, inc.



			USAN INN Naming 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 Commissioner Lester Crawford resigns Food and Drug Administration Commissioner Lester Crawford resigned from his post Friday, with no specific reason cited other than it was time to step aside, according to The Associated Press. His resignation was noted as a "surprise." According to the White House, the resignation was effective immediately, Reuters reported. Just two months ago, Crawford was elevated to commissioner. His tenure at the FDA was marked by increasing criticism relating to the handling of Merck & Co. Inc.'s recall of Vioxx (rofecoxib) and the agency's decision last month to delay a final ruling on over-the-counter sales of Barr Pharmaceuticals Inc.'s emergency contraceptive, known as Plan B (levonorgestrel). Neither an acting FDA director nor a new candidate was immediately named, although Reuters reported that President Bush asked Andrew von Eschenback, director of the National Cancer Institute, to serve as acting commissioner. USAN INN Naming Genentech stops enrollment in Phase II Avastin trial Genentech Inc. discontinued enrollment in a multicenter, single-arm Phase II study of Avastin (bevacizumab) in platinum refractory ovarian cancer patients due to a higher rate of reported gastrointestinal perforations than that seen in previous Avastin trials. Five perforations occurred in the gastrointestinal tract of the 44 patients enrolled in the proposed 53-patient trial. Although GI perforation is a known potential side effect of the drug, in this Phase II trial it was seen in more patients than expected, Genentech said. "The limited overall number of GI perforations seen in this study prevent us from ascertaining definitive risk factors for this adverse event. Patients enrolled in this study had more advanced disease, which typically involves the bowel, and had received more prior chemotherapy than in previous clinical trials of Avastin in ovarian cancer," explained Dr. Hal Barron, Genentech's chief medical officer. The firm stopped trial enrollment after consulting with the Food and Drug Administration. The company will inform patients currently enrolled in the trial of the new safety information. The patients, in consultation with their physician, may continue to receive Avastin or choose to discontinue treatment. Genentech does not expect this action to affect the company's plans to study Avastin in earlier-stage ovarian cancer or other tumor types. The trial patients had previously failed to respond to platinum-based therapy, which is currently the standard treatment for the disease. Avastin is currently approved in combination with 5-fluorouracil-based chemotherapy for first-line treatment of metastatic colorectal cancer. Genentech shares closed at $85.83, down $2.17, or 2.5 percent, in heavy trading on the New York Stock Exchange. USAN INN Naming Mercks AIDS vaccine candidate showing better-than-expected results; enrollment to be expanded Clinical tests of Merck & Co. Inc.'s experimental AIDS vaccine, MRKAd5, are exceeding expectations by eliciting a stronger-than-expected immune response, The Wall Street Journal reported. This strong response even occurred in patients who had developed antibodies against the vaccine's adenovirus due to previous infections. The trial's success is leading Merck to double trial enrollment to 3,000 participants. The trial was designed to determine immune response to the vaccine by healthy volunteers. The study may be able to indicate whether these immune reactions can prevent or control AIDS, but trial results that would indicate this will not be available until at least 2008. The vaccine uses an adenovirus with man-made copies of three AIDS virus genes attached to it. The genes are designed to gather the body's T-cells, "which seek and destroy human cells infected by HIV," The Journal explained. MRKAd5 boosted T-cells by 50-fold to 100-fold, which is an immune reaction comparable to that of successful vaccines for smallpox or measles, Lawrence Corey, principal investigator of the Seattle-based research group HIV Vaccine Trials Network, told The Journal. However, the vaccine does not elicit antibodies, another important element of immune protection, The Journal added. USAN INN Naming Late-stage trial of Biomira's lung cancer vaccine delayed; Phase IIb results "promising" Biomira Inc. said a Phase III trial for its investigational non-small cell lung cancer vaccine will be delayed because of a problem it discovered during the manufacturing process. The product, BLP25 liposome vaccine, or L-BLP25, was scheduled to enter late-stage studies later this year. However, a stability issue--that is, how well the drug holds up under normal storage--was identified, leading the company to push the initiation of the Phase III trial into 2006. Biomira is working with its contract manufacturer to correct the problem, possibly caused by excess moisture in the product, according to a press release. Biomira and Merck KGaA are collaborating on the vaccine's development. Separately, results of a recent Phase IIb trial of the company's vaccine that included patients with advanced stage NSCLC revealed a 4.4-month longer median survival for those randomized to the L-BLP25 arm compared with those who received only best supportive care. However, the study authors noted that this survival difference did not reach statistical significance. The results did show that the greatest benefit was observed in vaccinated patients with stage IIIB locoregional NSCLC, which Biomira said makes up approximately 25 percent of patients with this form of cancer. Specifically, the observed two-year survival rate for patients with stage IIIB locoregional disease was 60 percent for the L-BLP25 arm versus 36.7 percent for the best supportive care arm. "The results reported here are promising and suggest that this minimally toxic vaccine might be valuable as maintenance therapy," the researchers concluded. These findings were published in the Sept. 20 issue of the Journal of Clinical Oncology. Biomira shares closed at $1.42, down $0.10, or 6.6 percent, in heavy trading on the Nasdaq. USAN INN Naming FDA accepts Kings sNDA for Altace for slowing progression of kidney disease in certain patients King Pharmaceuticals Inc. said the Food and Drug Administration accepted its supplemental New Drug Application for Altace (ramipril) for use as initial therapy in a multidrug regimen to delay the progression of chronic kidney disease in hypertensive patients with nondiabetic kidney disease. The ACE inhibitor is currently approved for treating hypertension, among other indications, King noted. The request for this new indication is based on data from two studies. In the AASK trial, which included 1,094 black individuals with hypertension, researchers compared Altace with two other hypertension agents--a beta blocker and a calcium channel blocker. The results showed that Altace appeared to be more effective in slowing the decline of kidney function. In the other trial--REIN--Altace slowed the decline in kidney function and reduced the incidence of end-stage renal disease. King noted this study included mostly white patients. Altace is marketed in the United States by Monarch Pharmaceuticals Inc., a subsidiary of King and Wyeth Pharmaceuticals, a unit of Wyeth. USAN INN Naming AstraZeneca submits NDA for asthma drug Symbicort AstraZeneca Plc submitted a New Drug Application to the Food and Drug Administration for approval of Symbicort (budesonide/formoterol) for the maintenance treatment of asthma in patients aged 12 years or older. The NDA submission is seeking approval for two strengths of Symbicort, 80 mcg/4.5 mcg and 160 mcg/4.5 mcg, and is based on a total of 27 Phase I, II and III trials. The trials were designed to assess the efficacy and safety of Symbicort in a metered dose inhaler. Symbicort is a combination of budesonide, an inhaled corticosteroid, and formoterol, a rapid and long-lasting beta2-agonist. This combination of products is recommended by the National Institutes of Health for patients whose asthma is uncontrolled on inhaled steroid therapy alone or whose asthma is currently controlled on an inhaled steroid plus a separate inhaled long-acting beta2-agonist. Currently, Symbicort is available in the form of a dry powder inhaler device, Turbuhaler, in 93 countries worldwide. Sales of Symbicort reached $502 million in the first half of 2005, up 21 percent, according to the company. USAN INN Naming HHS formally approves Medicare prescription drug plans The U.S. Department of Health and Human Services formally approved prescription drug plans that will offer coverage under the new Medicare prescription drug benefit starting Jan. 1. Every state will have a drug plan available to beneficiaries, and each region in the country will have between 11 and 20 organizations that offer prescription drug plans. In every state but Alaska, at least one prescription drug plan will be available for a premium of less than $20 a month, HHS indicated. In all, nine organizations will be offering drug coverage nationwide, including Medco Health Solutions Inc., Aetna Life Insurance Co., Connecticut General Life Insurance Co., Coventry Health and Life Insurance, MemberHealth Inc., Pacificare Life and Health Insurance Co., Silverscript Insurance Co., UniCare, United Health Care Insurance Co. and WellCare Health Plans. Companies can begin marketing their plans Oct. 1. All plans are required to provide coverage at least as good as Medicare's standard coverage, which pays on average 75 percent of drug costs after a $250 deductible, up to $2,250 in total drug spending, HHS said. The coverage also pays approximately 95 percent after $3,600 in out-of-pocket costs to protect against very high drug expenses. Additionally, in 44 states, beneficiaries can select a Medicare Advantage plan that provides prescription drug coverage for no additional cost. In 37 states, beneficiaries will be able to choose a new regional PPO plan. "As we approach the start of enrollment on Nov. 15, Medicare will work with our partners in every state to help people with Medicare make their decisions," Centers for Medicare & Medicaid Services Administrator Dr. Mark McClellan said in an agency release. USAN INN Naming USAN INN Naming Sanofi-aventis SA Sanofi-aventis SA will defend itself against a patent lawsuit by Novo Nordisk A/S, which could delay the U.S. launch of sanofi's new insulin treatment, Apidra (insulin glulisine [rDNA origin] injection), according to analysts cited by Reuters. However, a sanofi spokeswoman said the case would not delay Apidra's launch. Novo believes sanofi's OptiClik pen injection system infringes patents covering its own FlexPen delivery device. "We believe the Novo allegation of patent infringement is without merit and we intend to defend our rights in this matter. We are weighing our options," Jean-Marc Podvin, a sanofi spokesman, told Reuters. USAN INN Naming USAN INN Naming Biogen Idec Inc. Biogen Idec Inc. and Cellectis SA entered into a research collaboration and license agreement to engineer a novel customized Meganuclease Recombination System. Cellectis said the companies will design the system to enable reproducible high yield production of target proteins in mammalian cells. Financial terms were not disclosed. USAN INN Naming USAN INN Naming OSI Pharmaceuticals Inc. OSI Pharmaceuticals Inc., Genentech Inc. and F. Hoffmann-La Roche Ltd.'s Tarceva (erlotinib) received European Union marketing approval for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. The approval was based on a pivotal Phase III trial that included 731 patients with advanced NSCLC. Treatment with Tarceva resulted in significantly longer survival--6.7 months versus 4.7 months--compared with placebo, which represented a 42.5 percent improvement. Additionally, 31 percent of the patients who received Tarceva were alive at one year compared to 22 percent in the placebo arm. USAN INN Naming USAN INN Naming Flamel Technologies Inc. Flamel Technologies Inc.'s IFN-alpha-XL trial produced positive preliminary Phase I/II data in patients with chronic hepatitis C virus infection, demonstrating its safety, tolerability and long-acting activity. IFN-alpha-XL also had positive effects on viral load and interferon activity biomarkers, data showed. IFN-alpha-XL uses Flamel's Medusa nanoparticle technology to provide a long-acting formulation of interferon alpha that may have enhanced efficacy and reduced toxicity compared with unmodified or polyethylene glycol-modified interferon formulations, the firm said. USAN INN Naming USAN INN Naming


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