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Product BrandingBrand 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 sends approvable letter to NPS for osteoporosis treatment The Food and Drug Administration determined that NPS Pharmaceuticals Inc.'s New Drug Application for Preos (parathyroid hormone [rDNA origin]), an injectable osteoporosis treatment, is approvable.According to NPS, the FDA requested additional clinical information about the potential risk of hypercalcemia associated with the drug. Although the company's pivotal Phase III TOP study showed that Preos significantly reduced the risk of fracture in postmenopausal women with osteoporosis, the drug also resulted in a higher incidence of hypercalcemia as compared with placebo. In addition, the agency asked for more data about the reliability and use of the injection device for delivery of the drug, NPS said. The company plans to meet with the FDA to discuss these issues and determine whether additional trials are needed, noting that it will then be better able to estimate Preos' approval and launch dates. NPS shares closed at $8.77, down $5.27, or 37.5 percent, in heavy trading on the Nasdaq. Product Branding FDA advisory board to discuss Lilly's Gemzar for ovarian cancer A Food and Drug Administration advisory board released briefing documents regarding the use of Eli Lilly and Co.'s cancer drug Gemzar (gemcitabine hydrochloride) in combination with chemotherapy to treat patients with advanced ovarian cancer. Release of the documents precedes a meeting of the Oncologic Drugs Advisory Committee to discuss whether Gemzar should be approved for this indication. Gemzar is approved to treat non-small cell lung, pancreatic and metastatic breast cancers. Lilly filed a supplemental New Drug Application for the injectable drug to be used with carboplatin, a chemotherapeutic agent, in treating patients with advanced ovarian cancer that has relapsed at least six months after platinum-based therapy has been completed. A Phase III study of Gemzar included 356 patients who met this specific criteria. Patients were treated with carboplatin plus Gemzar or carboplatin alone. Results showed that the combination therapy met the trial's primary endpoint by adding 2.8 months to median progression-free survival, but it did not appear to increase overall survival. In addition, the drug demonstrated increased toxicity, predominantly anemia, neutropenia and thrombocytopenia, resulting in more red blood cell and platelet transfusions and greater use of granulocyte colony stimulating factors and erythropoietic agents. The committee mentioned several reasons in the briefing document not to approve the drug, including the fact that other available chemotherapy regimens have proved to be effective in prolonging survival in this setting. "The main issue is whether adding 2.8 months to median progression-free survival at a cost of additional toxicity with no apparent effect on survival is a sufficient basis for Gemzar approval for this use," the documents stated. Product Branding Enbrel efficacious, well tolerated in patients with psoriasis through 96 weeks The safety and efficacy of Amgen Inc. and Wyeth's Enbrel (etanercept) are maintained and incrementally improved through 96 weeks of therapy among patients with moderate to severe plaque psoriasis, according to recent data. Researchers randomized 618 patients with moderate to severe psoriasis to receive subcutaneous injections of Enbrel 50 mg twice weekly (administered three to four days apart) or placebo in a blinded fashion for 12 weeks. After the first 12 weeks, both groups of patients could then receive the same dosage of Enbrel for an additional 84 weeks. Several endpoints were used in the study, including the proportion of patients who achieved a 50 percent improvement in the Psoriasis Area and Severity Index (PASI 50), PASI 75 and PASI 90; the mean improvement from baseline in PASI scores with time; and the safety of the study drug. At 12 weeks, 47 percent of patients in the Enbrel group (n=311) had achieved PASI 75 compared with 5 percent of patients in the placebo group (n=307). By week 24, after 12 more weeks of the drug in the open-label period, 60 percent of patients in the Enbrel group achieved PASI 75, while 48 percent of patients in the placebo group achieved this level (after 12 weeks of treatment with the study drug). By week 48, 63 percent of patients in the Enbrel group achieved PASI 75 compared with 61 percent in the placebo group (36 weeks of exposure to Enbrel). The improvements seen through week 48 were generally continued through week 96. At week 96, 79 percent of patients in the placebo group achieved PASI 50 compared with 83 percent of patients in the Enbrel group. The percentage of patients who achieved PASI 75 at week 96 was 52 percent for the placebo group and 51 percent for the Enbrel group. Finally, 23 percent of patients in the placebo group achieved PASI 90 at week 96 compared with 23 percent in the Enbrel group. The researchers noted that this study represents almost 1,000 patient-years of exposure to the study drug and that the study will continue through week 144. "Extended exposure to 50 mg [Enbrel] twice weekly provided sustained and incremental improvement in the response in psoriasis measures, with exposure-adjusted rates of adverse events and infections similar to those in patients receiving placebo," they concluded. These data were presented at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco. Product Branding BMS' Baraclude hepatitis drug more effective than GSK's Epivir, studies show Bristol-Myers Squibb Co.'s treatment for chronic hepatitis B, Baraclude (entecavir), is more effective than GlaxoSmithKlinePlc's Epivir (lamivudine), according to two studies published in the March 9 issue of The New England Journal of Medicine. The two studies were double-blind, controlled Phase III trials that compared the efficacy and safety of Baraclude therapy with Epivir therapy. The primary endpoint for both trials was histologic improvement, which was defined as a decrease of at least two points in the Knodell necroinflammatory score, without worsening of fibrosis. In the first trial, 715 patients with hepatitis B e antigen (HbEAg)-positive chronic hepatitis B were randomized to receive 0.5 mg of Baraclude or 100 mg of Epivir once daily for a minimum of 52 weeks. The setup of the second trial was identical, but included 648 patients with the same disease characteristics. None of the patients in either study had been previously treated with a nucleoside analogue. The results for both trials were fairly similar. In the first study, 72 percent of patients in the Baraclude group demonstrated a histologic improvement after 48 weeks compared with 62 percent of patients in the Epivir group. In the second trial, 70 percent of patients who received Baraclude demonstrated improvement, while 61 percent of patients who received Epivir did so. Furthermore, both studies showed that the serum hepatitis B virus was undetectable in more patients in the Baraclude group than in the Epivir group (67 percent vs. 36 percent, respectively, in the first study; 90 percent vs. 72 percent, respectively, in the second). No viral resistance to Baraclude was seen in either study, and both drugs had similar safety profiles. The lack of viral resistance to Baraclude is important, the authors of the first study stressed. Several studies have shown that after four years of therapy with Epivir, nearly 70 percent of patients develop hepatitis B virus mutants that are resistant to the drug, they added. Product Branding Development time for pharmaceuticals decreasing, not contributing to rising prices, study shows The amount of time needed to get a prescription drug approved decreased between 1992 and 2002, according to researchers who say it is unlikely that longer clinical trial times are contributing to rising prescription drug prices. The study, which was published in the March/April issue of the journal Health Affairs, retrospectively examined the development times of drugs by drug characteristics and by government regulatory designations. To be included in the study, all drugs had to be human therapeutic drugs listed on the Federal Register Government Printing Office Web site before May 2003. A total of 168 drugs approved between 1992 and 2002 were included in the analysis. The results showed that after an Investigational New Drug application had been filed with the Food and Drug Administration, the median total development time was 6.4 years, including a median 5.1-year clinical trial phase and a median 1.2-year regulatory review phase. According to the researchers, the total time needed to have a drug approved after filing an IND has decreased overall; further, clinical trial periods have not increased and are trending downward. Thus, the FDA approval time has actually decreased. In fact, the median development time from IND to approval decreased from more than 10 years in 1985 to less than 4 years in 1995. Overall, median post-IND development times appear to be longer for biopharmaceuticals, first-in-class drugs and orphan drugs than for other types of drugs, but the differences were not statistically significant. Fast track status, however, shortened the median development time by more than two years, and drugs that had annual sales exceeding $100 million actually took a year less to be developed than did drugs with lower sales. The authors noted that although longer clinical trial periods have been cited as justification for higher drug prices, their findings suggest that "development times are not a factor in rising drug prices." As a possible alternative explanation, they referred to earlier studies showing that drug prices are affected by certain market factors, including the availability of substitutes and any therapeutic advantages a drug might have. Product Branding Fast track designations accounted for 20 percent of all active investigational drugs from 1998 to 2005, analysis shows The Food and Drug Administration granted nearly 500 fast track designations between 1998 and 2005, accounting for approximately 20 percent of all active investigational drugs in clinical development programs worldwide during that period, according to a study by the Tufts Center for the Study of Drug Development. "The fast track program has had a significant public health impact by speeding access to drugs to treat AIDS, breast cancer, leukemia and other diseases that afflict millions of patients and result in the loss of tens of thousands of lives every year in the [United States]," said Christopher Milne, author of the study. The study reported that cancer-related programs today account for 40 percent of all fast track designations, while HIV/AIDS drugs account for 8 percent. In 2001, HIV/AIDS drugs accounted for 20 percent of all fast track designations. On average, fast track products take approximately eight years to develop, the same average development time as non-fast track standard and priority review drugs, according to Tufts. The development times vary considerably between therapeutic areas with cancer drugs taking the longest time to develop (nine years on average). Anti-infective drugs, mostly for HIV/AIDS, take five years to develop and rare disease drugs and orphan indication drugs take seven years to develop. According to the report, approximately one-third of the fast track programs are experiencing problems, with efficacy issues in late-stage trials being the major contributing factor. Product Branding Product Branding The White House The White House plans to formally nominate Dr. Andrew von Eschenbach as the Food and Drug Administration's commissioner, The Wall Street Journal reported. Von Eschenbach, who is the director of the National Cancer Institute, is currently the acting commissioner of the agency. The Journal said the question of whether von Eschenbach would have to give up his NCI post could hamper the nomination, noting that the confirmation process is likely to be difficult and "tangled with controversial issues such as the Plan B emergency contraceptive and stem-cell research." Last September, the previous FDA commissioner, Lester Crawford, resigned after only two months on the job, a move The Journal said was "likely tied" to speculation about his finances. Product Branding Product Branding Shire Plc Shire Plc said the resubmission of a New Drug Application to the Food and Drug Administration for Daytrana (methylphenidate) transdermal system is being treated as a Class I resubmission. Daytrana, an investigational transdermal patch formulation for methylphenidate designed as a once-daily treatment for attention-deficit/hyperactivity disorder in children aged 6 to 12 years, was licensed to Shire from Noven Pharmaceuticals Inc. The FDA requested further information from Shire in an approvable letter issued Dec. 23, 2005. The company expects action from the FDA by April 9. Product Branding Product Branding Guidant Corp. Guidant Corp. enrolled its first participant in a first-in-man clinical trial designed to evaluate the safety of an investigational fully bioabsorbable everolimus-eluting stent platform for the treatment of coronary artery disease. The stent is designed to be fully absorbed by vascular tissue after the restoration of blood flow and drug elution. The trial is a non-randomized, international study that will enroll up to 60 patients. Researchers will assess the safety of the stent at six months and continue follow-up for five years. Everolimus was developed by Novartis AG under the brand name Certican for the prevention of organ rejection following a heart transplant. The drug, which Guidant licensed from Novartis to use in drug-eluting stents, has not yet been approved. Product Branding Product Branding Berlex Inc. Berlex Inc. entered into a collaboration with ChemDiv Inc. to work on the discovery of potential new lead compounds against several selected G protein-coupled receptor targets. Under the terms of the agreement, ChemDiv will use its integrated synthetic and medicinal chemistry capabilities to collaborate with Berlex in the search for new disease therapies. Financial terms of the agreement were not disclosed. Product Branding
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