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Hyperion Therapeutics Receives Special Protocol Assessment Approval From FDA For Pivotal Phase III Trial In Urea Cycle Disorders
Hyperion Therapeutics announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the pivotal Phase III trial of investigational product HPN-100 (glycerol phenylbutyrate) in adults with urea cycle disorders (UCD). The SPA is a written agreement between the trial sponsor and the FDA regarding the design, endpoints, and planned statistical analysis of the Phase III trial to be used in support of a New Drug Application (NDA).
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Boston Scientific's Urology/Gynecology Products Featured In Studies At International Urogynecological Association Annual Meeting
Boston Scientific Corporation (NYSE: BSX) announced that results from nine studies involving the Company"s Urology/Gynecology products will be presented at the 34th Annual Meeting of the International Urogynecological Association (IUGA). Presentations will feature Boston Scientific"s pelvic floor reconstruction systems and mid-urethral sling systems used to treat pelvic floor prolapse and stress urinary incontinence (SUI). The Company will also sponsor a symposium highlighting long-term registry data comparing the benefits of experienced-based versus evidence-based outcomes for patients treated with mid-urethral slings. The IUGA Congress will be held June 16-20 at the Villa Erba Conference Center in Como, Italy.
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Knocking The Wind Out Of Asthmatics: Help From Hippocrates
Last week the FDA knocked the wind out of asthmatics by requesting the manufacturers of Singulair, a popular leukotriene blocking asthma and allergy drug, to upgrade their warning against psychotic side effects. Further respiratory distress was imposed on Zicam users when the FDA also last week announced warnings that the drug may cause a loss of smell.
Mental Health

Good Bet In Market Pullback: Health-Care Shares

"As sentiment and the stock market increasingly look bearish, look for the recent outperformance in health care to continue," The Wall Street Journal reports. Health-care firms were "hardly a leader" during the "initial run of stocks following the March lows," but they also "fared much better during the market"s plummet. Last week, "health care was the one exception to a sliding market." Katie Stockton, chief market technician for MKM Partners, "says it is likely most of the health-care sector will outperform and not just large pharmaceutical companies" (Rogow, 6/23). Business Week reports that health care"s reputation as a "defensive" stock market sector that "resists recession" is now "being put to the test. The result? More than a year into a nasty recession, health-care profits have barely budged. In the current scheme of things, that"s a pretty good performance." But deals and proposals for health care reform "could create major and unpredictable shifts in the way health care is paid for in the U.S," and many health care firms are "unquestionably feeling the effects of the economic slowdown." Walgreen, for example, "disappointed investors with lower-than expected earnings" as "higher costs ate into profit margins." Sales of prescriptions were up, "but sales results were weighed down by slow consumer spending in the rest of the store," and "the recession has only heightened competition between Walgreen and its rivals." And "even as it deals with the bad economy and a tough competitive landscape, Walgreen - like other health-care-related stocks - could be hugely affected by Obama"s health-care reform plans. The cost-cutting deal between Obama and drug companies is one sign of how much the sector"s profitability could be squeezed" (Steverman, 6/22). Meanwhile, Dow Jones Newswires reports on a pharmaceutical analyst who "thought he knew all about the U.S. health-care system" until he was diagnosed with Hodgkin"s disease. "Now, with the cancer in remission, [Robert] Hazlett brings a deeper appreciation of patients" needs to his job." Hazlett says his illness has made him more sensitive to patient"s perspectives and has also "left him conflicted about the link between profits and life-saving drugs" (Loftus, 6/22). This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org. © Henry J. Kaiser Family Foundation. All rights reserved.


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