Hyperion Therapeutics Completes Phase 2 Data Analysis And Schedules End Of Phase 2 Meeting With FDA For HPN-100 (Medical News Today)
Hyperion Therapeutics, Inc. reported completion of data analysis for its Phase 2 clinical trial designed to evaluate the safety, tolerability and ammonia scavenging effects of HPN-100 versus BUPHENYL(R) (sodium phenylbutyrate), the current standard of care in patients with urea cycle disorders. Data from the trial will be presented at an upcoming medical conference.

Watson Announces the NDA for a 6-Month Formulation of TRELSTAR(R) Accepted for Filing by FDA for the Treatment of ... (PR Newswire via Yahoo! Finance)
Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today announced that its New Drug Application for a 6-month formulation of TRELSTAR , a luteinizing hormone releasing hormone agonist, has been accepted for filing by the U.S.

Personalized Medicine Will Lead To Changes In FDA Approval Process For New Medications, Von Eschenbach Says (Medical News Today)
Personalized medicine -- the ability to predict how patients will react to certain medications based on their genetic profiles -- will lead to changes in clinical trials and the business model for the pharmaceutical industry, as well as the FDA approval process for new treatments, agency commissioner Andrew von Eschenbach said on Friday during a speech to business students at St.