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Depomed Reports Results From Two Phase 3 Clinical Trials Evaluating Non-Hormonal Therapy for Menopausal Hot Flashes
MENLO PARK, Calif., Oct 12, 2009 -- Depomed, Inc. (NASDAQ:DEPO) announced today top-line results from the BREEZE 1 and 2 Phase 3 clinical trials evaluating the safety and efficacy of SeradaTM, an investigational non-hormonal extended release formulation of gabapentin for the treatment of menopausal hot flashes.
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Cerner Receives FDA Clearance for Fetal Monitoring Solution
KANSAS CITY, Mo. -- Oct. 5, 2009 -- Despite advances in technology and medical record keeping, most patient records are missing an important piece of data. Currently, fetal monitoring waveform data gathered throughout a woman's pregnancy is either kept on paper or in a separate system outside of the electronic health record (EHR). Fetal waveforms capture important data such as irregular infant heartbeats and history of distress that can be used to help identify health problems, but that data is...
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Changed definition of safe contraception in clinical trials
Danish Medicines Agency, 2 October 2009--We have updated section 5.1 Contraception in the Guideline for applications for authorisation of clinical trials of medicinal products in humans.
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FDA Approves Additional Use for IUD Mirena to Treat Heavy Menstrual Bleeding in IUD Users
October 1, 2009 -- The U.S. Food and Drug Administration today approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of...
PPD Names Deborah Covington as Global Head of Observational Studies and Pregnancy Registries
WILMINGTON, N.C. (September 9, 2009) - PPD, Inc. (Nasdaq: PPDI) today announced the appointment of Deborah Covington, Dr.PH., as global head of observational studies and pregnancy registries. In this role, she will...