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Clinical Data, Inc. Announces Approval Of Generic Name Vilazodone, First In A New Class Of Experimental Treatments For Depression
Clinical Data, Inc. (NASDAQ: CLDA) announced today that the United States Adopted Name Council (USAN) has approved the generic name vilazodone hydrochloride. Vilazodone, if approved, would represent a first-in-class drug for the treatment of depression, due to its novel dual mechanism of action as both a potent and selective serotonin reuptake inhibitor (SSRI) and a partial agonist of the 5-hydroxytryptamine 1a (5-HT1A) receptor. Thus, vilazodone combines first-line therapy for depression with 5-HT1A partial agonism, an accepted adjunctive treatment for depression and a first-line therapy for anxiety disorders. Clinical Data has recently completed the second of two positive Phase III registration studies. Results of these studies will form the basis of a new drug application (NDA) that the Company intends to submit with the U.S. Food and Drug Administration (FDA) by the end of 2009.

Newly Released Nixon Tapes Reveal Reaction To Roe V. Wade
President Richard Nixon, who was in office when the Supreme Court issued its 1973 decision in Roe v. Wade, in secret recordings from January and February of that year discussed his views on abortion with an aide, the New York Times reports. The comments were among more than 150 hours of tape and 30,000 pages of documents made public Tuesday by the National Archives" Nixon Presidential Library. The tapes were recorded by secret microphones in the White House"s Oval Office. Nixon in the tapes expressed ambivalence over the decision, as well as concern that increased access to abortion leads to "permissiveness" and that "it breaks the family." Nixon also said that he believed there was a need for abortion in some cases, including interracial pregnancies and rape. He said, "There are times when an abortion is necessary. I know that." He added, "When you have a black and a white. Or a rape" (Savage, New York Times, 6/24).Broadcast CoverageNPR"s "All Things Considered" on Tuesday reported on Nixon"s abortion comments and political reaction to Roe at the time of the decision (Totenberg, "All Things Considered," NPR, 6/23).
News of the day
Breakthrough In The Quantum Control Of Light Could Impact Drug Design
Researchers at UC Santa Barbara have recently demonstrated a breakthrough in the quantum control of photons, the energy quanta of light. This is a significant result in quantum computation, and could eventually have implications in banking, drug design, and other applications.
Diagnostics

Disease Markers That Will Aid Arthritis Research

A combination of biochemical and MRI markers will allow improved measurement of osteoarthritis (OA) progression. The biomarkers, described in BioMed Central"s open access journal Arthritis Research and Therapy, will be useful for the design and interpretation of trials of new disease modifying drugs. Erik Dam, from Nordic Bioscience, Denmark, worked with a team of researchers to develop and evaluate the markers. He said, "Presently, there is no disease-modifying OA drug with a consistent, documented effect despite several clinical attempts in late stage phases. We believe that effective therapies could be demonstrated, if tools were available that allow identification of rapid progressors for inclusion in trials. With this in mind, we investigated whether combinations of biochemical and MRI-based biomarkers might improve diagnosis and prognosis of knee osteoarthritis". Dam and his colleagues included 159 subjects in their trial. After exclusions, a total of 287 knees were measured. At baseline and after 21 months, biochemical (urinary collagen type II C-telopeptide fragment, CTX-II) and MRI-based markers were quantified. MRI markers included cartilage volume, thickness, area, roughness, homogeneity, and curvature in the medial tibio-femoral compartment. Joint space width, the presently accepted marker for population selection in clinical studies, was measured from radiographs. According to Dam, "The best individual diagnostic marker was cartilage roughness and the best individual prognostic marker was homogeneity. The aggregate cartilage longevity marker (combining CTX-II, volume, area, thickness, congruity, roughness, and homogeneity) performed very well both diagnostically and prognostically - and superior to the individual biochemical and MRI markers. We attribute this to the combination of markers with complementary information about cartilage quantity (e.g. volume), quality (e.g. homogeneity), and breakdown (CTX-II) that together allow superior diagnosis/prognosis". The proposed aggregate marker methodology may have a direct impact on the design of clinical studies. The researchers claim, "By allowing the selection of a high risk population, the study sample size can be lowered while still improving the chance of a positive study outcome. This should facilitate the development of effective drugs". Notes: Identification of progressors in osteoarthritis by combining biochemical and MRI-based markers Erik B Dam, Marco Loog, Claus Christiansen, Inger Byrjalsen, Jenny Folkesson, Mads Nielsen, Arish A Qazi, Paola C Pettersen, Patrick Garnero and Morten A Karsdal Arthritis Research & Therapy (in press) http://arthritis-research.com/ Graeme Baldwin BioMed Central


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