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Below are companies from the BioMedReports.com FDA Calendar, which have either pending FDA decisions or pending clinical trial results that may have a major impact on each of the underlying stock prices.
On 24/06/09, Spherix Incorporated (NASDAQ:SPEX), an innovator in biotechnology for diabetes therapy, and a provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced positive preliminary results from a Phase 2 clinical trial of its novel compound, Naturlose(R) (D-tagatose), in the treatment and management of Type 2 diabetes. The Phase 2 trial is expected to be completed in early 2010.
On 24/06/09, Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ | Quote | Chart | News | PowerRating) and UCB (Euronext Brussels:UCB) announced positive preliminary top-line results from the second of two Phase III clinical trials of sodium oxybate (JZP-6) for the treatment of fibromyalgia. Confirming the positive results from the first Phase III study, this international, placebo-controlled trial of sodium oxybate to treat fibromyalgia achieved its key endpoints. As in the first randomized, double-blind fibromyalgia study, sodium oxybate significantly decreased pain and fatigue and improved daily function and patient global impression of change. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use.
On 24/06/09, Abiomed, Inc. (NASDAQ: ABMD), today announced the successful implant of its AbioCor Total Replacement Heart, performed at Robert Wood Johnson University Hospital by Mark Anderson, M.D., associate professor of surgery at UMDNJ-Robert Wood Johnson Medical School and chief of the section of cardiac surgery at both the medical school and Robert Wood Johnson University Hospital. This is the first AbioCor implant since the completion of clinical trials and Humanitarian Device Exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) on September 5, 2006.
On 24/06/09, ImmunoCellular Therapeutics, Ltd. (OTC:IMUC) a biotechnology company, announced that the company has signed an agreement with Formatech, Inc. for the manufacture of IMUC's cancer stem cell vaccine product candidate, ICT-121, for an upcoming clinical trial. The Phase I clinical trial of ICT-121 will target glioblastoma (brain cancer) and is expected to begin early next year, pending clearance by the FDA. ICT-121 is an "off-the-shelf" product, and this agreement calls for Formatech to prepare the vials of cancer vaccine for the clinical trial under a GMP (Good Manufacturing Practices) environment. ICT-121 is the company's lead product candidate that targets cancer stem cells and may have applicability to multiple types of cancer.
A full, detailed report on the developments and how they affect other FDA decisions and approvals is available at BioMedReports.com
Biotech investors interested in seeing the complete database of clinical trials and upcoming FDA decisions can access that information here:
http://biomedreports.com/fda-calendar.html
Disclosure: No positions.
About BiomedReports.Com
BioMedReports.com is a news portal covering the biomedical news and financial sector. It features its own blog, discussion forum, stock research reports, news feeds, videos, press release capability, stock commentaries, and other unique content - including FDA and Clinical Trial Calendars plus a database that includes about 1,000 stocks and exchange-traded funds from the healthcare sector which are organized into various new healthcare stock indexes.
For more biomedical sector and investment news, go to www.BioMedReports.com
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