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Below are brief summary updates to the site's database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results:
Electro-Optical Sciences (NASDAQ:MELA): On 4/6/09, MELA announced the submission to the FDA of its Premarket Approval (PMA) application for MelaFind, a non-invasive, point-of-care instrument to assist in the early diagnosis of melanoma, the leading cause of death from skin cancer. Positive top line data from the MelaFind pivotal study, the largest prospective clinical study ever conducted in melanoma detection, were announced in February 2009 and subsequently presented at several major international dermatology meetings in March and May. The Company's final analysis of the data demonstrated that for all subgroups analyzed, the sensitivity of MelaFind was greater than 95% (lower confidence bound) and MelaFind specificity was statistically significantly higher than that of study clinicians. As announced previously, the FDA has granted expedited review (six months) for the MelaFind PMA, resulting in an estimated decision date deadline of 12/4/09.
Affymax (NASDAQ:AFFY): On 3/6/09, AFFY announced that the independent Data Monitoring Committee (DMC), which provides oversight for the Phase 3 program for Hematide, has completed another review and has informed the company that the cumulative safety data generated thus far from the EMERALD and PEARL Phase 3 trials support continuation of the studies. In the Phase 3 program, Hematide is being evaluated to treat anemia in chronic renal failure patients on dialysis and not on dialysis. The Phase 3 program, which consists of four trials, was initiated in October 2007. Affymax announced that enrollment was complete in all four Phase 3 trials in November 2008 and reiterated its expectation for a NDA submission in 2010.
On 4/6/09, ViroPharma (NASDAQ:VPHM) announced that it received a Complete Response Letter (CRL) from the FDA, which requested that the Company conduct another clinical trial of its drug Cinryze before it will consider a new approval to expand use of the drug. Cinryze treats hereditary angioedema (HAE), a genetic disease that can cause dangerous swelling in the throat and extremities. The drug is already approved as a routine preventive treatment for angioedema attacks, and VPHM is trying to gain additional marketing approval for the drug as a treatment for acute attacks. The FDA wants a new clinical trial because the placebo-controlled study included in the Company's application was not strong enough. VPHM reported that the FDA did not mention any safety concerns for Cinryze in the CRL and the Company did not specify how long a new study might take.
On 3/6/09, Pfizer (NYSE:PFE) Animal Health announced that the FDA approved the first canine cancer therapy in the U.S., Palladia (toceranib phosphate), which was developed by the Company to treat mast cell tumors in dogs. PFE expects to make the product available for purchase early next year. On the same day, Merck (NYSE:MRK) announced that it was exploring strategic options for the sale of its animal health division, which includes a joint venture (Merial) with Sanofi-Aventis (NYSE:SNY), as well as the animal health division of Schering-Plough (NYSE:SGP) as part of the two companies planned merger.
Disclosure: No positions.
A full, detailed report on the developments and how they affect other FDA decisions and approvals is available at:
http://biomedreports.com/articles/most-popular/1155-fda-calendar-updates-abt-affy-azn-lly-mela-pfe-vphm.html
Biotech investors interested in seeing the complete database of clinical trials and upcoming FDA decisions can access that information here:
http://biomedreports.com/component/content/article/548.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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