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Below is a summary of updates to the BioMedReports FDA Calendar, which includes a database of about 200 entries. The calendar tracks companies with pending new drug, biological agent, or medical device new product decisions at the FDA and includes the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.
On 8/6/09, Dyax Corp. (NASDAQ:DYAX) announced today that the FDA accepted the Company's submission in response to the FDA's March 2009 Complete Response Letter (CRL), which outlined requirements for approval of DX-88 for the treatment of acute attacks of hereditary angioedema (HAE). In connection with the acceptance, the FDA assigned Dyax's BLA a new PDUFA action date of 12/1/09, which represents a six-month, Class 2 Review. In the CRL received 3/25/09, the FDA requested submission of a Risk Evaluation and Mitigation Strategy (REMS) and additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA. Dyax believes these issues are fully addressed in its reply, which was submitted 6/1/09.
Below are two biomed stocks on the move today as a result of clinical trial news, which are highlighted in this article of top percentage movers and trading volume leaders for Monday 8/6/09.
Shares of Arena Pharma (NASDAQ:ARNA) climbed higher by about 25% on Monday (08/6/09) after the Company said its obesity drug candidate lorcaserin helped patients lose and keep off weight in a clinical trial. Arena said patients who took lorcaserin had "highly significant" weight loss in their first year, and they were more likely to maintain the weight loss in their second year than those who took a placebo. The Company, which announced the results at the American Diabetes Association conference in New Orleans, said lorcaserin patients fared better in terms of cardiovascular risk, and the drug was not associated with heart valve problems or depression.
Meanwhile, Progenics Pharma (NASDAQ:PGNX) on Monday (08/6/09), announced that its collaborator, Ono Pharmaceutical Co., Ltd. in Osaka, Japan, has begun clinical testing in Japan of Relistor (methylnaltrexone) subcutaneous injection, the first-in-class medicine approved in the U.S., Canada, the European Union, Australia and Latin American countries for the treatment of opioid-induced constipation. PGNX also announced the discontinuation of development for PRO 206, a pre-clinical compound for the treatment of hepatitis C virus (HCV) infection, in line with its ongoing initiative to allocate resources to the most important programs in order to increase operating efficiencies, and that it will instead focus on its second-generation HCV-entry inhibitor portfolio, anticipating selection of a new development candidate in 2010.
A full, detailed report on the developments and how they affect other FDA decisions and approvals is available at BioMedReports.com:
http://biomedreports.com/articles/most-popular/1174-seven-extreme-fda-medical-device-trades.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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