Below is a summary of updates to the
<font> BioMedReports.com FDA Calendar </font> , which includes a database of 284 entries as of 7/28/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include 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 clinical trial results.
On 2/20/09, Schering-Plough (NYSE:SGP) resubmitted its Saphris (asenapine) sublingual tablets NDA in response to the FDA’s complete response letter from January 2009 for the acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy. An FDA Advisory Panel meeting is scheduled for 7/30/09 and SGP is in the process of being acquired by Merck (NYSE:MRK). In
<font> briefing documents posted online </font> , the Agency’s director of psychiatry products Thomas Laughren stated, "we generally are in agreement that the sponsor has provided adequate support to suggest effectiveness,” and also that the drug's safety profile was "acceptable" and appears to be "qualitatively similar to that observed for other atypical antipsychotic drugs.”
On 7/28/09, Shire (NASDAQ:SHPGY) announced that it received a Complete Response Letter (CRL) for Intuniv (guanfacine) Extended Release from the FDA. This decision comes following labeling discussions with the FDA that did not result in agreement in time to meet the PDUFA date. The FDA did not identify safety concerns regarding Intuniv in the CRL or request new clinical studies. Shire and the FDA will continue to work together to resolve the remaining labeling language over the next 4-8 weeks. Shire stated in the PR that the Company is confident on quickly reaching an agreement on the final product label and anticipates a launch during 4Q09 for Intuniv.
On 7/28/09, Elron Electronic Industries (NASDAQ:ELRN) announced that Medingo Ltd., a group company held 92% by Elron and its subsidiary RDC – Rafael Development Corporation Ltd., has received an informal notice, by electronic mail, that the FDA has granted clearance to market its Solo MicroPump Insulin Delivery System in the United States. A formal and detailed letter from the FDA has not yet been received, and Elron will issue an immediate release once a formal letter is received from the Agency.
On 7/28/09, Cardium Therapeutics (AMEX:CXM) and its subsidiary Tissue Repair Company (TRC) provided an update on the completion of their MATRIX Phase 2b clinical study and announced plans to provide detailed safety and efficacy data for their Excellarate product candidate around the end of September. The MATRIX trial, a prospective, randomized, double-blind, placebo-controlled study, has enrolled 124 diabetic patients with non-healing, lower extremity neuropathic ulcers. The companies also reported that results from the MATRIX clinical study are expected to be used to support additional studies and applications of Tissue Repair's Gene Activated Matrix (GAM) technology for ulcers and other potential applications, including not only the repair of soft tissue injuries such as diabetic or pressure ulcers, but hard tissue injuries such as those affecting bone.
Additional information regarding the use of Excellarate for the potential treatment of diabetic foot ulcers and other potential GAM product candidates is expected to be reported over the next several weeks and months. CXM stated that more than 90% of the patients enrolled into the MATRIX study have now completed their initial 12-week evaluation period with respect to key safety and efficacy criteria. While the efficacy data from the MATRIX study remains blinded as final patients advance through the 12-week evaluation period, there continues to be no safety concerns since announcement of completion of patient recruitment in May 2009.
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