Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 277 entries as of 7/23/09. 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 7/23/09, Aradigm (NASDAQ:ARDM) announced it received clearance from the FDA for its inhaled liposomal ciprofloxacin Investigational New Drug (IND) application. The initial clinical protocol under this IND is an international, randomized, double-blind, placebo-controlled Phase 2b study designed to evaluate the Company’s inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis (BE). This orphan drug condition is a chronic severe respiratory disease and there is currently no drug specifically approved for its treatment in the U.S. The Phase 2b study will enroll 96 patients and the primary efficacy endpoint will be the change from baseline in the sputum Pseudomonas Aeruginosa colony forming units following once-daily dosing of two different dose levels vs. placebo for a four-week treatment period. Secondary endpoints will include quality of life measurements and improvement of outcomes with respect to exacerbations. Lung function changes will be monitored for safety.
On 7/23/09, Columbia Labs (NASDAQ:CBRX) announced that the Company signed an agreement with PharmaBio Development, Inc. under which Columbia can extend its final royalty payment on sales of Striant (testosterone buccal system) from November 2010 to November 2011. The final payment is estimated at approximately $16.4 million. CBRX stated that the deal will allow the Company to focus its energy on the PREGNANT Study, which is a Phase 3 clinical trial of Prochieve 8% for the prevention of preterm birth in women with a short cervix at mid-pregnancy. CBRX expects to complete enrollment by late 2009, report results in mid-2010 and, if the results are positive, obtain FDA approval in mid-2011.
On 7/22/09, Takeda Pharma [TYO:4502] (OTC:TKPHY) announced that the FDA has extended its review of a new combination diabetes drug combining its top-selling Actos and the experimental medicine alogliptin until 9/4/09. The combination pill is not expected to be approved by the Agency because on 6/26/09 Takeda received a complete response letter (CRL) from the FDA for the Company's New Drug Application (NDA) for alogliptin by itself.
Alogliptin is a selective dipeptidyl peptidase IV (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise. The FDA and Takeda have been in discussions about conducting a new clinical trial to assess the cardiovascular safety profile of alogliptin.
On 7/22/09, Medtronic (NYSE:MDT) received a unanimous recommendation from a FDA Advisory Panel for a new type of heart valve that can be implanted without the open heart surgery required for traditional valves. Approval was recommended for the Melody heart valve for a limited group of people born with cardiac defects. A final decision is pending by the FDA, which typically follows the recommendations of its Advisory Panels. The Melody valve is already approved in Europe and Canada.
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