Below is a summary of updates to the
BioMedReports.com FDA Calendar, which includes a database of 293 entries as of 7/31/09. 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 7/30/09, Achillion Pharma (NASDAQ: ) stated that it expects shortly to conclude the Company's opt-in discussions with Gilead (NASDAQ: ) regarding its ability to advance ACH-1095 into the clinic on its own, and assuming the positive outcome of those discussions, ACHN is actively preparing for a pre-IND consultation with the FDA regarding ACH-1095 (a NS4A antagonist for the treatment of hepatitis C virus or HCV). ACHN plans to report the results of its consultation with GILD in the coming months.
On 7/30/09, ACHN announced that late in 2Q09 the Company initiated Phase 1 studies with its hepatitis C virus (HCV) protease inhibitor (ACH-1625) and continues to receive data regarding the drug's safety and tolerability profile that is expected to be announced late this summer. As ACHN continues this study in patients with HCV, the Company expects to have efficacy data during the winter.
On 7/31/09, Roche (VTX:ROG) (RHHBY.PK) announced that the FDA accepted the Company's resubmission for approval of rheumatoid arthritis treatment Actemra (tocilizumab) with a Class II (six-month) review designation for an expected FDA decision in early 2010. In December 2008, the FDA requested additional non-clinical data on Actemra, including a proposed risk evaluation and mitigation strategy (REMS) and non-clinical studies evaluating the effect of Actemra on peri- and post-natal development and fertility. In July 2008, the FDA Arthritis Advisory Committee recommended approval of the drug by a 10-1 vote.
On 7/31/09, Genzyme (NASDAQ: ) announced that the FDA will re-inspect the company's Allston Landing manufacturing facility.
