Updated Calendars of FDA Decisions and Clinical Trials

The accompanying tables below [click to enlarge] include:

• an updated calendar of 80 expected FDA new product decisions and
• 83 pending clinical trial result estimates and pending FDA re-submissions.

Click here for a link to my previous FDA calendars and click here for a list of 14 extreme FDA trades of companies with market caps below $100M. Below is a summary of new entries and updates on the calendars since I last posted.

1.) Genentech (DNA) expects to report results in mid-April in its Avastin colon cancer adjuvant trial, in addition to pending FDA decisions to expand product labels for Avastin in relapsed brain cancer (gliobalstoma) by 5/5/09, Avastin in combination with interferon alfa-2a for the treatment of metastatic renal cell (kidney) carcinoma by 8/1/09, and Xolair (omalizumab) to extend its use in asthma therapy to kids age 6 and older by the end of October.

2.) Takeda Pharma (TKPHY.PK) announced that the FDA would miss the 1/18/09 PDUFA date for its Febuxostat NDA in the treatment of hyperuricemia (once-daily oral treatment of high uric acid levels in gout patients). The FDA is simply behind schedule on pending inspection of clinical trial sites and Febuxostat previously was recommended for approval by an advisory panel.

3.) Dendreon (DNDN) moved up the timeline from mid-year to April for the release of Provenge clinical trial results for prostate cancer as part of its rolling BLA submission.

4.) Genzyme (GENZ) should hear back from the FDA on its sNDA to expand the label for Clolar (clofarabine) in the treatment of adult acute myeloid leukemia - AML). The 1/24/09 date is for the agency to accept the filing and decide if a six-month, priority review will be granted.

5.) ChemGenex Pharma (CXSP) received Orphan Drug status for Omacetaxine in the treatment of Myelodysplastic Syndromes and expected to complete its rolling NDA submission by mid-year.

Comments

[Ohad Hammer]

Very nice summary, Thanks!

2009 Jan 22 08:12 AM

[Ardeis]

Please include Discovery Labs which has a Class I review of Surfaxin due on or before April 21st I believe.


On Jan 22 08:12 AM Ohad Hammer wrote:

> Very nice summary, Thanks!

2009 Jan 22 09:18 AM

[Mike Havrilla]

DSCO is included on the bottom calendar of pending FDA decisions and I have profiled it in previous articles with PDUFA date of 4/17/09 for Surfaxin Class II review after latest resubmission last year.


On Jan 22 09:18 AM Ardeis wrote:

> Please include Discovery Labs which has a Class I review of Surfaxin
> due on or before April 21st I believe.

2009 Jan 22 09:22 AM

[DaveC]

Thanks for a great summary!

2009 Jan 22 03:00 PM

[JG08]

Please add Avanir Pharmaceuticals (Nasdaq: AVNR). Data from their confimatory phase 3 study is expected in 3Q09

2009 Jan 22 08:58 PM

[JG08]

Please include Avanir Pharmaceuticals (Nasdaq: AVNR). Data from their confimatory phase 3 study is expected in 3Q09

2009 Jan 22 08:59 PM

[Mike Havrilla]

Thanks, I just added AVNR to the clinical trial calendar for 3Q09:
Pivotal Phase 3 Results Expected 3Q09 for Zenvia (dextromethorphan/quin... + pending Ph3 trial for neuropathic pain



On Jan 22 08:59 PM JG08 wrote:

> Please include Avanir Pharmaceuticals (Nasdaq: seekingalpha.com/symbo...).
> Data from their confimatory phase 3 study is expected in 3Q09

2009 Jan 22 09:05 PM

[Cynthia]

I just read an article on NewsInferno.com that negative results from clinical trials are often not published or experience serious publication delays. Scary.

2009 Jan 22 11:51 PM

[Mike Havrilla]

This pertains to publishing the articles in a medical journal, but if the companies are public the results must be disclosed to shareholders in the form of a press release.


On Jan 22 11:51 PM Cynthia wrote:

> I just read an article on NewsInferno.com that negative results from
> clinical trials are often not published or experience serious publication
> delays. Scary.

2009 Jan 23 09:13 AM

[Biota]

A good one to keep an eye on for would be life sciences search engine Vadlo.com.

2009 Jan 24 11:37 AM