Mike Havrilla's  Instablog

 

The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 115 entries through 4/14/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description. 

 

The Clinical Trial Calendar includes 126 entries through 4/14/09 and encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

 

1.) Cell Therapeutics (CTIC): On 4/14/09, CTIC began a rolling submission of a NDA to the FDA for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). CTI expects to complete the submission during 2Q09 and will request priority review (six month) which if granted could lead to an approval decision from the agency during 4Q09. Click here for my most update recent article on CTIC and follow this link for my overview article from two months ago.

 

2.) Dendreon (DNDN): DNDN will release the highly anticipated results this morning with a conference call schedule for 9am (ET) for its IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of PROVENGE (sipuleucel-T), the Company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer. In March 2007, a FDA advisory panel recommended approval of Provenge, but the agency declined to approve the therapeutic cancer vaccine until additional data was available from the IMPACT study (with a target of at least a 22% reduced risk of death versus placebo to file for FDA approval).

 

3.) Medicis Pharma (MRX): Ipsen (France: IPN.PA) and its U.S. partner Medicis MRX announced today that the companies are in active labeling and Risk Evaluation and Mitigation Strategy (REMS) discussions with the FDA for their pending BLA seeking marketing approval for Ipsen’s botulinum toxin type A product in both therapeutic and aesthetic indications. Analysts expect a 2H09 approval for Reloxin, which reflects a delay from the original PDUFA decision date deadline of 4/13/09. Reloxin would compete with Allergan's (AGN) Botox as a cosmetic treatment for wrinkles and is already approved for use in over 20 countries outside the U.S. (marketed as Azzalure).

 

4.) Medarex (MEDX), Johnson & Johnson (JNJ): MEDX announced that it will receive a undisclosed milestone payment from its licensing partner, Centocor Ortho Biotech (a JNJ division), in connection with the Canadian marketing approval on 4/13/09 for SIMPONI (golimumab or CNTO 148) as a once-monthly sub-que injection for the treatment of adults with active forms of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

 

SIMPONI is a new, human anti-tumor necrosis factor (TNF) monoclonal antibody that was generated by Medarex's UltiMAb technology that targets and neutralizes both the soluble and membrane-bound forms of TNF-alpha. The PDUFA decision date deadline for the drug is 4/27/09 for U.S. marketing approval.

 

Disclosure: No positions.