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 112 entries through 4/6/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description.
The Clinical Trial Calendar includes 127 entries through 4/6/09 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.) Theravance (THRX). The FDA accepted Theravance's NDA today for Telavancin as a once-daily injectable antibiotic in the treatment of hospital-acquired pneumonia (HAP), including MRSA strains of antibiotic-resistant and other Gram-positive bacteria. The FDA has established a goal of a standard 10-month review of the telavancin NDA, resulting in PDUFA decision date deadline of 11/26/09 and triggering a milestone payment of $10M from THRX partner, Astellas Pharma (ALPMF.PK).
This is the second telavancin NDA filed with the FDA, which is currently reviewing telavancin for the treatment of complicated skin and skin structure infections (cSSSI), for which a Complete Response Letter (CRL) was received on 2/26/09. The CRL requires a Risk Evaluation and Mitigation Strategy (REMS), data on patients with certain renal risk factors from the cSSSI and HAP studies, revisions to the draft label, and a safety update.
2.) Gilead Sciences (GILD) and Teva Pharma (TEVA): GILD recieved notice today of a Paragraph IV challenge by Teva as part of an Abbreviated New Drug Application (ANDA) filing to the FDA requesting permission to manufacture and market a generic version of HIV drug Atripla (a three-drug combination in a single tablet).
Gilead is currently reviewing the notice letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Teva. Such a lawsuit would restrict the FDA from approving Teva’s ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first. Atripla is currently protected by 15 patents, which are listed in the FDA’s Approved Drugs Products List and all 15 patents would need to be invalidated or expired before a generic version of Atripla could be marketed.
3.) Alnylam Pharma (ALNY), a leading RNA interference (RNAi) therapeutics company, today announced that it has initiated a Phase 1 human clinical trial of ALN-VSP to evaluate its safety and pharmacological parameters in patients with advanced liver cancers, including hepatocellular carcinoma and other solid tumors with liver involvement.
ALN-VSP is an RNAi therapeutic comprised of two small interfering RNAs (or siRNAs, the molecules that mediate RNAi) formulated in a lipid nanoparticle and designed to target two genes which are crucial to the growth and development of cancer cells. Pre-clinical data in mice tumor models have demonstrated robust efficacy of ALN-VSP, including suppression of targeted genes, demonstration of an RNAi mechanism of action, tumor reduction, and extension of survival.
4.) ReNeuron Group PLC (UK: RENE.L) (US: RNUGF.PK) announced positive preclinical data today for its CTX stem cell line in the treatment of peripheral artery disease (PAD), which is a chronic and progressive condition that restricts the flow of blood in the limbs.
The Company's CTX stem cell line was injected IM into mice with restricted blood supply in their limbs and the cells resulted in a significant recovery of blood flow and tissue perfusion. The results of this study will be presented later this week at the UK National Stem Cell Network Conference.
ReNeuron plans to continue gathering preclinical data in an effort to begin clinical studies within the next two years. The Company will also begin a clinical trial for disabled stroke patients using the same CTX stem cell line as the basis for ReN001 therapy for this indication since receiving UK regulatory approval to conduct the trial earlier this year in January.
$45.05 (04/06/09)
