Well, No news yet on CTIC are they waiting till after bell ? FDA approval today?

Beret still holding on to ILMN. looks like it might have a better week tomorrow.

made a killing with DDSS today. wasnt as lucky with SPPI tho. I'm just hoping its not another HEB all over again.

Nice list there, Doc.  Thanks..  Have one that must have slipped under the radar for ya... I got this stock a few weeks ago...

July 28, 2009: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement

Agenda

The committee will discuss new drug application (NDA) 22-449, binodenoson injectable, lyophilized solid 250 micrograms vial, King Pharmaceuticals Research and Development, Inc., for the proposed indication: Short acting coronary vasodilator for use as an adjunct to noninvasive myocardial perfusion imaging tests to detect perfusion abnormalities in patients with known or suspected coronary artery disease

The trading symbol for King Pharma  is:  KG


Happy Trading...  /:)

dr banner said: good call on KG.

i cant believe i missed ELAN and TTHI.. I can't find anything that would cause it to jump so high

 J&J bought a $1.5 billion stake in ELAN, and I'm not quite sure what happened in TTHI's  case

Javelin Pharma (AMEX:JAV) ($1.22):A NDA filing for Ereska is possible by late 2009. On 6/23/09, JAV reported that it successfully completed a safety study of Dyloject in the U.S. and plans to submit a NDA for FDA approval in the fall of 2009.

 

 Acrux (ARUXF.PK) ($1.03) announced that its Testosterone MD-Lotion development program achieves key milestone and will be commercialized as Axiron. Achieved enrollment of 150 men in a pivotal Phase 3 open-label trial as planned with trial results expected 3Q09 and a FDA submission anticipated by the Compnay during December 2009.

 

Vivus (NASDAQ:VVUS) ($5.90) and Orexigen Therapeutics (NASDAQ:OREX) ($5.67) also expect to report pivotal Phase 3 clinical trial results during 3Q09 for their experimental weight loss drugs Qnexa and Contrave, respectively.

 

Cardium (AMEX: CXM) ($1.85) announced the completion of recruitment for the Phase 2b MATRIX clinical trial to evaluate the safety and efficacy of Excellarate for the treatment of non-healing diabetic foot ulcers. The MATRIX Data and Safety Monitoring Board has reviewed safety data collected from study participants as of 4/21/09 and reported that Excellarate appears to be both safe and well tolerated, with no serious adverse events attributable to the study product. The Company expects to report on key efficacy data in September 2009, including the percentage of patients achieving complete wound closure, the rate of wound closure and the reduction of wound size at various time points.

 

 

 Biodel (NASDAQ:BIOD) ($4.69) updated its plans to submit a new drug application (NDA) to the FDA during 2H09 for approval to market VIAject for the treatment of diabetes. The NDA will be based upon results from multiple pharmacokinetic and pharmacodynamic studies, studies of VIAject in patients with Type 1 and Type 2 diabetes on post-prandial glycemic control compared to regular human insulin and the rapid-acting analog, Humalog, as well as the two completed Phase 3 studies of VIAject in patients with Type 1 and Type 2 diabetes. Biodel is now preparing its NDA submission and initiating studies designed to further differentiate the therapeutic potential of VIAject from existing rapid-acting prandial insulins.

 

 Avanir Pharma (NASDAQ:AVNR) ($2.15) provided an update on its lead, Phase 3 compound called Zenvia (dextromethorphan + quinidine). AVNR completed target enrollment on 3/16/09 of patients into the STAR trial, which is a confirmatory Phase 3 clinical trial of Zenvia in patients exhibiting signs and symptoms of pseudobulbar affect. The randomized, multi-center, international STAR trial is designed to compare the effects of Zenvia 30/10 mg, Zenvia 20/10 mg and placebo on the rates of involuntary crying and laughing episodes. The final number of patients exceeded the original target by approximately 20% allowing a larger safety database and increased statistical power for the study. AVNR affirmed guidance that top-line data from the confirmatory Phase 3 STAR trial is expected no later than September 2009.

 

Alexza Pharma (NASDAQ:ALXA) ($2.36) announced update on AZ-004 (Staccato loxapine) NDA timeline as the Company continues its scale-up of commercial manufacturing and quality systems processes. ALXA expects an AZ-004 NDA submission to the FDA during the first quarter of 2010 (1Q10). Alexza is developing AZ-004 for the acute treatment of agitation in patients with schizophrenia or bipolar disorder.

 

 

Celsion (NASDAQ:CLSN) ($4.47) provided an update on the status of its lead oncology compound in clinical development, ThermoDox, which is a proprietary heat-activated liposomal encapsulation of doxorubicin. ThermoDox is currently being evaluated under a Special Protocol Assessment with the FDA in a 600 patient, global Phase 3 trial in patients with non-resectable primary liver cancer. Enrollment in the global Phase 3 primary liver cancer study includes 33 clinical sites activated to date with plans to increase the number of sites to 65 by the end of 2009. CLSN expects to substantially complete patient enrollment in this trial within the first quarter of 2010 (1Q10). CLSN is also conducting a pivotal Phase I/II recurrent chest wall breast cancer clinical trial for ThermoDox and is enrolling patients at four clinical sites with expected completion of patient enrollment for this study in the second quarter of 2010 (2Q10).

 

GenVec (NASDAQ:GNVC) ($0.72) announced that overall survival data in locally advanced pancreatic cancer patients treated with TNFerade in GenVec's ongoing Phase 3 Pancreatic Cancer Clinical Trial with TNFerade (PACT) were presented at ASCO. The analysis concluded that TNFerade appeared to be safe and well-tolerated, indicating a 25% reduction in the risk of death in the TNFerade plus standard-of-care (SOC) arm compared to the patients receiving SOC alone. In the SOC patients, 75% of the patients died within approximately 11.8 months. However, in the TNFerade plus SOC group, 75% of the patients did not die until approximately 19.4 months. GenVec's PACT trial is a multi-center, randomized, active, and controlled study of 330 patients designed to evaluate the safety and efficacy of TNFerade plus standard of care versus standard of care alone in patients with locally advanced pancreatic cancer. The next interim analysis is expected to occur after two-thirds of the events (or 184 deaths) have occurred in the trial. Results are expected to be announced in early 2010.

 

Antigenics (NASDAQ:AGEN) ($1.93) announced results of an interim analysis from the Company's ongoing global patient survival registry, which showed that patients with kidney cancer at intermediate risk of disease recurrence demonstrated an approximately 46% lower risk of death when treated with Oncophage (vitespen) cancer vaccine compared with observation (n = 362; P = 0.036; hazard ratio [HR] = 0.54). The interim analysis from the patient registry, INSPIRE, reflects a median follow-up of 4.5 years from the largest, randomized Phase 3 kidney cancer trial ever completed to date in the adjuvant setting. The patient registry was launched in order to confirm encouraging overall survival trends observed from the Phase 3 non-metastatic kidney cancer study. Final results from INSPIRE are expected mid-2010. AGEN expects a decision on its European marketing application by late 2009 and the Company has not filed for U.S. marketing approval of the drug as of yet.

 

Osteotech (NASDAQ:OSTE) ($4.28) announced that it has completed enrollment for the clinical trial of its DuraTech BioRegeneration Matrix. Based upon Osteotech's proprietary HCT (human collagen technology) platform, DuraTech is used to repair dura mater (the tough, outermost membrane surrounding the brain and spinal cord) during cranial surgical procedures. DuraTech is the first of several products that Osteotech is developing based upon its first-in-class HCT platform. A total of 60 patients were enrolled in the clinical study and the trial will evaluate the patients at 30 and 90 days post-operatively to assess the safety of DuraTech compared to historical surgical procedure outcomes. Osteotech plans to utilize the results stemming from this trial to support its 510(k) filing for marketing clearance with the FDA during 3Q09 with expected marketing clearance before year-end.

 

pSivida (NASDAQ:PSDV) ($1.77) announced that two newly-published peer reviewed scientific papers showed that Fluocinolone acetonide (FA) both inhibited VEGF (vascular endothelial growth factor) production and protected retinal cells and function (a neuroprotective effect). These findings support expanding the treatment indications for the Company's lead product, Iluvien, a miniaturized, injectable, sustained-release drug delivery system that releases FA directly into the eye. Iluvien is being evaluated in Phase 3 clinical trials for the treatment of Diabetic Macular Edema. Initial data from the 950-patient trials are expected to be reported by the end of 2009, with a NDA filing scheduled for early 2010. PSDV stated that the newly-published results support expanding the use of Iluvien beyond DME to include conditions such as wet and dry AMD (age-related macular degeneration) for which Phase 2 trials are currently underway; and other degenerative conditions such as retinitis pigmentosa.

 

Transdel Pharma (OTC:TDLP) ($1.40) announced that the Company anticipates reporting top-line results from their current Phase 3 study of Ketotransdel during 3Q09. The Phase 3 study consists of a randomized, double-blind, placebo controlled trial to evaluate the efficacy and safety of Ketotransdel, a topical cream based non-steroidal anti-inflammatory drug (NSAID), in acute soft tissue injuries of the upper and lower extremities. The multi-center trial is being conducted at approximately 30 sites in the U.S. and will enroll about 350 patients. TDLP plans to initially seek FDA approval of Ketotransdel for the treatment of acute pain and then expand the label to include additional indications such as osteoarthritis.

  

 

CytRx Corp. (NASDAQ:CYTR) ($1.19) announced that it filed a report (including results from an animal toxicology study) with the FDA in response to the Agency's partial clinical hold on the Company's Phase 2b efficacy clinical trial with its molecular chaperone regulator drug candidate arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). CYTR expects that the FDA will review the report during 3Q09 and stated that the Agency's partial clinical hold was unrelated to data generated by human studies and arimoclomol has been studied in seven Phase 1 and two Phase 2 clinical trials without any significant adverse events.

 

I believe that Dr, Banner will tell you just as I will, that all of the Pharmas that we post here, are just to bring them to your attention, in case you hadn't been doing any looking.   It is, as always, your responsibility to do your own research  on anything added here.  Neither of us post these for any gain on our part.   Quite honestly, on this list I just now added here, I don't currently own any of these Pharmas..  just like I suggest to you, I also will do more research and make my own decision as to whether or not I wish to buy any of these stocks.

Happy Trading...  /:)

AKRX..  I don't know how this one has been flying under the radar.. we never even listed it in all of our posts here.. but it got an FDA approval yesterday for an injection, and the stock hasn't moved, other than a very short pop yesterday morning barely after opening.  Was that it? 
Do you know anything about this one, Doc?...  Something to think about.


Happy Trading...  /:)