Genta Inc. released the results from a pilot study on advanced melanoma incorporating the Company’s cancer drug Genasense(R) (oblimersen sodium). This study was featured earlier this week in a presentation at the World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers in Berlin, Germany, an international conference organized every year by a co-leader of the AGENDA trial, the European Association of Dermatologic Oncology (EADO).

Genasense, delivered for the first time in a high-dose, 1-hour intravenous (IV) format, was used along with the most common melanoma drug temozolomide (Temodar(R); Schering Plough, Inc.), and a paclitaxel suspension (Abraxane(R); Abraxis Bioscience, Inc.). Using a standard dose and schedule of Genasense, 500 mg over 24 hours for 7 days, showed good tolerability for 18 patients and was associated with clinical activity in prior results using this investigational combination of drugs.

Genasense, administered in this more aggressive schedule (1-hour IV twice a week for 4 weeks at 900 mg

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Maxygen, Inc. (NASDAQ: MAXY) is committed to developing superior versions of existing major protein pharmaceuticals. The company’s lead product candidates meet the demands of substantial market opportunities such as cancer and autoimmune diseases. Well positioned for growth, Maxygen has a number of promising product candidates and the financial strength required to drive them through clinical development.

Maxygen currently has three protein pharmaceuticals advancing towards clinical development. Behind its product candidates, the company has developed a broad pipeline of other human therapeutics products that are in earlier stages of development. In addition to these, Maxygen also believes its proprietary technologies could transform the design and development of vaccines.

The company’s MAXY-G34 product candidate was designed to be an improved next-generation granulocyte colony stimulating factor for the treatment of neutropenia, a severe decrease in neutrophil cell counts in the blood. MAXY-G34 may help the body make white blood cells more quickly than the

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We are pleased to hear that the US Food and Drug Administration (FDA) accepted and filed for review Cell Therapeutics’ (CTIC) New Drug Application (NDA). The company is seeking FDA approval (NDA filed in June 2009) for pixantrone for the treatment of relapsed and refractory non-Hodgkin’s lymphoma (NHL). Though an action date is yet to be published, the company expects the FDA to take a final decision regarding the review status by Sept 4.

Earlier in June, Cell Therapeutics presented encouraging results from a phase III trial of pixantrone. Although the efficacy data for pixantrone were encouraging, we are concerned about its side effects. While, neutropenia was 41.2% for pixantrone versus 19.4% for comparator, leukopenia was 23.5% for pixantrone versus 4.5% for comparator.

Although the grade 3, 4 cardiac disorder was similar among the two treatment groups (1.5% vs. 1.5%), there was a higher incidence of serious cardiac disorders in patients

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Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar 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.

Allos Therapeutics [ALTH: 7.19, -0.13 (-1.78%)]: On 5/30/09 , ALTH updated data from the Company’s pivotal Phase 2 PROPEL study of pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The overall response rate for pralatrexate as evaluated by central independent

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Surge of CTIC on PIX301 Trial Data: Sustainable?Pixantrone is more efficacious than comparators but with safety concernsYesterday afternoon (June 1), Cell Therapeutics, Inc. (CTIC) presented updated final results of its pivotal phase III EXTEND (PIX301) trial of Pixantrone in relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) at the 2009 American Society for Clinical Oncology (ASCO) Annual Meeting held in Orlando, Florida.The PIX 301 EXTEND trial was a phase III single-agent trial of Pixantrone for patients with relapsed or refractory aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial enrolled 140 patients and patients were randomized to receive either Pixantrone (N=70) or another single-agent drug (N=70) currently used for the treatment of this patient population and selected by the physician.Efficacy data encouragingThe efficacy data were encouraging. Patients treated with ...

For Immediate Release

Chicago, IL - March 27, 2009 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Cognizant Technology Solutions Corp. (CTSH), Infosys Technologies, Ltd. (INFY), Wipro Ltd. (WIT), Amgen, Inc. (AMGN) and AK Steel (AKS).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=4579.

Here are highlights from Thursday's Analyst Blog:

Cognizant Sails in Choppy Waters

Recent outlook for companies in the IT Services sector has not been positive, and the sentiment has been supported by datapoints through CY2009. However, companies like Cognizant Technology Solutions Corp. (CTSH), Infosys Technologies, Ltd. (

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Amgen, Inc. (AMGN), a global biotechnology company, is focused on the development and commercialization of human therapeutics. The company's key products are Epogen/Aranesp (anemia), Neupogen/Neulasta (neutropenia), and Enbrel (inflammatory disease). Results over the past few quarters demonstrate the challenging, but stabilizing ESA market.Nevertheless, we still feel as though the pipeline is significantly undervalued, and we continue to recommend the name as a long-term Hold within the biotechnology sector. Recent positive news on phase III denosumab is a big reason we continue to be positive on Amgen. Our price target is $56.Based on our 2009 through 2013 model, the 5-year earnings CAGR [compound annual growth rate] of 7% is generally in-line with that of most large-cap pharmaceutical companies. Yet it is well below some of the larger biotechnology peers such as Genentech (DNA), Biogen (BIIB), Celgene  (CELG), Genzyme (GENZ) and Gilead ...

Amgen, Inc. (AMGN), a global biotechnology company, is focused on the development and commercialization of human therapeutics. The company's key products are Epogen/Aranesp (anemia), Neupogen/Neulasta (neutropenia), and Enbrel (inflammatory disease).Results over the past few quarters demonstrate the challenging, but stabilizing ESA [erythropoiesis stimulating agents] market. Nevertheless, we still feel as though the pipeline is significantly undervalued, and we continue to recommend the name as a long-term hold within the biotechnology sector.Recent positive news on phase III denosumab is a big reason we continue to be positive on Amgen. Our price target is $62.Read the full analyst report on AMGN. "AMGN" Free Stock Analysis: Buy? Sell? Hold?Zacks Investment Research