GlaxoSmithKline (GSK) and Denmark-based Genmab received some good news with the US Food and Drug Administration’s (FDA) approval for Arzerra (ofatumumab), a monoclonal antibody for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow.  Arzerra is approved for cancer patients who are no longer responding to the current available treatment options using fludarabine and alemtuzumab. Following the approval, Genmab has become eligible to receive a milestone payment of DKK 116 million (approximately $23 million) from Glaxo.  Earlier, in May 2009, Arzerra had received a positive recommendation from the FDA's Oncologic Drugs Advisory Committee (ODAC) in which the panel had voted 10-3 in favor of the drug. They had found that Arzerra provided some clinical benefit to patients with CLL whose disease was refractory to fludarabine and alemtuzumab.  Arzerra has been approved by the FDA under the accelerated approval process ...

On Monday morning, the Food and Drug Administration panel approved Arzerra, a leukemia treatment that will be marketed and commercialized by GlaxoSmithKline Plc (ADR) (NYSE:GSK). As per the announcement made by the GSK executives, Arzerra is for those patients who have failed to respond to other therapies that cure leukemia. This new drug marketed by GSK was originally developed by GlaxoSmithKline and Genmab A/S, a Danish company. The drug is designed to treat patients with chronic lymphocytic leukemia also known as CLL and for those whose disease has progressed despite previous treatments with other cancer drugs.

GSK is a global healthcare company that is more into the creation and development, manufacturing and marketing of various pharmaceutical products including vaccines and over the counter medicines and other health related

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Genzyme Corporation (GENZ) recently reported positive results from a randomized phase III study that was conducted with Campath (alemtuzumab) in combination with Fludara (fludarabine phosphate) in relapsed or refractory chronic lymphocytic leukemia (CLL) patients.  The company reported that patients treated with Campath and Fludara (FluCAM) experienced a significant improvement in progression free survival (PFS), compared to patients receiving only Fludara. The study was designed to detect at least a 50% overall improvement in PFS in the FluCAM arm compared to the Fludara arm.  Although the company did not disclose full results, Genzyme announced that the trial’s independent data safety monitoring board, in a pre-planned interim analysis, determined that the study achieved its primary endpoint and recommended early closure of the trial.  We look forward to detailed results from the study in December at the American Society of Hematology. Impressive PFS results could help the combination ...

On Friday, Trubion Pharmaceuticals, Inc. (TRBN) agreed to jointly develop and commercialize TRU-016 globally with Facet Biotech Corp. (FACT).  TRU-016 is undergoing early-stage studies for chronic lymphocytic leukemia (CLL).   The deal requires Facet to make a $20 million upfront payment to Trubion coupled with an additional $176.5 million on the achievement of certain milestones. Further, Facet has agreed to buy 2.24 million shares of newly issued Trubion common stock for $10 million. The companies have agreed to contribute equally towards costs related to development, commercialization and promotional activities. All global operating profits will be shared equally.   The TRU-016 program is focused on the development of a novel CD37-targeted therapy for B-cell malignancies, such as Non-Hodgkin's lymphoma (NHL) and CLL. CD37 is a clinically validated target for the treatment of B-cell malignancies and TRU-016 has been designed for a desired therapeutic label surrounding B-cell depletion in these

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On July 7, 2009, Celgene International Sàrl, the Swiss unit of biopharmaceutical company Celgene Corp. (CELG) filed  a New Drug Application (NDA) with the Japanese Ministry of Health, Labor and Welfare (MHLW) for Revlimid in combination with dexamethasone for the treatment of multiple myeloma (MM) patients with at least one prior therapy. The filing was based on the safety and efficacy results of two late-stage trials – the North American trial MM-009 and the International trial MM-010 which evaluated Revlimid plus dexamethasone in MM patients with at least one prior therapy. The studies were published in the New England Journal of Medicine in November 2007. The Revlimid–dexamethasone combination for the treatment of MM patients with at least one prior therapy is already approved in nearly 50 countries worldwide. Revlimid was granted orphan drug status in Japan in February 2008 for deletion 5q myelodysplastic syndromes (MDS) as ...

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.  

On 5/19/09, Biogen [BIIB: 50.69, +0.30 (+0.60%)] and Genentech (acquired by Roche) [RHHBY: 0.00, N/A (N/A)] announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the FDA for Rituxan (rituximab) plus standard chemotherapy for people with

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Alexion: One-Drug Wonder Continues - How Long Can This Be Sustained? Soliris sales continues to grow in 1Q09Late last week, Alexion Pharmaceuticals, Inc. (ALXN) reported first quarter 2009 financial results. Soliris sales were in line with our expectation of $81.3 million -- up 78.1% y-o-y and 5% sequentially.Due to strong Soliris sales, Alexion has been enjoying profitability since the second quarter last year. In 1Q09, adjusted net income was $14.6 million, with diluted earnings per share (EPS) of $0.16. Excluding share-based expenses, Alexion achieved a net income of $22.5 million or EPS of $0.25 in 1Q09. First quarter net income and EPS were less than our estimate of $17.6 million and $0.19 per share due to higher R&D and SG&A expenses. Soliris (eculizumab) is a humanized monoclonal antibody complement inhibitor, which blocks cleavage of the C5 component of the complement ...

Highlights include Biogen Idec, Inc. (BIIB), AstraZeneca plc (AZN), Bristol-Myers Squibb, Inc. (BMY) and Sanofi-Aventis SA (SNY).R&D Day Highlights the Best Pipeline In Biotech

Last week, Biogen Idec (BIIB) held an R&D Day, highlighting the broad depth of the company's pipeline. In total, Biogen Idec boasts 7 programs in phase III registration programs and 20 other programs in phase II "proof-of-concept" programs. Biogen's development programs span oncology, neurology and cardiovascular disease, and include both small molecules and biologics. In our opinion, it's the best pipeline in biotech.

Phase III / Registration programs include:   

BG-12: An anti-inflammatory second generation oral fumaric acid molecule that offers a more convenient and potentially neuroprotective treatment option for multiple sclerosis. BG-12 is currently in 2 phase III trials, DEFINE and CONFIRM, with data expected in 2010 and 2011.     ...

Highlighted companies include Biogen Idec (BIIB), Genentech (DNA), Merck (MRK) and Sanofi-Aventis (SNY).At 13x our 2009 EPS of $4.05 per share, we believe that Biogen Idec's (BIIB) stock is too attractive to ignore. Valuation is below the biotech peer-group average, where several names are trading at a significant premium.The company should post non-GAAP EPS up roughly 11% in 2009, even with all the Tysabri PML issues. However, valuation alone is not enough of a reason to buy the stock. We are comfortable with owning the name here based on two other reasons.Firstly, Biogen has a significant late-stage pipeline. There are 22 programs in phase II or beyond. Six of these products are in phase III registration programs right now: lumiliximab for chronic lymphocytic leukemia (CLL), galiximab for non-Hodgkin's lymphoma (NHL), BG-12 for relapsing / remitting multiple sclerosis (RR-MS), ...

Gene Marcial, Business Week’s Stock Guru and Inside Wall Street columnist recommended the following stocks, which can be tracked at:

http://trackthepros.com/

1. Noble

a. global demand for offshore drilling services and day rates for equipment use are on the rise,”

b. Noble is operating at near-full capacity, having signed long-term contracts as demand for rigs continues to exceed supply.

c. Noble’s diversified fleet of 62 deepwater and shallow drilling rigs is mainly in the Middle East (25%), with less than 15% in any other single region. Its deepwater rigs in the Gulf of Mexico were not damaged by Hurricane Gustav.

d. solid play on growing demand for drilling equipment with a strong presence in Brazil, Mexico, West Africa, Europe, and the Middle East.

CombiMatrix

a. What’s behind the stock’s climb to 16.03 on Sept. 3, up from 4.50 a year ago? The company is in a hot sector: DNA diagnostics. It develops DNA microarrays—chips that let

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