Today Amgen Inc. (AMGN) announced submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for its potential next blockbuster drug, denosumab. The indications for which Amgen is seeking FDA approval are treatment and prevention of postmenopausal osteoporosis (PMO) in women, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The BLA submission contains data from six phase-III trials involving more than 11,000 patients.Denosumab is a fully human monoclonal antibody target receptor activator of nuclear factor kappa B ligand (RANK-L). The clinical data on denosumab, or D-Mab as management calls it, is impressive. In July 2008, Amgen release top-line data from the pivotal trial testing denosumab in 7,800 women with postmenopausal osteoporosis over a 3-year period. Data from the trial showed taking denosumab subcutaneous injections once every six months resulted in statistically ...

S&P Slashes RBS Rating; Dendreon’s Big Boost; Eli Lilly Comes Out Ahead on ImClone; AgFeed’s Hungry For Its Own Shares; Bank of America Surprises with Loss; Paulson Taps Another Goldman Exec.

Cell Genesys (Nasdaq:CEGE) focuses on the development and commercialization of novel biological therapies for patients with cancer. The company’s lead product platform, GVAX immunotherapy for cancer, holds the potential to treat multiple types of cancer, including prostate cancer, leukemia, pancreatic cancer and lung cancer.

The company today announced the U.S. Food and Drug Administration has placed an expected partial clinical hold on phase 3 program for GVAX. The halt follows the company’s August 27, 2008 announcement in which it said it will end the VITAL-2 phase 3 trial for GVAX.

Cell Genesys terminated the trial after its Independent Data Monitoring Committee (IDMC) observed an imbalance in deaths between two treatment arms of the VITAL-2 study, which compared GVAX immunotherapy in combination with Taxotere to Taxotere plus prednisone in patients with advanced prostate cancer.

In today’s announcement, Cell Genesys said the FDA confirmed that patients in the VITAL-1 phase 3 trial

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Cell Genesys, Inc. (Nasdaq: CEGE) focuses on the development and commercialization of biological therapies to treat multiple types of cancer. The company’s lead product platform, GVAX immunotherapy, holds the potential to treat various types of cancer, including prostate cancer, leukemia, pancreatic cancer and lung cancer. Cell Genesys today announced it has terminated VITAL-2, the second of two phase III clinical trials of GVAX.

The trial was set to compare GVAX immunotherapy in combination with Taxotere to Taxotere combined with prednisone in patients with advanced-stage prostate cancer. However, after reviewing an imbalance in deaths between the two treatment arms of study, the company’s Independent Data Monitoring Committee (IDMC) recommended the trial end to ensure patient safety.

“Patient safety is always our paramount concern and so we have immediately responded to the recommendation of the IDMC. We are currently notifying all participating clinical trial sites and regulatory agencies that enrollment of new patients

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The fate of Dendreon Corp.'s (DNDN) key product candidate, Provenge prostate cancer vaccine, will be dependent on the ongoing IMPACT phase III trial. Positive interim results from the trial in October will enable the company to amend the biologic license application filing for Provenge. Therefore, we maintain our Hold rating on the shares.

The Food and Drug Administration's approvable letter was a surprise to us since it usually follows the advice of its expert panel which recommended the immediate approval of Provenge at its March 29, 2007 meeting. The decision may delay the approval and launch of Provenge until 2009 at the earliest. Approval of Provenge is critical for the financial performance of the company because the product has blockbuster status and successful commercialization of Provenge can drive a company of Dendreon's size to strong profitability.

Unless the company signs a commercialization deal for Provenge, the only upcoming positive catalyst

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BSD Medical Corp. (Nasdaq: BSDM) is part of the global fight against cancer. The company develops systems for cancer therapies requiring precision-focused heat through microwave technologies. Today the company announced its European distributor was awarded a contract from Azienda Ospedaliera Institui Ospitalieri Di Verona (the Institute) to replace its existing hyperthermia system with BSD’s BSD-2000/3D system.

The BSD-2000/3D deep regional hyperthermia system is scheduled for delivery in August 2008, and will replace the Institute’s current system, which has been used since 1996. The BSD-2000/3D will be the first of its kind in Italy, and the 15th utilized in Europe.

“We are pleased to further expand our activities in the field of clinical hyperthermia, the single most potent radiation sensitizer available. We are looking forward to close working relationships with all of the ESHO [European Society for Hyperthermic Oncology] member institutes in advancing hyperthermia cancer treatment,” Dr. Sergio Maluta, head of the

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A good balance sheet and a couple of of late-stage hormone therapy products underlie recently appointed CEO Dr. David Mazzo’s enthusiasm for the future prospects of the 16-year-old, Quebec-based biopharmaceutical firm Æterna Zentaris

The following is a bio-stock catalyst report covering a trading calendar of regulatory events & key clinical trial results through early 2008 on major bio-stocks: