Recently, Dendreon Corp. (DNDN) announced that it intends to file an amendment to its existing Biologic License Application (BLA) for its prostate cancer vaccine Provenge in Nov. 2009. We believe that the US Food and Drug Administration (FDA) will approve Provenge in the first half of 2010 based on the positive phase III IMPACT (IMmunotherapy for Prostrate AdenoCarcinoma Treatment) trial results announced in Apr. 2009.   If approved, Dendreon will become the first company to receive approval for an anti-cancer immunotherapy based vaccine. In development studies, Provenge boosted survival rates in men with advanced prostate cancer beyond any currently available treatments. Unlike traditional vaccines that prevent diseases, Provenge treats it by stimulating the body's own immune system to attack cancer cells. We also expect the company to announce a partner for Provenge in Europe soon while Dendreon itself will market the drug in the U.S.   Prostate cancer ...

Dendreon Corporation (DNDN) is likely to become the first company to receive approval from the US Food and Drug  Administration (FDA) for an anti-cancer, immunotherapy based vaccine, as it released phase III IMPACT (IMmunotherapy for Prostrate AdenoCarcinoma Treatment) trial results for its key product candidate, Provenge, in April 2009. Provenge boosted survival rates in men with advanced prostate cancer beyond any currently available treatments. Dendreon intends to file an amendment to its existing Biologic License Application (BLA) in the fourth quarter of 2009. We believe that the FDA will approve Provenge in the first half of 2010 based on the positive late-stage study results. We also expect the company to announce a partner for Provenge in Europe soon while Dendreon itself will market the drug in the U.S. We believe Provenge could have blockbuster potential if it is approved by the regulators. Prostate cancer is the most ...

Provectus Pharmaceuticals, Inc.

(Public, OTC:PVCT)

StocksHaven Investments profiles one of the most exciting up-and-coming anti-cancer companies in the industry, Provectus Pharmaceuticals (OTC:PVCT). They have one of the deepest pipelines of any small cap biotech, focusing on treatments for: Melanoma, Psoriasis, Atopic Dermatitis, Breast Cancer, and Liver Metastasis. With three drugs nearly ready to enter Phase III, including one nearly entering Phase II for Breast Cancer, one of the largest target markets worldwide and seeking “compassionate use” in Australia and USA, look for Provectus to make a splash within the next couple of months.

They are developing and testing one of the most exciting anti- cancer compounds. It has been demonstrating significant effectiveness against Melanoma in Phase 2 clinical trials and it offers promising treatment for breast, liver and other solid tumor based metastatic cancers. The compound developed by Provectus, known as PV-10, is a

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Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of about 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following additional categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

On 6/4/09, Abbott Labs [ABT: 45.42, +0.86 (+1.93%)] and AstraZeneca [AZN: 43.34, +1.70 (+4.08%)] announced that the companies have submitted a New Drug Application (NDA) to the FDA for an investigational compound to treat mixed dyslipidemia, a combination of two

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Provectus Pharmaceuticals, Inc. (OTC BB: PVCT) announced that they have commenced recruitment for their Phase 2 clinical trial of the company’s lead oncology agent PV-10 at a fifth major center, now covering the northeastern United States. The new center joins the other company’s centers located in Sydney, Brisbane and Adelaide, Australia, and Houston, Texas.

Sanjiv Agarwala, M.D. has been appointed as the principal investigator at the new center, located at St. Luke’s Hospital & Health Network, in Bethlehem, PA. Over the next several months, the company intends to continue expansion of the study to include sites in other major population centers in Australia as well as several sites in the United States.

Phase 2 clinical testing of PV-10 is designed to assess the agent as a treatment for Stage III and IV metastatic melanoma, the most aggressive and deadly form of skin cancer. The multi-center study will

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Provectus Pharmaceuticals Inc. (OTCBB: PVCT) specializes in effective, affordable and minimally invasive oncology and dermatology therapies to treat diseases such as melanoma and psoriasis. The company today announced it is recruiting for its phase 2 clinical trials of PV-10 for the treatment of stage III and IV metastatic melanoma, the most deadly form of skin cancer.

The company is focusing on recruiting 80 subjects at a fourth center in Adelaide, Australia to test the efficacy of PV-10. Throughout the next several months, Provectus expects to expand its study to incorporate subjects in other areas of Australia, as well as several sites in the United States.

“Opening the center at Adelaide is the continuation of our expansion of our phase 2 program in melanoma to multiple sites including the U.S.,” Craig Dees, Ph.D., CEO of Provectus stated in the press release. “It is another important step in our effort to get

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The FDA has published a table with the names of products and potential signals of serious risks and/or new safety information identified for these products during 1Q08 in the AERS database. The FDA notes that patients should not stop taking these medications and should consult their prescriber with any questions as the agency will investigate each of the claims further before taking action or issuing more definitive statements on the reported concerns. Some highlights from this table of products that are sold by public-traded pharma and biotech companies are listed below in the following format: active ingredient (brand name) - company(ies) - new safety information reported. Duloxetine (Cymbalta) - Eli Lilly (LLY) - Urinary retention Heparin - Baxter (BAX) & APP Pharma (APPX) - Anaphylactic-type reactions Lapatinib (Tykerb) - GlaxoSmithKline (GSK) – Liver toxicity Lenalidomide (Revlimid) - Celgene (CELG) – ...