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

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 5/28/09, Incyte Corp. [INCY: 3.64, +0.06 (+1.68%)] announced that based on recent input from the FDA regarding the Company’s request for a Special Protocol Assessment (SPA) for INCB18424 for patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) and post-essential thrombocythemia myelofibrosis

Lixte Biotechnology [[LIXT.OB]] was founded as a diagnostics company in 2005 evaluating biomarkers (indicators of disease at the molecular level), but has shifted its focus to become a cancer drug discovery operation.

Lixte engages in the discovery of anti-cancer compounds to improve the treatment of malignancies with few effective treatment options, such as certain types of brain cancer. Other areas of early-stage, preclinical drug discovery include: (1) improved anti-fungal treatments for patients with compromised immunity (e.g. HIV/AIDS, bone marrow transplantation); (2) neurodegenerative conditions such as Alzheimer’s and Parkinson’s disease; and (3) biomarker assays for diagnostic and prognostic applications in the detection of disease and monitoring of treatment effectiveness.

Since Lixte is a development-stage company which does not generate any revenue, the ability to obtain financing to fund research and drug discovery operations will be a key factor this year. The Company estimates minimum funding requirements of $750,000 for this year, which will

Our Director of Marketing’s Grandfather died of a massive brain tumor when she was only about a year old. His last days were a combination of comatose and automatic speaking. He recited every line that he had ever spoken on stage (he was in the entertainment industry). Although she doesn’t remember it, it was very traumatic for her family.

Recurrent Glioblastoma Multiforme is the most common type of malignant primary brain tumor in adults. Treatment success has not significantly changed over the last 20 years, with most patients living less than one year after diagnosis despite aggressive surgery, radiation and chemotherapy. Additionally, Brain stem cell cancer is the most lethal cancer in children, with a survival rate of less than one year after diagnosis.

NeoPharm’s agreement with NINDS will serve as another step in pursuing the validation of the company’s proprietary drug, Cintredekin Besudotox (IL13-PE38QQR) (“IL-13”) and its impact on possibly