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Ridaforolimus achieves primary endpoint in Phase 3 trial for metastatic soft-tissue and bone sarcomas

ARIAD Pharmaceuticals, Inc., today announced top-line data showing that ridaforolimus, an investigational oral mTOR inhibitor, met the primary endpoint of improved progression-free survival (PFS) compared to placebo in the Phase 3 SUCCEED trial conducted in patients with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy.

19 Jan 2011

Profectus BioSciences commences GENEVAX IL-12 phase 1 study for HIV

Profectus BioSciences, a leader in the development of therapeutic and preventive vaccines against infectious diseases and cancers, and the AIDS Clinical Trials Group announced today the initiation of a phase 1 study of Profectus' multi-antigen HIV plasmid DNA vaccine administered with various doses of GENEVAX™ interleukin-12 pDNA adjuvant and delivered using the electroporation based TriGrid™delivery system developed by Ichor Medical Systems.

6 Jan 2011

Spectrum submits FUSILEV sNDA for treatment of colorectal cancer

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced it submitted a supplemental New Drug Application with the U.S. Food and Drug Administration (FDA) for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection.

5 Jan 2011

New guideline provides evidence-based recommendation for children undergoing tonsillectomy

A multidisciplinary clinical practice guideline, "Tonsillectomy in Children" will be published in the January issue of Otolaryngology-Head and Neck Surgery.

3 Jan 2011

Profectus' GENEVAX IL-12 pDNA adjuvant improves vaccine-induced response rate in Phase I HIV study

Profectus Biosciences, Inc., a leader in the development of therapeutic and preventive vaccines against infectious diseases and cancers, announced today that its GENEVAX™ IL-12 pDNA adjuvant has significantly improved the vaccine-induced response rate in a Phase I clinical study of an experimental DNA vaccine for the prevention of HIV infection.

15 Dec 2010

Everolimus plus tamoxifen delays disease progression in HR+/HER2- metastatic breast cancer

A new study shows that the addition of everolimus (Afinitor® tablets) to the hormonal therapy tamoxifen in patients with hormone-receptor positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer who have been previously treated with an aromatase inhibitor (AI) delays disease progression compared to tamoxifen alone. These results were presented today at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium in San Antonio, Texas.

10 Dec 2010

European Commission approves Pfizer's SUTENT for pancreatic neuroendocrine tumors

Pfizer Inc. announced today that the European Commission has approved SUTENT (sunitinib malate) for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors (NET) with disease progression in adults.

2 Dec 2010

Study reveals role of VSV in killing cancer cells through turning off major survival signal

Researchers from Boston University School of Medicine (BUSM) have identified a mechanism by which specific viruses acting as oncolytic agents can enter and kill cancer cells. This finding, which is currently featured in an online edition of the Journal of Virology, could help lead to the development of more targeted treatments against many types of cancer.

2 Dec 2010

Researchers show an oncolytic virus switches off cancer cell survival signal

1 Dec 2010

Spectrum's FUSILEV sNDA accepted by FDA for review

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the complete response regarding its supplemental New Drug Application (sNDA) for FUSILEV® (levoleucovorin) for Injection for treatment of patients with advanced metastatic colorectal cancer.

29 Nov 2010

Pfizer's Phase 3 AXIS 1032 trial for metastatic renal cell carcinoma meets primary endpoint

Pfizer Inc. announced today that the Phase 3 AXIS 1032 trial (A4061032), studying the investigational compound axitinib in previously treated patients with metastatic renal cell carcinoma (mRCC), has met its primary endpoint, demonstrating that axitinib significantly extended progression-free survival when compared to sorafenib, in the study population.

20 Nov 2010

AVEO announces results from tivozanib Phase 1b clinical trial for advanced gastrointestinal cancers

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced results from a Phase 1b clinical trial evaluating the company's lead product candidate, tivozanib, a highly potent and selective inhibitor of VEGF receptors 1, 2, and 3, in combination with FOLFOX6, a standard chemotherapy regimen, in patients with advanced gastrointestinal (GI) cancers.

19 Nov 2010

Clinical trial results of Threshold's TH-302 hypoxia-activated prodrug presented at 16th CTOS annual meeting

Threshold Pharmaceuticals, Inc. today announced clinical trial results related to Threshold's clinical stage hypoxia-activated prodrug, TH-302. The results were presented at the 16th Annual Connective Tissue Oncology Society (CTOS) Meeting taking place in Paris, France from November 11 to 13, 2010.

12 Nov 2010

China Sky third quarter total revenue decreases 16.3% to $36.2 million

China Sky One Medical, Inc., a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China, today announced financial results for the third quarter of 2010.

8 Nov 2010

Spectrum submits complete response to FDA's CRL for FUSILEV to treat colorectal cancer

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced that on Friday, October 29, 2010 it submitted a complete response to the "Complete Response" letter issued by the U.S. Food and Drug Administration (FDA), regarding its supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for Injection for treatment of patients with advanced metastatic colorectal cancer.

1 Nov 2010

Sandoz initiates voluntary recall of Methotrexate Injection

Sandoz Inc. announced today it has initiated a voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product ("methotrexate") to the consumer/user level. Consistent with its commitment to quality and patient safety, Sandoz is initiating this voluntary recall of all 24 lots of the affected product following the finding of small glass flakes by Sandoz quality control in a limited number of vials in four lots.

28 Oct 2010

ARIAD's oral ridaforolimus improves PFS in patients with metastatic endometrial cancer

Pharmaceuticals, Inc. today announced interim results of a randomized, open‐label, active-control multicenter Phase 2 study of oral ridaforolimus, an investigational mTOR inhibitor, in patients with metastatic or recurrent endometrial cancer. Based on this interim analysis, the study demonstrated a statistically significant improvement in the primary endpoint of median progression-free survival (PFS) in patients receiving single-agent ridaforolimus compared to patients receiving standard-of-care treatment.

26 Oct 2010

Threshold announces TH-302 Phase 1/2 clinical trial interim results

Threshold Pharmaceuticals, Inc. today announced interim results from an ongoing Phase 1/2 clinical trial in various solid tumors related to its hypoxia-activated prodrug, TH-302. The results were presented at the European Society for Medical Oncology (ESMO) Annual Meeting being held in Milan, Italy.

13 Oct 2010

Access highlights clinical benefits of MuGard at ESMO conference

Access Pharmaceuticals, Inc., a biopharmaceutical company specializing in products for cancer and supportive care, announced the highlights from a poster presentation on European clinical experience of MuGard at this year's European Society of Medical Oncology Conference in Milan, Italy.

11 Oct 2010

Eli Lilly presents ALIMTA Phase III trial results at ESMO Annual Meeting

Eli Lilly and Company announced today that its global Phase III trial evaluating ALIMTA (pemetrexed for injection) in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck (SCCHN) did not meet its primary endpoint for overall survival. Data were presented for the first time today at the 35th Annual Meeting of the European Society for Medical Oncology (ESMO).