The U.S. Food and Drug Administration (FDA) has granted approval for PROVENGE® (sipuleucel-T | Dendreon Corporation) for treating asymptomatic or minimally symptomatic, metastatic, hormone-resistant (castrate-resistant) prostate cancer (CRPC). It acts by eliciting an immune response against a prostate cancer-specific antigen, prostatic acid phosphatase (PAP). The drug formulated from patient-specific white blood cells, is not indicated for preventing the development or progression of prostate cancer. Continue Reading

The hypoglycemic effect of thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR) agonists, has been proven through various well-designed clinical trials. However, since they are reported to cause fluid retention, guidelines from international medical bodies caution the use of these drugs in patients with New York Heart Association (NYHA) class III and IV heart failure (HF). Now, data obtained from a multi-center open-label trial further corroborates the enhanced risk for HF events in type 2 diabetic patients on rosiglitazone medication. The results of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) study, published in the recent issue of the European Heart Journal, support the warnings put forth for the use of TZDs in diabetic patients on treatment with metformin or sulfonylurea mono or combined therapy. Continue Reading

The aberrant expression of several microRNA (miRNA) molecules, which play a crucial role in the regulation of gene expression, has been associated with hepatocarcinogenesis. Now, researchers at the National Cancer Institute, in collaboration with Fudan University, University of Hong Kong, and Ohio State University, have identified a miRNA molecule that could help predict the survival of patients with hepatocellular carcinoma (HCC), and also their response to interferon alpha adjuvant treatment, post-surgery. The findings of the study are published in the recent issue of The New England Journal of Medicine. Continue Reading

Miscarriage occurs in 10%-25% of all clinically recognized pregnancies, with around <5% of women reporting 2 consecutive miscarriages and nearly 1% women experiencing ≥3 recurrent episodes of pregnancy loss. The etiology of miscarriage is unexplained in approximately 50%-75% of couples with recurrent pregnancy loss. Now a randomized controlled study, published in the recent issue of Human Reproduction, reports the potential of subcutaneous administration of granulocyte-colony stimulating factor (G-CSF) as an effective strategy to improve the pregnancy outcome in patients with idiopathic recurrent miscarriages. Continue Reading

Dronedarone (Multaq® | Sanofi-aventis) received regulatory approval from the U.S. Food and Drug Administration for maintaining normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter (heart rhythm disorders). The FDA approval was based on results obtained from five randomized multicenter clinical trials, comprising of approximately 6,300 patients. However, due to the increased mortality in one of the trials (ANDROMEDA study), the drug’s label contains a boxed warning from the FDA, prohibiting its use in patients with severe heart failure. Continue Reading

A novel artificial cervical disc, BRYAN® developed by Medtronic, Inc. gained approval from the U.S. Food and Drug Administration (FDA) for the treatment of single-level cervical disc diseases like radiculopathy and/or myelopathy. A titanium-polyurethane device, the Bryan Cervical Disc is implanted in milled pockets of adjacent vertebral bodies from C3-C7 to substitute a diseased or bulging natural cervical disc. The disc permits flexion/extension, translation, axial rotation, and lateral bending of the cervical spine and circumvents the limitations associated with the potential alternative, anterior cervical discectomy and fusion (ACDF). Continue Reading

Renal cell cancer, the most common type of kidney cancer, develops in the lining of the kidney tubules. Several drugs are being studied to treat the cancer as a single agent or in combination with other anti-tumor drugs. Now, a phase I trial has reported the safety and efficacy of the combination treatment involving temsirolimus (TEM) and bryostatin (BRYO) for metastatic renal cell carcinoma (RCC). Findings of the study were presented at the annual meeting of the American Society of Clinical Oncology, held at Orlando, Florida, during May 29-June 2, 2009. Continue Reading

A recent multicenter phase II study suggests that weekly administration of nanoparticle albumin-bound (nab)-paclitaxel (ABRAXANE® | Abraxis BioScience, Inc.) has superior antitumor activity and safety compared to docetaxel (Taxotere® | Sanofi-aventis) for the first-line treatment of metastatic breast cancer. A statistically and clinically significant progression-free survival of >5 months was noted in patients receiving 150 mg/m² nab-paclitaxel weekly than those receiving 100 mg/m² docetaxel every three week (q3w). The study results are published in the recent issue of the Journal of Clinical Oncology. Continue Reading

Iloperidone (Fanaptâ„¢ | Vanda Pharmaceuticals Inc.), an atypical antipsychotic drug, received the U.S. Food and Drug Administration (FDA) approval for the acute treatment of schizophrenia in adults. The approval is based on safety data from over 3,000 patients and the results of two placebo-controlled short-term clinical studies, demonstrating the efficacy of iloperidone in reducing the symptoms of schizophrenia. Continue Reading

The dependence of various cancer cells on the glycolytic pathway for their energy requirements has also been correlated with the aggressiveness of different types of tumors. Now, a recent study has found a novel glycolysis inhibitor, 3-BrOP that lowers the growth of neuroblastoma by 75% in xenograft models. The results of the study have been presented at the 22^nd annual meeting of the American Society of Pediatric Hematology/Oncology held at San Diego, California, during April 22-25, 2009. Continue Reading