Posted on 13 May 2010.
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
Posted in Basic Sciences, Chemotherapeutics, Clinical Research, Drug Development, Featured, Immunology, Medicine, Oncology, Pharma, Pharma Industry
Posted on 11 May 2010.
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
Posted in Basic Sciences, Cardiology, Clinical Research, Critical Care, Diabetes, Endocrinology, Internal Medicine, Medicine, Patient Care, Pharma, Pharmacology, Pulmonology
Posted on 04 November 2009.
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
Posted in Basic Sciences, Biochemistry, Biotechnology, Clinical Research, Gastroenterology, Infectious Diseases, Internal Medicine, Lab Medicine, Medicine, Molecular Biology, Oncology, Pathology, Pharma, Pharmacology, Virology
Posted on 30 July 2009.
Miscarriage occurs in 10%-25% of all clinically recognized pregnancies, with around <5% of women reporting 2 consecutive miscarriages and nearly 1% women experiencing â‰¥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
Posted in Basic Sciences, Clinical Research, Fertility, Genetics, Gynecology, Immunology, Medicine, Pharmacology, Women's Health
Posted on 23 July 2009.
Dronedarone (MultaqÂ® | 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 drugâ€™s label contains a boxed warning from the FDA, prohibiting its use in patients with severe heart failure. Continue Reading
Posted in Basic Sciences, Cardiac Surgery, Cardiology, Clinical Research, Drug Development, Medicine, Pharma, Pharma Industry
Posted on 30 June 2009.
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
Posted in Basic Sciences, Clinical Research, Head and Neck, Medical Devices, Medical Technology, Orthopedics, Surgical Specialties
Posted on 16 June 2009.
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
Posted in Chemotherapeutics, Clinical Research, Drug Development, Nephrology, Oncology, Pharma
Posted on 04 June 2009.
A recent multicenter phase II study suggests that weekly administration of nanoparticle albumin-bound (nab)-paclitaxel (ABRAXANEÂ® | Abraxis BioScience, Inc.) has superior antitumor activity and safety compared to docetaxel (TaxotereÂ® | 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
Posted in Chemotherapeutics, Clinical Research, Drug Delivery, Medical Technology, Medicine, Oncology, Pharma, Pharma Industry, Radiodiagnosis, Women's Health
Posted on 16 May 2009.
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
Posted in Basic Sciences, Clinical Research, Drug Development, Internal Medicine, Medicine, Mental Health, Neurology, Pharma, Pharma Industry, Psychiatry, Psychology
Posted on 15 May 2009.
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 22nd annual meeting of the American Society of Pediatric Hematology/Oncology held at San Diego, California, during April 22-25, 2009. Continue Reading
Posted in Basic Sciences, Chemotherapeutics, Clinical Research, Fetal Medicine, Internal Medicine, Medicine, Mental Health, Neurology, Oncology, Pediatrics, Pharma