Approval summary: erlotinib maintenance therapy of advanced/metastatic non-small cell lung cancer (NSCLC).

On April 16, 2010, the U. S. Food and Drug Administration (FDA) approved erlotinib tablets (Tarceva®; OSI Pharmaceuticals, Inc.

Effect of carbonated drink on excisional palatal wound healing: a study on Wistar rats.

Background: Millions of people worldwide consume carbonated drinks every day. The effects of these drinks on hard tissues in the mouth have been proved beyond doubt. Only a little has been done so far to assess the effects of carbonated drinks on oral soft tissues.

Synthesis and antimicrobial activity of 2-substituted [4-(1,3,4-oxadiazol-2-yl methyl)] phthalazin-1(2H)-one derivatives.

A series of new 2-substituted [4-(1,3,4-oxadiazol-2-yl)methyl]phthalazin-1(2H)-one derivatives 7a-h to 9a-h were designed and synthesized from methyl (4-oxo-3,4-dihydrophthalazin-1-yl)acetate (4), which in was turn prepared from phthalic anhydride. The structure of synthesized new compounds were characterized by spectral data and screened for their antimicrobial activities against various bacteria and fungi strains. Several of these compounds showed antimicrobial activity.

NO (nitric oxide): the ring master.

The migration and proliferation of endothelial cells affect the process of angiogenesis or the formation of blood vessels. Endothelial cells interact with each other to form ring-like structures in monolayers and tubular structures in matrigels. However, the transit phase between the individual endothelial cells and fully formed tubular structures is yet to be established.

Folotyn (pralatrexate injection) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma: U.S. Food and Drug Administration drug approval summary.

Purpose: On September 24, 2009, the U.S. Food and Drug Administration granted accelerated approval for Folotyn (pralatrexate injection, Allos Therapeutics, Inc.

Chemical analysis of dentin surfaces after Carisolv treatment.

Aims And Objectives: This study was done to characterize the surface chemistry after caries excavation with burs and Carisolv 2, by analyzing the relative amounts of organic and inorganic content, and also to analyze the penetration of the adhesive after etching and bonding using Micro Raman spectroscopy.

Materials And Methods: Twenty extracted molars with caries were distributed into the following groups and treated accordingly. Group 1-excavation with bur (10 teeth), and Group 2-excavation using Carisolv 2 (10 teeth).

FDA approval summary: temsirolimus as treatment for advanced renal cell carcinoma.

This report summarizes the U.S. Food and Drug Administration (FDA)'s approval of temsirolimus (Torisel), on May 30, 2007, for the treatment of advanced renal cell carcinoma (RCC).

Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.

Background: The Office of Oncology Drug Products (OODP) in the Center for Drug Evaluation and Research at the US Food and Drug Administration began reviewing marketing applications for oncological and hematologic indications in July 2005. We conducted an overview of products that were reviewed by the OODP for marketing approval and the regulatory actions taken during July 2005 to December 2007.

Methods: We identified all applications that were reviewed by the OODP from July 1, 2005, through December 31, 2007, and reviewed the actions that OODP took.

Purification and immunological characterization of a 12-kDa allergen from Epicoccum purpurascens.

Exposure to Epicoccum purpurascens is implicated in respiratory allergies and asthma. Several allergens of clinical importance were identified in Epicoccum extract (EE), but only one allergen has been isolated and characterized. In the present study, a 12-kDa allergen was isolated from an Epicoccum spore-mycelial extract by concanavalin-A sepharose, reverse-phase hydrophobic and gel filtration chromatography.

Electrocautery adenoidectomy outcomes: a meta-analysis.

Objective: Review the published literature regarding clinical outcomes of suction electrocautery adenoidectomy (ECA) in pediatric patients.

Data Source: The MEDLINE database was systematically reviewed for articles reporting on the use of ECA.

Review Methods: Each study was independently reviewed by each investigator.

Sorafenib for the treatment of unresectable hepatocellular carcinoma.

Purpose: To describe the U.S. Food and Drug Administration (FDA) review and approval of sorafenib (Nexavar; Bayer Pharmaceuticals Corp.

Abortion and long-term mental health outcomes: a systematic review of the evidence.

Claims that women who have elective abortions will experience psychological distress have fueled much of the recent debate on abortion. It has been argued that the emotional sequelae of abortion may not occur until months or years after the event. Despite unclear evidence on such a phenomenon, adverse mental health outcomes of abortion have been used as a rationale for policy-making.

Lenalidomide in combination with dexamethasone for the treatment of multiple myeloma after one prior therapy.

Purpose: Lenalidomide (CC-5013, Revlimid; Celgene Corporation, Summit, NJ), a thalidomide analogue, was granted approval by the U.S. Food and Drug Administration (FDA) on June 29, 2006, for use in combination with dexamethasone in patients with multiple myeloma (MM) who have received at least one prior therapy.

FDA drug approval summary: lapatinib in combination with capecitabine for previously treated metastatic breast cancer that overexpresses HER-2.

On March 13, 2007, the U.S. Food and Drug Administration approved lapatinib (Tykerb tablets; GlaxoSmithKline, Philadelphia), an oral, small molecule, dual tyrosine kinase inhibitor of ErbB-2 and ErbB-1, for use in combination with capecitabine for the treatment of patients with human epidermal growth factor receptor (HER)-2-overexpressing metastatic breast cancer who had received prior therapy including an anthracycline, a taxane, and trastuzumab.

A clinically relevant major cross-reactive allergen from mesquite tree pollen.

Background: Prosopis juliflora (mesquite) is one of the major sources of pollinosis in tropical and semi-arid countries of the world. The present study was undertaken to purify and characterize a major cross-reactive allergen from this tree species.

Materials And Methods: Mesquite pollen extract was purified using reverse-phase chromatography.

Effect of proteolytic activity of Epicoccum purpurascens major allergen, Epi p 1 in allergic inflammation.

Enzymes play an important role in inducing airway inflammation, but knowledge is limited to few proteins. This study was carried out to assess the role of Epi p 1, a serine protease of Epicoccum purpurascens, in inducing allergy and inflammation in a murine model. Balb/c mice were sensitized with Epi p 1 active protease (EAP) or Epicoccum extract.

Tasigna for chronic and accelerated phase Philadelphia chromosome--positive chronic myelogenous leukemia resistant to or intolerant of imatinib.

Purpose: This Food and Drug Administration (FDA) approval report describes the data and analyses leading to the approval by the FDA of nilotinib (Tasigna, AMN-107; Novartis Pharmaceuticals Corporation), an inhibitor of Bcr-Abl tyrosine kinase, for the treatment of chronic-phase (CP) and accelerated-phase (AP) chronic myelogenous leukemia (CML) resistant to or intolerant of imatinib.

Experimental Design: The FDA approval of the efficacy and safety of nilotinib was based on the results of an ongoing single-arm, open-label, phase 2 clinical trial. The primary end point for CML-CP was unconfirmed major cytogenetic response.

Ixabepilone in combination with capecitabine and as monotherapy for treatment of advanced breast cancer refractory to previous chemotherapies.

Purpose: To describe the considerations leading to marketing approval of ixabepilone in combination with capecitabine and as monotherapy for the treatment of advanced breast cancer that is refractory to other chemotherapies.

Experimental Design: Data from one randomized multicenter trial comparing combination therapy with ixabepilone and capecitabine to capecitabine alone were analyzed for support of the combination therapy indication. For monotherapy, a single-arm trial of ixabepilone was analyzed.