FDA Approves Tris Pharma's New Drug Application for Karbinal ER

In continuation of my update on Karbinal (carbinoxamine maleate)...

FDA, has approved its New Drug Application (NDA) for Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5mL, the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children ages 2 and up.

FDA Approves Tris Pharma's New Drug Application for Karbinal ER

Androgen receptors found to be a potential target in breast cancer

In continuation of my update on Enzalutamide

We know that, The androgen receptor (AR), also known as NR3C4 (nuclear receptor subfamily 3, group C, member 4), is a type of nuclear receptor that is activated by binding of either of the androgenic hormones testosterone or dihydrotestosterone  in the cytoplasm and then translocating into the nucleus. The androgen receptor is most closely related to the progesterone receptor, and progestins in higher dosages can block the androgen receptor...

Estrogen and progesterone receptors, and the gene HER2 - these are the big three markers and/or targets in breast cancer. Evidence presented at the AACR Annual Meeting 2013 adds a fourth: androgen receptors.

"This is a continuing line of work with all evidence pointing toward the addition of the androgen receptor as potential target and useful marker in all of the major subtypes of breast cancer," says Jennifer Richer, PhD, investigator at the University of Colorado Cancer Center and co-director of the CU Cancer Center Tissue Processing and Procurement Core.

 The finding of androgen receptors (AR) as a potential target in breast cancer is especially important in light of its prevalence in breast cancers that don't express other hormone receptor targets or have developed resistance to treatments that target estrogen dependence. Overall, approximately 77 percent of breast cancers are positive for AR, including 88 percent of cancers that are estrogen receptor positive, 59 percent of those that are HER2 positive, and 20-32 percent of triple negative breast cancers.....

Androgen receptors found to be a potential target in breast cancer

Reduced melatonin levels linked to greater diabetes risk - Life Extension Update

In continuation of my update on Melatonin....

"Melatonin receptors have been found throughout the body in many tissues including pancreatic islet cells, reflecting the widespread effects of melatonin on physiological functions such as energy metabolism and the regulation of body weight," Ciaran McMullan and colleagues at Brigham and Women's Hospital noted in their introduction to the article. "Loss-of-function mutations in the melatonin receptor are associated with insulin resistance and type 2 diabetes. Additionally, in a cross-sectional analysis of persons without diabetes, lower nocturnal melatonin secretion was associated with increased insulin resistance."

The researchers matched 370 women who developed diabetes while enrolled in the Nurses' Health Study with 370 nondiabetic participants. Morning urine samples obtained upon enrollment in 2000 were analyzed for the ratio of 6-sulfoxymelatonin (the major metabolite of melatonin) to creatinine in order to estimate overnight melatonin secretion.

Women with diabetes had a 6-sulfatoxymelatonin to creatinine ratio that was significantly lower than that of the control group. Among those whose ratio was among the lowest of the participants, the adjusted risk of developing diabetes was more than twice that of women whose ratio was among the highest group.

"This is the first time that an independent association has been established between nocturnal melatonin secretion and type 2 diabetes risk," announced Dr McMullan, who is a researcher in the Renal Division and Kidney Clinical Research Institute at BWH. "Hopefully this study will prompt future research to examine what influences a person's melatonin secretion and what is melatonin's role in altering a person's glucose metabolism and risk of diabetes."

"It is interesting to postulate from these data, in combination with prior literature, whether there is a causal role for reduced melatonin secretion in diabetes risk," the authors remark. "Further studies are needed to determine whether increasing melatonin levels (endogenously via prolonged nighttime dark exposure or exogenously via supplementation) can increase insulin sensitivity and decrease the incidence of type 2 diabetes."

Ref : http://jama.jamanetwork.com/article.aspx?articleid=1674239

Reduced melatonin levels linked to greater diabetes risk - Life Extension Update

FDA Approves Invokana to Treat Type 2 Diabetes

In continuation of my update on Canagliflozin

We know that, Canagliflozin (Invokana) is drug for the treatment of type 2 diabetes developed by Johnson & Johnson. In March 2013,  canagliflozin became the first in a new class of drugs for diabetes treatment to be approved. It is an inhibitor of subtype 2 sodium-glucose transport protein (SGLT2), which is responsible for at least 90% of the glucose reabsorption in the kidney. Blocking this transporter causes blood glucose to be eliminated through the urine..

FDA Approves Invokana to Treat Type 2 Diabetes

Ganetespib Shows Potency Against Lung Cancer

In continuation of my update on Ganetespib

Ganetespib Shows Potency Against Lung Cancer

FDA Approves Stivarga for Advanced Gastrointestinal Stromal Tumors

In continuation of my update on Stivagra

We know that, Regorafenib (BAY 73-4506, commercial name Stivarga) is an oral multi-kinase inhibitor developed by Bayer which targets angiogenic, stromal and oncogenic receptor tyrosine kinase (RTK). Regorafenib shows anti-angiogenic activity due to its dual targeted VEGFR2-TIE2 tyrosine kinase inhibition. It is currently being studied as a potential treatment option in multiple tumor types.

Now...

FDA Approves Stivarga for Advanced Gastrointestinal Stromal Tumors

FDA Approves Tecfidera - a New Treatment for Multiple Sclerosis

We know that, Dimethyl fumarate (DMF) is the methyl ester of fumaric acid. DMF was initially recognized as a very effective hypoxic cellradiosensitizer. Later, DMF combined with three other fumaric acid esters (FAE) was licensed in Germany as oral therapy for psoriasis (Fumaderm). Other diseases, such as necrobiosis lipoidica, granuloma annulare, and sarcoidosis were also found to respond to treatment with DMF in case reports or small patient series. Recently, phase III clinical trials found that DMF (BG-12) successfully reduced relapse rate and time to progression of disability in multiple sclerosis. DMF is thought to haveimmunomodulatory properties without significant immunosuppression.

In a non-medical use, DMF was applied as a biocide in furniture or shoes to prevent growths of mold during storage or transport in a humid climate. However, due to incidences of allergic reactions after skin contact the European Union banned DMF in consumer products since 1998, and since January 2009 the import of products containing DMF was also banned...

Now...

FDA Approves Tecfidera - a New Treatment for Multiple Sclerosis

FDA Approves Kadcyla for Late-Stage Breast Cancer

We know that, Trastuzumab emtansine  in the United States, ado-trastuzumab emtansine, trade name Kadcyla) is anantibody-drug conjugate consisting of the monoclonal antibody trastuzumab (Herceptin) linked to the cytotoxic agentmertansine (DM1). Trastuzumab alone stops growth of cancer cells by binding to the HER2/neu receptor, whereas mertansine enters cells and destroys them by binding to tubulin. Because the monoclonal antibody targets HER2, and HER2 is only over-expressed in cancer cells, the conjugate delivers the toxin specifically to tumor cells.

In the EMILIA clinical trial of women with advanced HER2 positive breast cancer who were already resistant to trastuzumab alone, it improved survival by 5.8 months compared to the combination of lapatinib and capecitabine. Based on that trial, the U.S. Food and Drug Administration (FDA) approved marketing on February 22, 2013.

Trastuzumab emtansine was developed by Genentech. The planned cost is expected to be $9,800 a month, or $94,000 for a typical course of treatment..

Now....

FDA Approves Kadcyla for Late-Stage Breast Cancer

Warner Chilcott Announces FDA Approval of New Ulcerative Colitis Product Delzicol

We know that, Mesalazine , also known as mesalamine (USAN) or 5-aminosalicylic acid (5-ASA), is an anti-inflammatory drug used to treat inflammatory bowel disease, such as ulcerative colitis and mild-to-moderate Crohn's disease. Mesalazine is a bowel-specificaminosalicylate drug that acts locally in the gut and has its predominant actions there, thereby having few systemic side effects.

As a derivative of salicylic acid, mesalazine is also thought to be an antioxidant that traps free radicals, which are potentially damaging byproducts of metabolism

Warner Chilcott plc announced that the United States Food and Drug Administration (FDA) has approved its new 400 mg mesalamine product indicated for the treatment of ulcerative colitis. The product will be marketed as Delzicol (mesalamine) 400 mg delayed-release capsules. The Company anticipates that it will commercially launch Delzicol in March 2013.

Warner Chilcott Announces FDA Approval of New Ulcerative Colitis Product Delzicol

Takeda Receives FDA Approval for Kazano (alogliptin and metformin) for Type 2 Diabetes

Takeda Pharmaceuticals U.S.A., Inc. today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Kazano (alogliptin and metformin HCl) for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise. 

Kazano contains alogliptin, a dipeptidyl peptidase-4 inhibitor (DPP-4i) that is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). Kazano combines alogliptin with metformin HCl, a widely used anti-diabetes medication, in a single tablet.

The most common adverse events (greater than or equal to 4%) reported with alogliptin include nasopharyngitis, headache and upper respiratory tract infection. Common adverse events (greater than or equal to 4%) reported with Kazano include upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain and urinary tract infection.

Takeda is committed to providing type 2 diabetes patients with treatment options that help address their needs, and is planning to commercially launch Kazano in the summer of 2013.

Takeda's consolidated financial statements for the 2012 fiscal year will not be impacted by the FDA approvals.

Takeda Receives FDA Approval for Kazano (alogliptin and metformin) for Type 2 Diabetes