FDA Approves Amitiza for Opioid-Induced Constipation

We know that, Lubiprostone (marketed under the trade name Amitiza) is a medication used in the management of chronic idiopathic constipation and irritable bowel syndrome. It was approved by the U.S. Food and Drug Administration (FDA) for this purpose on 31 January 2006.

Now, has approved Sucampo’s supplemental new drug application (sNDA) for Amitiza (lubiprostone) (24 mcg twice daily) as the first and only oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. The effectiveness of Amitiza in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established...

FDA Approves Amitiza for Opioid-Induced Constipation

New potential target for cancer therapy identified

In continuation of my update on telomerase...

Source: http://www.cell.com/cell-reports/retrieve/pii/S2211124713001186?_returnURL=http://linkinghub.elsevier.com/retrieve/pii/S2211124713001186?showall=true

The enzyme telomerase is overexpressed in almost all cancer cells, and previous research efforts have failed to identify good telomerase inhibitors. The study by Dr. Woodring Wright and UT Southwestern colleagues in the April 4 issue of Cell Reports identifies a new approach for inhibiting telomerase, which is an enzyme that drives uncontrolled division and replication of cancer cells.

Alternative splicing allows genetic information to be assembled in different ways and is almost always controlled by DNA sequences that are immediately adjacent to the parts of a gene that code for protein. "In the case of the telomerase gene, we found that these controlling regions are located very far from the protein coding regions and that they contain unusual DNA sequences," said Dr. Wright, professor of cell biology and internal medicine. "Their unusual DNA structure suggests that humans regulate telomerase in a very different fashion that we may be able to exploit to develop inhibitors of the enzyme."

Most of the splice variants that telomerase makes are inactive, but Dr. Wright's team demonstrated that it was possible to shift the splicing to make even less active telomerase, potentially providing a new approach for cancer therapy....

New potential target for cancer therapy identified

New drug stimulates immune system to kill infected cells in animal model of hepatitis B infection

In a study conducted at Texas Biomed's Southwest National Primate Research Center, researchers found that the immune modulator GS-9620 (see structure below), which targets a receptor on immune cells, reduced both the virus levels and the number of infected liver cells in chimpanzees chronically infected with hepatitis B virus (HBV). Chimpanzees are the only species other than humans that can be infected by HBV. Therefore, the results from this study were critical in moving the drug forward to human clinical trials which are now in progress.

The new report, co-authored by scientists from Texas Biomed and Gilead Sciences, appears in the May issue of Gastroenterology. Gilead researchers had previously demonstrated that the same therapy could induce a cure of hepatitis infection in woodchucks that were chronically infected with a virus similar to human HBV.

"This is an important proof-of-concept study demonstrating that the therapy stimulates the immune system to suppress the virus and eliminate infected liver cells," said co-author Robert E. Lanford, Ph.D., of Texas Biomed. "One of the key observations was that the therapy continued to suppress virus levels for months after therapy was stopped.

The current therapy for HBV infection targets the virus and works very well at suppressing viral replication and delaying progression of liver disease, but it is a lifelong therapy that does not provide a cure.

"This GS-9620 therapy represents the first conceptually new treatment for HBV in more than a decade, and combining it with the existing antiviral therapy could be transformative in dealing with this disease," stated Lanford.

Ref: http://www.gastrojournal.org/article/S0016-5085%2813%2900169-8/abstract?referrer=http://www.sciencedaily.com/releases/2013/04/130426152556.htm?utm_source=feedburner

New drug stimulates immune system to kill infected cells in animal model of hepatitis B infection

Research on soy-based treatment for colorectal cancer presented at AACR annual meeting

In continuation of my update on genistein

Genistein is one of several known isoflavones.Genistein was first isolated in 1899 from the dyer's broom, Genista tinctoria; hence, the chemical name derived from the generic name. The compound nucleus was established in 1926, when it was found to be identical with prunetol. It was chemically synthesized in 1928.

Led by Randall Holcombe, MD, and Sofya Pintova, MD, both from Mount Sinai, the research team treated colon cancer cell lines with genistein and found that it inhibited cell growth and blocked Wnt signaling hyperactivity. The findings are counter to some other tumor types, such as breast, for which soy, because it has estrogen-like properties, increases the risk of developing tumors. Drs. Holcombe and Pintova are launching a clinical trial later this year for patients with metastatic colorectal cancer, which utilizes genistein in combination with chemotherapy based on this research.

"Genistein is a natural product with low toxicity and few side effects and our research shows that it may be beneficial in treating colorectal cancer," said Randall Holcombe, MD, Professor of Medicine in the Division if Hematology and Oncology at the Icahn School of Medicine at Mount Sinai. "This is an exciting area of research and we look forward to studying the benefits of this compound as an adjunctive treatment in colorectal cancer in humans."

Research on soy-based treatment for colorectal cancer presented at AACR annual meeting

Dexmedetomidine may be an effective treatment option for opioid-induced hyperalgesia

We know that, Dexmedetomidine (trade names Precedex, Dexdor) is a sedative medication used by intensive care units and anesthetists. It is relatively unusual in its ability to provide sedation without causing respiratory depression. Like clonidine, it is an agonist of α₂-adrenergic receptors in certain parts of the brain.  It is the S-enantiomer of medetomidine, used in veterinary medicine. The drug has been developed by Orion Pharma...

Now researchers have reported that, Dexmedetomidine may be an effective treatment option for opioid-induced hyperalgesia.....

Dexmedetomidine may be an effective treatment option for opioid-induced hyperalgesia

In continuation of my update on canagliflozin/Invokana...

We know that, Canagliflozin (Invokana) is a drug for the treatment of type 2 diabetes. It was developed by Mitsubishi Tanabe Pharma and is marketed under license by Janssen, a division of Johnson & Johnson. Canagliflozin 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. In March 2013, canagliflozin became the first SGLT2 inhibitor to be approved in the United States...

FDA Approves Invokana to Treat Type 2 Diabetes

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