Saturday, May 11, 2013

FDA Approves Breo Ellipta to Treat Chronic Obstructive Pulmonary Disease (COPD)


  The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate above structure) and vilanterol (below structure)  inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations......


























Thursday, May 9, 2013

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...


Wednesday, May 8, 2013

New potential target for cancer therapy identified

In continuation of my update on telomerase...




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


Tuesday, May 7, 2013

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."



Monday, May 6, 2013

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

We know that, Dexmedetomidine (trade names PrecedexDexdor) 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.....

Friday, May 3, 2013

FDA Approves Invokana to Treat Type 2 Diabetes

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

Thursday, May 2, 2013

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.

Wednesday, May 1, 2013

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.....