MAPLE GROVE, Minn., Aug. 16, 2013 /PRNewswire/ — Upsher-Smith Laboratories, Inc., today announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Vogelxo™ (testosterone) gel for topical use CIII
http://www.pharmalive.com/upsher-smith-gets-tentative-nda-approval-for-vogelxo-gel
Theravance Inc. said Wednesday it is antibiotic Vibativ is now back on the market. Vibativ was approved as a treatment for complex skin infections in 2010, and it was approved for use against hospital-acquired pneumonia in June 2013. It is Theravance’s only approved drug.
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http://www.dddmag.com/news/2013/08/vibativ-back-market?et_cid=3425506&et_rid=523035093&type=cta
PARSIPPANY, N.J. and DUBLIN, IRELAND – August 9, 2013 – Actavis, Inc. (NYSE: ACT) and Warner Chilcott plc (NASDAQ: WCRX) today announced that they have received approval from the French Competition Authority for Actavis’ pending acquisition of Warner Chilcott. The companies previously received approval from the German Federal Cartel Office and have now received all ex-U.S. antitrust clearances required to complete the transaction.
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http://www.pharmalive.com/french-authorities-approve-actavis-acquisition-of-warner-chilcott
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Bethlehem
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AZATHIOPRINE
generic licensing news
http://newsletter.lead-doctors.com/ef1/preview_campaign.php?lf1=932543337a665012625317e9856877
Azathioprine is a chemotherapy drug, now rarely used for chemotherapy but more for immunosuppression in organ transplantation and autoimmune disease such as rheumatoid arthritis or inflammatory bowel disease or Crohn’s disease. It is a pro-drug, converted in the body to the active metabolite 6-mercaptopurine. Azathioprine acts to inhibit purine synthesis necessary for the proliferation of cells, especially leukocytes and lymphocytes. It is a safe and effective drug used alone in certain autoimmune diseases, or in combination with other immunosuppressants in organ transplantation.
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Azathioprine was synthesized by George Herbert Hitchings and Gertrude Elion in 1957 (named BW 57-322) to produce 6-mercaptopurine (6-MP) in a metabolically active but masked form, and at first used as a chemotherapy drug.
Robert Schwartz investigated the effect of 6-MP on the immune response in 1958 and discovered that it profoundly suppresses the formation of antibodies when given to rabbits together with antigens. Following the work done by Sir Peter Medawar and Gertrude Elion in discovering the immunological basis of rejection of transplanted tissues and organs, and Schwartz’s researches on 6-MP, Sir Roy Calne, the British pioneer in transplantation, introduced 6-MP as an experimental immunosuppressant for kidney and heart transplants. When Calne asked Elion for related compounds to investigate, she suggested azathioprine, which was subsequently found out to be superior (as effective and less toxic to the bone marrow) by Calne. On 5 April 1962, with regimens consisting of azathioprine and prednisone, the transplantation of kidneys to unrelated recipients (allotransplantation) was successful for the first time.For many years, this kind of dual therapy with azathioprine and glucocorticoids was the standard antirejection regimen, until ciclosporin was introduced into clinical practice (by Calne as well) in 1978.Ciclosporin has now replaced some of the azathioprine use due to a longer survival time, especially in heart-related transplantations.Moreover, despite being considerably more expensive, mycophenolate mofetil is also increasingly being used in place of azathioprine in organ transplantation, as it is associated with less bone marrow suppression, fewer opportunistic infections, and a lower incidence of acute rejection
Azathioprine is a thiopurine linked to a second heterocycle (an imidazole derivative) via a thioether. It is a pale yellow solid with a slightly bitter taste and a melting point of 238–245 °C. It is practically insoluble in water and only slightly soluble in lipophilic solvents such as chloroform, ethanol and diethylether. It dissolves in alkaline aqueous solutions, where it hydrolyzes to 6-mercaptopurine.
Azathioprine is synthesized from 5-chloro-1-methyl-4-nitro-1H-imidazole and 6-mercaptopurine in dimethyl sulfoxide (DMSO). The synthesis of the former starts with an amide from methylamine and diethyl oxalate, which is then cyclizised and chlorinated with phosphorus pentachloride; the nitro group is introduced with nitric and sulfuric acid.
Azathioprine (INN, /ˌæzəˈθaɪɵpriːn/, abbreviated AZA) is an immunosuppressive drug used in organ transplantation and autoimmune diseases and belongs to the chemical class of purine analogues.[1] Synthesized originally as a cancer drug and a prodrug for mercaptopurine in 1957, it has been widely used as an immunosuppressant for more than 50 years.[2]
Azathioprine acts as a prodrug for mercaptopurine, inhibiting an enzyme that is required for the synthesis of DNA. Thus it most strongly affects proliferating cells, such as the T cells and B cells of the immune system.[3][4]
The main adverse effect of azathioprine is bone marrow suppression, which can be life-threatening, especially in people with a genetic deficiency of the enzyme thiopurine S-methyltransferase.[5] It is also listed by the International Agency for Research on Cancer as a Group 1 carcinogen (carcinogenic to humans).[6]
Azathioprine is produced by a number of manufacturers under different brand names (Azasan by Salix in the U.S., Imuran by GlaxoSmithKline in Canada, the U.S., Australia, Ireland and Great Britain, Azamun in Finland and Imurel in Scandinavia and France, among others).
Azathioprine is used alone or in combination with other immunosuppressive therapy to prevent rejection following organ transplantation, and to treat an array of autoimmune diseases, including rheumatoid arthritis, pemphigus, systemic lupus erythematosus, Behçet’s disease and other forms of vasculitis, autoimmune hepatitis, atopic dermatitis, myasthenia gravis, neuromyelitis optica (Devic’s disease), restrictive lung disease, and others. It is also an important therapy and steroid-sparing agent for inflammatory bowel disease (such as Crohn’s disease and ulcerative colitis) and for multiple sclerosis, which are immune-mediated as well.
In the United States it is currently approved by the Food and Drug Administration (FDA) for use in kidney transplantation from human donors, and for rheumatoid arthritis. Other uses are off-label.
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A five-year agreement between Roche and Unitaid’s Medicines Patent Pool (MPP) will make more antiviral drugs available at knock-down prices in developing countries.
Roche has agreed to supply Valcyte (valganciclovir) at a discount of up to 90% in 138 designated countries, to treat patients with cytomegalovirus as a complication of HIV. The agreement also allows for third parties to license Roche’s valganciclovir patent and develop generic versions of the drug after one year of exclusive sales.
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This unassuming weed is currently the source for of the anticancer drug ingenol © Floral Images/Alamy
US scientists have developed the first efficient and scalable route for the total synthesis of ingenol – a plant-derived diterpenoid used to treat precancerous skin legions. The work offers cheaper and faster production of the drug than the current, inefficient plant extraction route, and could pave the way for the chemical synthesis of many other complex natural compounds.
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http://www.rsc.org/chemistryworld/2013/08/total-synthesis-outshines-biotech-anticancer-drug-ingenol
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6-Shogaol, an active constituent of ginger, inhibits breast cancer cell invasion by reducing matrix metalloproteinase-9 expression via blockade of nuclear factor-κB activation.
Br J Pharmacol. 2010 Dec ;161(8):1763-77. PMID: 20718733
H Ling, H Yang, S-H Tan, W-K Chui, E-H Chew
Department of Pharmacy, National University of Singapore, Singapore, Singapore.
BACKGROUND AND PURPOSE: Shogaols are reported to possess anti-inflammatory and anticancer activities. However, the antimetastatic potential of shogaols remains unexplored. This study was performed to assess the effects of shogaols against breast cancer cell invasion and to investigate the underlying mechanisms.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3010581/
Shogaol, also known as (6)-shogaol, is a pungent constituent of ginger similar in chemical structure to gingerol. Likezingerone, it is produced when ginger is dried or cooked.
Shogaols are artifacts formed during storage or through excess heat, probably created by a dehydration reaction of the gingerols. The ratio of shogaols to gingerols sometimes is taken as an indication of product quality.
The name ‘shogaol’ is derived from the Japanese name for ginger (生姜、shōga).
Shogaol is rated 160,000 SHU on Scoville scale. When compared to other pungent compounds, shogaol is moderately more pungent than piperine, but less than capsaicin.
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6-Shogaol is isolated from the dried or cooked rhizomes or roots of the plant Zingiber officinale (ginger). It is a perennial reed-like plant with annual leafy stems, about a meter (3 to 4 feet) tall. 6-Shogaol is a dehydrated 6-gingerol molecule that has lost a molecule of water during the drying or cooking process.
Ginger produces clusters of white and pink flower buds that bloom into yellow flowers. Because of its aesthetic appeal and the adaptation of the plant to warm climates, ginger is often used as landscaping around subtropical homes. Traditionally, the root is gathered when the stalk withers; it is immediately dried, scalded, or washed and scraped, to kill it and prevent sprouting.
6-Shogaol is isolated from dried or cooked ginger root using ethanol and other organic solvents followed by chromatographic purification. Aphios isolates 6-shogaol utilizing near-critical and supercritical fluids using CXF and CXP enabling technology platforms as alternatives to ethanol and conventional organic solvents techniques.
Ginger (Zingiber officinale Roscoe, Zingiberaceae) is a medicinal plant that has been widely used in Chinese, Ayurvedic and other global herbal medicinal practices since ancient times for a wide array of ailments including arthritis, rheumatism, sprains, muscular aches, pains, sore throats, cramps, constipation, indigestion, vomiting, hypertension, dementia, fever, infectious diseases and helminthiasis (Ali et al., 2008).
Ginger has been approved for use by Germany’s Commission E, the agency responsible for regulating the use of herbal products in that country (Blumenthal, 1998). Ginger has recently been studied scientifically for its effect on nausea and vomiting associated with motion sickness, surgery, pregnancy and cancer chemotherapy.
There may be several mechanisms of action in play relative to the antiemetic properties of ginger. It has been reported that the antiemetic qualities may be derived from ginger’s anti-serotonin 3 effects on the gastrointestinal and central nervous system (Chaiyakunapruk et al., 2006). In a study of guinea pig ileum, it was found that certain ingredients of ginger (6-, 8- and 10-gingerols) inhibit the anti-serotonin 3 receptor function (Huang et al., 1991 and Yamahara et al., 1989). In addition, these active ingredients have been shown to affect gastric motility and potentially have an antispasmodic effect on the gastrointestinal system (Hashimoto et al., 2002 and Suekawa et al., 1984).
Pan et al. (2008) investigated the inhibitory effects of 6-shogaol and a related compound, 6-gingerol, on the induction of nitric oxide synthase (NOS) and cyclooxygenase-2 (COX-2) in murine RAW 264.7 cells activated with LPS. Their results show that 6-shogaol downregulates inflammatory iNOS and COX-2 gene expression in macrophages by inhibiting the activation of NF-κB by interfering with the activation PI3K/Akt/I κB kinases IKK and MAPK.
Ali B, Blunden G, Tanira M and Nemmar A. (2008). Some phytochemical, pharmacological and toxicological properties of ginger (Zingiber officinale Roscoe): A review of recent research. Food and Chemical Toxicology. 46(2): 409-420.
Blumenthal M, Busse W, Goldberg A, Gruenwald J, Hall T, Klein S, Riggins C and Rister R. (1998). The Complete German Commission E monographs. Therapeutic Guide to Herbal Medicines, Austin TX, American Botanical Council.
Chaiyakunapruk N, Kitikannakorn N, Nathisuwan S, Leeprakobboon K and Leelasettagool C. (2006). The efficacy of ginger for the prevention of postoperative nausea and vomiting: a meta-analysis. Am. J. Obstet. Gynecol. 194, 95–99.
Chen C, Kuo M, Wu C and Ho C. (1986). Pungent Compounds of Ginger (Zingiber officinale Roscoe) Extracted by Liquid Carbon Dioxide. Journal of Agriculture and Food Chemistry 34(3): 477-480.
Hashimoto K, Satoh K, Murata P, Makino B, Sakakibara I, Kase Y, Ishige A, Higuchi M and Sasaki H. (2002). Component of Zingiber officinale that improves the enhancement of small intestinal transport. Planta Medica. 68:936-9.
Huang Q, Iwamoto M, Aoki S, Tanaka N, Tajima K, Yamahara J, Takaishi Y, Yoshida M, Tomimatsu T and Tamai Y. (1991). Anti-5-hydroxytryptamine 3 effect of galanolactone, diterpenoid isolated from ginger. Chem. Pharm. Bull. (Tokyo) 39, 397–399.
Pan M, Hsieh M, Hsu P, Ho S, Lai C, Wu H, Sang S and Ho C. (2008). 6-Shogaol suppressed lipopolysaccharide-induced up-expression of iNOS and COX-2 in murine macrophages. Mol Nutr Food Res. 52(12):1467-77.
Suekawa M, Ishige A, Yuasa K, Sudo K, Aburada M and Hosoya E. (1984). Pharmacological studies on ginger: I. Pharmacological action of pungent constituents, (6)-gingerol and (6)-shogaol. J Pharmacobiodyn. 7:836-48.
Yamahara J, Rong H, Iwamoto M, Kobayashi G, Matsuda H and Fujimura H. (1989). Active components of ginger exhibiting anti-serotonergic action. Phytother. Res. 3, 70–71.
Introduction
Plants had been used for medicinal purposes long before recorded history. Ancient Chinese and Egyptian papyrus writings describe medicinal uses for plants as early as 3,000 BC. Indigenous cultures (such as African and Native American) used herbs in their healing rituals, while others developed traditional medical systems (such as Ayurveda and Traditional Chinese Medicine) in which herbal therapies were used;…………………………..
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http://www.pharmatutor.org/articles/all-about-antidiabetic-plant-coccinia-indica
