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Drug:<\/strong> Linzess 851199-59-2<\/a> CAS NO<\/p>\n L<\/small>-Cysteinyl-L<\/small>-cysteinyl-L<\/small>-glutamyl-L<\/small>-tyrosyl-L<\/small>-cysteinyl-L<\/small>-cysteinyl-L<\/small>-asparaginyl-L<\/small>-prolyl-L<\/small>-alanyl-L<\/small>-cysteinyl-L<\/small>-threonylglycyl-L<\/small>-cysteinyl-L<\/small>-tyrosine cyclo(1-6),(2-10),(5-13)-tris(disulfide)<\/p>\n Linaclotide is a peptide consisting of 14 amino acids<\/a>. The sequence is<\/p>\n H\u2013Cys<\/a>1<\/sup>\u2013Cys2<\/sup>\u2013Glu<\/a>3<\/sup>\u2013Tyr<\/a>4<\/sup>\u2013Cys5<\/sup>\u2013Cys6<\/sup>\u2013Asn<\/a>7<\/sup>\u2013Pro<\/a>8<\/sup>\u2013Ala<\/a>9<\/sup>\u2013Cys10<\/sup>\u2013Thr<\/a>11<\/sup>\u2013Gly<\/a>12<\/sup>\u2013Cys13<\/sup>\u2013Tyr14<\/sup>\u2013OH<\/p>\n There are three disulfide bonds<\/a>: Between Cys1<\/sup> and Cys6<\/sup>, between Cys2<\/sup> and Cys10<\/sup>, and between Cys5<\/sup> and Cys13<\/sup>.[8]<\/a><\/sup><\/p>\n Linaclotide<\/strong> (marketed under the trade name Linzess<\/strong>) is an experimentalpeptide<\/a> agonist<\/a> of guanylate cyclase 2C<\/a> that is undergoing clinical trials for use in treating abdominal pain in patients with irritable bowel syndrome<\/a> (IBS) accompanied by constipation<\/a>. The drug also looks promising in the treatment of gastroparesis<\/a>, chronic intestinal pseudo-obstruction<\/a> (CIPO), andinertia coli<\/em> as well.[1]<\/a><\/sup> The drug was developed by Ironwood Pharmaceuticals, based in Cambridge, Massachusetts<\/a>.<\/p>\n Linaclotide was approved by the FDA on August 30, 2012 for the treatment of chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults.[2]<\/a><\/sup> It became available in US pharmacies on December 17, 2012. [3]<\/a><\/sup> That same month, it was forecast by market research firm Decision Resources to achieve blockbuster status by 2021.[4]<\/a><\/sup><\/p>\n The National Institutes of Health<\/a> (NIH) estimates that as many as 20% of Americans may experience signs of irritable bowel syndrome, with approximately one-third of those affected experiencing constipation often accompanied by abdominal pain, affecting as many as 10 million Americans.Laxatives<\/a> can assist with constipation but don’t treat pain, while use ofopiates<\/a> to treat pain can aggravate constipation. While low-cost laxatives and pain killers would likely be tried first, linaclotide targets both associated conditions in a once-daily pill and could be used if standard treatments are unsuccessful in treating symptoms, though it would likely cost as much as several dollars per day.[5]<\/a><\/sup><\/p>\n The approval of partner Ironwood’s linaclotide in late August is one of many reasons Forest Labs has been oft-cited as a takeover target<\/a> in biopharma. Forest markets the drug, which is OK’d for chronic idiopathic constipation and to treat irritable bowel syndrome with constipation. Morgan Stanley has estimated potential peak sales at $2 billion.<\/p>\n <\/p>\n <\/p>\n<\/div>\n <\/a><\/p>\n Company:<\/strong> Novartis<\/a> Afinitor (everolimus), an inhibitor of mTOR (mammalian target of rapamycin), is an antineoplastic agent.<\/p>\n Afinitor is specifically approved for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole.<\/p>\n Afinitor is supplied as a tablet for oral administration. The recommended dose of Afinitor for breast cancer is 10 mg, to be taken once daily, at the same time every day, either consistently with food or consistently without food.<\/p>\n FDA Approval<\/strong> Everolimus<\/strong> (RAD-001<\/strong>) is the 40-O<\/em>-(2-hydroxyethyl) derivative of sirolimus<\/a> and works similarly to sirolimus as an inhibitor of mammalian target of rapamycin<\/a> (mTOR).<\/p>\n It is currently used as an immunosuppressant<\/a> to prevent rejection<\/a> of organ transplants<\/a> and treatment of renal cell cancer and other tumours. Much research has also been conducted on everolimus and other mTOR inhibitors for use in a number of cancers.<\/p>\n It is marketed by Novartis<\/a> under the tradenames Zortress<\/strong> (USA) and Certican<\/strong> (Europe and other countries) in transplantation medicine, and Afinitor<\/strong> in oncology.<\/p>\n <\/p>\n <\/p>\n <\/p>\n <\/p>\n<\/div>\n<\/div>\n <\/p>\n <\/p>\n<\/div>\n SIGNIFOR (pasireotide diaspartate) injection is prepared as a sterile solution of pasireotide diaspartate in a tartaric acid buffer for administration by subcutaneous injection. SIGNIFOR is a somatostatin<\/a> analog. Pasireotide diaspartate, chemically known as (2-Aminoethyl) carbamic acid (2R,5S,8S,11S,14R,17S,19aS)-11-(4-aminobutyl)-5-benzyl-8-(4-benzyloxybenzyl)-14-(1H-indol-3ylmethyl)-4,7,10,13,16,19-hexaoxo-17-phenyloctadecahydro-3a,6,9,12,15,18hexaazacyclopentacyclooctadecen-2-yl ester, di[(S)-2-aminosuccinic acid] salt, is a cyclohexapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin.<\/p>\n The molecular formula of pasireotide diaspartate is C58<\/sub>H66<\/sub>N10<\/sub>O9<\/sub> \u2022 2C4<\/sub>H7<\/sub>NO4<\/sub> and the molecular weight is 1313.41. SIGNIFOR is supplied as a sterile solution in a single-dose, 1 mL colorless glass ampule containing pasireotide in 0.3 mg\/mL, 0.6 mg\/mL, or 0.9 mg\/mL strengths for subcutaneous injection.<\/p>\n <\/p>\n <\/p>\n <\/p>\n<\/div>\n
\nGeneric molecule: <\/strong>linaclotide
\nCompany:<\/strong> Ironwood Pharmaceuticals
\nApproval date: <\/strong>Aug. 30,2012<\/p>\n\n
<\/h2>\n
DR ANTHONY CRASTO,<\/h2>\n<\/div>\n<\/div>\n
Drug Name: Afinitor (everolimus)<\/h3>\n
\nApproval Status:<\/strong> Approved July 2012
\nTreatment Area:<\/strong> hormone receptor-positive, HER2-negative breast cancer<\/p>\nGeneral Information<\/h3>\n
\nThe FDA approval of Afinitor for the treatment of advanced hormone receptor-positive, HER2-negative breast cancer was based on a randomized, double-blind, multicenter study in 724 postmenopausal women with estrogen receptor-positive, HER 2\/neu-negative advanced breast cancer with recurrence or progression following prior therapy with letrozole or anastrozole.<\/p>\n<\/div>\n\n
\nDrug: <\/strong>Signifor<\/strong><\/div>\n
\nCompany: <\/strong>Novartis
\nApproval date: <\/strong>Dec. 14, 2012<\/p>\n<\/h2>\n