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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Rare Disease Awareness Day: Phenylketonuria (PKU)
The National PKU Alliance (NPKUA) is celebrating December 3rd as National Phenylketonuria (PKU) Awareness Day to educate and spread awareness about the rare disease PKU. The organization has a webpage where there is a list of activities that one can participate in to help advocate for PKU.
A Norwegian doctor in 1934 discovers PKU. PKU is a rare, inherited metabolic disease where the body is not able to use the amino acid, Phenylalanine. The disease is caused by a deficiency of the liver produced enzyme Phenylalanine Hydroxylase (PAH). Without PAH, Phenylalanine builds up in the blood and poisons nerve cells in the brain. If PKU is not treated shortly after birth, it can be destructive to the nervous system, causing mental retardation. The disease is detectable after birth with appropriate blood testing during routine neonatal screening.
A mutation in a gene on chromosome 12 causes the disease. When this gene is…
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CHINESE HERBS Ginkgo biloba for antidepressant induced sexual dysfunction.
Ginkgo biloba extract
Ginkgo (Ginkgo biloba; in Chinese and Japanese 銀杏, pinyin romanization: yín xìng, Hepburn romanization: ichō or ginnan), also spelled gingko and known as the maidenhair tree, is a unique species of tree with no close living relatives. The ginkgo is a living fossil, recognisably similar to fossils dating back 270 million years. Native to China,the tree is widely cultivated and was introduced early to human history. It has various uses in traditional medicine and as a food.
Ginkgo biloba extract (GBE, species Ginkgo biloba) has been used for centuries as part of the ancient Chinese pharmacopoeia in the treatment of respiratory ailments, cognitive impairment, and circulatory disorders. In recent years, Ginkgo has gained great worldwide acceptance for treatment of a number of medical conditions including tinnitus, cognitive decline in dementia, intermittent claudication, asthma, macular degeneration and, most recently, antidepressant induced sexual dysfunction.
The…
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PHASE 2 -TetraLogic’s BIRINAPANT for treatment of acute myeloid leukemia, pancreatic cancer, or ovarian cancer
BIRINAPANT, Apoptosis inhibitor
(2S,2’S)-N,N’-((2S,2’S)-((3S,3’S,5R,5’R)-5,5′-((6,6′-difluoro-1H,1’H-[2,2′-biindole]-3,3′-diyl)bis(methylene))bis(3-hydroxypyrrolidine-5,1-diyl))bis(1-oxobutane-2,1-diyl))bis(2-(methylamino)propanamide)
1260251-31-7 cas no
Birinapant is an antagonist of XIAP and cIAP1 with Kd value of 45 nM and <1 nM, respectively.
US20110003877,WO 2013049350 A1
| Molecular Weight: | 806.94 |
| Birinapant Formula: | C42H56F2N8O6 |
Birinapant, also known as TL32711, is a synthetic small molecule and peptido mimetic of second mitochondrial-derived activator of caspases (SMAC) and inhibitor of IAP (Inhibitor of Apoptosis Protein) family proteins, with potential antineoplastic activity. As a SMAC mimetic and IAP antagonist, TL32711 binds to and inhibits the activity of IAPs, such as X chromosome-linked IAP (XIAP) and cellular IAPs 1 and 2. Since IAPs shield cancer cells from the apoptosis process, this agent may restore and promote the induction of apoptosis through apoptotic signaling pathways in cancer cells. IAPs are overexpressed by many cancer cell types and suppress apoptosis by binding and inhibiting active caspases-3, -7 and -9…
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New varicose vein treatment gets U.S. approval
Varithena, a varicose vein treatment that dissolves veins as an alternative to surgical removal, should be available in the second quarter of 2014 after receiving FDA approval, its manufacturer announced.
Lovers of short skirts, rejoice: A new treatment for varicose veins has been approved in the U.S., its maker says.
British pharmaceutical firm BTG announced this week that its treatment, Varithena — previously known as Varisolve — has been given Food and Drug Administration approval.
Varithena uses an injectible foam to dissolve veins as an alternative to surgical removal, Reuters reported.
Speaking to Reuters on Tuesday, the company’s chief executive Louise Makin said the product would set a new standard for the treatment of both the symptoms and appearance of varicose veins.
“We look forward to the commercial U.S. launch in the second quarter of 2014, and to continuing to advance our plans to expand use into other geographies…
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US FDA grants breakthrough therapy designation to Boehringer Ingelheim’s volasertib to treat patients with AML
Volasertib
755038-65-4
CHEMICAL NAMES
1. Benzamide, N-[trans-4-[4-(cyclopropylmethyl)-1-piperazinyl]cyclohexyl]-4-[[(7R)-7-
ethyl-5,6,7,8-tetrahydro-5-methyl-8-(1-methylethyl)-6-oxo-2-pteridinyl]amino]-3-
methoxy-
2. N-{trans-4-[4-(cyclopropylmethyl)piperazin-1-yl]cyclohexyl}-4-{[(7R)-7-ethyl-5-methyl-8-
(1-methylethyl)-6-oxo-5,6,7,8-tetrahydropteridin-2-yl]amino}-3-methoxybenzamide
CODE DESIGNATION BI 6727
| Ingelheim, Germany Thursday, September 19, 2013, 16:00 Hrs [IST] |
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Boehringer Ingelheim’s volasertib, a selective and potent polo-like kinase (Plk) inhibitor, for the treatment of patients with acute myeloid leukaemia (AML), a type of blood cancer. |
http://www.pharmabiz.com/NewsDetails.aspx?aid=77733&sid=2
Volasertib (also known as BI 6727) is a small molecule inhibitor of the PLK1 (polo-like kinase 1) protein being developed byBoehringer Ingelheim for use as an anti-cancer agent. Volasertib is the second in a novel class of drugs called dihydropteridinone derivatives.[1]
Mechanism of action
Volasertib is a novel small-molecule targeted therapy that blocks cell division by competitively binding to the ATP-binding pocket of the PLK1 protein. PLK1 proteins are found in the nuclei of all dividing cells and control multiple stages of…
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Durata Therapeutics Announces FDA’s Acceptance for Priority Review of NDA for Dalvance (dalbavancin hydrochloride)
| CAS No. | 171500-79-1 |
| Chemical Name: | Dalbavancin |
| Synonyms: | MDL 63397;Dalbavancin |
| CBNumber: | CB41028737 |
| Molecular Formula: | C88H100Cl2N10O28 |
| Formula Weight: | 1816.71 |
CHICAGO, Nov 26, 2013 (GLOBE NEWSWIRE via COMTEX) — Durata Therapeutics, Inc. DRTX +6.48% today announced that the New Drug Application (NDA) for its investigational drug, Dalvance (dalbavancin hydrochloride) for injection, has been accepted for priority review by the U.S. Food and Drug Administration (FDA) with an action date of May 26, 2014. Durata is seeking FDA approval of Dalvance(TM) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive microorganisms, including MRSA (methicillin resistant Staphylococcus aureushttp://www.drugs.com/nda/dalbavancin_131126.html
Dalbavancin is prepared by chemical modification of the natural glycopeptide complex A-40,926 as described in Malabarba and Donadio (1999) Drugs of the Future 24(8):839-846. The predominant component of dalbavancin is Factor Bo, which accounts for >75% of the whole complex.
[0042] The amount of each of the components present in a dalbavancin composition is dictated by a variety of factors, including, for example, the fermentation conditions employed in the preparation of the natural glycopeptide complex A-40926, which is the precursor to dalbavancin (see, e.g., U.S. Pat. No.5,843,679), the conditions employed to recover A-40926 from the fermentation broth, the chemical reactions employed to selectively esterify the caxboxyl group of the sugar moiety of A-40926, the conditions employed to amidate the peptidyl carboxyl group, the conditions employed to saponify the ester of the carboxyl group of the N-acylaminoglucuronic acid function, the conditions employed to recover dalbavancin from the synthetic mixture, and the like.
the semisynthetic glycopeptide dalbavancin was synthesized from the natural antibiotic A 40926, originally isolated from an Actinomadura culture (Malabarba et al., 1998, U.S. Pat. No. 5,750,509). Dalbavancin has shown greater efficacy against various bacterial strains than vancomycin or the antibiotic linezolid and represents a promising new treatment for skin and soft tissue infections (see, e.g., Jabés et al., 2004, Antimicrob. Agents Chemother. 48:1118-1123). According to U.S. Pat. No. 5,750,509, dalbavancin is a glycopeptide antibiotic with a monomethyl moiety at its N15 amino (see FIG. 1 for numbering), and this N15-monomethyl amino could be free (i.e. —NHCH3) or protected with an amino protecting group such as t-butoxycarbonyl, carbobenzyloxy, arylalkyl or benzyl. The method for making certain of the dalbavancin components reported in the ‘509 patent also produced N15,N15-dialkyl analogs of dalbavancin in minor-quantities, but these molecules were not characterized.
Dalbavancin (INN, trade name Zeven) is a novel second-generation lipoglycopeptideantibiotic. It belongs to the same class as vancomycin, the most widely used and one of the few treatments available to patients infected with methicillin-resistant Staphylococcus aureus (MRSA).[1]
Dalbavancin (BI397) is a novel semisynthetic lipoglycopeptide that was designed to improve upon the natural glycopeptides currently available, vancomycin and teicoplanin.[2]
It possesses in vitro activity against a variety of Gram-positive pathogens[3][4] includingMRSA and MRSE.[5] It is a once-weekly, two-dose antibiotic that Pfizer acquired when it bought Vicuron Pharmaceuticals in 2005.[6]
Dalbavancin has undergone a phase III clinical trial for adults with complicated skin infections, but in Dec 2007 the FDA said more data was needed before approval.[6] On September 9, 2008, Pfizer announced that it will withdraw all marketing applications in order to conduct another Phase 3 clinical trial.[7] Durata Therapeutics acquired the rights to dalbavancin in December 2009 and has initiated two new Phase III clinical trials for treatment of acute bacterial skin and skin structure infections.[8] Preliminary results in Dec 2012 looked good.[9]
- Vicuron Pharmaceuticals Submits New Drug Application for Dalbavancin to U.S. Food and Drug Administration
- Scheinfeld NS. (May 2006). “Dalbavancin: A review for dermatologists.”. Dermatology Online Journal 12 (6). Unknown parameter
|numero=ignored (help) PMID 17083861 - Chen AY, Zervos MJ, Vazquez JA (2007). “Dalbavancin: a novel antimicrobial”. Int. J. Clin. Pract. 61 (5): 853–63. doi:10.1111/j.1742-1241.2007.01318.x. PMC 1890846.PMID 17362476.
- Das B, Sarkar C, Biswas R, Pandey S (2008). “Review: dalbavancin-a novel lipoglycopeptide antimicrobial for gram positive pathogens”. Pak J Pharm Sci 21 (1): 78–88. PMID 18166524.
- Dalbavancin: A Novel Lipoglycopeptide Antibacterial
- UPDATE 1-Pfizer says US FDA wants more data on antibiotic. Dec 2007
- “Pfizer Will Withdraw Global Marketing Applications for Dalbavancin to Conduct a New Trial” (Press release). Pfizer Inc. 2008-09-09. Retrieved 2008-09-11.
- Durata Begins Dalbavancin Study Enrollment. Drug Discovery & Development – October 05, 2011.
- Durata Therapeutics Announces Phase 3 Clinical Trial Results for Dalbavancin in the Treatment of ABSSSI
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