Durata Therapeutics Announces FDA’s Acceptance for Priority Review of NDA for Dalvance (dalbavancin hydrochloride)

New Drug Approvals

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, V-Glycopeptide, VER-001, BI-397 factor B0, BI-397
Vicuron Pharmaceuticals (Originator)
5,31-Dichloro-38-de(methoxycarbonyl)-7-demethyl-19-deoxy-56-O-[2-deoxy-2-(10-methylundecanamido)-beta-D-glucopyranuronosyl]-38-[N-[3-(dimethylamino)propyl]carbamoyl]-42-O-alpha-D-mannopyranosyl-N15-methylristomycin A aglycone; (3S,15R,18R,34R,35S,48S,50aR
Dalbavancin, which is also referred to in the scientific literature as BI397 or VER001, is a semi=synthetic glycopeptide mixture, the properties of which have been reported in U.S. Pat. Nos. 5,606,036, 5,750,509…

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VBL Therapeutics announced FDA has granted Fast Track designation to its lead oncology drug VB-111

New Drug Approvals

GT-111 is a gene therapy product candidate in early clinical development for the treatment of advanced differentiated thyroid cancer, for the treatment of relapsed glioblastoma multiform and for the treatment of ovarian cancer.
patents, VBL Therapeutics
WO 2011083466, WO-2011083464, WO-2012052878

VBL Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead oncology drug VB-111, for prolongation of survival in patients with recurrent glioblastoma multiforme (rGBM).

Read more…http://www.dddmag.com/news/2013/11/vbls-cancer-drug-gets-fast-tracked?et_cid=3625663&et_rid=523035093&type=cta

VB-111 – highly targeted anti-angiogenic agent for the specific inhibition of tumor vascular growth

VB-111 is the first highly targeted anti-angiogenic agent for the specific inhibition of tumor vascular growth to use VTS™™, our proprietary platform technology, for cancer therapy. VB-111 is an IV-administered anti angiogenic agent that works in a manner akin to a “biological knife” to destroy tumor vasculature, thus cutting off blood vessels feeding the tumor.

Preclinical Insights

VB-111 has shown…

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Teva Gets Orphan Drug Designation for Treanda

New Drug Approvals


Teva Announces Additional Regulatory Exclusivity for TREANDA® (Bendamustine HCI) for Injection

Orphan Designation combined with pediatric extension provides regulatory exclusivity through April 2016 for indolent B-cell non-Hodgkin lymphoma indication

JERUSALEM, November 27, 2013 –(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for TREANDA through October 2015 for indolent B-cell non-Hodgkin lymphoma (iNHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.http://www.pharmalive.com/teva-announces-additional-regulatory-exclusivity-for-treanda

read my old post, contains synthesis


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New Drug Approvals


(-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide



Names: 2(S)-(2-oxopyrrolidin-1-yl)butyramide
Manufacturers’ Codes: UCB-L059; SIB-S1
Trademarks: Keppra (UCB)
FDA UNII: 44YRR34555
MF: C8H14N2O2
MW 170.21
Percent Composition: C 56.45%, H 8.29%, N 16.46%, O 18.80%

Crystals from ethyl acetate, mp 117°. [a]25D -90.0° (c = 1 in acetone). Soly (g/100 ml): water 104.0; chloroform 65.3; methanol 53.6; ethanol 16.5; acetonitrile 5.7. Practically insol in n-hexane. LD50 in male mice, male rats (mg/kg): 1081, 1038 i.v. (Gobert, 1990).

Mp: mp 117°C

O’Neil, M.J. (ed.). The Merck Index – An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 978
Optical Rotation: [a]25D -90.0° (c = 1 in acetone)
Specific optical rotation: -90 deg at 25 deg C/D (c = 1 in acetone)
Toxicity data: LD50 in male mice, male rats (mg/kg): 1081, 1038 i.v. (Gobert, 1990)
Therap-Cat: Anticonvulsant.

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