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The U.S. Food and Drug Administration approved Ofev (nintedanib) for the...

Nintedanib FDA approves Ofev to treat idiopathic pulmonary fibrosis 10/15/2014  The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis...

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System Suitability for USP Chromatographic Methods

Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: System Suitability for USP Chromatographic Methods How should system suitability tests (SSTs) be structured for USP monographs? More about...

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Advanced Intermediate Flow Studies: Nevirapine

Originally posted on SynthFlow: After looking through a number of flow articles that describe and illustrate processes toward the production of drug final products and advanced intermediates, I...

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USV Limited , WO 2014167577 Synthesis of dabigatran….NEW PATENT FEATURE ON...

USV Limited http://www.usvindia.com/ 16-Oct-2014        pub date WO-2014167577-A2 PATENT FEATURE ON THIS BLOG Title of the invention: “”SYNTHESIS OF DABIGATRAN”.” Applicants: USV LIMITED (IN)....

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DRUG SPOTLIGHT…MONTELUKAST

  MONTELUKAST MK-0476 (Montelukast, L-706631) US 8,007,830, US 5,565,473*PED, MERCK Pat exp…Aug 3, 2012 NPP Mar 26, 2015 NPP=new patient population exclusivity...

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PRANLUKAST

    PRANLUKAST Antiasthmatic. Benzamide, N-(4-oxo-2-(1H-tetrazol-5-yl)-4H-1-benzopyran-8-yl)-4-(4-phenylbutoxy)-  N-(4-Oxo-2-(1H-tetrazol-5-yl)-4H-1-benzopyran-8-yl)-p-(4-phenylbutoxy)benzamide...

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Unanimous FDA panel support for Novartis’ secukinumab

Unanimous FDA panel support for Novartis’ secukinumab October 21, 2014 Kevin Grogan Advisors to the US Food and Drug Administration have voted unanimously to support approval of Novartis’ secukinumab...

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Celgene oral Crohn’s drug GED-0301, Mongersen impresses in Phase II

Nogra制药,Celgene Nogra Pharma Limited 公司寡核苷酸(Oligonucleotides) 克罗恩病(Crohn’s disease) Shares in Celgene Corp have risen steadily following promising mid-stage data of its closely-watched Crohn’s disease...

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What is a Drug Master File? by DR ANTHONY MELVIN CRASTO… An introduction with...

What is a Drug Master File? DR ANTHONY MELVIN CRASTO An introduction with case study of an API ……………. DMF by Anthony Crasto from ANTHONY MELVIN CRASTO Ph.D worlddrugtracker Filed under: Uncategorized...

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FLOW SYNTHESIS IN ACTION

      Multi-step synthesis using modular flow reactors: the preparation of yne-ones and their use in heterocycle synthesis I.R. Baxendale, S.C. Schou, J. Sedelmeier, S.V. Ley, Chem. Eur. J. 2010, 16,...

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Piecing together the puzzle: understanding a mild, metal free reduction...

Originally posted on ORGANIC CHEMISTRY SELECT: Piecing together the puzzle: understanding a mild, metal free reduction method for large scale synthesis of hydrazines D.L. Browne,* I.R. Baxendale, S.V....

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Ibudilast

IBUDILAST AV-411 KC-404 MN-166 2-methyl-1-(2-propan-2-ylpyrazolo[1,5-a]pyridin-3-yl)propan-1-one KYORIN Kyorin Seiyaku Kk……….INNOVATOR Properties: Crystals from hexane, mp 53.5-54°. Slightly sol in...

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NDA, ANDA AND IND by DR ANTHONY CRASTO

Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: NDA, ANDA AND IND by DR ANTHONY CRASTO ………. NDA ANDA IND by Anthony Crasto from ANTHONY MELVIN CRASTO Ph.D worlddrugtracker View...

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ABBREVIATED NEW DRUG APPLICATION (ANDA) by Anthony crasto

Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: ABBREVIATED NEW DRUG APPLICATION (ANDA) by Anthony crasto ABBREVIATED NEW DRUG APPLICATION (ANDA) by Anthony crasto from ANTHONY MELVIN...

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ROFECOXIB

ROFECOXIB MK-966, MK-0966, Vioxx 162011-90-7 C17-H14-O4-S 314.3596 \ Percent Composition: C 64.95%, H 4.49%, O 20.36%, S 10.20% LitRef: Selective cyclooxygenase-2 (COX-2) inhibitor. Prepn: Y. Ducharme...

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Continuous Flow Ligand-Free Heck Reactions Using Monolithic Pd[0] Nanoclusters

    Continuous Flow Ligand-Free Heck Reactions Using Monolithic Pd[0] Nanoclusters N. Nikbin, M. Ladlow, S.V. Ley, Org. Proc. Res. Dev., 2007, 11, 458-462. http://pubs.acs.org/doi/abs/10.1021/op7000436...

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A Microcapillary Flow Disc (MFD) Reactor for Organic Synthesis

  A Microcapillary Flow Disc (MFD) Reactor for Organic Synthesis, C.H. Hornung, M.R. Mackley, I.R. Baxendale and S.V. Ley and, Org. Proc. Res. Dev., 2007, 11, 399-405....

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Optimisation of Conditions for O-Benzyl and N-Benzyloxycarbonyl Protecting...

Optimisation of Conditions for O-Benzyl and N-Benzyloxycarbonyl Protecting Group Removal using an Automated Flow Hydrogenator K.R. Knudsen, J. Holden, S.V. Ley and M. Ladlow, Adv. Syn. Cat. 2007, 349,...

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Cordyceps  – Rare parasitic fungi could have anti-flammatory benefits

Originally posted on Clinicalnews.org: 19 Nov 2012 Caterpillar fungi (Cordyceps) are rare parasites found on hibernating caterpillars in the mountains of Tibet. For centuries they have been highly...

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Prefacing the e-Book Epilogue: Metabolic Genomics and Pharmaceutics

Originally posted on Leaders in Pharmaceutical Business Intelligence: Prefacing the e-Book Epilogue: Metabolic Genomics and Pharmaceutics Author and Curator: Larry H. Bernstein, MD, FCAP Adieu, adieu,...

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