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FDA approves Praluent for the treatment of high LDL cholesterol
26 August 2015 Sanofi and Regeneron have announced that the US Food and Drug Administration (FDA) has approved Praluent® (alirocumab) Injection. Praluent is indicated as an adjunct to diet and...
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Mahendra Chemicals gets FDA Warning Letter with Focus on “Data Integrity”
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: A Warning Letter issued by the US Food & Drug Administration (FDA) to an Indian API manufacturer on 13 July 2015 shows again a clear...
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Sandoz, Pfizer closing Mumbai API plant
Sandoz closing Mumbai API plant but says it remains committed to India By Dan Stanton+, 15-Jul-2015 Sandoz will shutter an Indian API facility in 2016 as part of a manufacturing refocus in the region....
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Vintafolide
Vintafolide, EC-145 , MK-8109 mw 1917.041, cas 742092-03-1, mf C86 H109 N21 O26 S2...
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FDA approves Repatha to treat certain patients with high cholesterol
FDA approves Repatha to treat certain patients with high cholesterol 08/27/2015 05:10 PM EDT The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who...
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New Parathyroid Disease Drug Etelcalcetide Seeks FDA Approval
Etelcalcetide, AMG 416 AMG-416; Etelcalcetide hydrochloride; KAI-4169; KAI-4169-HCl; ONO-5163; Telcalcetide; Velcalcetide; Velcalcetide hydrochloride D-Argininamide,...
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Polymorph case study……….Duvelisib
Duvelisib Infinity and AbbVie partner to develop and commercialise duvelisib for cancer INK 1197; IPI 145; 8-Chloro-2-phenyl-3-[(1S)-1-(9H-purin-6-ylamino)ethyl]-1(2H)-isoquinolinone...
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DABIGATRAN PART 1/3
Dabigatran (Pradaxa in Australia, Canada, Europe and USA, Prazaxa in Japan) is an oral anticoagulant from the class of the direct thrombin inhibitors. It is being studied for various clinical...
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DABIGATRAN PART 3/3
WO2015124764 ERREGIERRE S.P.A. [IT/IT]; Via Francesco Baracca, 19 I-24060 San Paolo D’argon (IT) Erregierre SpA DABIGATRAN ETEXILATE MESYLATE, INTERMEDIATES OF THE PROCESS AND NOVEL POLYMORPH OF...
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Neovacs Receives First Regulatory Approvals for a Phase IIb Trial of...
NEOVACS, a leader in active immunotherapies for the treatment of autoimmune diseases, today announced that it has been granted first approvals by regulatory agencies and ethics committees in several...
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Ximelagatran
Ximelagatran 192939-46-1, EXANTA N-[(1R)-1-cyclohexyl-2-[(2S)-2-[[[[4-[(hydroxyamino)iminomethyl]phenyl]methyl]amino]carbonyl]-1-azetidinyl]-2-oxoethyl]-glycine, ethyl ester C24H35N5O5...
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FDA approves new drug treatment for nausea and vomiting from chemotherapy
see synthesis at……..http://newdrugapprovals.org/2013/11/10/rolapitant-nda-in-2014/ FDA approves new drug treatment for nausea and vomiting from chemotherapy September 2, 2015 Release The U.S. Food and...
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How to become a QP for Europe
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: Both the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of...
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How to document a Product Transfer? Example templates!
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: All participants of the GMP training course “GMP-compliant Product Transfer” will receive a special version of the Guideline Manager CD...
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Lemborexant
Lemborexant E2006 CAS Number: 1369764-02-2 Chemical Name: (1R, 2S) -2 – {[(2,4-dimethylpyrimidin-5-yl) oxy] methyl} -2- (3-fluorophenyl ) N (5-fluoropyridin-2-yl) cyclopropanecarboxamide Indication:...
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DABIGATRAN PART 2/3
Dabigatran etexilate (a compound of formula (I)) is the international commonly accepted non-proprietary name for ethyl...
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Bococizumab
STRUCTURAL FORMULA Heavy chain QVQLVQSGAE VKKPGASVKV SCKASGYTFT SYYMHWVRQA PGQGLEWMGE 50 ISPFGGRTNY NEKFKSRVTM TRDTSTSTVY MELSSLRSED TAVYYCARER 100 PLYASDLWGQ GTTVTVSSAS TKGPSVFPLA PCSRSTSEST...
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Vandetanib
Vandetanib; 443913-73-3; Zactima; ZD6474; Caprelsa; ZD 6474; Vandetanib (INN, trade name Caprelsa) is an anti-cancer drug that is used for the treatment of certain tumours of the thyroid gland....
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Novartis launches first US ‘biosimilar’ drug at 15 percent discount
Zarxio, filgrastim-sndz Novartis launches first US ‘biosimilar’ drug at 15 percent discount LONDON/ZURICH: Novartis kicked off a new era in U.S. medicine on Thursday with the launch of the first...
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Christopher Conway has been appointed to lead AMRI ’s discovery business...
Christopher Conway, Senior Vice President, Global Sales and Marketing Christopher Conway has been appointed to lead the company’s discovery business strategy as Senior Vice President of Discovery and...
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