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A Novel and Practical Synthesis of Ramelteon
RAMELTEON An efficient and practical process for the synthesis of ramelteon 1, a sedative-hypnotic, is described. Highlights in this synthesis are the usage of acetonitrile as nucleophilic reagent to...
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Lesogaberan
Lesogaberan AZD-3355, AZD3355, [(2R)-3-amino-2-fluoropropyl]phosphinic acid, 344413-67-8 Molecular Formula: C3H8FNO2P+ Molecular Weight: 140.073285 g/mol...
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Sarpogrelate, 사르포그렐레이트염산염
Sarpogrelate 135159-51-2,HYROCHLORIDE 125926-17-2 (free base) 5-HT 2a receptor antagonist Useful for treating arterial occlusive disease and ischemic heart disease. Sarpogrelate (Anplag, MCI-9042,...
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EMA approves AstraZeneca’s lesinurad to treat gout patients
EMA approves AstraZeneca’s lesinurad to treat gout patients British-Swedish drugmaker AstraZeneca has received approval from European Medicines Agency (EMA) for its lesinurad 200mg tablets to treat...
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BioCryst’s BCX4161 receives FDA fast-track designation to treat HAE
BioCryst’s BCX4161 receives FDA fast-track designation to treat HAE BioCryst Pharmaceuticals has received fast-track designation from the US Food and Drug Administration (FDA) for its BCX4161, an...
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Amgen/Onyx file multiple myeloma drug in US, EU…..a supplemental New Drug...
Carfilzomib synthesis………http://newdrugapprovals.org/2014/08/05/amgens-multiple-myeloma-drug-shows-promise-in-phase-3-trial/ supplemental New Drug Application filed Amgen and its subsidiary Onyx...
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LUCITANIB a VEGFR/FGFR dual kinase inhibitor in Phase 2 trials
LUCITANIB 6-[7-[(1-aminocyclopropyl)methoxy]-6-methoxyquinolin-4-yl]oxy-N-methylnaphthalene-1-carboxamide 6-(7-((l-aminocyclopropyl)methoxy)-6-methoxyquinolin-4-yloxy)- N-methyl- 1 -naphthamide...
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Data exclusivity for medicinal products in Europe…8+2+1 approach
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: Data exclusivity for medicinal products in Europe The pharmaceutical sector is heavily regulated, with significant costs associated with...
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Marketing Authorisation in Europe
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: Authorisation Procedures for medicinal products Procedures for evaluating medicinal products and granting marketing authorisation The...
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Generic drugs in the EU
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: Process of reviewing and assessing the dossier to support a medicinal product in view of its marketing (also called licensing, registration,...
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AYURVEDA……..Dronapushpi (দ্রোনপুষ্পি)
Dronapushpi is Sanskrit name of plant Leucas cephalotes. It is a medicinal herb that grows as a weed in India and many South East Asian countries. The folk use of this herb is for treating scorpion...
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Lead-oriented synthesis: a new concept to aid drug-discovery process
Figure 2. a. Fragment-based screening: Small and structurally diverse molecules (circles represent functional groups) are screened for a biological target, and they are combined and modified to...
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(sNDA)…..FDA okays Shire ADHD drug Vyvanse (lisdexamfetamine dimesylate) for...
Yet more good news for Shire has come with the US Food and Drug Administration approving its attention-deficit hyperactivity disorder blockbuster Vyvanse for binge-eating disorder, the first...
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EDIVOXETINE REVISITED
EDIVOXETINE, LY 2216684 (1R)-2-(5-fluoro-2-methoxyphenyl)-1-[(2S)-morpholin-2-yl]-1-(oxan-4-yl)ethanol UNII-3W9N3F4JOO, 1194508-25-2, Edivoxetine [USAN], Edivoxetine (USAN/INN), Edivoxetine...
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Falsified Results of Analysis at Indian Pharmaceutical Manufacturer
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: Indian pharmaceutical manufacturers increasingly attract attention by breaching GMP rules. In a further case the analysis results not...
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FDA approves Pfizer’s Ibrance (palbociclib) for postmenopausal women with...
PALBOCICLIB Mechanism of action: selective inhibitor of the cyclin-dependent kinases CDK4 and CDK6 Indication: Estrogen receptor-positive (ER+), HER2-negative (HER2 -) breast cancer FDA approves...
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USP Chapter Visual Inspection of Injections published
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: The long-awaited USP Chapter <1790> regarding the 100% visual control of injections has been issued in the Pharmacopeial Forum 41(1)...
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Route Design in the 21st Century: The ICSYNTH Software Tool as an Idea...
The new computer-aided synthesis design tool ICSYNTH has been evaluated by comparing its performance in predicting new ideas for route design to that of historical brainstorm results on a series of...
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Takeda’s ixazomib soon to be filed for multiple myeloma
Takeda’s flagship experimental cancer drug ixazomib is a giant leap closer to being filed with regulatory authorities around the globe for multiple myeloma, after turning in a solid performance in...
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Quality by Design in Action 1: Controlling Critical Quality Attributes of an...
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: The importance of Quality by Design (QbD) is being realized gradually, as it is gaining popularity among the generic companies. However, the...
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