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Lupin launches insulin glargine in India
Lupin launches insulin glargine in India: Indian pharma company, Lupin Limited announced a strategic distribution agreement with LG Life Sciences of South Korea to launch Insulin Glargine, a novel...
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Road map to 2015, The European Medicines Agency’s contribution to science,...
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: One of the European Medicines Agency’s long-term strategic goals is to foster researchand the uptake of innovative methods in the...
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Turkish man pleads guilty to importing illegal cancer drugs
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: August 15, 2014 Release Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of...
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Antimicrobial resistance
Antimicrobials are medicines that kill or inactivate microbes, small disease-causing organisms. They include antibiotics, which are used against bacteria. After being exposed to an antimicrobial...
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Wednesday, 20 August 2014 Glenmark enters Oncology with the Discovery and the...
August 20, 2014: Glenmark Pharmaceuticals S.A. (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), announces the discovery and initiation of IND enabling studies of a...
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FDA approves new drug Cerdelga (eliglustat) to treat a form of Gaucher disease
August 19, 2014 Release The U.S. Food and Drug Administration today approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare...
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Drug from Mediterranean weed kills tumor cells in mice – Thapsia garganica
Originally posted on Clinicalnews.org: Just a three-day course reduced the size of human prostate tumors grown in mice by an average of 50 percent within 30 days ‘Molecular grenade’ now in clinical...
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Which SOPs are required by GMP?
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: ECA is receiving a lot of questions on SOPs (Standard Operating Procedures) needed in a GMP environment. The most interesting is the one on...
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Indian Sterile Manufacturer receives FDA Warning Letter and changes company...
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: Marck Biosciences Ltd. to “Amanta Healthcare Ltd.”, effective from June 24, 2014. Click here to visit website atwww.amanta.co.in Indian...
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With Persistence And Phase 3 Win, Amicus Nears First Drug Approval …….Migalastat
Migalastat hydrochloride CAS Number: 75172-81-5 hydrochloride CAS BASE….108147-54-2 ABS ROT = (+) +53.0 ° Conc: 1 g/100mL; Solv: water ; 589.3 nm; Temp: 24 °C IN Van den Nieuwendijk, Adrianus M. C....
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Etirinotecan pegol (NKTR-102) エチリノテカンペゴル: A Next-Generation Topoisomerase I...
Etirinotecan pegol (NKTR-102) 848779-32-8 PEG-irinotecan Also known as: NKTR-102; UNII-LJ16641SFT; 848779-32-8 Molecular Formula: C161H192N20O40 Molecular Weight: 3047.35718 Nektar Therapeutics...
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FDA Approves Eliquis (apixaban) for the Treatment of Deep Vein Thrombosis and...
Thursday, August 21, 2014 – Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has approved a Supplemental New...
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Plerixafor…………..an immunostimulant used to mobilize hematopoietic stem cells...
Plerixafor cas 110078-46-1 CXCR4 chemokine antagonist Stem cell mobilization [CXCR4 receptor antagonist] A bicyclam derivate, highly potent & selective inhibitor of HIV-1 & HIV-2. Bone marrow...
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A CASE OF H.I.V. POSITIVE WITH TUBERCULER INFECTION ; एच० आई०वी० के साथ...
Originally posted on आयुर्वेद : आयुष ; ई०टी०जी० आयुर्वेदास्कैन : AYURVEDA : E.T.G. AyurvedaScan ; आयुष आविष्कार ; ई० एच० जी० होम्योपैथीस्कैन : E.H.G. HomoeopathyScan: कुछ दिन पहले एच०आई०वी० से...
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FDA GIVES INSYS PHARMACEUTICAL CANNABIDIOL ORPHAN STATUS
FDA Gives Insys Pharmaceutical Cannabidiol Orphan Status Insys Therapeutics Inc., a specialty pharmaceutical company that is developing and commercializing innovative drugs and novel drug delivery...
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Iroko Pharmaceuticals Gains FDA Approval of Zorvolex for Management of...
Iroko Pharmaceuticals Gains FDA Approval of Zorvolex for Management of Osteoarthritis Pain August 25, 2014 — Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to...
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FDA ALLOWS MARKETING OF FIRST ZNT8AB AUTOANTIBODY TEST TO HELP DIAGNOSE TYPE...
FDA allows marketing of first ZnT8Ab autoantibody test to help diagnose type 1 diabetes Today, August 20, 2014, the U.S. Food and Drug Administration allowed marketing of the first zinc...
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Handling of OOS Results in Europe
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: FDA’s Guidance on Out-of-Specification Results has been seen as the state of the art regarding the handling of OOS results. In the...
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Best practice paper on visual inspection to be published in September 2014
Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: The ECA working group on visual inspection, which was founded this year, is going to publish its first document during the ECA event...
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Aripiprazole lauroxil ……….Alkermes submits new drug application
Aripiprazole 7-[4-[4-(2,3-dichlorophenyl)-1- piperazinyl]butoxy]- 3,4-dihydro-2(1H)-quinolinone. END AUG 2014 The US Food and Drug Administration (FDA) has received a new drug application (NDA) from...
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