regulator
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Nutra Pharma receives regulatory approval to market Nyloxin in India
Nutra Pharma has received approval in India for its Nyloxin line of pain relievers.
regulator | 11 August 2011
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AstraZeneca's NEXIUM receives first regulatory approval in Japan
AstraZeneca announced that NEXIUM (esomeprazole magnesium) 10 mg and 20 mg capsules have received regulatory approval in Japan for the treatment of acid-related conditions including non-erosive reflux disease (NERD), reflux esophagitis, and peptic ul…
regulator | 01 July 2011
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PharmaNet offers guidance on regulatory pathway for biosimilars development
PharmaNet is offering guidance on the regulatory pathway for biosimilar development in the United States, following a FDA hearing. The two day public hearing aimed to obtain input from interested stakeholders on specific issues and challenges as…
regulator | 11 February 2011
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EU regulators okay Qlaira
Bayer Schering Pharma has successfully concluded the European registration procedure for the introduction of Qlaira in the new indication treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception. The…
regulator | 30 October 2010
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Avandia hit hard by European and US regulators
Expert comment from Datamonitor healthcare analyst Christine Henry: "Although Avandia franchise sales have already declined significantly from a high of US$3.2 billion in 2006 worldwide to US$1.2 billion in 2009, the suspension of sales in Europe …
regulator | 15 October 2010
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MicroRNA identifies as key regulator of blood cell development
miRagen Therapeutics announces the publication of data demonstrating the essential role of microRNA-451 (miR-451) in the regulation of erythropoiesis, the process of red blood cell production in the body. Published in the August 1 issue of the j…
regulator | 18 August 2010
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Botox headache for regulators and payors
Martin Adams, healthcare analyst at Datamonitor comments that “Approval in the UK for Allergan’s Botox (onabotulinumtoxinA) for the prevention of chronic migraine bodes well for the US and other EU filings but even so there remain significant hur…
regulator | 06 August 2010
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Regulatory Compliance of Equipment Qualification
With the majority of API being produced in Asia for Western pharmaceutical companies, compliance with current GMP regulations has become a topic of great importance for Asian drug manufacturers. This article looks at the regulatory compliance in the qualification of laboratory testing equipment.
regulator | 01 June 2010
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RAPS Selects ForeignExchange for Regulatory Affairs Translation
The Regulatory Affairs Professional Society (RAPS) has selected ForeignExchange Translations to translate the former’s Fundamentals of Japanese Regulatory Affairs handbook. RAPS publishes books that help regulatory professionals navigate the la…
regulator | 25 February 2010
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Glycotope Receives Regulatory Approval for Cancer Study
Glycotope, a German Biotech company, has received regulatory approval by German and Italian regulatory authorities for a Phase I study of its lead antibody GT-MAB 2.5-GEX for the treatment of various solid cancers. The approvals indicate the suit…
regulator | 04 December 2009
