FDA approves packaging plant as Almac welcomes US clients
Almac says that FDA approval of its commercial packaging plant will open doors to fulfill demand from the US market.
Archives for February 6, 2013
SFDA may forge closer ties with Swissmedic
The SFDA wants to forge closer ties with regulators in Switzerland, to date the only country granted exemption from new EU API import laws.
Clarification
Aspen in Plans to Acquire Merck's Dutch API Plant
Merck has revealed plans to sell its Dutch API facility though will retain the sites other manufacturing facilities.
M&A motivations differ for CROs and PE investors but deals will continue, says broker
CROs invest in scope and scale while private-equity groups buy firms they can expand according to Fairmount Partners’ managing director, Neal McCarthy.
GVKBIO extends license of biomarker database to FDA
GVK Bioscience has granted the US FDA further access to its clinical biomarker database following an extension of its license agreement.
GSK, European Parliament Begin Push for Clinical Trial Transparency
A storm is brewing over the release of clinical trial data as GlaxoSmithKline on Tuesday took a step away from UK and US industry groups and said it intends to publish clinical study reports for all approved medicines dating back to when the company was...
Quality System Tweaks Necessary to Meet Final Combo Product cGMP Rule
The US Food and Drug Administration’s (FDA) release of a final rule on cGMP for combo products raises a number of questions as to how drug and device companies will tweak or overhaul their quality systems and which suppliers of products will need to...