Jan 2, 2013
By:
Patricia Van Arnum
Additional approvals in December have helped to outpace a recent high set in 2011.
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Dec 21, 2012
By:
Patricia Van Arnum
The agency recommends to avoid the use of to dibutyl phthalate and di(2-ethylhexyl) phthalate in CDER-regulated drug and biologic products, including prescription and nonprescription products.
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Dec 18, 2012
By:
Patricia Van Arnum
FDA has issued a draft guidance to assist applicants in the submission of summary-level clinical-site data.
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Dec 4, 2012
By:
Patricia Van Arnum
Myriad Genetics reports that the US Supreme Court has granted certiorari agreeing to hear the company's gene patentability case.
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The launch of a global cross-pharmaceutical Investigator Databank follows the formation of TransCelerate BioPharma, another industry collaboration to address challenges in drug development.
Nov 19, 2012
By:
Patricia Van Arnum
The launch of a global cross-pharmaceutical Investigator Databank follows the formation of TransCelerate BioPharma, another industry collaboration to address challenges in drug development.
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Nov 7, 2012
By:
Patricia Van Arnum
Watson Pharmaceuticals has completed its EUR 4.25 billion ($5.4 billion) acquisition of the Actavis Group. The combination creates the world's third largest generic-drug pharmaceutical company, with anticipated pro forma combined 2012 revenues in excess of $8 billion, according to Watson.
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Oct 23, 2012
By:
Patricia Van Arnum
Ben Venue Laboratories has resumed production on a limited number of manufacturing lines in the company's Bedford, Ohio, facilities.
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Oct 3, 2012
By:
Patricia Van Arnum
Merck Serono's Asceneuron is the third company to be spun off from the company's Entrepreneur Partnership Program that was launched to mitigate the impact from recent restructuring at its Geneva site.
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The manufacturing capacity-sharing model between Merck and MedImmune ushers in a new paradigm of "co-opetition."
Oct 1, 2012
By:
Patricia Van Arnum
The manufacturing capacity-sharing model between Merck and MedImmune ushers in a new paradigm of "co-opetition."
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