Patricia Van Arnum

As biopharmaceutical/pharmaceutical companies increase their development of biologic-based drugs, companies providing analytical instrumentation and laboratory testing goods and services are, in turn, offering improved tools for biologic characterization, biomanufacturing, and related testing.

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

Additional approvals in December have helped to outpace a recent high set in 2011.

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.

FDA has issued a draft guidance to assist applicants in the submission of summary-level clinical-site data.

Myriad Genetics reports that the US Supreme Court has granted certiorari agreeing to hear the company's gene patentability case.

The launch of a global cross-pharmaceutical Investigator Databank follows the formation of TransCelerate BioPharma, another industry collaboration to address challenges in drug development.

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.

Ben Venue Laboratories has resumed production on a limited number of manufacturing lines in the company's Bedford, Ohio, facilities.

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.