The USP and FDA must work to identify counterfeited or intentionally adulterated products before they enter the healthcare system by collaborating on the modification of monographs, according to Margaret Hamburg.
Integration expenses, lower revenues, higher R&D spending and rising corporate costs impact PPD in Q1, but cancellations back to normal levels and requests for proposals increase.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Quintiles, Harlan Laboratories and Emerald BioStructures.
Charles River Laboratories (CRL) has admitted that areas of overlap created by the WuXi acquisition will lead to a “refinement of certain operating units” but is yet to disclose details.
Charles River Laboratories (CRL) is to acquire WuXi PharmaTech for $1.6bn (€1.2bn), creating a global CRO capable of offering fully integrated services from molecule creation to first-in-human testing.
US CRO Medpace has move into medical device trials with acquisition of Symbios Clinical in a bid to tap into what CEO August Troendle said was a growth area for the contract research sector.
The incoming Xcellerex CEO plans to move the company from validation to penetration, boosting revenues and client base, and invest in the contract manufacturing side of the business.
ACRO is aiming to increase recognition and analysis of the value CROs bring to drug development, spanning their role as strategic partners throughout the process, by funding academic research.
Colorcon has acquired excipient business NP Pharm, adding sugar spheres to its portfolio and production capacity that will become “an integral part” of its manufacturing network.
Delegates lucky enough to have made the trip to Interphex 2010 in New York, US bore witness to the launch of a wide range of new drug manufacturing technologies with products by O'Hara, Corning and PTI being some of the highlights.
Syntagon is implementing a strategic pricing initiative to give “substantial cost savings” to pharma and biotech companies taking compounds into Phase I and II clinical trials.
Lonza has reported stronger demand in the first quarter, but volatility remains in the custom manufacturing sector and it is uncertain if improvements “represent true and full economic recovery”.
Datatrak has added Safety Export to its eClinical suite, reducing errors, shortening timelines and cutting costs by ending reliance on paper to exchange data between sites, sponsors and regulators.
KryoTrans International claims its developmental KT1500 reusable container for drug shipments will be first passive temperature-controlled unit capable of accepting pallets and a boon for CROs in the globalised trial sector.
