SOCMA and the EFCG want the US FDA to make inspection of overseas API manufacturing sites mandatory, with the facilities paying for the costs themselves.
CRO and Pharma patient recruitment efforts can benefit from social networks and online patient groups, but clarification from the US FDA is still needed.
The Japanese drug sector seems to have survived the earthquake and tsunami that struck the country largely unscathed, with early reports suggesting that most manufacturing sites have escaped damage.
Wuxi PharmaTech finished the fourth quarter and the full year 2010 on a high driven by growth across all business units and the payoff from former suitor Charles River Laboratories (CRL).
Regional production hubs created by technology transfer can improve public health and drive economic development in low- to mid-income countries, says Eli Lilly
US healthcare giant Johnson & Johnson (J&J) has recalled 384,000 of its insulin cartridges on concerns the products could cause serious health problems for diabetics.
GEA Pharma Systems, the German drug processing equipment manufacturer, has signed a representation agreement with Swedish hi-tech firm Christian Berner Tech Trade.
CSM GlobalPharma has announced plans to invest $65m in a manufacturing facility in Kigali, Rwanda in collaboration with the Rwandan Development Board (RDB).
Warnex will provide central laboratory services for Genzyme Canada as part of the US biotech’s lysosomal storage disease (LSD) testing programme in Canada.
Contract research organisation (CRO) Maccine will set up a preclinical imaging laboratory in partnership with the Singapore Bioimaging Consortium (SBIC) under a deal announced late last week.
AstraZeneca has become the latest drug firm to invest in Russian manufacturing capcity with the announcment of plans for a $150m facility in the country’s Kaluga region.
Late-stage cancer trials are the biggest challenge for pharmaceutical and biotech firms according to data presented at the Biotechnology Industry Organisation's (BIO) CEO and investor conference in Washington DC, US this week.
A global compulsory register of all contractors and subcontractors involved in each clinical trial should be created to increase transparency, according to a study.
Indian CRAMS firm Jubilant Life Sciences had an unhappy third quarter of fiscal 2011 with profits falling despite gains in generics and API manufacturing.
QPS Holdings has acquired Taiwan’s Center of Toxicology and Preclinical Sciences (CTPS), continuing its expansion in the region’s rapidly expanding drug development sector.
Establishment of complex regulated preclinical studies in China is going to take a lot longer than expected, says CRL, with significant progress taking at least five years.
Albany Molecular Research Inc. (AMRI) has posted a fourth quarter loss for 2010 after charges relating to a non-cash goodwill and fixed asset impairment of $35.2m.
PPD and Charles River Laboratories (CRL) finished 2010 with very different quarters, each posting results that illustrate trends within the CRO sector.
The United States Pharmacopeoia (USP) will help regulators in sub-Saharan Africa ensure drug quality in a new scheme designed to boost testing and analysis capacity.