AMRI’s plant in Rensselaer, New York gained SafeBridge potent compound certification this week after an effort that spokesperson Andrea Schulz said istestament to the firm's "willingness to go the extra mile”.
Malgorzata Szerszeniewska, CEO of Central and Eastern Europe’s (CEE) “newest” CRO EastHorn, says maintaining ethical standards is crucial to sustaining the rapid patient recruitment rates that characterise the region.
Quotient Bioresearch has secured the supply of 14C labelled compounds for its customers ahead of its move to a new purpose built facility in Cardiff through an extension of its agreement with GE Healthcare (GEHC).
The EFPIA’s European Vaccine Manufacturers (EVM) group has denied allegations that its members were involved in hyping up the threat of the H1N1 pandemic to boost vaccine sales.
Fujitsu has launched a SaaS-based data management system which it claims can speed up clinical trials, eliminate set up and maintenance costs and allow CROs and sponsors to use the same IT environment.
Quintiles Transnational has selected US ePRO solutions provider Invivodata to help it meet growing regulatory pressure to focus on the patient perspectives during trials.
New Jersey, US-based contractors Catalent Pharma Solutions and Compass Pharma Services expanded their respective blister pack offerings last week, both citing growing drug industry demand.
Latin America, new services and mid-sized pharma clients are targets for the incoming CEO of Clearstone Central Laboratories, who set out his vision for the business in an interview with Outsourcing-Pharma.
Lonza will shut down its API plant in Riverside, Pennsylvania, US by the end of the year as part of a plan to cut costs and shift small-molecule production to Asia.
Conducting trials in smaller patient populations when developing personalised medicines poses challenges, such as how to recruit patients fast enough, but these can be overcome using adaptive methods, according to a CEO.
Outsourcing-pharma presents a round up of all the latest deals and developments in the contract research space. This week Synexus closes ClinPharm deal, GVK joins ResearchPoint Global and CliniPace wins gNO contract.
Pall says its acquisition of MicroReactor Technologies (MRT) broadens its offering in the $1bn (€689m) a year global biopharmaceutical process development market.
The SCDM says that edit checks are a crucial component of achieving error-free data and has updated its Good Clinical Data Management Practices (GCDMP) resource with a best practice guide.
US clinical trial review groups Independent Review Consulting (IRC) and Ethical Review Committee (ERC) are to merge and operate under the name Ethical and Independent Review Services (E&I).
A recently completed manufacturing and filling capacity expansion will help Florida Biologix meet deadlines and win repeat business according to company director Richard Snyder.
WuXi AppTec is partnering with Qiagen to develop biomarkers, assay panels and personalised healthcare diagnostics and will use these, and existing technologies, to further clients’ projects.
GSK says it will start making its BPH drug Avodart (dutasteride) at its facility in Poznan, Poland when it completes a PLN70m (€17m) capacity upgrade in January next year.
Daiichi-Sankyo subsidiary Luitpold Pharmaceuticals has acquired PharmaForce, giving it a 40,000 sq ft cGMP compliant sterile manufacturing facility and a 20,000 sq ft API production plant.
The Hong Kong pharma sector should aim to adopt current World Health Organisation (WHO) GMP standards for drug manufacture within two years, according to a new report.
inVentiv Health claims the acquisition of ParagonRx positions it as the leading supplier of REMS services in the pharmaceutical contract services sector.
The US Department of Justice (DOJ) has given partial approval for Amcor’s takeover of Alcan after announcing it would now limit its review to Alcan’s Medical Flexible operations.
Ranbaxy Laboratories has sold its Chinese JV, Ranbaxy Guangzhou China Limited (RGCL), as part of a new approach to the country’s rapidly expanding drug market.
Zydus Cadila has become the first Indian pharma company to begin multi-centre clinical trials of a H1N1 vaccine after it received approval from the Drug Controller General of India (DCGI).
The Nucleotide Research Complex, the largest such facility in the Middle East, is now operational and ready to house companies’ research and development, analytical, diagnostic and equipment training activities.
Rexam will close its pill and tablet bottle making facility in New Hampshire, US by the end of the year to further align global plastics operations according to new CEO Graham Chipchase
Novartis intends to acquire the remaining 75 per cent of Alcon for $39.3bn (€27.3bn), adding to the shares it bought in April 2008 and giving the big pharma control of the ophthalmic specialist.
US CRO Pacific Biometrics is to be renamed Pacific Biomarkers, after shareholders voted in favour of the change at the company’s AGM earlier this month.
Patheon says a slowdown in “outsourcing decision making,” manufacturing problems in Puerto Rico and cost related to JLL’s takeover bid hurt it in fiscal 09.
Trials contractor Kendle International will use a management platform developed by US software group MetricStream to help control its global compliance and quality assurance operations.
The Indian pharmaceutical market was worth $10.8bn (€7.5bn) this year and will more than double in value by 2014 according to a new industry report by Cygnus Business Consulting & Research.
US software firm Instem will establish an office in Shanghai, China, to provide customer support, client management, development and sales support to its Chinese pharmaceutical and life sciences R&D clients.
Sanofi Pasteur has recalled four lots of its pediatric H1N1 vaccine in the US that were found to have fallen below potency limits despite being be in spec at the time of manufacture.
US eClinical firm Phase Forward has created the new executive role, “chief privacy officer,” to ensure it complies with the latest data protection and privacy regulations governing the trial sector.
GSK says UK plans to apply a reduced tax rate to all drugs patented after 2013 will encourage investment, provided it is applied to products already being developed.
