The CEO of Covance has warned it will be “very, very difficult” for CROs expanding through M&A to integrate assets, and the process could see clients go elsewhere.
An evidence-based approach to planning during protocol development is key to successful patient recruitment according to Joseph Kim, director of clinical operations at Shire Pharmaceuticals.
Pharmaceutics International (Pii) has expanded its range of formulation and process development services with the addition of bioavailability boosting hot-melt extrusion (HME) capabilities.
INC Research CEO James Ogle tells Outsourcing-pharma.com that the acquisition of fellow CRO Kendle was about building a presence in emerging trial hotspots and pharmaceutical markets.
In June global drug giant Pfizer began what it described as the world’s first ‘virtual trial’ using mobile technology to collect data from patients in their own homes rather than at research sites.
PPD posted an improved set of financials for Q2 days after announcing a review of its long-term plan and capital structure following speculation it was looking for a buyer.
India’s Central drugs standard control organisation (CDSCO) has issued new draft guidance of clinical trials and new drug approvals that pave the way for potential electronic submissions.
India’s CDSCO has issued draft guidance designed to help active pharmaceutical ingredient (API) importers streamline the submission and registration process.
CRO financial results season begins this week amid reports PPD could be sold, with other service providers and private equity viewed as potential bidders.
US CRO Parexel says the pharmaceutical industry’s desire to access international markets is the key challenge facing regulatory experts in the contract research sector.
Chiltern says that strategic partnering in the contract research sector enables CROs to plan for the longer term and is having a tangible impact on brining drugs to market.
US CRO Celerion gained Brazilian National Health Surveillance Agency (Agência Nacional de Vigilancia Sanitaria ANVISA) approval for its bioanalysis labs in Lincoln, Nebraska and in Belfast, Northern Ireland.
Gerresheimer will expand its pharmaceutical packaging plant in the Czech Republic to meet growing demand for plastic systems and to further expand a key training hub.
The Pharmaceutical Research and Manufacturers of America (PhRMA) has welcomed proposed changes to US patent laws that would alter the basis for patent awards.
US stem-cell therapy firm NeoStem predicts that output of its China-based generic antibiotics subsidiary Suzhou Erye Pharmaceutical will increase after further manufacturing approval from the SFDA.
GlaxoSmithKline (GSK) has announced plans to buy its joint venture Shenzhen GSK Neptunus Biologicals (GSKNB) to expand influenza vaccine production capacity in China.
US drugmaker Baxter International has been ordered to pay compensation of $625,000 to the estate of man who received a dose of heparin that was contaminated with over-sulfated chondroitin sulphate (OSCS).
Indian contract research organisation (CRO) GVK Biosciences has signed a deal allowing pharmaceutical researchers across the US to access its clinical biomarker database.
The fall in the number of trials conducted in Russia in Q1 is a ‘temporary blip’ says Synergy Research Group general manager Igor Stefanov, who cites recent changes to the approval process, rather than a drop in demand, as the key factor.
Pfizer has begun what it claims is the world’s first ‘virtual’ trial and says that such innovation is needed to make sure clinical research is sustainable.
Switzerland-based life sciences supplier Lonza says it will invest CHF10m (€8m) to expand a Singapore plant that is part of its custom biomanufacturing business.
