India is considering strengthening compulsory licensing provisions, which allow third parties to produce patented products, in response to concerns about overseas takeovers and drug prices.
The Asia Pacific trial sector grew during the global economic downturn as sponsors sought to improve access to patients, cut costs and improve data quality according to Novotech CEO Alek Safarian.
Questions about the ethics and scientific validity of trials conducted under the Pediatric Exclusivity Provision have been raised after researchers found many studies used sites outside the US.
Spaulding Clinical has renovated its Phase I pharmacology unit, citing both sponsor and regulatory demand for centralized cardiac monitoring as drivers.
Improving safety and efficacy coupled with drug industry desire for “stronger” patents will drive growth of the biologics sector over the next five years, according to new research.
Producing conjugate vaccines in recombinant E coli is potentially simpler and more cost-effective than alternatives, say researchers, but the method suffers from low yields.
Drug industry focus on clinical data quality, cost and speed is key driver for recent growth of Hungarian trials business says patient recruitment specialist Synexus.
Warnex says demand for contract analysis services increase in Q2 thanks to expansion in diagnostics market and forecasts growth opportunities in India.
Quintiles says it is confident that all proper procedures were followed during a 2006 study of Theravance’s antibiotic telvancin being audited by Indian drug regulators.
Penwest Pharmaceuticals raises guidance citing Opana ER royalties, deals and patent settlements as Q2 highlights; but warns that job cuts likely under cost cutting plan.
AMRI recorded a $6.0m (€4.6m) operating loss in the second quarter as restructuring charges and the lack of milestone payments offset contract service gains.
Ockham looks east for patient recruitment, setting up partnership with Russlan Clinical Research (RCR) to increase access to in-demand clinical trial destination.
In the first of a series of special in-pharmatechnologist podcasts Kate Wilber, Image Solutions’ (ISI) director of regulatory Services, Europe discusses the emerging trends in BPO and talks about how it can benefit drugmakers.
Recently-acquired Italian R&D facility helps Aptuit win new contract after local neuroscience-focused developer Siena Biotech names the CMO as “supplier of choice.”
Charles River Laboratories (CRL) has abandoned plans to buy Wuxi Pharmatech after the $1.6bn (€1.2bn) takeover failed to gain sufficient shareholder support.
Demand for drug discovery services is growing again according to Domainex, who predicted that we will see greater pharmaceutical industry reliance on specialist CROs going forward.
Significant biopharm consolidation has played a key role in reshaping the drug development sector. Viq Pervaaz, senior vice president at Aon Consulting, discusses the changes and how they will impact on contract research organizations (CRO).
Icon reported a dip in operating income in the second quarter but an upturn in new business, and the cash to pursue M&A, make it reasonably positive about the future.
Japanese researchers look set to have another option for biomarker analysis, after Thermo Fisher Scientific unveils plans for Tokyo research laboratory unit.
Research into the use of quadrupole resonance spectroscopy (QR) for non-invasive, non-destructive detection of counterfeits has been boosted by a grant.
CRO Quintiles says biomarkers give insight into cancer drug candidates’ efficacy earlier in the development process, reducing trial costs and duration.