Clinical trials in Latin America recruited 91 per cent more patients per site than studies conducted in the US from 2005 to 2009, according to EU MAA data.
SCM Pharma says demand for specialised contract manufacturing services is growing as the pharma industry focuses on niche indications, biologics and the development of potent medicines.
Novartis aims to focus on the development of specialty medicines in a new long-term strategy to boost profitability in a rapidly changing healthcare environment.
Globalisation is the main challenge to drug supply chain security according to USP scientist Desmond Hunt, who says greater collaboration is the key to maintaining product integrity
The Association of Clinical Research Organisations (ACRO) has welcomed new trial inspection guidance released by India’s Central Drugs Standard Control Organisation.
Last week everything from co-processed excipients to Viagra-stuffed teddies were discussed at AAPS 2010. Now, with the show having finished, we present our personal take on the event.
Combatting counterfeit drugs through forging stronger partnerships is beyond profit, it is about saving lives, AstraZeneca principal scientist Dr Michael Claybourn told a workshop on global drug quality at the AAPS annual meeting in New Orleans.
IMS Health predicts China will become the world’s second largest pharmaceutical market by 2015 due to robust economic growth and healthcare reforms that allow for increased spending on drugs.
Patient recruitment is boosted by health condition awareness strategies and financial incentives, according to research, but various methods of randomisation and consent design have no impact.
API maker AMRI cited arbitration costs, efforts to address a US FDA warning letter and acquisitions as key factors in Q3 loss, but predicted that large-scale contract manufacturing business will drive final quarter gains.
In the 20 month period before the heparin crisis no Chinese producers were inspected by the FDA and efforts during and since have been hindered by legal and practical challenges.
Kendle recorded a 64 per cent drop in Q3 operating income and expects its strategic review of early stage, which will establish a fair value and consider all options, to be complete next quarter.
The US FDA’s Puerto Rico office may be “having difficulty” monitoring drug manufacturing in the country according to the Congressional Committee on Oversight and Government Reform.
WuXi has received GLP certification from the SFDA for its toxicology facility in Suzhou, China and, in a separate development, is providing CAS’ SciFinder to its staff.
Adding Indian cGMP HPAPI capabilities builds on Arch’s strategy of differentiating through technology and establishes it in an emerging and profitable sector.
Overseas offices will help the FDA schedule inspections more quickly in times of crisis but, as yet, employees based abroad have visited relatively few facilities.
Biopharm are increasingly assessing the threat counterfeiting and diversion pose to emerging biotechs when planning an acquisition, according to a white paper.
B. Braun is recalling lots of its injectable anticoagulant, Heparin, manufactured in 2008, after finding a sample used to manufacture Heparin Sodium USP active pharmaceutical ingredients (APIs) was contaminated.
Overseas FDA offices have realised immediate benefits but strategic planning is needed to ensure the ventures, critical aspects of the agency’s ability to ensure drug quality, are long-term successes according to the GAO.
Drug industry demand for chemical intermediates and development projects has rebounded significantly in the last 12 months according to UK group Endeavour Specialty Chemicals.
PPD signs clinical imaging and formulation development collaborations, reorganises reporting units and cites “improved performance in emerging markets” and spending controls as key to third quarter gains.
PPD is collaborating with the Himalayan Institute and Hospital Trust (HIHT University) to form a large investigator site and expand its network of investigators in Northern India.
Indian CRAs need knowledge of ethics, clinical trial execution and general topics, such as the drug development process, according to a survey into training needs.
The WHO is today initiating a pilot prequalification programme for selected APIs used in drugs for HIV and related diseases, antimalarials and anti-tuberculosis medications.
Revision to FDA guidance on adverse event reporting is a positive step and forms part of a welcome increased focus on safety, says the CEO of Prism Ideas.
Eli Lilly has unveiled plans to close its Singapore R&D centre by the end of the year and relocate discovery operations to its global headquarters in the US.
Prosonix expects high demand for innovative particle processing technologies in the $24bn (€17bn) a-year respiratory pharmaceuticals market over the next few years.
A week of global anti-counterfeiting law enforcement coordinated by Interpol led to the shutdown of 290 websites, seizure of 11,000 packages and confiscation of 1m pills.
