New research suggests pharmas trialing drugs in BRIC countries are opting to work with smaller, home-grown contract research organisations (CROs) with local knowledge rather than multinational players.
Pfizer has welcomed Government commitments to keep Ireland’s 12.5 per cent corporation tax rate in face of recent EU pressure to increase it as a condition of the €85bn 7-year IMF bailout.
GlaxoSmithKline will sell its oral penicillin manufacturing facility in Tennessee, US, to Dr Reddy’s for an undisclosed sum, along with US rights to its Augmentin and Amoxin brands.
The Christie cancer centre in Manchester, UK, has opened a £35m (€41m) early phase clinical trial unit to help develop new treatments for a range of cancers.
SGS Life Sciences will expand bioanalytical capacity at its facility in Poitiers, France in the latest stage of its effort to become the biggest biologics testing services firm by 2014.
Production of BioDelivery Sciences International’s (BDSI) chronic pain treating drug, ONSOLIS, has resumed after a temporary voluntary shut down at contract manufacturers, Aveva Drug Delivery Systems.
ACTA was finalised last week but controversies remain, with research warning it could “create significant barriers to international trade, especially in generic medicines”.
Demand for drug discovery, development services and active pharmaceutical ingredients (APIs) were the main growth drivers in Q3 according to Wuxi Pharmatech.
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.
Johnson & Johnson and Millennium Pharmaceuticals have recalled several thousand vials of the anti-cancer drug, Velcade following reports of white particles floating in the medicine.
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.
India’s Central Drugs Standard Control Organization (CDSCO) has drawn up guidelines for regulators and sponsors to help tighten up clinical trial inspection procedures.
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.
An academic clinical research centre that claims CROs markedly increase costs and reduce trial monitoring to box ticking, statements disputed by ACRO, has described its adoption of an in-house system.
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.
The FDA significantly increased the number of concluded post-marketing requirements and commitments (PMR/PMC) in the 2009 fiscal year, according to a report.
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.
Inaccurate predictions based on animal models are the biggest cause of clinical failure according to Scottish CRO Biopta, which says use of human tissue samples for preclinical development would cut attrition rates.
Minipigs are a practical and flexible model for safety testing which probably provide better prediction of toxicity in humans than rats and dogs, according to EU funded research.
Biopharm are increasingly assessing the threat counterfeiting and diversion pose to emerging biotechs when planning an acquisition, according to a white paper.
ACRO wants the US FDA’s overseas offices to play more of a role in monitoring clinical trials, and is calling for an additional $35m (€25.3m) to fund the work.
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.
