Pfizer, GlaxoSmithKline, Roche and 26 other large pharmaceutical companies will provide about $5.85m (3.5m Euros) over three years to fund an Interpol initiative to combat pharmaceutical counterfeits and crime.
California-based CRO Agility Clinical and EU-based PSR Orphan Experts have partnered to allow orphan drug companies to utilize their safety and regulatory knowledge in both markets.
CRO WuXi PharmaTech has announced 22% net revenue growth in 2012 as its China-based lab services grew significantly. That trend is expected to continue with double-digit growth in 2013.
The European Commission (EC) says timelines for new laws requiring that risky drugs are marked for extra safety monitoring take industry practicalities into account.
The US FDA’s ability to inspect facilities, trial sites, and deal with all but its most pressing priorities will be restricted by mandatory government spending cuts according to the Alliance for a Stronger FDA.
Pharmaceutical firms targeting the European market should expect drug review fees to increase by 2.6 per cent from April according to the European Medicines Agency (EMA).
A Canadian subsidiary of India’s largest CMO (contract manufacturing organization) was cited by the US FDA for failing to investigate rejected batches of product or implement further preventive actions.
A new partnership between a niche cancer drug discovery company and biotech powerhouse Celgene could pave the way for the future of cancer drug discovery and delivery.
Food industry controls do not ensure porcine trypsin is virus-free according to the EMA, which proposes testing procedures for drugmakers which use the reagent in a new consultation document.
The US FDA has completed its re-inspection of Hospira’s Rocky Mount, North Carolina, plant and cited the company with 20 violations, three of which were repeat observations, according to an SEC filing.
Contract drug developer Particle Sciences has recently chosen China-based CRO Crystal Pharmatech to analyse the bioavailability and material properties of its developing compounds, and the collaboration may turn into a joint venture.
Industry groups BIO and PhRMA are airing their discontents about US FDA draft guidance that could force sponsors to submit redundant clinical datasets for each trial site and waste time in critical pre-IND/BLA meetings.
The US FDA has warned API manufacturer Abbey Color about its inadequate stability program and unreliable water purification system, both of which were cited as earlier violations.
US API manufacturers are getting increasingly worried about the looming July 2 deadline to come into compliance with the EU’s new requirements for written GMP certification.
The US FDA says draft guidelines on risk-based immunogenicity testing of protein drugs will encourage the pharma industry to continue development efforts.
European API distributors may see costs increase if guidelines requiring quality systems and ‘management representatives’ at distribution points are adopted.
Excipient firms that skip lot testing or use alternative analysis methods should justify their decisions according to a new COA guide issued by IPEC Americas.
PPD has expanded its central lab testing services at its Brussels and Singapore labs and will offer additional services in microbiology, peripheral blood mononuclear cell and molecular pathology services.
Hospira says bringing medical device manufacturing operations up to code will take 'a lot of work' after Lake Forest, Illinois plant is hit with US FDA Form 483.
Drug Master File (DMF) completeness reviews required under GDUFA could take three months and should be sought before ANDA submission according to the US Food and Drug Administration (FDA).
The FDA and Health Canada recently opened for industry comment new guidance from the International Conference on Harmonisation on the photosafety testing of drug compounds.
In its third warning letter released this year for a foreign manufacturer, the FDA has warned Novo Nordisk for failing to follow procedures designed to prevent contamination. But the company downplayed the impact of the letter and said it won’t create...
The US Food and Drug Administration’s (FDA) release of a final rule on cGMP for combo products raises a number of questions as to how drug and device companies will tweak or overhaul their quality systems and which suppliers of products will need to comply,...
Icon has agreed to purchase the clinical trials services division of Cross Country Healthcare for $52m to primarily expand its staffing, pharmacovigilance and drug safety services.
The US pharma industry in 2012 saw the lowest number of reported cargo thefts and the lowest average value per incident since the data collection began in 1996.
Highly sought-after guidance on quality agreements for contract manufacturing organizations (CMOs) and biosimilar developers is expected in 2013, according to a list of future guidance documents released by the US Food and Drug Administration (FDA).
Clinical trial inspectors are being called on by the European Medicines Agency (EMA) to focus their efforts more on findings that are likely to impact the benefit-risk evaluation of a drug.
Parexel may have raised its forecast for fiscal 2013 after reporting a 26% hike in second quarter revenues this week, but analysts still have concerns about its spending.
As the Food and Drug Administration (FDA) ramps up its inspections of foreign pharma manufacturers in an attempt to root out GMP inconsistencies and faulty processes, a recent warning letter to Taiwanese manufacturer Beanne Chemical may serve as an example...
The Association of Clinical Research Organizations (ACRO) and others are cautioning the FDA against issuing guidance that could muddle or duplicate the responsibilities of institutional review boards (IRBs) and trial sponsors or CROs.
The US Food and Drug Administration (FDA) has finalized a rule clarifying current good manufacturing practice (cGMP) requirements for single-entity and co-packaged drug-device combination products with few changes to its proposed rule from 2009.
Covance management sounded relatively upbeat about its expectations for 2013 as late-stage clinical trials continue to grow and IT spending begins to taper off, company officials said on Friday.
The European Medicines Agency (EMA) is looking to integrate guidance from the International Conference on Harmonization (ICH) and US Food and Drug Administration (FDA) into the revisions of two annexes related to its process validation and good manufacturing...
European drugmakers are seeking between six months and a year to prepare and print updated product information, including the black symbol for drugs that require additional monitoring as part of their approval.
AmerisourceBergen has announced upbeat Q1 results as contributions from Consulting Services and World Courier offsets ongoing cost issues in Drug Distribution.
Despite conflicting media reports and confusion over where India stands in its regulation of clinical trials, Indian drug officials have until the end of January to respond to a Supreme Court order seeking answers on their alleged lax oversight of trials.
Following the release of FDA and EMA guidance in 2011 calling for CROs and trial sponsors to take a more risk-based approach to monitoring trials, companies have begun offering products to improve source data verification and more efficiently monitor their...
Outsourcing-Pharma.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Parexel, AmerisourceBergen and Norwich Pharmaceuticals.
