Japan’s membership of the PIC/S international inspection and manufacturing scheme bodes well for patients in Japan and elsewhere according to the Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency (MHLW)
Hospira has recalled one lot of the anaesthetic Bupivacaine after a customer discovered orange and black particles floating and embedded in a glass vial.
‘Epoch making’ revisions to Japanese drug laws have provided a pathway for development of safer, more innovative drugs according to MHLW director, Haruo Akagawa.
Medidata has reported its strongest ever quarter and says strategic CRO partnerships and risk-based monitoring offer opportunities to penetrate more of the market.
Pfizer reduced costs 40% without cutting jobs at a facility in Sweden using an alternative approach to organisational and cultural behaviour, and hopes to do the same at its newly acquired Austrian plant.
Understanding international regulatory demands, manufacturing standards and overcoming cultural barriers are key for Asian drugmakers looking to enter Western markets, says market access CRO ELC Group.
The US FDA has hit cancer-drug API maker Yunnan Hande Bio-Tech with a warning letter citing concerns over potential manipulation of quality test data at a plant in China.
CRO Pharmaceutical Product Development (PPD) has opened a central laboratory in Shanghai, China, in order to meet growing client demand for scientific and technical services there.
Cash-strapped investigator sites seeking new ways to ensure they get paid promptly will find some new forms of relief in a recently formed Site Advocacy Group (SAG) created by INC Research and the Society for Clinical Research Sites (SCRS).
The EDQM is revising its water for injection (WFI) monograph to accomodate cheaper and greener alternatives to distillation and has called on injectable drugmakers to contribute.
Roche’s Ventana Medical Systems will help Astellas find patients likely to be helped by its candidate cancer drug ASP5878 in a deal that could yield a commercial companion diagnostic.
Full-service CRO (contract research organization) CTI Clinical Trial and Consulting Services is expanding its use of Medidata’s Clinical Cloud platform to improve operational efficiencies, data accessibility and decision-making processes for its clinical...
Concerns climate change will see malaria, West Nile virus and chikungunya spread to the UK are legitimate according to Public Health England, even though no insects carrying such diseases have been detected to date.
Publishing summary clinical trial results poses no threat to patient privacy according to the WHO, which says enforcing transparency laws and incentivising sponsors is key to making sure data from all trials is reported.
Drug, vaccine and medical device developers should publish all trial results according to the WHO, which says anything less skews R&D priorities and public healthcare investment.
Trial participant payment tech firm Greenphire has moved to a new Philadelphia headquarters to add capacity and plans to hire 40 more staff by the end of the year.
Waltham, Massachusetts-based CRO Parexel has launched three new academic programs in Germany, Japan and the US, designed to prepare students for careers in the biopharma industry.
In a sign that pharmaceutical regulators are merging their regulations further, Australia’s TGA (Therapeutic Goods Administration) is seeking to adopt 10 EMA (European Medicines Agency) guidelines on quality, biologics, clinical efficacy, safety, and...
Fighting drug fakers relies on collaboration according to supply chain security group RX-360, which says drugmakers put rivalries on hold in the war against counterfeiters.
Three Amgen manufacturing sites, along with Pfizer’s Perth, Australia site are part of a list of more than 100 US FDA Form 483s issued so far in 2015, according to a list obtained by In-Pharmatechnologist.com thanks to the FOIA (Freedom of Information...
Central lab services provider LabConnect will be moving its operations center in Johnson City, Tenn., to a new 42,000-square-foot custom-built facility effective May 7.
The reputation of Indian clinical trials has been damaged by the “unjustified” suspension of medicines tested by GVK Biosciences, Pharmexcil says as it attacks the evidence submitted by French regulators.
Following a May 2014 inspection, US FDA officials have issued a warning letter with multiple cGMP (current good manufacturing practice) deficiencies for Hospira’s manufacturing facility in Liscate, Italy.
The Director of the new 'super' Office of Pharmaceutical Quality must address issues surrounding increasing globalisation and manufacturing complexity, the FDA says as it begins the recruitment process.
Pharma has focused investment in lower risk specialty and orphan diseases to the detriment of 80% of the population, according to Sanofi’s head of R&D who calls for regulatory convergence to help reverse the trend.
Although the abuse-deterrent technology is still relatively new, the FDA has released final guidance explaining to manufacturers how to conduct studies to demonstrate that an opioid formulation has abuse-deterrent properties.
Margaret Hamburg has called for increased regulatory co-operation to tackle the issues raised by globalisation of the drug industry as she steps down as Commissioner of the US FDA.
Publisher BioMed Central has withdrawn 43 papers from its scientific journals after discovering a conspiracy to rig peer review runs deeper than previously thought.
Ensuring drugs, APIs and excipients are safe will be a focus for the EMA, which says it will explore supplier inspection databases and using trade deals like TTIP to promote GMP standards globally.
British MPs have signed an anti-animal cruelty pledge which scientists warn would “cripple” disease research and outlaw 89% of preclinical animal research.
Indiana’s new “religious freedom” law is discriminatory and will make it harder to attract the staff needed to develop drugs for cancer and Alzheimer's disease according to Eli Lilly.
Testing the toxicity of drug candidates in animals is archaic and unreliable according to PETA, which joined preclinical CROs at SOT to put forward alternatives.
Biosimilar firms seeking US approval will not have to commit to share manufacturing data with reference drug firms before reviews, after the FDA rejected Amgen’s request for such a rule.
Makers and distributors of APIs (active pharmaceutical ingredients) will have to track their products throughout the supply chain and meet rules on cold chain transport and outsourcing under revised guidance from the European Commission.
Cancer Research UK, the world’s largest charitable funder of cancer research, has selected Medidata’s clinical cloud to support the charity’s drug discovery research.
Research tool supplier Horizon Discovery Group and ArcherDX, a supplier of Next Generation Sequencing (NGS) fusion detection, have signed an Original Equipment Manufacture (OEM) agreement that will see Horizon’s Reference Materials supplied as a standalone...
Several FDA officials are currently visiting India and meeting with manufacturer CEOs and government officials to discuss the way the agency’s inspections are expected to change over time.
Gene-editing technology CRISPR-Cas9 must not be used to alter human DNA until the risks have been researched and the ethical issues considered, say scientists.
Speculation GSK's meningitis B vaccine Bexsero will soon be available on the UK National Health Serivice will be welcomed by campaigners, protein supplier Sandoz and its parent company, Novartis.
