As part of an effort to increase transparency, the EMA (European Medicines Agency) has published the first summary of a risk-management plan (RMP) of a newly authorised medicine.
WuXi PharmaTech is partnering with Pacific Biomarkers to gain access to its menu of validated biomarker assays to support WuXi's integrated clinical trial testing services.
Patheon has merged with Royal DSM's pharmaceutical products business to form DPx in a $2.65bn (€1.9bn) deal that analysts believe has created the world's second biggest CMO.
FDA guidance on product design has driven demand by pharma for tailored designs for tablet colour, size and shape, specialist consultancy Colorcon told Outsourcing-Pharma.com.
The Alliance for a Stronger FDA has expressed disappointment that President Obama’s FY 15 budget request for FDA falls short of what the agency needs to fulfill its responsibilities.
The New Zealand Medicines and Medical Services Safety Authority is looking to update its abbreviated evaluation process, which is intended to be a simpler and quicker process than the standard evaluation process.
Plans to give customs officers the power to seize and destroy suspected fake medicines as they move through the EU have been welcomed by industry group EFPIA.
In a conference call Friday, FDA Commissioner Margaret Hamburg explained the importance of her recent trip to India, calling for more harmonization between the regulators.
Parexel says a service which manages regulatory activities for already approved drugs fills a gap in the market for pharmaceutical companies feeling the pressure to be efficient.
Fraudsters who try to extort money by impersonating regulators are an ongoing problem, the US FDA says, after the Gujarat FDCA warns drugmakers about a new scam.
The European Commission (EC) has increased the pressure on Ireland, Italy, Poland and Slovenia to fall into line with other EU member States and introduce anti-drug counterfeiting legislation.
As Commisioner Margaret Hamburg flies back from an eight day tour of India, the US Food and Drug Administration (FDA) says it is recruiting seven new drug investigators in the country.
A new study published in the Institute of Physics Science reveals that Chinese researchers have developed gold nanoparticles that may help deliver cancer treatments to specifically targeted cells.
It is too early to predict what impact proposed changes to US rules on chemical plant security and anti-terrorism measures would have on the drug industry according to PhRMA.
The US Food and Drug Administration (FDA) has issued Amgen with a Warning Letter at its Thousand Oaks, California plant citing violations in the production of monoclonal antibody combination products.
Theorem Clinical Research has announced the formation of a strategic alliance with Decision Driver Analytics (DDA) to integrate health economics and outcomes research, predictive modeling and definitive analysis to maximize return on investment for pharmaceutical...
NSF International has acquired the auditing subsidiary of the International Pharmaceutical Excipients Council of the Americas (IPEC) as part of a way to ensure a more streamlined supplier qualification process.
European drug manufacturers will have to control the critical aspects of their operations through qualification and validation over the lifecycle of the product and process, according to a new draft GMP guideline from the European Commission.
The National Institutes of Health and 10 pharmaceutical companies have launched a partnership to transform the current model for identifying and validating promising biological targets for Type 2 diabetes, Alzheimer’s disease, lupus and rheumatoid arthritis.
Indian health minister Sh Ghulam Nabi Azad has defended the quality of the country’s drug exports, telling visiting US FDA Commissioner Margaret Hamburg that “affordable” does not mean cheap and spurious.
US drug regulators have claimed recent law changes that enhance communication with pharmaceutical manufacturers helped prevent 140 potential drug shortages in 2013.
inVentiv Health has extended its partnership with NeuroVive Pharmaceutical AB to bring their drugs to treat acute cardiovascular and neurological conditions to market.
US Food and Drug Administration Commissioner Margaret Hamburg will travel to India from February 10-18 to strengthen the agency’s cooperation with Indian regulators at a time when India needs some direction.
SGS Life Science Services has expanded its laboratories in Wokingham, UK with a 7,000-sq ft extension which will house biologics stability and formulation testing.
The US Department of Justice is supplementing financial punishments for pharmaceutical companies violating FDA rules with corporate integrity agreements (CIAs), said the US Assistant Attorney General.
Pharmaceutical services provider UDG Healthcare (formerly United Drug) announced today the integration of its sales, marketing and medical service divisions into one group, named Ashfield.
Shipments of chicken pox vaccines from a troubled Belgian facility should recommence in early Q2 2014, says GSK, though the root cause of the manufacturing issues are still unknown.
Cambridge Isotope Laboratories (CIL) is working with Nexomics Biosciences to provide isotope-labeled proteins to nearly all of the world’s largest pharmaceutical companies.
Daiichi-Sankyo says ensuring API supply could be a problem at Ranbaxy’s US finished product sites after imports are banned from yet another of its Indian facilities.
Eli Lilly is spending €75m ($102m) to meet latest global anti-counterfeiting regulations, its security experts said in an exclusive interview with in-Pharmatechnologist.com.
Aurobindo says it can make the loss making European generics operations it is buying from Actavis profitable by combining them with its production network in India.
The US FDA is positioned to increase drug plant inspections in China after US President Barack Obama signed a $1.1tr (€881bn) budget for fiscal 2014 into law on Saturday.
