Cell therapy and radiotracer production has halted at two facilities operated by the US National Institutes of Health (NIH) after consultants raised concerns about quality and manufacturing standards.
The International Clinical Trial Center Network (ICN) adopts Clinerion's patient recruitment system as an official service to help its members speed trail startup.
Celgene has exercised its option to develop and commercialize therapeutic antibody candidates that target CD19 - a protein found on cancerous B cells - in a deal with Juno therapeutics.
After announcing it won’t acquire Pfizer last week, Allergan has announced a partnership with Heptares to advance medications for neurological disorders.
Digital health is continuing to play an influential role in the future of clinical research, but progression should be balanced with practicality, says Quintiles.
The acquisition of a medical imaging company builds on Medidata’s clinical trial process portfolio as it prepares for an increased need for imaging data in clinical trials.
For the third year in a row, about 30% of Deloitte poll respondents say their companies experienced supply chain fraud, waste, or abuse in the previous year.
As Turkey becomes one of the world’s fastest growing economies, GE Healthcare launches collaborative research scheme to support Turkish biopharmaceutical industry.
There is no evidence PET (polyethylene terephthalate) packaging poses a threat to health but use of phthalate excipients should be minimized according to an Indian Government committee.
Cadila Healthcare has confirmed receipt of a notice of concern (NOC) about its vaccine plant in Moraiya, India five months after the WHO inspectors criticized operations.
A new artificial intelligence-enabled solution redacts confidential information from clinical study reports with 99% accuracy in preparation for publication.
China’s national development and reform committee (NDRC), which oversees pricing across industries, has announced plans to introduce further mandated price cuts.
The US FDA has ordered new labelling changes for immediate-release (IR) opioids but rejects claims that such products pose the same risks as extended-release (ER) opioids.
Drug companies should share more details of their APIs and the green credentials of the companies that supply says an award winning environmental researcher.
Zenith Technologies and SEA Vision have teamed up to offer drugmakers a service they say will bring “seamless compliance” to upcoming serialisation regulations.
BioPharmaSpec has set up business development teams for the Indian and Asia-Pacific markets and predicted increased demand for biosimilar characterisation services.
Covance has rolled out a consulting designed to help trial sponsors check that mobile apps they plan to use in clinical research meet with regulatory guidelines.
The slowdown in developing markets has prompted many pharmaceutical firms to focus on specialty drugs according to an IMS Health analyst, who predicted that the trend will accelerate.
The drug industry needs to rethink what defines a ‘high-risk’ candidate say an expert calling for more detailed pharmacological studies in the wake of the BIA 10-2474 tragedy.
Generic drugs in China must demonstrate bioequivalence (BE) to branded medicines under new CFDA rules prohibiting the use of locally-made generics as reference products.
Scientists in Europe have proposed a cost-effective way of monitoring chemicals in EU waters - including pharmaceuticals - using unmanned sampling devices.
An influenza vaccine produced in tobacco plants could make a big impact in the market if it reaches the market in the US in time for the 2018-19 flu season, says a market analyst.
