Medical device clinical trials have increased 63% since 2012 and a market void for mid-size device CROs could present a significant opportunity for growth.
ATLAS Global Compliance is a Software-as-a-Service (SaaS) solution that helps clinical trial sponsors to “disclose locally and comply globally,” says TrialScope CEO.
Synergy Pharmaceuticals Inc has launched a set of smartphone emojis – the Poop troop – to help chronic constipation sufferers express the physical and emotional impact of their disease in text messages.
Proposed legislation would enable contract research organizations (CRO) to claim an R&D tax credit – increasing incentive to conduct clinical trials in the US.
The International Air Transport Association (IATA) has certified a DHL air freight station in Leipzig, Germany for the cold storage and shipment of APIs and finished pharmaceuticals.
The inability to identify the best clinical trial sites is a big problem – and one of the major challenges negatively affecting drug pricing and sponsors, says CEO.
As many as 400 contract manufacturing organisations (CMOs) will not be ready for upcoming US and EU track-and-trace regulations, says supply chain services firm TraceLink.
The expanded facility features an additional 4,200 square feet of space to enhance its microbiology, sterility testing, and microbial ID service offerings.
Sandoz and Aurobindo are among drugmakers which will need to provide alternative bioequivalence data after the EMA recommended suspension of medicines tested by Micro Therapeutic Research Labs.
Marken has secured two new operating licenses in Argentina, allowing it to provide a full range of logistics services to the country’s clinical trial market.
The US FDA has issued AstraZeneca with a second CRL for its hyperkalaemia candidate Zs-9 after finding problems at a Texas facility operated by subsidiary Zs Pharma.
The European Commission has rejected PIC/S criticism of a plan to develop GMP for advanced therapies and stressed that separate rules will not mean a lowering of standards.
Separate GMP rules for advanced therapies would put patients at risk according to the PIC/S, which has called on the European Commission (EC) to rethink the idea.
DHL Global Forwarding plans to certify seven US stations in the Americas throughout 2017 with the remaining global stations slated for certification by the end of the second quarter.
The US Justice Department has announced Charles River Laboratories International Inc. will pay the US government $1.8m to settle claims that it violated the False Claims Act.
US patients and physicians favour domestically-made biosimilars according to Coherus Biosciences. But if quality is assured should the manufacturing location matter?
Last week, President Donald Trump announced Scott Gottlieb as his nomination for the new US FDA commissioner – a candidate that ACRO says, “understands the complexities of drug development.”
The Danish Medicines Agency (DKMA) has cleared Europharma DK ApS to resume drug sales and distribution after the firm appointed a new managing director.
PCI Pharma Services has tripled its serialization capacity ahead of US DSCSA and EU FMD deadlines with follow-on investments planned to finalize its serialization infrastructure.
A second Megafine Pharma plant has landed a US FDA warning letter for cGMP violations, including sourcing API intermediate materials from a facility on import alert.
The Health Products Regulatory Authority of Ireland (HPRA) has said it did not recommend renewal of the GMP certificate for Wockhardt’s site in Shendra, Aurangabad.
