News
U.S. Biosimilar Approvals Poised to Grow, but Market Uptake Faces Challenges
March 5th 2015Biosimilar approvals in the United States are expected to increase during the next five years, but safety concerns among physicians and the need for greater regulatory clarity concerning therapeutic interchangeability could hinder market uptake.
Lilly and IU School of Medicine Partner on Rotation Program for Medical Students
March 5th 2015Through a partnership with Lilly USA, third- and fourth-year medical students from IU School of Medicine are learning about drug development and how the many physicians working at Lilly play different and important roles in bringing new and innovative medicines to patients.
TMF Reference Model Version 3.0 to be Released at DIA Annual Meeting
March 4th 2015Building on the most widely leveraged standardized reference in TMF management today, with version 2.0 used by more than a hundred life science sponsors, CROs and technology vendors, the next major release of the TMF Reference Model will incorporate feedback from its extensive industry
Japanese Regulatory Agency Licenses Certara’s Biosimulation Software
March 2nd 2015Certara®, a global biosimulation technology-enabled drug development and drug safety consulting company, announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is equipping its pharmacometrics team with Certara’s Phoenix® biosimulation solutions and its Simcyp™ Population-based Simulator.
Catalent Expands European Clinical Packaging Capabilities
March 2nd 2015Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, has today announced several expanded capabilities within its European Clinical Supply Services network.
Real World Evidence in a Clinical Trials World
March 1st 2015The Randomized Clinical Trial (RCT) is considered the gold standard of research and adds credibility to the efficacy or effectiveness of an investigational new drug. However, with a growing need for post-marketing safety databases, and increased need to collect qualitative information from patients in the pre- and post-market of a drug the evidence gathering from clinical trials onward is expanding. This eBook examines the growing trends of evidence gathering and how that impacts the clinical trials industry.
ERT to Acquire PHT Corporation
February 27th 2015ERT, a leading global solution provider for high- quality patient safety and efficacy endpoint data collection, and PHT Corporation (PHT), the eClinical innovator leading the adoption of patient-driven mobile apps for improved clinical research, announced today that they have signed a definitive agreement under which ERT will acquire PHT.
Changing the Context of European Pharma
February 26th 2015It seems only yesterday that the future for European pharma was personalized medicine. The European Union first gave the term official status in a formal paper in 2008, entitled a Renewed Vision for the Pharmaceutical Sector, in which the Commission included a section on ‘Towards more personalized medicines’.
