Clinical Trial Authorization (CTA) is mandatory to conduct clinical trials in humans. CTA can only be obtained after submission of a group of scientific documents in the form of Investigational Medicinal Product Dossier (IMPD).
BioLight Life Sciences Investments announced that DiagnosTear has received all necessary approvals from Sheba Medical Center near Tel Aviv to begin a clinical study with its TeaRx, point-of-care Dry Eye Syndrome diagnostic assay.
EMA will launch a final round of targeted consultations with key stakeholders on its draft policy on proactive publication of and access to clinical-trial data at the beginning of May 2014.
PanOptica has raised up to $45m in a Series B financing to fund the clinical program for its lead compound, PAN-90806, a pharmacologically unique small-molecule selective inhibitor of VEGF
Developing a new medicine is a sophisticated and complex task which initially begins with the understanding of disease or condition as thoroughly as possible. At first, the researchers conduct studies in cells, tissues and animal models to determine whether the disease or condition can be influenced by new molecule.
Epic Sciences has announced an agreement with Laboratory Corporation of America Holdings (LabCorp) to expedite sample processing for Epic's circulating tumor cell (CTC) technology to support European clinical trials.
Israel-based clinical-stage pharmaceutical firm Oramed Pharmaceuticals has received its third patent in Australia for oral administration of exenatide from the Australian government's patent office 'IP Australia'.
PBR Staff Writer Published 25 March 2014 US-based Goodwin Biotechnology has entered into an agreement with Aspyrian Therapeutics for the technology transfer, process development, scale-up, and cGMP manufacturing of a new Antibody Drug Conjugate (ADC) for use in Phase I clinical trials.