A new Amino Acid, the FDA and New Regulations in Europe are our main topics of discussion this week!


1.  A New Synthetic Amino Acid for an Emerging Class of Drugs  A synthetic amino acid has been developed that can impact the 3D structure of bioactive peptides and enhance their potency.
2.  FDA Fast-Tracks Merck & Co Antibiotic  Relebactam, when used intravenously for urinary tract and intra-abdominal infections, is now considered a Qualified Infectious Disease Product (QIDP) with fast-track status.
3. Major Changes to Clinical Trials Regulation in the EU  New clinical trials regulation could save researchers over $1 billion a year!  The main purpose of the regulation is to “streamline the clinical trial authorization and harmonize requirements for clinical trials in Europe”.