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”.