Monday, August 8, 2016
The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, has launched a clinical trial of a vaccine candidate intended to prevent Zika virus infection. The early-stage study will evaluate the experimental vaccine’s safety and ability to generate an immune system response in participants. At least 80 healthy volunteers ages 18-35 years at three study sites in the U.S., including the NIH Clinical Center in Bethesda, Maryland, are expected to participate in the trial. Scientists at NIAID’s Vaccine Research Center (VRC) developed the investigational vaccine—called the NIAID Zika virus investigational DNA vaccine—earlier this year.
REGENXBIO, a biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy based on its proprietary NAV Technology Platform, has announced that the FDA has granted Rare Pediatric Disease Designation to RGX-121, REGENXBIO’s investigational gene therapy product candidate for the treatment of Mucopolysaccharidosis Type II (MPS II).
Sunovion Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for SUN-101/eFlow, an investigational treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
Mixed experience with the Sunshine Act
The FDA approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.
Morphochem, a clinical-stage pharmaceutical company, has announced that the FDA has designated Morphochem’s intravenous (IV) antibacterial product candidate MCB3837 as a Qualified Infectious Disease Product (QIDP) for the treatment of Clostridium difficile infection (CDI). At the same time, the FDA has granted Fast Track designation to the compound’s development program for the treatment of CDI. MCB3837 is the IV prodrug of MCB3681, an antibacterial targeted at the treatment of CDI, which is a serious and potentially fatal disease regarded as an urgent healthcare threat.
Puma Biotechnology, a biopharmaceutical company, has submitted a New Drug Application (NDA) to the FDA for its lead product candidate PB272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin)-based therapy.
Enrollment strategies in the PMI Cohort Study will bolster diversity in clinical research industry-wide