FDA grants orphan status for Lipocine’s preterm birth prevention drug
Orphan drug status will provide the company with certain financial benefits such as tax credits for clinical trials, and waiver of prescription drug user fee for the marketing
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have granted paediatric clinical trial waivers to Shanton Pharma for its lead candidate SAP-001, easing the drug’s regulatory paths to approval.
Anthim is a candidate for future acquisition into the Strategic National Stockpile, the U.S. government’s repository of critical medical supplies for biowarfare preparedness. Anthim has been developed under
Vitesse is a unique collaboration model initiated by Baxter Ventures to focus on the development of antibody and protein-based therapeutics in the areas of immunology, hematology, and oncology.
The trial met its primary endpoint of time from randomization to first clinical fracture (HR=0.5, 95 percent CI 0.39-0.65, p<0.0001). The observed 50 percent reduction in fractures between
The drug development and license agreement between Transposagen and Janssen, which was announced in November of 2014, has been transferred to Poseida. The three-year drug development partnership and