Career for Deputy Manager in Regulatory Affairs at Aspiring-Solutions
Our client is a well reputed API/ Pharma Co. with one of its plant located at Nashik.
Post : Deputy. Manager-Regulatory Affairs (US/ EU markets)
Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Prolia® (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP). The sBLA, which was submitted on July 28, 2017, is based on a Phase 3 study evaluating Prolia compared with risedronate in patients receiving glucocorticoid treatment. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of May 28, 2018.
Médecins Sans Frontières/Doctors Without Borders India has filed a petition before the High Court of Delhi to overturn the patent granted on the pneumococcal conjugate vaccine (PCV) to the US pharmaceutical corporation Pfizer.