Research & Development
Leo Pharma Joins Certara's PBPK Simcyp Simulator Consortium
12 December 2019 - - Danish pharmaceutical company Leo Pharma has licensed US-based model-informed drug development and decision support Certara's proprietary Simcyp Population-based Simulator an...
US FDA grants Dermira's lebrikizumab fast track designation
12 December 2019 - The US Food and Drug Administration (FDA) has granted United States-based Dermira fast track designation for its lebrikizumab intended for the treatment of moderate-to-severe atopic...
Dyve Biosciences Receives FDA Clearance to Begin Phase 2 Study of DYV-700 for Treatment of Acute Gout Pain
11 December 2019 - - US-based topical skin penetration technology developer Dyve Biosciences, Inc. has received clearance from the US Food and Drug Administration to proceed with a Phase 2 trial of DY...
Civica Rx, Hikma to Ship Heparin and Seven Other Essential Injectable Medicines
11 December 2019 - - US-based generic drug specialist Civica Rx and UK-based generic pharmaceutical company Hikma Pharmaceuticals plc (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) plans to beg...
Vertex Wins European Commission Nod for Kalydeco in Infants with Cystic Fibrosis Ages 6 Months to Less Than 12 Months with Certain Mutations in the CFTR Gene
11 December 2019 - - The European Commission has granted approval of the label extension for Kalydeco (ivacaftor) to include the treatment of infants with cystic fibrosis ages 6 months to less than 12...
Genentech submits Xolair sBLA with FDA for the treatment of nasal polyps in adult patients
11 December 2019 - Biotechnology company Genentech said on Wednesday that it has filed its supplemental Biologics License Application (sBLA) for Xolair with the US Food and Drug Administration (FDA) f...