Effector Wins Orphan Designation from FDA in Diffuse Large B-Cell Lymphoma March 16, 2017 The primary goals will be to establish a maximum tolerated dose and recommended dose for further evaluation. Read More
PIC/S Sets Roadmap on GMP Projects for Next Two Years March 15, 2017 The group intends to work on further implementing its training program and improving collaborations with other associations. Read More
Merck and Pfizer file Three Ertugliflozin Applications in Type 2 Diabetes March 15, 2017 The clinical development program involved nine Phase III trials. Read More
NICE Recommends Amgen’s Vectibix for Metastatic Colorectal Cancer March 14, 2017 The appraisal is not NICE’s final guidance for the drug. Read More
NICE Endorses Intercept’s Ocaliva as Treatment for Chronic Liver Disease March 13, 2017 Ocaliva is an option for patients that do not fully respond to or are intolerant to the current treatment. Read More
FDA Approves Prolonged Shelf Life and Storage Temperature for Orfadin March 13, 2017 Orfadin is a synthetic reversible inhibitor indicated for use as an adjunct to dietary restrictions. Read More
FDA Grants Orphan Drug Designation to Prometic’s PBI-4050 for Alström Syndrome March 10, 2017 The company is investigating the effects of PBI-4050 on multiple organs. Read More
NICE Backs Expanded Use of Merck's Erbitux as Initial Treatment for Colorectal Cancer March 10, 2017 The endorsement is based on clinical evidence that showed Erbitux improves patient survival. Read More
FDA Approves Noctiva for Nocturnal Polyuria, Following Ad Comm Recommendations March 9, 2017 Serenity initially pursued an approval of Noctiva to treat the broader symptom of nocturia. Read More
OncoSec Receives Fast Track for IL-12 Therapy March 6, 2017 The company is planning a Phase IIb single-arm trial of ImmunoPulse. Read More
Zykadia Wins FDA Priority Review in First-Line Metastatic NSCLC March 3, 2017 The FDA also granted a Breakthrough Therapy designation to Zykadia. Read More
Revlimid Earns EC Approval and FDA-Expanded Indication for Multiple Myeloma Following Stem Cell Transplant March 2, 2017 The decision to approve Revlimid as monotherapy in that setting was based on the results of two cooperative group-led studies. Read More