NICE Gives Nod to Amicus’ Galafold for Fabry Disease January 10, 2017 Galafold is to be reimbursed only when enzyme replacement therapy is the alternative treatment. Read More
EU Grants Orphan Designation to ARMO BioSciences Immunotherapy for Pancreatic Cancer January 9, 2017 The candidate received an orphan designation from the FDA as well. Read More
FDA Grants Astellas Fast Track Designation for Peanut Allergy Vaccine January 6, 2017 The candidate is designed to reduce or eliminate sensitivity to peanut allergens. Read More
FDA Approves Biogen’s Spinraza as First Treatment for Spinal Muscular Atrophy January 5, 2017 The approval was based on a clinical trial of 121 patients with infantile-onset SMA. Read More
CHMP Recommends 7 Drugs for Approval in the EU January 4, 2017 In addition, the CHMP recommended extensions of indication for nine more medicines. Read More
Two-Thirds of Drugs Approved in 2016 Granted Priority Review January 3, 2017 The FDA approved 22 novel drugs in 2016, down from 45 approvals the year before. Read More
Apellis Wins FDA Fast Track Designation for APL-2 in PNH January 3, 2017 The candidate is intended for those who continue to experience hemolysis and require red blood cell transfusions. Read More
EMA’s Priority Medicines Eligibility and FDA Breakthrough Therapy Designation Awarded to Juno and Celgene’s JCAR017 January 3, 2017 EMA’s CHMP granted JCAR017 access to its Priority Medicines scheme. Read More
FDA Grants Priority Review to Tesaro’s Niraparib December 28, 2016 Its PDUFA date is set for June 2017. Read More
Pfizer Announces FDA Will No Longer Require Warning Label for Its Chantix Medication December 23, 2016 The FDA made its decision based on results from an 8,144-subject study. Read More
NICE Rebuffs Reimbursement of Takeda’s Hodgkin’s Lymphoma Drug Adcetris December 22, 2016 Takeda submitted new data and analyses to NICE. Read More
FDA Grants Priority Review to AstraZeneca’s Durvalumab December 20, 2016 The application is based on the results of a Phase I/II trial. Read More