Category: Approval

July 3, 2017 Off

FDA’s new orphan drug modernization plan

By Dino Mustafić

As the the number of orphan drug designation requests has steadily increased over the past five years, the FDA has a new plan to complete reviews of all orphan drug designation requests 90 days, that are older than 120 days (the backlog) while maintaining consistent, scientifically rigorous reviews; and after 90 days, 100% of all new orphan drug designation requests will receive a response by the agency within 90 days of receipt. 

July 3, 2017 Off

Bone Therapeutics adds new board members

By Dino Mustafić

Bone Therapeutics, the Belgium-based bone cell therapy company focused on orthopaedics and bone diseases, has elected a new Chairman of the Board of Directors, while the previous chairman will continue as a Non-Executive Director.

June 30, 2017 Off

Oxford BioDynamics names new CFO

By Dino Mustafić

Oxford BioDynamics, focused on the epigenetic biomarkers based on regulatory genome architecture, for use within the pharmaceutical and biotechnology industry, has appointed new chief financial officer who is expected to join the company by the mid of September 2017.