Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The European Medicines Agency (EMA) on Wednesday announced that it recently granted eligibility to three new treatments as part of its PRIME scheme, which focuses on medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.
The newly added medicines, which are considered priority medicines by EMA, include Cymabay Therapeutics’ MBX-8025, which is intended to treat Primary Biliary Cholangitis, a chronic liver disease, Atara Bio’s Allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes (ATA129), which is intended to treat patients with Epstein-Barr virus-associated Post Transplant Lymphoproliferative Disorder in the allogeneic hematopoietic cell transplant setting who have failed on rituximab, and Albireo’s A4250, which is for the treatment of Progressive Familial Intrahepatic Cholestasis, which is also a liver disease.
The recommendations were made at EMA’s Committee for Medicinal Products for Human Use (CHMP) October 2016 meeting, during which the committee also denied six PRIME requests, including three oncology treatments.
An overview of the requests granted and denied under the PRIME scheme includes:
Once a candidate medicine has been selected for PRIME, EMA will:
In July, EMA added four other medicines to the PRIME scheme, which is similar to the US Food and Drug Administration's breakthrough threapy program.
PRIME: priority medicines
Tags: PRIME, priority medicines, oncology