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The European Medicines Agency released new guidelines on developing treatments for Crohn’s disease and ulcerative colitis set to take effect Jan. 1. Read More
The agency discourages using the Crohn’s Disease Activity Index (CDAI) to assess efficacy because of questions about its reliability and validity. Read More
The European Medicines Agency released new guidelines on developing treatments for Crohn’s disease and ulcerative colitis set to take effect Jan. 1. Read More
In its fifth annual drug shortage report to Congress, the FDA called 2017 “a challenging year” with shortages up again from 2016 despite a steady overall improvement since 2011. Read More
The FDA published draft guidance to assist developers of monotherapeutic, combination and adjunctive drug treatments for major depressive disorder (MDD), offering considerations for nonclinical safety and clinical pharmacology. Read More
In its fifth annual drug shortage report to Congress, the FDA called 2017 “a challenging year” with shortages up again from 2016 despite a steady overall improvement since 2011. Read More
The increased use of fast track regulatory pathways has led to the FDA having the shortest median approval time for new active drug substances in 2017 compared to five other international regulatory agencies, according to the UK-based Centre for Innovation in Regulatory Science (CIRS). Read More
“We were delighted to be one of the first companies to work with the PRIMA service, and collaborate with NICE on improving this valuable tool,” said Peter Wheatley-Price, Takeda UK’s market access and pricing director. Read More
In enrolling patients in prophylaxis trials, sponsors should ensure that patients have no detectable CMV infection post-transplantation within five days before the beginning of therapy. Read More
The European Medicines Agency issued a report card on the first two years of its Priority Medicines (PRIME) Scheme, highlighting that it has received and processed 177 requests for eligibility for the program that provides early scientific and regulatory support for medicines based on promising preliminary clinical evidence. Read More