EMA Unveils New Data in Mid-year Report
During the first six months of 2014, the number of scientific advice and protocol assistance requests for human medicines received by the EMA increased by 16%
During the first six months of 2014, the number of scientific advice and protocol assistance requests for human medicines received by the European Medicines Agency (EMA) increased by 16% compared with the same period in 2013, according to the agency’s mid-year report presented to the Management Board on 2 October 2014.
Among the other highlights in the report are:
- The number of orphan designation applications was 138, a 30% increase over results in the first six months 2013. There was an 8% increase in pediatric procedure applications.
- EMA received 43 initial evaluation applications between January and June 2014, an increase of 19% compared with the same period of last year. This rise was mostly due to more generics applications received. The annual forecast for initial applications has been revised upwards from 88 to 118.
- New orphan medicinal product applications saw an increase to 9 applications (from 5 in 2013) in the first six months of 2014, thus returning to the level of applications in 2011-2012. The number of new non-orphan medicinal product applications received by the end of June 2014 fell slightly, compared to the same period of 2013 (20 versus 24).
- Biological medicinal product applications remained at the same low level as in 2013, as was also the case for hybrid and abridged applications.
For a full copy of the mid-year report, click here. (PDF)
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
