The European Society for Medical Oncology (ESMO) recently held its first in-person congress since the COVID-19 pandemic. The conference, held in Paris, brought together more than 22,000 attendees to share and discuss the latest evidence and issues in cancer care. A common thread running through the congress program was ESMO’s …
NHS England’s Rare Disease Action Plan: Renewed focus on access to innovative drugs
In England, February 2022 has seen the lifting of all COVID-19 restrictions. As we cautiously enter a “new normal” after the disruption caused by the pandemic, there is renewed focus on previous healthcare priorities. The development and commercialization of innovative treatments for rare diseases has long been an area of …
The Biosimilars Landscape: What All Developers Need to Know
As biosimilars to treat rheumatic diseases begin get approval from the FDA, biosimilar development remains a hot topic in drug development. Sponsors estimate a 35% growth of biosimilars in their development pipelines by 2020, but face a wide variety of regional and global markets along with shifting guidelines and recommendations, …
Understanding Regulatory and Market Access Considerations With Drug Abuse Potential
Each assessment for abuse liability is as unique as the molecule in question, reiterating the importance of early awareness, understanding the current regulatory landscape, and being able to plan your development and post-marketing accordingly. In our previous blog post, we focused on the value of early drug abuse potential testing. …