Are Biopharma Companies Ready for Today's Regulatory Challenges? The biopharmaceutical sector is rapidly evolving, with companies constantly innovating to develop new treatments for a variety of diseases. However, navigating the regulatory landscape remains a significant challenge. Stricter
AbbVie, renowned for its portfolio of groundbreaking treatments, has achieved a major milestone with the FDA's approval of Vyalev, a novel combination therapy aimed at providing extended movement control for patients with advanced Parkinson’s disease. The approval represents more than just a t
RNA editing has long been a topic of fascination within the field of genetic research. Recent advancements by Wave Life Sciences have transformed this curiosity into a real-world application, with their trials showing promising results for treating alpha-1 antitrypsin deficiency (AATD). This
Ellorarxine, a groundbreaking drug compound developed by Nevrargenics, is showing remarkable promise in the treatment of Amyotrophic Lateral Sclerosis (ALS) and has recently received approval from the MHRA to advance to human trials. This news brings a glimmer of hope to the over 5,000 individuals
Clinical Outcome Assessments (COAs) play a pivotal role in the drug development process. These tools, which measure the impact of a treatment on patients' health status, encompass several types: Patient-Reported Outcomes (PROs), Clinician-Reported Outcomes (ClinROs), Observer-Reported Outcomes
In a significant development for global health preparedness, RedHill Biopharma Ltd. has partnered with the Biomedical Advanced Research and Development Authority (BARDA) to advance opaganib, a promising treatment for Ebola virus disease (EBOV). This collaboration marks a crucial step in combating
