Ahead of an expected surge in regulatory filings, the FDA is establishing the Genetic Metabolic Diseases Advisory Committee to provide advice on treatments for these complex and challenging conditions.
Tag Archive for: clinical trial design
Health economic models do a specifically great job at helping us gain insight to explain, predict, and understand the value drivers for a therapy. These insights thereby enable companies to more precisely plan clinical trial design, other evidence development, and commercial strategy.
AstraZeneca Plc on Monday won the dismissal of a U.S. shareholder lawsuit claiming that it concealed problems in developing its COVID-19 vaccine, making it unlikely the treatment would win regulatory approval in the United States.
Clariness will support Bayer Pharma AG’s new study review process, which combines international insights from patients, investigators, and independent bodies. While traditionally Pharmabiotech companies only gather limited insights and feedback from a few parties, and on a regional level, this international and holistic approach is believed to be the future of study reviews.
Thanks to the meteoric rise of digital health, the role of data and analytics has also become central across the drug development life cycle, impacting every touch point from pipeline research and development to clinical trial design and implementation. A critical area that has fallen short, however, is applying a commensurate level of enthusiasm and expense for market research in the early phase as that afforded to downstream commercialization efforts. Compounding this challenge is the continued marginalization of disenfranchised communities.