Marketing a portfolio of high-risk drugs is a precarious proposition but Celgene Corp.has turned it into a profitable business model. Extreme risk management is not for everyone: it works best for high-price specialty products. Celgene has two products under risk management programs: thalidomide (Thalomid) and lenalidomide (Revlimid). Amylin Pharmaceuticals Inc. and Intarcia Therapeutics Inc. are also interested in risk management programs.
By Kate Rawson
The best thing that ever happened to Celgene Corp. was commercializing the most notorious human drug ever marketed.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
