Biogen Idec brilliantly convinced FDA's advisory experts to let the multiple sclerosis drug back on the market. FDA and the drug industry should prepare for the worst. One projection has 100,000 patients eligible for the immunosuppressant once it returns to the market. If there's significant penetration of that population, the drug's discoverer says it could be the setting for a public health disaster.
By Ramsey Baghdadi
If you were told the plane you were about to board had a 1 in 1,000 chance of going down,...
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.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
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.
