By Ramsey Baghdadi
If you were told the plane you were about to board had a 1 in 1,000 chance of going down,...
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,...
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.