FDA’s proposal to withdraw the approval of Avastin for MBC is based on a new standard for the efficacy showing that a therapy must make in first-line MBC. The Agency previously -- and appropriately -- followed a more flexible approach based on data showing a medicine’s effect on PFS [progression-free survival] or other disease progression endpoints, together with data on OS [overall survival].
Sandra Horning, Michael Labson, Paul Schmidt
On January 16, Genentech formally requested a hearing on FDA's proposed withdrawal of the accelerated approval for Avastin in metastatic...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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.
