The Federal Circuit ruled that AstraZeneca cannot claim infringement of unpatented uses of rosuvastatin; the court affirmed the validity of section viii labeling carve-outs.
AstraZeneca Pharmaceuticals LP lost its fight to block ANDAs of Crestor (rosuvastatin) that carve out patented indications of the cholesterol-lowering drug. Generic manufacturers will thus be able to launch their products when Crestor’s composition patent expires in 2016.
In a Feb. 9 decision, the U.S. Court of Appeals for the Federal Circuit affirmed a district court ruling that...
Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.
Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.
China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.
