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Sanofi and Regeneron’s Dupixent (dupilumab) continues its march against a host of chronic inflammatory diseases, posting positive phase 3 data in children with eosinophilic esophagitis, a chronic inflammation of the esophagus associated with acid reflux, gastrointestinal problems, difficulty eating and failure to thrive. Read More
The FDA’s review of proposed instructions for use (IFU) for a new drug, biologic or combination product will focus on accuracy and consistency with the agency-approved prescribing information, according to a final labeling guidance issued yesterday. Read More
More encouraging news about potential hemophilia therapeutics emerged this week, with Sanofi announcing “unprecedented” phase 3 data on efanesoctocog alfa, a bioengineered clotting factor, and fitusiran, an RNA therapeutic that lowers antithrombin. Read More
Just before their trial wrapped up, Allergan and Teva Pharmaceuticals reached a $54 million settlement agreement with the city of San Francisco over the companies’ role in the opioid crisis there. Read More
Viatris, formerly Mylan, now must pay out a settlement of $264 million to consumers, insurers and pension funds who sued the company over steep price spikes for EpiPen, which is used to quickly administer epinephrine to treat potentially fatal allergic reactions. Read More