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The companies argued that there was no scientific evidence available at the time of the initial labeling of the drugs to justify including such warnings. Read More
Alnylam Pharmaceuticals announced that a year-long phase 3 trial of its drug patisiran showed that the therapy met both its major objectives in patients with transthyretin-mediated amyloidosis (ATTR) with cardiomyopathy, improving patients’ ability to walk and increasing their quality of life. Read More
A U.S. appeals court panel has said no to resurrecting a 2019 lawsuit alleging that AbbVie broke antitrust laws by using a “patent thicket” to cover its blockbuster monoclonal antibody Humira from copycat drugs coming to market, thus exploiting the patent system. Read More
The combination of Merck’s blockbuster anti-PD-1 therapy Keytruda and Eisai’s Lenvima failed to show superiority to the standard of care of Lenvima alone as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). Read More
The FDA has approved Coherus BioSciences’ Cimerli (ranibizumab-eqrn) as the first interchangeable biosimilar for Roche’s retinal disease blockbuster Lucentis across all five of its indications. Read More