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Regulators in Japan have proposed changes to the standards for using biological ingredients during the manufacture of pharmaceuticals, quasi-drugs and medical devices. Read More
Alimera Sciences has won FDA approval of its eye drug Iluvien after several years of negotiations with the agency to address potential safety concerns. Read More
The FDA is requiring new cardiac and cerebral warnings for Genentech’s asthma drug Xolair, based on an evaluation of long-term safety data, but the agency stopped short of mandating the strictest black box warning. Read More
A federal judge has tossed out some conspiracy claims brought against Abbott and its spinoff AbbVie over an alleged coupon scheme to boost sales of their branded arthritis drug Humira and testosterone therapy AndroGel. Read More
Actavis said it will continue marketing the original formulation of its blockbuster Alzheimer’s drug Namenda for 60 days longer than originally planned, as the drugmaker faces antitrust allegations over its plans to withdraw the product in favor of a newer version. Read More
Gilead Sciences is on track to launch another hepatitis C drug in Europe after an advisory panel of the European Medicines Agency recommended approval of Harvoni. Read More
AstraZeneca received good news Friday when a key European committee recommended approval of its new drug to treat opioid-induced constipation and a diagnostic test that can help identify patients for its cancer drug Iressa. Read More