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Two prominent UK drug organizations say they’re “generally supportive” of MHRA’s contingency plans if the UK exits the EU on March 29 without a deal, but expressed concern about orphan drugs and centrally authorized product licenses, among other issues. Read More
The PTO’s Patent Trial and Appeal Board invalidated two patents for Sanofi’s cash cow Lantus (insulin glargine) siding with Mylan in its inter partes review proceedings. Read More
The FDA withdrew a proposed rule on Thursday that would have allowed generic drugmakers to independently update and distribute revised labeling to reflect new safety data. Read More
Kripke argued the risk controls are needed because the drugs increase a patient’s risk of all-cause mortality and numerous serious conditions. Read More
“ICH Q12 is recognizing that too many changes require regulatory reporting and often at too high a reporting level, stifling innovation and creating potential global supply challenges,” Eli Lilly said. Read More
“Medicare isn’t proposing to set prices in Medicare Part B; it already sets prices in Medicare Part B,” said John O’Brien, senior advisor to the HHS Secretary for drug pricing reform. Read More
The FDA will step up enforcement efforts against stem cell clinics in the coming months, Commissioner Scott Gottlieb told participants at the FDLI Enforcement, Litigation and Compliance Conference in Washington, D.C., on Wednesday. Read More