Takeda’s patent for its multiple myeloma drug Velcade was restored and extended for five more years after a federal appeals court overturned a district court ruling. Source: Drug Industry Daily

The FDA is launching a voluntary pilot program for manufacturers, distributors, and dispensers to help develop package-level tracing systems required by 2023 under the Drug Supply Chain Security Act. Source:…

Drugmaker Tubilux Pharma manufactured products in conditions that risked contamination and failed to properly test its products before release, according to the FDA. Source: Drug Industry Daily

The FDA plans to examine if substantive risk information about a drug can be effectively communicated via character-limited social media platforms like Twitter or if just a link will do.…

Any major changes to the way the 340B drug discount program is regulated and overseen will require action from Congress, experts told a House subcommittee Tuesday. Source: Drug Industry Daily

A Senate Appropriations subcommittee on Tuesday approved a bill that would provide $2.8 billion in discretionary funding for the FDA in fiscal 2018. Source: Drug Industry Daily

FDA Commissioner Scott Gottlieb expanded on his drug competition action plan at a day-long agency meeting on generic competition Tuesday. To make the process more transparent, the agency is considering…

A PET finished dose manufacturer in Ohio was cited by the FDA after investigators witnessed numerous cGMP violations and potential quality problems on a January site visit. Source: Drug Industry…

An FDA-requested report from the National Academies of Sciences, Engineering and Medicine said it is possible to slow the spread of the opioid epidemic without limiting access to properly prescribed…

Eli Lilly & Co. settled with several generic companies to resolve pending litigation over a unit dose patent for Cialis (tadalafil), delaying potential ANDA competition. Source: Drug Industry Daily