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The European Commission issued a Statement of Objections to Teva over its 2005 “pay-for-delay” deal with Cephalon in which Teva agreed not to market a cheaper generic for Cephalon’s sleep disorder drug Provigil (modafinil). Read More
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. Read More
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. Read More
The court ruled an Actavis product would infringe on Lilly’s patent for the Alimta vitamin regimen regardless of the diluent used in reconstitution or dilution. Read More
Drugmaker Tubilux Pharma manufactured products in conditions that risked contamination and failed to properly test its products before release, according to the FDA. Read More
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. Read More
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. Read More
A Senate Appropriations subcommittee on Tuesday approved a bill that would provide $2.8 billion in discretionary funding for the FDA in fiscal 2018. Read More