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The FDA remains seriously concerned about drug shortages as manufacturers in Puerto Rico continue their slow recovery from Hurricane Maria, but the shortage of IV saline product should improve by the end of the year, Commissioner Scott Gottlieb said in his latest update. Read More
A class of indirect purchasers filed an antitrust suit against Allergan over the transfer of its Restasis patents to the St. Regis Mohawk tribe and other anticompetitive practices that inflated the drug’s price. Read More
Pfizer reached a $94 million settlement with a class of direct purchasers over claims it used fraudulent patents to keep generic competition off the market for its anti-inflammatory drug Celebrex. Read More
An Ohio federal judge denied a new trial to plaintiffs in a lawsuit against Abbott Laboratories who claimed their son was born with birth defects because the company failed to warn of the risks associated with its anticonvulsant drug Depakote. Read More
The Supreme Court appeared divided Monday on the constitutionality of the PTO’s patent re-examination process of inter partes review — in a debate with wide implications for drugmakers on whether patents are considered private property and if they can only be invalidated through a trial by jury. Read More