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Teva intends to meet with the FDA to renew its efforts to launch a generic version of Mylan’s EpiPen by 2018, after many have called into question the price of Mylan’s allergy treatment. Read More
Thirty-five states have filed an antitrust lawsuit against Indivior, alleging the company engaged in anticompetitive practices to block generics and inflate the price of the company’s opioid addiction treatment Suboxone. Read More
The FDA will revise its recommendations for the submission of quality metrics and provide advice on comparative analyses for drug-device generics before the year ends. Read More
The United Nations High-Level Panel on Access to Medicine is proposing that governments rely on compulsory licenses to improve patient access to medicines in a highly anticipated report that has been met with dismay from industry. Read More
While the overall price of generics under Medicare Part D fell since 2010, hundreds of products experienced “extraordinary” price hikes of at least 100 percent, the U.S. Government Accountability Office said. Read More
The U.S. Department of Justice issued grand jury subpoenas to Taro Pharmaceuticals and two of the company’s senior officials over the pricing of its generics, the drugmaker revealed in an SEC filing. Read More
The FDA expects to refine the review process and fee structure for biosimilar products in the next iteration of the Biosimilar User Fee Act to improve efficiency and resource availability. Read More
A federal judge rendered Janssen’s composition patent for Remicade invalid, marking a loss for the company engaged in ongoing efforts to block biosimilar competition. Read More
Three of four generics makers prevailed in a patent infringement lawsuit by Eli Lilly as a federal judge ruled that they either did not infringe on Eli Lilly & Co.’s patents or proved them to be invalid. Read More
A judge ruled that two patents covering Vanda Pharmaceuticals’ schizophrenia drug Fanapt were valid and one was infringed on by Roxane Laboratories. Read More