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Israeli pharma giant Teva is offering $43 billion to acquire rival generics maker Mylan, following weeks of widespread speculation about a possible deal, but the deal may not go down easy. Read More
In response to congressional pressures, the HHS inspector general will investigate how recent increases in generic drug prices have impacted the Medicaid rebate program and whether those increases exceeded the inflation rate in 2005 through 2014. Read More
In response to overwhelming requests from industry, the FDA is extending to June 8 the comment period on its draft rule overhauling the ANDA and 505(b)(2) approval processes. Read More
Teva is asking the U.S. Supreme Court to overturn a Pennsylvania state court ruling that would let individuals sue generics makers for failing to promptly update their labels in response to new safety concerns, a move some experts say directly contradicts federal statutes. Read More
Brandmaker AbbVie and generics firm Teva are facing a second lawsuit over accusations they illegally delayed generic competition on the cholesterol medication Niaspan. Read More
The FDA is seeking specific suggestions on potential changes to the Generic Drug User Fee Act Performance Goals and Procedures, ahead of negotiations to reauthorize the law, which expires Sept. 30, 2017. Read More
European regulators are looking to industry for suggestions on the best ways to get generic versions of topical drugs approved without having to conduct time-consuming and expensive clinical trials to prove bioequivalence. Read More
The FDA on Tuesday gave four drugmakers the green light to market generic versions of Otsuka’s blockbuster Tourette syndrome therapy Abilify, saying a labeling carveout would protect the brand maker’s pediatric exclusivity on the drug. Read More
Three years after introducing a trio of guidances explaining how sponsors must demonstrate biosimilarity to existing biological drugs, the FDA continues to stress the need for a “stepwise” approach when seeking approval. Read More