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Merck and Glenmark engaged in anticompetitive behavior by keeping a generic version of Zetia off the market, creating a monopoly and manipulating the drug price, according to a newly filed lawsuit seeking class action status in a Virginia federal court. Read More
Janssen filed suit in a federal court against Teva last week alleging patent infringement of its schizophrenia drug Invega Sustanna — a product that brought in more than $2 billion in 2016. Read More
CDER published an agenda of 98 upcoming draft guidances for the 2018 calendar year — including new recommendations for developing treatments for Alzheimer’s and amyotrophic lateral sclerosis. Read More
The PTO’s Patent Trial and Appeal Board ruled against a Janssen patent for its prostate cancer drug Zytiga, in another setback for the company in it its efforts to keep biosimilars and generics for its drugs off the market. Read More
The FDA issued a compounding policy priorities plan for 2018, highlighting manufacturing standards for outsourcing facilities and collaboration with state regulators. Read More
China FDA released draft regulations that would require medical representatives in China to register, and mandate that medical product marketing authorization holders provide adequate training. Read More