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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
Five health systems representing hundreds of U.S. hospitals plan to establish their own non-profit generic drug company to address drug shortages and bring competition to the generic drug market. Read More
DoD’s Office of Health Affairs and the FDA will collaborate in reviewing products meant to treat, prevent or diagnose serious or life-threatening conditions for troops. Read More
The suit alleges Cydan violated a September 2013 confidentiality agreement that barred the company from using the patients’ data for any reason beyond a possible joint venture. Read More
The FDA issued Imprimis Pharmaceuticals a warning letter after finding the firm made misleading claims about its eye care products on its website and social media, saying the violations created a public health concern. Read More
The FDA hit BODE Chemie with a Form 483 for failing to follow proper quality control procedures, in addition to other deficiencies at its facility in Hamburg, Germany. 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