The Seventh Circuit Court of Appeals in Chicago declined to revive several lawsuits against Pfizer over its testosterone drug Depo-T that had previously been among thousands of complaints in multidistrict…
Congress’s failure to pass a government funding bill last weekend means much — but not all — of FDA’s work will stop until an appropriations bill is passed. Source: Drug…
The FDA warned Chinese drugmaker Yicheng Chemical for inadequate documentation and manufacturing methods that could cause potential cross-contamination. Source: Drug Industry Daily
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…
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…
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. Source: Drug Industry…
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. Source:…
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…
A bipartisan group of senators introduced a bill that would broaden access to medication-assisted therapies for opioid addiction. Source: Drug Industry Daily
The FDA issued a compounding policy priorities plan for 2018, highlighting manufacturing standards for outsourcing facilities and collaboration with state regulators. Source: Drug Industry Daily