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The U.S. Court of Appeals for the Federal Circuit has upheld a prior victory for Bristol Myers Squibb and Pfizer covering two Eliquis (apixaban) patents, positioning the companies to keep exclusivity in the U.S. for the blockbuster oral anticoagulant until April 1, 2028. Read More
The FDA has revised its guidance on generic drug development and application submission during the COVID-19 public health emergency, providing additional information and clarification of existing policies but no policy changes. Read More
A new program at the Center for Drug Evaluation and Research (CDER) aims to develop novel excipients with the potential to lead to novel drug development. Read More
Reports of a vulnerability in the Blackberry operating system used in some pharmaceutical manufacturing equipment as well as in certain medical devices and device manufacturing has prompted the FDA to issue a cybersecurity alert. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) has issued its third untitled letter of the year to Deer Park, Ill.-based Eton Pharmaceuticals over advertisements for the company’s Alkindi Sprinkle (hydrocortisone) oral granule, a treatment for the pediatric hormone disorder adrenocortical insufficiency. Read More
Several drugmakers have offered suggestions in written comments to the FDA for revisions to the agency’s draft guidance on in vitro testing and labeling of oral drugs intended to be given by enteral tube. Read More
The FDA has finalized a guidance on one aspect of drug quality assessment: “Development and Submission of Near Infrared Analytical Procedures,” abbreviated NIR. Read More
The FDA observed a variety of quality issues during inspections of four drug facilities, including inadequate environmental monitoring, reviews of batch records, non-microbial contamination and — in one case — the lack of a quality unit. Read More
The FDA issued a warning letter to Syntec Pharma for failure to prevent cross-contamination and for other good manufacturing practice lapses at its drug facility in Farmingdale, N.Y. Read More