Denmark's Xellia Pharmaceuticals has bought the former Ben Venue plant, at one time the most notorious U.S. plant under FDA supervision, a facility responsible for dozens of recalls and a slew of drug shortages.
An FDA warning letter found that for years, Dr. Reddy's Laboratories was testing drug batches in a laboratory that the FDA was never told existed and often shipped to the U.S. products that had repeatedly failed tests for impurities.
The so-called 21st Century Cures Act, now making its way through Congress, is designed to speed up the FDA review process for potentially lifesaving medicines by encouraging approvals based on midstage data. But a new case study takes a look at what might have happened if a trio of once-promising Alzheimer's drugs had made it to market before their eventual Phase III failures, painting a grim picture of the bill's potential.
Obesity treatment devices have been in the regulatory spotlight in 2015 with two approvals for balloon-based devices and another for a neurostimulator. That makes for a total of 5 FDA-approved obesity devices--including the two banding devices that were already approved.
The U.S. Food and Drug Administration has issued a safety communication regarding a wide array of intravascular implanted devices and delivery tools that have coatings designed to reduce friction and improve maneuverability.
The regulator, which has faced criticism in the past over its failure to establish a policy, set out its position in a 12-page document.
BioMarin, preparing for a make-or-break FDA panel vote next week, got a harsh review from agency staff over its treatment for Duchenne muscular dystrophy, taken to task for "contradictory" efficacy data and "life-threatening" safety risks.
Just over a year ago, a Hikma sterile injectables plant in Portugal was grilled in a warning letter for a variety of failings, some that the FDA said it had been warned about before. But Jordan-based Hikma said today that the FDA has indicated those problems are behind it.
Swiss drug giant Novartis says it has taken "remedical action" to correct problems at two of its plants in western India that were given a warning letter by the U.S. Food and Drug Administration, according to a report by NDTV.
Several manufacturers are already developing vaccines to protect infants via maternal immunization, but the potential of such vaccines has "yet to be fully realized." This Friday, an FDA advisory panel will examine the development and licensing of these "maternal vaccines," MedPage Today reported.