When Hospira CEO F. Michael Ball discussed efforts to fix manufacturing quality failings in 2012, he warned the remediation project was likely to uncover a few "gators." In the end, Hospira found itself with a whole new swamp--on the device side of the business--but now believes it is nearing the end of its pharma fixes.
When AMRI bought Hyaluron in June 2010, it enjoyed a brief, two-month honeymoon before the FDA slapped the acquired sterile syringe and vial filling plant with a warning letter. The hangover has lasted three years, but now the agency has finally issued a letter to close out the failings it found at the Burlington site.
Danish diabetes care giant Novo Nordisk won FDA approval this week for two of its FlexTouch prefilled insulin pens, the NovoLog and Levemir.
When President Obama included a $10 million funding boost for FDA inspections in China in his budget submission in April, it looked like the regulator would begin strengthening its presence in the country. Since then, the project has stalled, with the FDA frustrated by an inability to obtain long-term visas for staff.
Keryx Biopharmaceuticals' shares jumped nearly 20% Tuesday morning on news that its chronic kidney disease drug Zerenex cleared a Phase II trial on nondialysis-dependent patients, possibly setting the stage for a broader indication once the much-scrutinized drug is approved.
AstraZeneca's terse, unexplained note that the U.S. Justice Department has triggered an investigation into its controversial late-stage study of Brilinta has stirred some deep-seated concerns among longtime observers of the company.
Edwards Lifesciences has recalled a fleet of its bypass catheters over deformed tips, and the FDA has assigned its most serious label to the effort, heaping trouble onto what has been a trying few weeks for the California devicemaker.
PricewaterhouseCoopers reports that Indian drug exports to the U.S. rose 32% in 2012, although it warns that quality failings could stymie future growth.
The FDA has moved tentatively into the world of smartphones and social media, with its guidance often lagging behind industry expectations and its own activities being grown carefully. These in-house initiatives are now due to gain a new component. The FDA is working on a drug shortages smartphone app.
A number of drugmakers have been looking to get drugs across the finish line for approval of first-line use in the treatment of chronic lymphocytic leukemia, and Roche's Genentech and Biogen Idec have gotten there first. The FDA today approved their drug Gazyva, a successor to Roche's Rituxan that it hopes will offset some of massive sales that drug generates when it finally succumbs to biosimilar competition.