The reauthorization of PDUFA committed the FDA to giving patients a stronger voice in regulatory decisions, particularly when assessing the benefits and risks of new drugs. The FDA is planning a series of meetings, and Genetic Alliance thinks it's found a way to accelerate the gathering of patient feedback--crowdsourcing.
Topera, developer of a 3-D device and mapping tool designed to detect cardiac rhythm problems, is ramping up commercial sales of its debut technology in the U.S. and Europe now that crucial regulatory sign-offs are in place.
Sanofi's multiple sclerosis drug Lemtrada may be too dangerous to warrant FDA approval, agency staff said, potentially damning news for an injection that has slogged through 25 years of back-and-forth development.
Bayer has taken another step toward fulfilling blockbuster ambitions for its eye drug Eylea. The German drugmaker asked European regulators to approve the vision-loss treatment for patients with diabetic macular edema. With diabetes on the rise all over the world, the new indication could offer long-term growth for the already fast-rising drug.
Medtronic picked up FDA approval to use some of its patient-safety software with devices from rivals St. Jude Medical and Boston Scientific, possibly giving the world's largest devicemaker a marketing boost in one of its flattening businesses.
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.