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After years of pressure from lawmakers and drugmakers, the Obama administration appears to be surrendering its push for a reduced seven-year exclusivity period for biologic drugs. Read More
With the new pharmaceutical track-and-trace law’s deadline for lot-level pedigrees looming, the FDA is still unclear about how it will regulate the complex requirement. Read More
The FDA plans to launch a study examining how consumers view risk information in direct-to-consumer (DTC) prescription drug advertisements, the latest study delving into how drugmakers craft ads. Read More
Congressional negotiators are working to hammer out a new federal budget proposal for fiscal 2014 and fiscal 2015, and a group of lawmakers hopes to use the budget deal to shield FDA user fee revenue from any across-the-board sequestration cuts. Read More
Eli Lilly’s plans for strong sales growth in 2014 have been set back, with the drugmaker saying Thursday its promising depression treatment edivoxetine has failed in late-stage testing. Read More
Drugmakers are pushing back against Australian draft guidance on batch release protocols, asking the Therapeutic Goods Administration (TGA) to allow authorized persons to release batches without access to the product’s complete marketing application. Read More
Dyax’s DX-2930, an experimental treatment for hereditary angioedema, has won FDA orphan drug designation. The human monoclonal antibody is designed to inhibit plasma kallikrein to reduce swelling, pain and inflammation associated with the disease, the drugmaker says. Read More
The CMS Tuesday clarified a top concern of drugmakers: which format to use for submitting reports required under the Physician Payment Sunshine Act. Read More
The flurry of FDA guidance issued this week explaining to compounders how to work with the FDA is part of the agency’s full-on effort to make registration as appealing as possible to compounders who may worry that regulatory oversight will hamper business. Read More
With the new pharmaceutical track-and-trace law’s deadline for lot-level pedigrees looming, the FDA is still unclear about how it will regulate the complex requirement. Read More
After years of pressure from lawmakers and drugmakers, the Obama administration appears to be surrendering its push for a reduced seven-year exclusivity period for biologic drugs. Read More