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The FDA wants to refine the methods it uses to assess patient perception of risk and benefit information in direct-to-consumer advertising, aiming to design more accurate DTC ad studies that don’t overtax the subjects. Read More
House lawmakers introduced bipartisan legislation yesterday that would give manufacturers of Ebola drugs a voucher that can be used to get priority review for a separate product. Read More
The FDA has warned two Florida-based compounders, one for repeatedly making drugs without a prescription and another for more than 30 adverse events connected to its products. Read More
A federal court decision this fall granting orphan drug marketing exclusivity to Depomed’s post-shingles pain drug Gralise will stand, after the FDA withdrew an appeal filed earlier this month. Read More
Mylan said earlier this month that it has launched a generic version of Warner Chilcott’s oral contraceptive Loestrin 24 Fe in the U.S., following final FDA approval. Read More
The Republican landslide in the midterm election will put GOP lawmakers in the driver’s seat on the generics labeling rule, user-fee negotiations and agency funding, but experts say the political shift’s impact remains uncertain. Read More
Biosimilars are expected to account for roughly 4 percent of all biologics sales over the next 10 years, saving the U.S. healthcare system an estimated $44.2 billion, according to new research that forecasts significantly lower savings from the products than another widely cited study. Read More
Citing quality problems at two of Ranbaxy’s Indian manufacturing facilities, the FDA has revoked its tentative approvals for two of the company’s ANDAs, one for a generic of AstraZeneca blockbuster Nexium and the other for Hoffman-LaRoche AIDS drug Valycte. Read More
The number of patent lawsuits filed over generic drug challenges has spiked this year, a development that coincides with the widely anticipated “patent cliff” of many brand drugs losing protection. Read More
AstraZeneca has filed a patent infringement lawsuit against Actavis subsidiary Watson over a proposed generic version of AZ’s diabetes drug Kombiglyze XR. Read More