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The FDA’s citizen petition process is overloaded with meritless petitions whose only purpose is to try to delay competition from generic drugs, despite past efforts at reforming it, the agency says. Read More
Australia’s supreme court has struck a victory for brandmakers in the country with a finding that extends the time they have to seek an extension on their drug patents. Read More
Drug and biologic makers would have to submit all clinical trial data to the federal government — including data for products not approved by the FDA — under a massive proposed expansion of data collection. Read More
The European Commission this week approved Gilead’s hepatitis C drug Harvoni, a decision that comes on the heels of approvals in the U.S., Canada and New Zealand. Read More
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
In a temporary win for generics manufacturers, the FDA says it will delay its controversial generic drug labeling rule by nine months while it reviews 119 comments it received about the measure. Read More
HHS decided not to issue an all-encompassing regulation on the 340B drug pricing program as intended, but will keep in place its earlier interpretive rule that requires manufacturers to provide certain orphan drugs at discounts of up to 50 percent. Read More
Pharmaceutical companies today spend an average of $2.6 billion to get their products to market, according to a new report that finds R&D costs have increased 145 percent over the past decade. Read More