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UK’s healthcare cost watchdog says Novartis must provide significantly more clinical trial data on its hives drug Xolair before the group can recommend the therapy for national coverage. Read More
Global sales of pharmaceuticals are expected to surge 30 percent to $1.3 trillion by 2018, as more high-priced therapies enter the market and fewer drugs face generic competition, a new study finds. Read More
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
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
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