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Europe’s drug regulatory agency has revised the conflict of interest policy for its scientific committee members and experts, a move that one attorney says recognizes the reality that most knowledgeable specialists have at least some commercial involvement. Read More
An advisory panel of the European Medicines Agency last week recommended approval of two AbbVie drugs for hepatitis C, a Genzyme drug for type 1 Gaucher disease, and a change in classification of HRA Pharma’s emergency contraceptive. Read More
The British government is looking to speed new drugs to market and provide faster patient access to medicines, an initiative that some industry experts say should include reforms of the UK’s healthcare reimbursement body. Read More
The recent spike in generic drug prices is not an isolated phenomenon, says a senator who introduced legislation yesterday that would require generics firms to provide a rebate to Medicaid if their prices rise faster than inflation, something that brandmakers already are required to do. Read More
Australia and New Zealand have abandoned plans for a joint drug regulatory agency, although both countries say they will continue to cooperate on regulations that are mutually beneficial. Read More
Mallinckrodt has sued the FDA over its decision last week to revoke the equivalence rating on the company’s generic version of Janssen’s attention deficit hyperactivity disorder drug Concerta. Read More
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
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