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In a matter of days, a momentous event will occur: a gene therapy will, for the first time anywhere in the Western hemisphere, be available commercially with full marketing approval.
A new mechanism for independently replicating research findings is one of several changes required to improve the quality of the biomedical literature.
Controversies surrounding government walk-in rights or patent eligibility that grabbed headlines in recent weeks presage broader changes in biomarker patenting.
The European Medicines Agency's request to make all clinical trial data available is key to countering bias in publication, drug prescription practice and health policy.
Proposed US legislation aiming to expand and expedite patient access to novel drugs represents a good start, but is unlikely to strongly boost approval numbers.
Thwarting bioterror by restricting the publication of research on a deadly avian flu virus, or any other potential biothreat for that matter, is doomed to fail.