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Drug companies that redact commercially confidential information from clinical study reports in Europe will have to justify their actions, a spokesman for the European Medicines Agency says. Read More
Drugmakers may distribute new risk information to physicians on approved products if they meet a set of standards around the validity of the information, the FDA said in its latest effort to relax limits on the distribution of journal articles and other texts to prescribers. Read More
With a deadline looming, the pharmaceutical industry still needs to decide which data systems are most efficient and cost-effective for implementing the federal track-and-trace law, experts say. Read More
Generic firm Glenmark Pharmaceuticals wants a federal appeals court to rehear its case over rights to the combination hypertension drug Tarka, arguing that an April decision was invalid because it incorrectly attributed exclusive patent rights. Read More
The European Medicines Agency has selected the first two drug candidates for inclusion in a pilot project, known as adaptive licensing, that aims to speed patient access to new treatments. Read More
Two prominent generic drugmakers in Canada won a regulatory victory last month when a federal judge ruled that the country’s regulator of patented medicine prices has no jurisdiction over licensed generic drug pricing. Read More
Sun Pharma is in the midst of another quality problem, this time involving a recall of 428,058 bottles of antihistamines and antidepressants after stability testing found issues with the products. Read More
Drugmakers considering names for new products in Europe will have to narrow their options to just two proposed names under a revised guideline from the European Medicines Agency. Read More