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Roche has settled its legal feud over Tarceva with Glenmark Pharmaceuticals, with both sides agreeing to drop lawsuits over patent rights in India. Read More
Last year was a productive one for the FDA’s CDER, which approved 45 novel drugs — an increase from its 2006 to 2014 average of 28, according to the agency’s 2015 Novel New Drugs Summary released Monday. Read More
The FDA has underestimated the burden that would be imposed on drug manufacturers in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance. Read More
The Italian Medicines Agency has issued a noncompliance statement to Rome-based radiopharmaceutical maker Iason Italia, hitting the company over deficiencies primarily related to sterility assurance. Read More