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Good data integrity practices are drawing attention on a global scale, as the World Health Organization — with the help of international regulators — has released draft guidance that attempts to bridge gaps between the principles of good data and record management and actual practices. Read More
Patent cases involving payments to delay generic competition have dropped 27 percent following a 2013 challenge to the practice, according to the Federal Trade Commission. Read More
Generic and biosimilars manufacturers are coming to the aid of Apotex in its drawn-out patent fight with Amgen, arguing that a district court order effectively punishes the Canadian drugmaker for following the law. Read More
While the FDA is speeding many drugs to the market, the agency lacks reliable, accessible data needed to conduct systematic oversight and meet postmarket safety reporting responsibilities, says a GAO report released Thursday. Read More
The FDA has delayed BioMarin’s plans to market drisapersen, the company’s Duchenne muscular dystrophy candidate, with a complete response letter calling for more evidence of the therapy’s benefits. Read More
Indian analysts attribute ongoing quality control issues with pharmaceutical exports to a dearth of pharmaceutical inspectors and a lack of uniform standards in the country. Read More
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