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The head of the World Health Organization is speaking out against the Trans Pacific Partnership, contending that the 12-country deal could cause drug prices to spike. Read More
India’s Central Drugs Standard Control Organization has unveiled three new guidelines that it says paves the way forward for more clinical trials in the country by reducing red tape for clinical research. Read More
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on a global scale, as the World Health Organization — with the help of international regulators — has released draft guidance that attempts to bridge gaps between the principles of good data and record management and actual practices.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
Roche’s Genentech unit and partner Exelixis scored a regulatory win Tuesday, with the FDA approving Cotellic as part of combination treatment for advanced melanoma. Read More
Serious deficiencies for producing sterile drug products have landed the Johnson Memorial Cancer Center an FDA warning letter, which was posted on the agency’s website Tuesday. Read More
Mylan may move forward with its proposed hostile takeover bid of Perrigo, so long as it divests seven generic drugs, the FTC determined in a Nov. 3 order. The move is the final regulatory hurdle for Mylan’s bid and eases the FTC’s concerns that the deal would harm competition. Read More