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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on a global scale, as the World Health Organization — with the help of international regulators — has released draft guidance that attempts to bridge gaps between the principles of good data and record management and actual practices.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
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
Manufacturers of new biologics could receive up to eight years of exclusivity in twelve counties under the Trans Pacific Partnership, a close reading of the deal shows. The specific terms of the contentious trade pact, which President Obama inked with 11 other countries back in October, were publicly released Nov. 6. Read More
The biopharmaceutical industry isn’t hiding its displeasure with a decision from the Centers for Medicare & Medicaid Services to treat all biosimilars based on the originator product as identical for billing and reimbursement purposes. Read More
President Barack Obama signed off on a budget bill Nov. 2 that will require generics makers to pay inflation-based rebates if prices rise too quickly, based on the inflation-adjusted baseline average manufacturer price. Read More