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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
CMS issued a letter to four drug companies that produce or sponsor HCV treatments — AbbVie, Gilead, Johnson & Johnson and Merck — seeking answers as to why these drugs are so costly. Read More
Since January, the FDA has issued 16 drug GMP warning letters covering 19 facilities, and more than three-fourths of those letters cited data integrity issues. Read More