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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
Manufacturers of new biologics could receive up to eight years of exclusivity in 12 countries under the Trans Pacific Partnership, a close reading of the deal shows. The specific terms of the contentious trade pact, which President Barack Obama inked with 11 other countries in October, were publicly released Nov. 6. Read More
The European Medicines Agency outlines the basic steps companies should follow when conducting post-approval efficacy studies to ensure the data meet regulatory standards for EU member-countries. Read More