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The Federal Trade Commission reached an agreement with Endo to settle claims that the company blocked the market entry of Opana ER and Lidoderm generics, and then refiled a lawsuit against Allergan and its former subsidiary Watson Laboratories with identical charges. Read More
The World Trade Organization ratified an amendment to the Trade Related Aspects of Intellectual Property Rights (TRIP) agreement, authorizing developing countries with limited production capacity to import generics when facing a drug shortage. Read More
The FDA has served drug manufacturer Eisai Inc. with a Form 483 after an investigation revealed laboratory control issues and incomplete records. Read More
Mylan has not reached a settlement with the Justice Department to resolve allegations that it misclassified its allergy therapy the EpiPen for a Medicaid program, and as a result, underpaid state rebates, the Centers of Medicare and Medicaid said. Read More
An industry-funded study suggests that brand drug manufacturers are not taking in as much of the gross drug expenditures than they did in previous years. Read More
The FDA has introduced a new designation for regenerative medicine therapies, laying out the submission requirements for sponsors seeking the expedited review that stems from the 21st Century Cures Act. Read More