We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The UK’s antitrust regulator alleges that Actavis and Concordia entered a pay-for-delay agreement to block the market entry of generic versions of hydrocortisone tablets and fix prices. Read More
Regulations on off-label use are not harmonized across the European Union — only 10 out of 21 surveyed member states have specific policies, according to an European Commission report. Read More
Sales of orphan drugs are expected to increase by 11 percent and account for 21 percent in the global prescription drug market over the next five years. Read More
A Chinese API maker relied on manipulated data and incomplete records to make decisions on batch releases, prompting the FDA to issue a warning letter to the company over data integrity. Read More
Three drugmakers have filed amicus briefs in support of Regeneron and Sanofi’s efforts to reverse a district court ruling that validated Amgen patents on Repatha and barred the companies from selling their cholesterol drug Praluent. Read More
Pfizer’s Hospira is drawing scrutiny from the FDA in a warning letter for failing to fully investigate quality defects, such as the presence of cardboard, in batches of injections and neglecting to take corrective measures. Read More