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Outcomes-based contracting may not help reduce drug prices, one witness cautioned lawmakers in a House Ways and Means subcommittee hearing on Thursday. Read More
An FDA advisory committee voted narrowly on Thursday against the effectiveness of Sanofi’s dengue virus vaccine and split evenly on its safety, except for children aged nine to 16. Read More
The FDA has decided not to require four-letter suffixes for already-approved or licensed biological products with no FDA-designated suffix in their proper names. Read More
The agency said it will not include substances on the list “unless the nomination identifies a drug product that must be produced from the bulk drug substance rather than from an FDA-approved drug product.” Read More
“Genentech needs to be held accountable for taking advantage of some of the sickest people in our country just so it can increase revenue,” said Mike Arias, an attorney for the plaintiffs. Read More
CDER plans to release 93 new or revised guidances for drugmakers in 2019, spelling out the center’s current thinking on issues ranging from risk-benefit assessments for opioids to exclusivity periods for generics. Read More
As HIV patient advocates urge the federal government to “break” drug patents in an effort to lower the prices of HIV drugs, an intellectual property think tank cautioned that the tactic could backfire. Read More
A bipartisan group of senators has introduced legislation that would address one of outgoing FDA Commissioner Scott Gottlieb’s pet peeves — the “patent thickets” preventing biosimilars from getting to market. Read More