The recently approved ALS drug edaravone (Radicava) will cost -- four times its $35,000 annual price tag in Japan, where it's been on the market as a stroke drug since 2002. (Forbes)
PTC Therapeutics says it will drop the price of the old steroid deflazacort for Duchenne muscular dystrophy to , dropping the $89,000 annual price tag set by its former owner Marathon Pharmaceuticals. (Endpoints News)
Today the FDA starts a 2-day hearing on " on pain management and safe use of opioid analgesics. Last year, an advisory committee concluded that the current REMS program for extended-release and long-acting opioids, which involved optional education, wasn't sufficient. The group recommended mandatory prescriber education, as well as a REMS program for immediate-release opioids.
The FDA approved Inspirion's -- the first immediate-release opioid product to win such claims. Last month, a panel of FDA advisors voted in favor of approval with abuse-deterrent claims for the intranasal and intravenous routes. There are nine extended-release opioids approved with such claims.
The Institute for Clinical and Economic Review launched a , finding that while the drugs may reduce abuse compared with non-abuse-deterrent formulations, they will substantially increase healthcare costs. "Given the limited data to support that ADFs actually reduce abuse and the likelihood that addiction, a more important outcome, is not reduced at all, the true value of these formulations appears low. Their use can be supported only if the costs are the same, or perhaps minimally higher, than the original formulations," Lewis Nelson, MD, of Rutgers New Jersey Medical School, a clinical reviewer on the report, told ڴŮ.
ICER also released a on drugs for tardive dyskinesia.
Teva's expected Copaxone successor laquinimod of reducing time to disability progression in relapsing multiple sclerosis in a phase III trial. (Endpoints News)
A sales exec for Insys was that he promoted. (STAT News)