Korea’s Green Cross Receives U.S. FDA Orphan Drug Status For Elaprase Biobetter
This article was originally published in PharmAsia News
South Korea’s Green Cross wins U.S. FDA orphan drug designation for Hunterase, its biobetter of Shire’s Elaprase to treat Hunter syndrome.
You may also be interested in...
Ravicti’s price tag is $250,000 to $290,000 per year while the upper WAC price for Valeant’s competing product Buphenyl is roughly $240,000 at the maximum dose; Hyperion has option to acquire Buphenyl.
Korea's Green Cross Files For Biobetter Of Shire's Hunter Syndrome Therapy Elaprase; Seeks Global Partners
SEOUL - South Korea's leading vaccine manufacturer Green Cross Corp. took a step forward in the biosimilars sector by submitting a marketing application to Korea FDA for a biobetter of Shire PLC's Elaprase (idursulfase) for Hunter syndrome. And now the company is looking for foreign partners
Multiple IPF drugs are being rushed into Phase III based on early-stage signals of efficacy and safety presented at the ATS meeting. Scrip spoke with the University of Pittsburgh's Kevin Gibson about the candidates, trial design, combination therapy and limitations of current therapy.