Top Regulatory News Stories – Week Ending June 22, 2018

The FDA issued a Complete Response Letter for Valeant’s Duobrii, flagging questions related to the drug’s pharmacokinetics, according to a June 18 statement from the company. https://www.biopharmadive.com/news/valeant-hit-crl-fda-rejection-psoriasis-drug-duobrii/525923/ Shire announced that the FDA has approved a label expansion for CINRYZE® (C1 esterase inhibitor), making it available to help prevent angioedema attacks in children aged 6 years[…]