Author: Dino Mustafić

May 18, 2017 Off

Oxford BioDynamics subsidiary signs exclusive Asia licence for breast cancer test

By Dino Mustafić

Oxford BioDynamics’s subsidiary Oxford BioDynamics Pte Limited, has signed an exclusive licence agreement with Nova Satra Diagnostics Asia Limited, to supply its proprietary products and reagents for the potential use in a non-invasive blood test to assist in the diagnosis of breast cancer, in complementation to current breast cancer screening procedures, across 13 territories in Asia.

May 18, 2017 Off

FDA OK’s Vertex’s cystic fibrosis drug

By Dino Mustafić

U.S. Food and Drug Administration (FDA) has approved Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for use in people with cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

May 17, 2017 Off

Hikma launches Ethacrynic Acid Tablets in the US market

By Dino Mustafić

Hikma Pharmaceuticals’s US subsidiary West-Ward Pharmaceuticals has launched Ethacrynic Acid Tablets USP in 25mg strength, the generic equivalent to Edecrin (ethacrynic acid) for the treatment of edema when an agent with greater diuretic potential than those commonly employed is required.

May 17, 2017 Off

Sobi’s hereditary tyrosinemia drug approved in Saudi Arabia

By Dino Mustafić

The Saudi Food and Drug Administration (SFDA) has approved Swedish Orphan Biovitrum’s (Sobi) Orfadin (nitisinone) capsules in all strengths (2 mg, 5 mg, 10 mg and 20 mg) for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

May 15, 2017 Off

US District Court upholds Horizon Pharma’s patent

By Dino Mustafić

The United States District Court for the District of New Jersey upheld the validity of Horizon Pharma’s patent covering Pennsaid (diclofenac sodium topical solution) 2% w/w, which Actavis Laboratories UT, Inc.(Actavis) has admitted that its proposed generic diclofenac sodium topical solution product would infringe.