Category: Europe

March 16, 2017 Off

Shire gets European approval for Llabel extension of Cinryze

By Dino Mustafić

Shire said on Thursday that the European Commission (EC) has approved a label extension granting three new indications for CINRYZE® (C1 inhibitor [human]), broadening its use to children with Hereditary angiodema (HAE), a rare, genetic disorder that results in recurring attacks of edema (swelling). The body sites most commonly affected are mainly the extremities and abdomen.

March 14, 2017 Off

FDA OK’s Novartis’s breast cancer drug

By Dino Mustafić

The US Food and Drug Administration (FDA) has approved Novartis’s Kisqali (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

March 13, 2017 Off

Ipsen wins MHRA’s approval for its breast cancer drug

By Dino Mustafić

Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, in coordination with fourteen other European regulatory agencies, has approved a new indication for Ipsen’s Decapeptyl as adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine-responsive early-stage breast cancer in women at high-risk of recurrence who are confirmed as pre-menopausal after completion of chemotherapy.