Category: Europe

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.

March 13, 2017 Off

GenSight Biologics reports €22M loss for 2016

By Dino Mustafić

GenSight Biologics, a biopharma company that discovers and develops innovative gene therapies for neurodegenerative retinal diseases and diseases of the central nervous system, has reported €22.1 million loss for 2016, which is increase of loss comparing last years €13.7 million.