The European Medicines Agency (EMA) has received an application from Bayer HealthCare for marketing authorization of its oral multi-kinase inhibitor, regorafenib, for the treatment of patients with gastrointestinal stromal tumors (GlST). ...
The Irish Medicines Board and the Netherlands' Medicines Evaluations Board have granted national phase approvals to Apricus Biosciences' Vitaros, indicated to treat patients with erectile dysfunction (ED). Vitaros now has four national ...
Tags: Apricus Bio, Medicine
The European Commission has granted marketing authorization for Teva Pharmaceutical Industries' Lonquex (lipegfilgrastim) to commercialize in all twenty eight countries of the European Union plus Norway, Iceland and Liechtenstein. ...
Grupo Ferrer Internacional, Alexza Pharmaceuticals' commercial partner, has begun sales of Adasuve inhalation powder, pre-dispensed (Staccato Loxapine) in the European Union (EU). The first sale triggered a $1.25m milestone payment to ...
Tags: Inhalation Powder, Grupo
Swiss drugmaker Novartis has announced that once-daily dual bronchodilator, Ultibro Breezhaler (QVA149), has achieved positive CHMP opinion for the treatment of chronic obstructive pulmonary disease (COPD). Ultibro Breezhaler was ...
Pharmadiet, the Spain subsidiary of OPKO Health, has obtained Spanish approval for commercialization of its oral and injectable formulations of citicoline, developed to enhance phosphatidylcholine levels in the brain. Agencia Espa ola de ...
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has confirmed its opinion for European marketing authorization of Pfizer's Xeljanz (tofacitinib citrate). Xeljanz is a novel, oral Janus kinase ...
The Italian Medicines Agency (AIFA) has granted market access to Cell Therapeutics for the medicinal product, Pixuvri (pixantrone), a novel aza-anthracenedione with structural and physiochemical properties Pixuvri has been approved as a ...
Toa Eiyo has received manufacturing and marketing authorization for Bisono Tape 4mg and 8mg medicines (Bisono Tape) in Japan from the Japanese Ministry of Health, Labour and Welfare (MHLW). Developed by Nitto Denko in partnership with Toa ...
Global pharmaceutical company Eisai has rolled out Aricept Dry Syrup 1%, a new medicine for Alzheimer's disease treatment Aricept (donepezil hydrochloride) in Japan. The formulation received Japan manufacturing and marketing authorization ...
Tags: Eisai, Disease Treatment
The European Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinion for Aegerion Pharmaceuticals' marketing authorization for Lojuxta (lomitapide) hard capsules. If approved, Lojuxta will be indicated for adult ...
Tags: Marketing Authorization, Medicine
Mitsubishi Tanabe Pharma is seeking manufacturing and marketing approval of TA-7284 (generic name: canagliflozin) in Japan. The company filed a new drug application to the Ministry of Health, Labor and Welfare in Japan for TA-7284 to ...
Tags: Mitsubishi, canagliflozin
Tokyo-based Astellas Pharma’s European subsidiary has announced that it has received marketing authorization from the Netherlands Medicines Evaluation Board (MEB) for Vesomni. The marketing authorization received for Vesomni is ...
Tags: Netherlands Meb, Medicine
Celgene International has obtained FDA priority review status for Abraxane (paclitaxel protein-bound particles for injectable suspension) supplemental new drug application (sNDA). The application covers the use of Abraxane and gemcitabine ...
Tags: Celgene sNDA, FDA Priority
Ipsen's Dysport has received marketing authorization from Health Canada for use in aesthetic medicine in the region. A division of Valeant Pharmaceuticals named Medicis Aesthetics Canada will market Dysport in the region. Ipsen's group ...
Tags: Health, aesthetic medicine