Drug Development Pharma - February 25, 2015
Bavarian Nordic to Present Findings at Symposium
Bavarian Nordic plans to present updated overall survival data from an NCI sponsored combination study of its active prostate cancer immunotherapy candidate PROSTVAC and ipilimumab, an immune checkpoint inhibitor, at the Genitourinary Cancers Symposium in Orlando, FL on Feb. 26. Approximately 20 perecent of men with advanced prostate cancer treated with PROSTVAC and Ipilimumab were alive 80 months after initiating […]
Drug Development Pharma - February 5, 2015
FDA OKs Novo Growth Drug
The U.S. Food and Drug Administration (FDA) has granted approval of Novo Nordisk’s Norditropin® FlexPro® 30 mg/3.0 mL, a prefilled injection pen for patients with growth hormone-related disorders. The FlexPro® 30 mg/3.0 mL device complements the existing FlexPro® products. “Novo Nordisk is committed to advancing growth hormone delivery devices with patients in mind,” said Eddie Williams, […]
Drug Development Pharma - January 30, 2015
ILUVIEN Approved in Finland
The Finnish Medicines Agency and the Ministry of Health in Luxembourg have granted marketing authorization for Alimera Sciences, Inc.’s drug ILUVIEN®, used in the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered unresponsive to available therapies. ILUVIEN is now approved for marketing in Austria, Belgium, Denmark, France, Germany, Ireland, Italy, the […]
Drug Development Pharma - January 28, 2015
FDA Approves Generic Nexium
AstraZeneca’s extended protection period for the $3 billion-selling heartburn drug Nexium has come to an end, now that the U.S. Food and Drug Administration (FDA) has approved the first generic version of Nexium. Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA, has won approval to market the medication in 20 and 40 milligram capsules. […]
Drug Development Pharma - January 26, 2015
EMA Accepts AZ Gout Drug
AstraZeneca’s application for lesinurad, an unevenly successful gout treatment, has been accepted by the European Medicines Agency (EMA). AstraZeneca acquired lesinurad as part of the $1.3 billion purchase of Ardea Biosciences in 2013. The EMA’s Committee for Medicinal Products for Human Use now will decide whether to grant approval to lesinurad to supplement the usual […]
Drug Development Pharma - January 23, 2015
Novo’s Saxenda Gets Approval
The Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), has issued a positive ruling for the use of Novo Nordisk’s Saxenda® (liraglutide 3 mg) in the treatment of obesity, according to a statement from the company. The CHMP recommends that Saxenda® be prescribed as an adjunct to a reduced-calorie diet and increased […]
