22:47 , Apr 19, 2018 |  BC Extra  |  Preclinical News

Synthetic tattoo could detect asymptomatic cancer

A team from ETH Zurich developed a synthetic cellular sensor that darkens a patient's skin in the presence of hypercalcemia -- a disorder associated with many cancers that often arises before signs of cancer --...
15:38 , Mar 30, 2018 |  BC Week In Review  |  Clinical News

Japan approvals include Hemlibra, Shingrix Galafold

Japan approved a basket of drugs including hemophilia drug Hemlibra emicizumab from Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), shingles vaccine Shingrix from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Fabry's disease drug Galafold migalastat from Amicus Therapeutics Inc....
22:09 , Mar 23, 2018 |  BC Extra  |  Company News

Japan approvals include Hemlibra, Shingrix, Galafold

Japan approved a basket of drugs including hemophilia drug Hemlibra emicizumab from Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), shingles vaccine Shingrix from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Fabry's disease drug Galafold migalastat from Amicus Therapeutics Inc....
01:01 , Jul 21, 2017 |  BC Week In Review  |  Clinical News

Kyowa submits NDA in Japan for evocalcet in secondary hyperparathyroidism

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) submitted an NDA in Japan for evocalcet (KHK7580, MT-4580) to treat secondary hyperparathyroidism in maintenance dialysis patients. Kyowa has rights to co-develop and co-market the calcium sensing receptor (CaSR)...
22:06 , May 31, 2017 |  BC Week In Review  |  Company News

Amgen suing FDA for Sensipar pediatric exclusivity

In a newly filed lawsuit, Amgen Inc. (NASDAQ:AMGN) is seeking to compel FDA to accept pediatric study reports related to hyperparathyroidism drug Sensipar cinacalcet and extend by six months Amgen's patent exclusivity for the drug....
23:14 , May 30, 2017 |  BC Extra  |  Company News

Amgen suing FDA for Sensipar pediatric exclusivity

In a newly filed lawsuit, Amgen Inc. (NASDAQ:AMGN) is seeking to compel FDA to accept pediatric study reports related to hyperparathyroidism drug Sensipar cinacalcet and extend by six months Amgen's patent exclusivity for the drug....
22:51 , Mar 1, 2017 |  BC Week In Review  |  Company News

Parsabiv sales and marketing update

Ono launched Parsabiv etelcalcetide in Japan to treat secondary hyperparathyroidism in patients on hemodialysis. The National Health Insurance (NHI) price of a 5 mg vial of Parsabiv, the starting dose given thrice weekly, is ¥1,283...
21:56 , Feb 9, 2017 |  BC Week In Review  |  Clinical News

Parsabiv regulatory update

FDA approved an NDA from Amgen for Parsabiv etelcalcetide to treat secondary hyperparathyroidism in adults with chronic kidney disease (CKD) on hemodialysis. The company said it would launch Parsabiv “shortly” and announce pricing for the...
01:01 , Dec 21, 2016 |  BC Week In Review  |  Clinical News

Parsabiv regulatory update

Ono said Japan approved Parsabiv etelcalcetide to treat secondary hyperparathyroidism in patients on hemodialysis. Parsabiv is a peptide calcimimetic that acts on the parathyroid gland to reduce production of parathyroid hormone (PTH). Ono has Japanese...
08:00 , Dec 14, 2015 |  BC Week In Review  |  Clinical News

KHK7580: Phase III started

Kyowa Hakko Kirin began a double-blind, dose-escalation, Japanese Phase III trial to compare oral KHK7580 once daily for 30 weeks vs. oral Regpara cinacalcet in about 600 patients. Kyowa has rights to co-develop and co-market...