BioCentury | May 9, 2016
Company News

PharmaMar sales and marketing update

...The U.K.’s NICE issued final guidance recommending against the use of Yondelis trabectedin from PharmaMar to...
...the evidence did not show added benefit for the cost compared to other options available. Yondelis...
BioCentury | Dec 21, 2015
Company News

J&J, PharmaMar sales and marketing update

...platinum to treat recurrent ovarian cancer. The guidance recommends against Caelyx in combination with Yondelis trabectedin...
...end-of-life treatment. Caelyx, a liposomal doxorubicin does not have U.K. marketing authorization for the indication. Yondelis...
BioCentury | Nov 9, 2015
Clinical News

Yondelis trabectedin regulatory update

...approved an NDA from Johnson & Johnson’s Janssen Research & Development LLC unit for Yondelis trabectedin...
...Caelyx pegylated liposomal doxorubicin. Liposarcoma and leiomyosarcoma are subtypes of STS. Janssen has rights to Yondelis...
...Ltd. , Tokyo, Japan Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Yondelis trabectedin ( ET-743...
BioCentury | Oct 19, 2015
Clinical News

Yondelis trabectedin regulatory update

...Japan approved Yondelis trabectedin from Taiho to treat soft tissue sarcoma (STS). Yondelis is approved in...
...combination with Caelyx pegylated liposomal doxorubicin and to treat STS as monotherapy. An NDA for Yondelis...
...S.A. , Madrid, Spain Taiho Pharmaceutical Co. Ltd. , Tokyo, Japan Product: Yondelis trabectedin ( ET-743...
BioCentury | Oct 12, 2015
Clinical News

Yondelis trabectedin: Updated Phase III data

...treated with an anthracycline and >=1 additional chemotherapy regimen showed that 1.5 mg/m 2 IV Yondelis...
...Yondelis did not improve median OS vs. dacarbazine (see BioCentury, June 22). An NDA for Yondelis...
...Ltd. , Tokyo, Japan Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Yondelis trabectedin ( ET-743...
BioCentury | Sep 28, 2015
Clinical News

Yondelis trabectedin: Phase II started

...began the open-label, European Phase II EORTC 1320 trial to compare 1.5 mg/m 2 IV Yondelis...
...vs. the standard of care based on the local investigator’s discretion in about 86 patients. Yondelis...
...Ltd. , Tokyo, Japan Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Yondelis trabectedin ( ET-743...
BioCentury | Sep 21, 2015
Clinical News

Yondelis trabectedin: Additional Phase II data

...An NDA for Yondelis is under Priority Review in the U.S. to treat advanced STS in...
...relapsed ovarian cancer. Johnson & Johnson’s Janssen Research & Development LLC unit has rights to Yondelis...
...Ltd. , Tokyo, Japan Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Yondelis trabectedin ( ET-743...
BioCentury | Sep 7, 2015
Clinical News

Long Acting rFactor lX: Interim Phase III data

Interim data from the open-label, international Phase III B-YOND extension trial in 116 patients with severe hemophilia B showed that no inhibitors have been reported with treatment of Alprolix. Patients in B-YOND received 1 of...
BioCentury | Jun 22, 2015
Clinical News

Yondelis trabectedin: Interim Phase III data

...treated with an anthracycline and >=1 additional chemotherapy regimen showed that 1.5 mg/m 2 IV Yondelis...
...IV dacarbazine every 3 weeks (12.4 vs. 12.9 months, HR=0.87, 95% CI: 0.644, 1.181 p=0.3741). Yondelis...
...Ltd. , Tokyo, Japan Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Yondelis trabectedin ( ET-743...
BioCentury | Jun 22, 2015
Clinical News

Yondelis trabectedin: Interim Phase II data

...that 7 of 17 evaluable patients with biphasic/sarcomatoid MPM who received 1.3 mg/m 2 IV Yondelis...
...were presented at the American Society of Clinical Oncology meeting in Chicago. An NDA for Yondelis...
...Ltd. , Tokyo, Japan Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Yondelis trabectedin ( ET-743...
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