20:43 , Dec 21, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Dec. 14, including Orphan Drug Besremi ropeginterferon alfa-2b to treat polycythemia vera and a pair of treatments from Shionogi & Co. Ltd. (Tokyo:4507). The...
23:22 , Dec 14, 2018 |  BC Extra  |  Company News

CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including Orphan Drug Besremi ropeginterferon alfa-2b to treat polycythemia vera and a pair of treatments from Shionogi & Co. Ltd. (Tokyo:4507). The agency...
20:53 , Dec 7, 2018 |  BC Week In Review  |  Company News

European patent for Clovis' Rubraca upheld

The European Patent Office upheld a patent covering the crystalline formulation of Rubraca rucaparib from Clovis Oncology Inc. (NASDAQ:CLVS), confirming patent protection through 2031. The company has filed for a supplementary protection certificate that would...
22:16 , Oct 31, 2018 |  BC Extra  |  Company News

Clovis falls on lower-than-expected Rubraca sales, guidance

Clovis Oncology Inc. (NASDAQ:CLVS) lost $4.98 (30%) to $11.63 on Wednesday after reporting that ovarian cancer drug Rubraca rucaparib generated 3Q18 sales of $22.8 million, less than analyst estimates of $30.3 million. Although the figure...
21:20 , Oct 26, 2018 |  BC Week In Review  |  Clinical News

Clovis' Rubraca leads to 44% ORR in Phase II for CRPC

Clovis Oncology Inc. (NASDAQ:CLVS) said twice-daily oral Rubraca rucaparib led to a confirmed objective response rate (ORR) by investigator assessment of 44% in 25 evaluable patients with a BRCA1/2 mutation in the Phase II TRITON2...
03:04 , Jun 30, 2018 |  BioCentury  |  Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate...
18:18 , Jun 1, 2018 |  BC Week In Review  |  Clinical News

Clovis' Rubraca approved in Europe for ovarian cancer

Clovis Oncology Inc. (NASDAQ:CLVS) said the European Commission granted conditional approval to an MAA for Rubraca rucaparib to treat ovarian cancer. The drug is approved to treat platinum-sensitive, relapsed or progressive ovarian cancer in the...
19:40 , May 29, 2018 |  BC Extra  |  Company News

Clovis' Rubraca approved in Europe for ovarian cancer

Clovis Oncology Inc. (NASDAQ:CLVS) said the European Commission granted conditional approval to an MAA for Rubraca rucaparib to treat ovarian cancer. The drug is approved to treat platinum-sensitive, relapsed or progressive ovarian cancer in the...
19:19 , Apr 27, 2018 |  BC Week In Review  |  Clinical News

BeiGene reports Phase I data for pamiparib in ovarian cancer

BeiGene Ltd. (NASDAQ:BGNE) reported preliminary data from nine evaluable ovarian cancer patients in the dose-escalation portion of a Phase I trial showing that pamiparib (BGB-290) led to two confirmed partial responses plus six cases of...
13:51 , Apr 13, 2018 |  BC Week In Review  |  Clinical News

FDA approves Clovis' Rubraca in maintenance setting

FDA approved an sNDA from Clovis Oncology Inc. (NASDAQ:CLVS) for Rubraca rucaparib as maintenance treatment for women with recurrent, platinum-sensitive ovarian cancer, regardless of BRCA mutation status. The agency also converted to regular approval its...