08:00 , Dec 22, 2014 |  BC Week In Review  |  Company News

CSL sales and marketing update

CSL said CMS extended to September 2015 a new technology add-on payment (NTAP) for Kcentra for the urgent reversal of anticoagulation with vitamin K antagonist therapy, including warfarin, in adults with acute major bleeding...
08:00 , Jan 20, 2014 |  BioCentury  |  Strategy

When more drugs lower costs

Geisinger Health System uses a pay-for-performance healthcare delivery model and expects increased prescription drug use will help drive total healthcare cost reductions. However, biotech and pharma companies still will need to demonstrate the outcomes and...
08:00 , Jan 13, 2014 |  BioCentury  |  Finance

Buyside View XXII: 'Grown up' means growth

Stephen Hansen Senior Writer  An increase in regulatory approvals and new breakthrough therapies has money managers buying into the concept that biotech has entered a new product cycle that provides a strong fundamental basis for growth....
08:00 , Dec 23, 2013 |  BC Week In Review  |  Clinical News

Kcentra 4-factor prothrombin complex concentrate regulatory update

CSL said FDA approved a label expansion for Kcentra to include the urgent reversal of anticoagulation with vitamin K antagonist therapy, including warfarin, in adults needing an urgent surgery or other invasive procedure. CSL already...
07:00 , Aug 19, 2013 |  BC Week In Review  |  Clinical News

Kcentra regulatory update

CSL said the Centers for Medicare and Medicaid Services (CMS) will provide hospitals with additional reimbursement payments beyond the predetermined standard rates for the use of Kcentra in an inpatient setting for the urgent reversal...
07:00 , Jul 1, 2013 |  BioCentury  |  Finance

2Q Stock Wrap-Up: If it ain't broke

Despite one segment that finished the second quarter in the red, all market cap groups are still up for the year. In 2Q13, the sector was led by large caps, which closed up 4%, marking...
07:00 , May 6, 2013 |  BC Week In Review  |  Clinical News

Kcentra regulatory update

FDA approved a BLA from CSL for Kcentra for the urgent reversal of anticoagulation with vitamin K antagonist therapy, including warfarin, in adults with acute major bleeding. Kcentra has a boxed warning on the risk...
07:00 , May 6, 2013 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory milestones Arena Pharmaceuticals Inc. (NASDAQ:ARNA) fell $0.77 to $7.63 on Friday's news it is withdrawing an MAA from EMA for obesity drug Belviq lorcaserin to gain more feedback on the application from CHMP. In March,...
00:49 , Apr 30, 2013 |  BC Extra  |  Company News

FDA approves CSL's Kcentra

FDA approved a BLA late Monday from CSL Ltd. (ASX:CSL) for Kcentra for the urgent reversal of anticoagulation with vitamin K antagonist therapy, including warfarin, in adults with acute major bleeding. Kcentra has a boxed...
08:00 , Jan 7, 2013 |  BioCentury  |  Finance

Buyside View XXI: Sunny side up

Stephen Hansen Senior Writer  A strong crop of early PDUFA dates and a sense that FDA is more navigable have given money managers in the U.S. and Europe a positive outlook for 2013, which they hope...