18:59 , Aug 10, 2018 |  BC Week In Review  |  Company News

CAR Ts approved for new technology add-on payments

CMS approved new technology add-on payments (NTAPs) for CAR T cell therapies Kymriah tisagenlecleucel from Novartis AG (NYSE:NVS; SIX:NOVN) and Yescarta axicabtagene ciloleucel from the Kite Pharma Inc. unit of Gilead Sciences Inc. (NASDAQ:GILD). Through the...
22:10 , Aug 3, 2018 |  BC Extra  |  Politics & Policy

ICER announces preliminary 2019 topics

The Institute for Clinical and Economic Review (ICER) released Thursday a preliminary list of drugs and other healthcare interventions that it may review in 2019. ICER's selection criteria include the projected timing and likelihood of...
17:47 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

Amgen's Blincyto among negative CHMP opinions

EMA's CHMP released a handful of negative opinions July 27, including one for Blincyto blinatumomab from Amgen Inc. (NASDAQ:AMGN) and, on re-examination, negative recommendations for Dexxience betrixaban from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) and Eladynos abaloparatide-SC...
20:34 , Jul 27, 2018 |  BC Extra  |  Company News

New Blincyto indication among negative CHMP opinions

EMA's CHMP released a handful of negative opinions Friday, including one for Blincyto blinatumomab from Amgen Inc. (NASDAQ:AMGN) and, on re-examination, negative recommendations for Dexxience betrixaban from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) and Eladynos abaloparatide-SC from...
15:36 , Jul 27, 2018 |  BC Week In Review  |  Company News

Sobi grabs Emapalumab, anticipates 2018 approval

Swedish Orphan Biovitrum AB (SSE:SOBI) received exclusive, worldwide rights from Novimmune S.A. (Plan-les-Ouates, Switzerland) to hematology candidate emapalumab (NI-0501). Novimmune will receive SEK450 million ($50.8 million) up front in cash, plus SEK3.6 billion ($406.5 million) in...
22:11 , Jul 20, 2018 |  BC Extra  |  Company News

Sobi grabs emapalumab, anticipates 2018 approval

Swedish Orphan Biovitrum AB (SSE:SOBI) received exclusive, worldwide rights from Novimmune S.A. (Plan-les-Ouates, Switzerland) to hematology candidate emapalumab (NI-0501). Novimmune will receive SEK450 million ($50.8 million) up front in cash, plus SEK3.6 billion ($406.5 million) in...
16:42 , Jul 20, 2018 |  BC Week In Review  |  Company News

Novartis halts price increases, reports 2Q earnings

Novartis AG (NYSE:NVS; SIX:NOVN) announced on July 18 that it will suspend for the rest of the year price increases in the U.S. The pharma made the announcement in conjunction with the release of its 2Q18...
19:59 , Jul 18, 2018 |  BC Extra  |  Company News

Novartis halts price increases, reports 2Q earnings

Novartis AG (NYSE:NVS; SIX:NOVN) announced Wednesday that it will suspend for the rest of the year price increases in the U.S. The pharma made the announcement in conjunction with the release of its 2Q18 earnings. On...
20:07 , Jul 13, 2018 |  BC Week In Review  |  Clinical News

EMA's CHMP recommends CAR Ts, rare disease therapies

EMA's CHMP recommended for approval Kymriah tisagenlecleucel and Yescarta axicabtagene ciloleucel, the first two CAR T therapies backed by the committee. CHMP also recommended a handful of other Orphan drug candidates, including Cablivi caplicizumab, a key...
18:55 , Jul 13, 2018 |  BC Week In Review  |  Company News

Kymriah deal to stay despite CMS shift on proposed pilot

Novartis AG (NYSE:NVS; SIX:NOVN) said on July 9 an outcomes-based contract for Kymriah tisagenlecleucel remains in effect with treatment centers. The contract is unaffected by CMS's decision not to pursue the pharma's proposal for a...