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...
21:53 , Aug 3, 2018 |  BC Extra  |  Company News

CAR Ts approved for additional hospital 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...
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...
20:26 , Jul 11, 2018 |  BC Extra  |  Politics & Policy

More scrutiny for value-based CAR T models

A letter from Rep. Elijah Cummings (D-Md.) to Office of Management and Budget Director Mick Mulvaney on Wednesday has increased concerns that biopharmas could face greater scrutiny when negotiating value-based pricing arrangements with CMS. ...
13:30 , Jul 11, 2018 |  BC Extra  |  Politics & Policy

FDA releases gene therapy guidance documents

FDA Wednesday released six draft guidance documents on gene therapy: three advising companies on how to use the technology to treat certain diseases, two about manufacturing and one on the design of long-term follow-up studies. The...
22:36 , Jul 9, 2018 |  BC Extra  |  Politics & Policy

Kymriah deal to stay despite CMS shift on proposed pilot

Novartis AG (NYSE:NVS; SIX:NOVN) said Monday 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 demonstration program...
03:05 , Jun 30, 2018 |  BioCentury  |  Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with the...