BioCentury | Jul 25, 2020
Regulation

FDA makes Gilead’s Tecartus, for mantle cell lymphoma, third U.S.-approved CAR T

Kite’s Tecartus has become the third CAR T cell therapy, after Kymriah and Yescarta, to earn FDA approval. On Friday, FDA granted accelerated approval to Tecartus brexucabtagene autoleucel from the Gilead Sciences Inc. (NASDAQ:GILD) unit...
BioCentury | May 29, 2020
Politics, Policy & Law

Proposed CMS rule for CAR Ts marks progress in reimbursing new technologies

It’s been four years since the first CAR T cell therapies were approved and inadequate reimbursement is still a barrier to access in the U.S. A new payment rule proposed by CMS aims to change...
BioCentury | May 15, 2020
Product Development

Allogene’s allogeneic CAR T data give first hint of threat to marketed autologous therapies

Phase I data to be presented by Allogene at this year’s ASCO meeting provide the first evidence that allogeneic CAR T therapies could challenge marketed autologous therapies on safety and efficacy. On Thursday, Allogene Therapeutics...
BioCentury | Feb 6, 2020
Product Development

Early signs CAR NKs could compete with CAR Ts in heme cancers

Early clinical data from CAR NK cells have started to roll in, and hint the modality could compete with CAR T cells on efficacy. Built into CAR NK cells are the benefits of off-the-shelf manufacturing...
BioCentury | Dec 21, 2019
Product Development

China a priority for Novartis’ Narasimhan

Novartis CEO Vasant Narasimhan says capitalizing on the rise of China, by prioritizing drug launches in the country, will be a key pillar of the pharma’s strategy over the next few years. A second pillar...
BC Extra | Dec 20, 2019
Company News

Regulatory roundup: Gilead, BMS seeking key approvals, plus news about AbbVie, Bavarian Nordic and more

A basket of regulatory news this week included submissions of closely watched products from Gilead and BMS, including the first-ever NDA for a candidate from Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG). Gilead Sciences Inc. (NASDAQ:GILD) is seeking...
BioCentury | Dec 13, 2019
Politics, Policy & Law

Novartis’ Narasimhan calls for value-based pricing--and access

Novartis CEO Vas Narasimhan believes drug prices and access should be based on value. He’s in favor of the use of cost-effectiveness assessments to justify drug prices -- which creates winners and losers -- and...
BioCentury | Dec 13, 2019
Product Development

Leveraging real-world data to assess the promise of CAR Ts, Dutch style

With the next set of expensive CAR T therapies poised to enter the market based on limited datasets, the Netherlands is proactively gathering the evidence it needs to make reimbursement decisions. The Dutch Health Institute...
BC Extra | Dec 9, 2019
Company News

Novartis downsizing internal efforts on CAR T in solid tumors

Novartis is pivoting away from internal development of CAR Ts in solid tumors, it said Thursday at its R&D day. The company is, however, pressing forward with the modality via partnerships, and plans to use...
BC Extra | Nov 20, 2019
Company News

Management tracks: Vifor, Relay, I-Mab, Yumanity, Savara and more

Vifor Pharma Ltd. (SIX:VIFN) hired Lee Heeson as president international. Heeson, who was president of worldwide markets responsible for the inflammation and immunology franchise in all ex-U.S. markets at Celgene Corp. (NASDAQ:CELG), will also join...
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