BioCentury | Jul 25, 2020

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 | Jun 8, 2020

Why an AZ-Gilead megadeal doesn’t make sense for investors

While neither AstraZeneca nor Gilead has quashed rumors of merger discussions that circulated over the weekend, investors in both companies should hope the chatter amounts to nothing. Both companies declined to comment on a Bloomberg...
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 | Apr 23, 2020

FDA’s options for staying on track with PDUFA timelines during COVID-19

The COVID-19 pandemic is severely limiting FDA’s ability to conduct in-person pre-approval site inspections, putting the agency’s ability to meet its regulatory timelines at risk. To avoid delays, companies need to prepare to provide all...
BioCentury | Apr 10, 2020
Product Development

April 9 Quick Takes: BMS tops off CAR T patent win; plus approval for Braftovi plus Erbitux, Merck, BMS, Liquidia, Circassia-AZ, Bridge

Award swells to $1.2B, plus royalties, in Kite CAR T suit  Bristol Myers Squibb Co. (NYSE:BMY) and Memorial Sloan Kettering Cancer Center will receive at least $1.2 billion from Gilead Sciences Inc. (NASDAQ:GILD) after a...
BioCentury | Mar 2, 2020

Gilead shows deal appetite, taking out ‘don’t eat me’ play Forty Seven for $4.9B

If Gilead’s takeout of Forty Seven isn’t the transformative oncology deal some have expected under Chairman and CEO Daniel O’Day, the $4.9 billion acquisition does give the company a clinical candidate that has already begun...
BioCentury | Feb 11, 2020
Product Development

Feb. 10 Product Development Quick Takes: Priority Review for Gilead CAR T cell therapy; plus Zai, Aquestive, Biohaven, Oculis, Blue Water, GlycoMimetics, Fluidi

Gilead’s second CAR T under Priority Review  Gilead Sciences Inc. (NASDAQ:GILD) said FDA accepted and granted Priority Review to a BLA for KTE-X19 to treat adults with relapse or refractory mantle cell lymphoma. The anti-CD19...
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 | Feb 5, 2020

Gilead signals ‘urgency’ for M&A, working ‘night and day’ on coronavirus response

To execute on its plan to launch 10 transformative medicines in 10 years, Gilead will make M&A a priority in bolstering its pipeline, CEO Daniel O’Day said on the company’s earnings call Tuesday. The company...
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