Aug 31 2017
The company did say that it's made an agreement with the USA government to pay for the drug only when pediatric or young adult patients with the cancer respond to treatment by the end of their first month.
Scientists often refer to this type of gene therapy as a "living drug" because it involves using genetically modified immune cells from patients. Once the cells are modified, they are infused back into the patient to kill the cancer cells. In the pivotal Novartis trial, 83 percent of patients achieved remission with a disease that has historically poor outcomes.
Kymriah, a cell-based gene therapy, is approved in the United States for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse. At the Novartis FDA panel, parents told their children's stories and pleaded with the committee to recommend the med.
Novartis' CAR-T, which will be marketed as Kymriah, leads an emerging field of cell therapies created to engineer the body's immune cells to seek out and destroy cancers.
"We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer", stated FDA Commissioner Scott Gottlieb.
With the treatments available now, fewer than 10 percent of patients with the relapsed, hard-to-treat leukemia are alive five years after diagnosis. CAR-T cell therapy gives patients stronger T cells to do that job. Pharma critics including KEI director Jamie Love and Patients for Affordable Drugs President David Mitchell have said that, because taxpayers funded early research, the public should be guaranteed affordable pricing. Novartis expects to have 32 centers around the country, mostly in large cities, running by year's end, with the first 20 offering care within the next month.
Army to release water from 2 Houston reservoirs, flooding nearby homes
Although Houston was not in the direct path of Harvey hitting it as a hurricane, it's experiencing record level rainfall. Two Houston reservoirs are overflowing, despite a controlled water release that aimed to prevent flooding downtown.
ACLU Files First Lawsuit Against Trump's Transgender Service Member Ban
Trump cited concerns over "tremendous medical costs and disruption that transgender in the military would entail". The ban was widely seen as an appeal by Trump, a Republican, to his conservative political base.
Kim Kardashian West poses as First Lady Jackie Kennedy in stunning photoshoot
Photographer Steven Klein had nothing but praise for Kardashian, saying, "As a model, Kim is a chameleon". The more you talk about things and keep them out in the open, the more they won't be taboo.
Because of these safety concerns, the FDA will require that hospitals receive special certification to use Kymriah, the agency said.
For some patients, the new CAR-T therapy might replace bone marrow transplants that cost more than half a million dollars, noted Grupp, who led the Novartis study.
Novartis officials said they will offer a patient assistance program to help people with out-of-pocket costs.
Manufacturing and delivery are more complex in CAR-T therapies than for a typical drug.
On Wednesday, the FDA also expanded approval for another drug, tocilizumab, to treat CRS in patients 2 and older.
This approval has sent shock waves throughout the cancer community.
Aug 31 2017
Apple iPhone 8: It's The Final Countdown!
The US-based news site says this is according to people briefed on the product, who have asked to remain anonymous. But so far it's the most detailed report we've seen so far of exactly how the iPhone 8 will actually work.
Aug 31 2017
Google debuts AR software ARCore for Android devices
For now, only the Google Pixel smartphones and the Samsung Galaxy S8 will be able to make use of the technology once it launches. AR is a far more interesting platform than VR, if for no other reason than you don't need any additional hardware to use it.
Aug 30 2017
Uber Said to Pick Expedia CEO to Lead Company Out of Crisis
Recode hears that Uber is voting for its new leader today (August 27th), and it will tell employees about the choice by mid-week. The company's website says it has grown to become one of the largest online travel companies in the world under his leadership.
Aug 29 2017
Forget $99.95, almost 3 million streamed Mayweather-McGregor for free
Iredeto believes 2,930,598 people illegally watched the fight on social media channels and streaming sites. Why Snoop? We know you like Mayweather and the Money team, but this was something shameful.
Aug 29 2017
Game of Thrones season 7 finale: Aidan Gillen on Littlefinger's risk
And then, after that, we saw Tormund and Beric Dondarrion still on top of the Wall , so at minimum, they were stranded up there. Had he taken a back seat in Winterfell after the arrival of Arya Stark to the city, perhaps he would still be alive.
Aug 29 2017
Samsung heir appeals his 5-year jail sentence
Lee's lawyer has steered media inquiries to Samsung, whose spokeswoman did not have any immediate comment about the appeal. Lee was handed down a five year jail sentence while prosecutors sought 12 years in prison.
Aug 29 2017
TDP Wins Andhra Pradesh's Nandyal By-Election by 27000 Votes
Speaking to the media at State Capital Amaravati , the Chief Minister said the by-election was an indicator of things to come. Most pollsters and both parties were prepared for a close finish.
Aug 29 2017
Lorde "Performed" At The VMAs, But She Didn't Sing At All
One Twitter follower wrote: "I came to see Lorde sing not to see her audition for So You Think You Can Dance". When she tweeted this, we wondered why her musical performance was so physically demanding.
Aug 29 2017
Xiaomi Mi 5X September 5 Launch Tipped: Features and Expected Price
Xiaomi recently teased a special event for that date, where it says a "flagship dual camera " device will be launched globally. In the Indian smartphone market, the Xiaomi Mi 5X will likely to be priced somewhere in between the Rs. 13,000 and Rs. 14,000.
Aug 27 2017
Kyle Walker-Peters signs new three-year contract with Tottenham Hotspur
Tottenham youngster Kyle Walker-Peters has been rewarded with a new contract as a result of his good performances. The new contract to Walker-Peters was definitely a good decision by Spurs.
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