FDA Approves Futuristic New Cancer Therapy, To Cost $475,000, Sending Biotechs Surging

The FDA on Wednesday opened a new era in cancer treatment, when it approved a landmark, futuristic new gene therapy-based approach to treat childhood leukemia, one which has produced unprecedented results in patients with the deadly cancer. Even the FDA called the approval “historic.”

“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Scott Gottlieb.

The CAR-T cell treatment, developed by Novartis and the University of Pennsylvania, is the first type of gene therapy to hit the U.S. market, and one in a powerful but expensive wave of custom-made “living drugs” being tested against blood cancers and other tumors. The therapy is made by harvesting patients’ white blood cells and rewiring them to home in on tumors. Novartis’s product is the first CAR-T therapy to come before the FDA, leading a pack of novel treatments that promise to change the standard of care for certain aggressive blood cancers.

“This is a brand new way of treating cancer,” said Dr. Stephan Grupp of Children’s Hospital of Philadelphia quoted by the AP, who treated the first child with CAR-T cell therapy — a girl who’d been near death but now is cancer-free for five years and counting. “That’s enormously exciting.”

This first use of CAR-T therapy is aimed at patients ill with a common pediatric cancer — acute lymphoblastic leukemia, or ALL — that strikes more than 3,000 children and young adults in the U.S. each year. While most survive, about 15 percent relapse despite today’s best treatments, and their prognosis is bleak.

The therapy will be marketed as Kymriah.

The price tag: $475,000 for a course of treatment. While the amount sounds staggering to many patients, it was far less than many analysts had expected. Still, David Mitchell, president of advocacy group Patients For Affordable Drugs, met with Novartis yesterday to talk about “how to arrive at a fair price for its new CAR-T drug,” but said the meeting was “disappointing.”

While the treatment’s approval had been seen as a foregone conclusion for months according to Stat News, its potential price has been the subject of speculation and debate. On Wednesday, Novartis revealed that it would charge $475,000 for a course of treatment, a price Bruno Strigini, the company’s head of oncology, said would allow (a few very wealthy) patients to access Kymriah while providing Novartis a return on its investment. The cost is well below Wall Street analyst expectations, which reached as high as $750,000 for a dose. And it’s cheaper than the roughly $700,000 price tag that U.K. regulators said would be fair considering Kymriah’s benefits.

In an attempt to make the drug more affordable, Novartis said it was working with Medicare on a system in which the government would only pay for CAR-T treatment if patients respond within a month.

Meanwhile, trial results of the drug have shown unprecedented success: in a clinical trial, a single dose of Kymriah left 83% of participants cancer-free after three months, results oncologists have hailed as a major advance for patients with few other options. The most frequent side effect was an inflammatory storm called cytokine release syndrome, a reaction to CAR-T that can prove fatal in some patients but is commonly controlled with immunosuppressant drugs.

“I think this is most exciting thing I’ve seen in my lifetime,” said Dr. Tim Cripe, an oncologist with Nationwide Children’s Hospital, at an FDA meeting on Kymriah in July.

Being truly revolutionary, the therapy has the price tag to justify it: the reason for the sky-high price of every treatment, unlike well-understood pills and commonly injected biotech drugs, CAR-T presents a radical new paradigm for doctors, regulators, and payers. CAR-T treatment uses gene therapy techniques not to fix disease-causing genes but to turbocharge T cells that cancer too often can evade. Researchers filter those cells from a patient’s blood, reprogram them to harbor a “chimeric antigen receptor” that zeroes in on cancer, and grow hundreds of millions of copies. Returned to the patient, the revved-up cells can continue multiplying to fight disease for months or years.

It’s a completely different way to harness the immune system than popular immunotherapy drugs called “checkpoint inhibitors” that treat a variety of cancers by helping the body’s natural T cells better spot tumors, according to the AP. CAR-T cell therapy gives patients stronger T cells to do that job. 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.

“I don’t want to be an apologist for high drug prices in the U.S.,” Grupp stressed. But if it’s the last treatment they need, “that’s a really significant one-time investment in their wellness, especially in kids who have a whole lifetime ahead of them.”

It remains unclear how lucrative a business opportunity Kymriah presents. There are about 3,100 new cases of ALL each year, but roughly 70 percent can be pushed into remission by standard therapy. That could leave just a few hundred patients who might be eligible for Novartis’s therapy, casting doubt on whether the company can get an outsize return on what will be a substantial manufacturing investment. Bloomberg estimates that the gene therapy is expected to generate $111 million in 2018 revenue, reaching blockbuster status, and $1 billion in sales, by 2024

However, as Stat News points out, the potential of CAR-T – a hot research area across several drug companies – goes far beyond Wednesday’s approval. Novartis is developing Kymriah for use in lymphoma, and its pipeline includes other CAR-T therapies targeting an array of blood cancers. Kite Pharma, recently acquired by Gilead Sciences, is awaiting FDA approval for a lymphoma therapy and is, like Novartis, developing a bevy of cell therapies it hopes can treat tumors liquid and solid. Juno Therapeutics, which slipped into a third place after its lead CAR-T ran into safety problems, has a similar focus.

News of the CAR-T’s approval sent the Nasdaq Biotech index surging to its biggest gain since June 21, up as much as 2.3%. Two-thirds of the 160 stocks in the NBI are higher, with six names making new 52-week highs: PRTK, SGMO, BIIB, EXEL, FOLD, MYGN, while the IBB, the iShares Nasdaq Biotechnology ETF, is within a few dollars of 18-month highs reached in late July.

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Power Companies Snubbed By Trump’s Tax Proposal

We have often thought that tax policy should be written by the U.S., Department of Agriculture. Who better to deal with all the sacred cows and gored oxen? As the Trump administration turns to address tax policy, eager for legislative victory, one aspect will unite Washington lobbyists. Those representing industries that presently receive a tax exception, will of course seek to retain it. Those industries lacking beneficial tax exemptions will exert considerable influence to obtain them. A cynical mind might suggest that our tax code’s complexity…

Sanders, Warren Tied For 2020 Democratic Presidential Nomination; Zuckerberg A Long-Shot

Despite Silicon Valley’s hopes, Mark Zuckerberg remains an outside long-shot bet to get the Democratic Presidential nomination for the 2020 election. The front-runners are Bernie Sanders and Elizabeth Warren, with Joe “soul of the nation” Biden in 4th …

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S. Sudan: Killing of US journalist ‘not targeted’

Author: 
AFP
Wed, 2017-08-30 17:56
ID: 
1504117627768154600

JUBA: South Sudan sought to defend on Wednesday the killing of a US journalist who was shot dead last week while embedded with rebel fighters.
Christopher Allen, a 26-year old reporter who had previously worked in Ukraine and Turkey, was shot in the head during a battle between the South Sudanese Army and rebels in the southwestern town of Kawa on Saturday.
“The killing of Christopher Allen was not targeted,” said Information Minister Michael Makuei, denying reports that government soldiers had deliberately killed him.
“But anybody on that side is usually a target,” he added.
Allen had been embedded with rebels from the SPLA-IO in order to report on South Sudan’s civil war, ongoing since late 2013. The government has made it increasingly difficult for journalists to access the conflict, which has been characterised by widespread murder, rape and displacement of civilians.
Makuei claimed Allen had been denied a visa “because of his hostile reports” and had therefore entered the country “illegally.” It is unclear whether Allen had indeed reported from South Sudan in the past.
“If Allen entered South Sudan illegally then he is a criminal,” said Makuei. “Had he not died we would have apprehended him and take him to the court.”
He added “it’s unfortunate. We regret his death.”
Makuei also said there was “nothing that could indicate he was a freelance journalist” and said that if Allen was reporting “on the activities of the rebels then definitely he was a rebel.”
Col. Paul Lam Gabriel, an SPLA-IO spokesman, disputed Makuei’s version of events saying Allen was wearing a clearly marked press badge and carrying a camera when he was killed.
“Allen was targeted. The person who shot saw him very clearly,” he said.
On Tuesday’s Allen’s body was handed over to officials from the US Embassy.

Main category: 

After leaving thousands homeless in Houston, Harvey hits Louisiana

Author: 
Reuters
Wed, 2017-08-30 20:01
ID: 
1504117425768131000

LAKE CHARLES, Louisiana/HOUSTON: The tropical storm that devastated Texas’ Gulf Coast spread to neighboring Louisiana on Wednesday, while the US energy hub of Houston remained paralyzed by a record rainfall that also drove tens of thousands of people from their homes.
Slow-moving Tropical Storm Harvey has killed at least 20 people and sent 30,000 to shelters since coming ashore on Friday near Corpus Christi, Texas, as the most powerful hurricane to hit Texas in more than 50 years. On Wednesday it went on to swamp a stretch of coast from Port Arthur, Texas, to Lake Charles, Louisiana.
Harvey was forecast to drop another 3-6 inches of rain on Wednesday, with a storm surge of up to 4 feet along the western part of Louisiana’s Gulf Coast. The floods shut the nation’s largest oil refinery in Port Arthur, Texas, in the latest hit to US energy infrastructure that has sent gasoline prices climbing.
As many as 10 inches of rain were expected in places, according to the National Weather Service.
Moody’s Analytics is estimating the economic cost from Harvey for southeast Texas at $51 billion to $75 billion, ranking it among the costliest storms in US history.
Port Arthur emergency officials were receiving about 300 phone calls per hour, mainly from residents whose homes were flooding, according to US Coast Guard spokesman Chief Petty Officer John Miller. About 20 people were rescued in the first two hours following sunrise, with seven helicopters and skiffs also doing house-to-house checks, he said.
“The situation is still very fluid in Port Arthur right now,” said Miller, who had no information on fatalities or injuries.
Flood waters inundated part of Port Arthur’s Bob Bowers Civic Center, forcing the residents who had sought shelter there into the raised seating stands, according to photos posted to social media. Efforts to reach Port Arthur emergency officials were not immediately successful.
About 300 people who had fled their homes around Lake Charles packed into a civic center that served as an emergency shelter.
The shelter was bracing for about 1,500 people rescued from floods by the US Coast Guard, said Angela Jouett, who is running the shelter.
One shelter resident, Edward Lewis, 54, said he awoke from a deep sleep on Monday night in his home in Lake Charles, swung his legs out of bed and landed in ankle-deep water. He flagged down a passing rescue boat and spent the rest of the night at a church before being taken on a city transit bus to the Lake Charles civic center on Tuesday.
“No one has said when we can go home,” he said.
In Beaumont, northeast of Houston, a woman clutching her baby daughter was swept away in raging flooding. The baby was saved but the mother died, Beaumont police said.
Harvey made landfall for a third time early on Wednesday, and was about 30 miles north of Lake Charles, Louisiana, near the Texas border at 11 a.m. EDT (1600 GMT) with winds up to 45 miles per hour (75 kph).
Clear skies in Houston on Wednesday brought relief to the fourth-largest US city after five days of downpours, although people leaving shelters faced new anxieties about the condition of the homes they had fled.
Handyman Mike Dickerson, 52, carried a grocery bag of his possessions through Houston’s streets as he tried to figure out how to make it back to his home, which was waist-deep in water the last time he saw it.
“A lot of people are going back now because everything looks dry around here. But people who lost everything have nowhere to go and are still at the convention center,” Dickerson said.
Flood damage in 49,000 homes
As of Wednesday morning, Texas officials said close to 49,000 homes had suffered flood damage, with more than 1,000 destroyed. Some 195,000 people have begun the process of seeking federal help, FEMA said.
Texas is investigating hundreds of complaints of price gouging involving loaves of bread offered for $15, fuel for $100 a gallon and hotels raising room rates, the state’s attorney general said on Wednesday.
US President Donald Trump visited Corpus Christi and Austin on Tuesday to survey damage from the first major natural disaster to test his crisis leadership and discuss the response with state officials.
“After witnessing first hand the horror & devastation caused by Hurricane Harvey, my heart goes out even more so to the great people of Texas!” Trump said on Twitter on Wednesday.
The storm made it less likely that Trump would act on his threat to shut the federal government over funding for a border wall, Goldman Sachs economists said on Wednesday. They now estimate the probability of a shutdown at 35 percent, down from 50 percent previously.
The nation’s largest refinery, Valero Energy Corp’s 335,000 barrel-per-day facility in Port Arthur was shut, said sources familiar with plant operations.
The storm has affected nearly one-fifth of US refining capacity, sparking concerns about gasoline supply. The national average gasoline price rose to $2.404 a gallon, up six cents from a week ago, with higher spikes in Texas.
Harvey has drawn comparisons with Hurricane Katrina, which devastated New Orleans 12 years ago, killing more than 1,800 people and causing some $108 billion in damage.

Main category: 
related_nodes: 
Texas storm Harvey breaks historic rainfall record
Oil markets roiled as Harvey hits US petroleum industry
Houston crippled by catastrophic flood, mass evacuations ordered

Watch Live: President Trump Explains His Tax Reform Plan

In what is speculated to be a speech heavy on populist rhetoric and light on actual details, Trump will take the stage in Springfield, Missouri this afternoon to kick off what will undoubtedly be a long slog by Republicans to pass a tax reform bill. 

Undoubtedly the decision to start the tax legislation discussion with a rally-type event is an effort by the Trump administration to garner public support in advance… something that never happened with the Obamacare repeal effort and was frequently blamed for the epic failure of Congress to pass the legislation.

Of course, the real question is whether tax reform is even possible given the fractured Republican party in the House and a very narrow Republican majority in the Senate.  Certainly recent history would suggest not so much.

Tune in below for the live feed:

 

* * *

For those who missed it, below is our preview of today’s speech from earlier this morning.

Later this afternoon, at 2:30pm to be exact, President Trump will take the stage at the birthplace of ‘Mainstreet USA’, Springfield, Missouri, to kickoff his push for tax reform.  But, if you’re expecting details on exactly what your future effective tax rate might be and/or how your mortgage interest deduction might be impacted, then you’re likely in for a ‘yuge’ disappointment. 

As Politico points out this morning, Trump’s tax speech has been drafted by White House aide Stephen Miller, the leader of the nationalist arm of the White House staff, as oposed to Chief Economic Advisor Gary Cohn which means it will be heavy of the populist flare and light on the details.

President Donald Trump will launch a major push for a sweeping tax overhaul with a speech Wednesday in Missouri aimed at convincing his base — and the rest of the nation — that he has a fresh vision for “unrigging” the American economy and isn’t just repackaging the trickle-down economics of past Republican presidents.

 

Wednesday’s speech in Springfield is being built around the sale of tax reform as a populist policy, according to five senior administration officials.  The tax speech is being drafted by senior White House aide Stephen Miller, a leader of the nationalist wing of the administration.

 

“One of the keys to selling tax reform is the president making the point that tax reform will unrig this economy by stripping out the special-interest deductions and carve-outs that riddle this code,” said Tim Phillips, president of Americans for Prosperity, a group founded by the billionaire industrialist Koch brothers that is spending heavily to push changes to the tax code.

 

“This won’t be a speech about specifics but instead about the case that we have to get growth faster and wages faster and get people to focus on that and the impact on workers’ take-home pay,” a senior White House official said. “It’s about faster growth on the corporate side and making the individual side much simpler and easier.”

After a briefing with White House aides yesterday, Axios similarly framed today’s tax speech as the “why not how” speech:

A “why not how” speech: Trump won’t mention specific tax rates or show his hand on controversial issues like whether to allow companies to fully expense equipment; instead he’ll explain why tax reform is needed.

 

Theme: “Springfield is the place where Route 66, commonly referred to as the Main Street of America, got its start,” said an official on the call. “And now it’s going to be the place where America’s Main Street begins its comeback.”

 

Bottom line: Many of the big issues on tax reform remain unsettled; and tomorrow’s speech by the president won’t provide any clarity on those. The White House wants Congress to take the lead and own these difficult decisions — e.g. the fight over full expensing — but expect Trump to put more gusto into his tax reform sales pitch than he did with health care. (He’s genuinely enthusiastic about tax cuts whereas he never was with health reform. Whether he can remain focused, however, and avoid detours into rants about “fake news” and his myriad enemies, is another question.)

Trump

 

Meanwhile, after an abysmal failure on the Obamacare repeal effort, it seems that the Trump White House is becoming better at the whole ‘political thing’ and has even polled which phrases are best for selling tax reform to the public.

In Trumpian style, he’ll try out new phrases for selling the policy like “Jump-start America” and “Win again.”

 

Republicans have polled the phrase “tax reform is about unrigging the economy,” and it’s done well with swing voters, people familiar with the data said. Treasury Secretary Steven Mnuchin has been using the phrase repeatedly.

So what actual details might we get, if any?  Beyond highlighting a couple of deductions that may be eliminated (sorry about that electric car deduction, Elon) and calling for ‘lower’ tax rates for corporations and middle-income folks, not much.

The speech is expected to frame the issue around wiping out some deductions that benefit mostly higher-income taxpayers, making the U.S. corporate system more globally competitive and simplifying the individual system. He is expected to discuss lower rates for middle-income taxpayers as an instant pay raise for everyday Americans, while arguing that lowering the corporate tax rate would make it easy for companies to expand — improving Americans’ quality of life.

 

Trump, however, is not expected to go into much detail about deductions and loopholes on Wednesday as congressional Republicans and the White House continue to haggle over which ones to target. The administration is leaving much of the detailed work to Hill Republicans on the major tax-writing committees.

 

Among possible deductions that the White House could support eliminating are those for the use of electric cars, historic preservation and fashioning a ranch into a cattle-breeding facility.

 

Some Senate Republicans and the White House want to continue the practice of businesses deducting the cost of investments along a steady schedule, which could allow for a bigger cut in the top corporate rate from its current 35 percent level, administration officials said.

Of course, the real question is whether tax reform is even possible given the fractured Republican party in the House and a very narrow Republican majority in the Senate.  Certainly recent history would suggest not so much.

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Is Cactus Gas The Future Of Biofuel?

The prickly pear cactus (locally known as nopal) is ubiquitous in Mexico. Farmed in massive quantities across the nation, it’s a local food staple, an ancient sacred symbol, and the centerpiece of the nation’s flag. Now, it could be the key to the nation’s energy future. In the past, the spiny outer layer of the cactus has always been a waste product, but no longer–a group of scientists in Mexican green energy start up Suema discovered a way to turn it into a completely sustainable biogas. The pilot project dedicated to developing…

Sudan’s al-Bashir pardons jailed human rights advocate

Sudanese President Omar al-Bashir has issued a presidential decree pardoning Dr Mudawi Ibrahim, a prominent rights activist arrested last year for alleged spying. Last December, Ibrahim was detained — and held without trial — after being accused of conducting “espionage” against the Sudanese government at the behest of foreign entities. A court accused the activist of “fabricating” information that was later used in an Amnesty International report about Khartoum’s alleged use of chemical weapons in the restive Darfur region. Along with a handful of his colleagues, Ibrahim had also faced accusations of attempting to undermine the Sudanese state, making unauthorized contact with foreign embassies, and treason — all offenses that can potentially carry the death penalty. Ibrahim’s lawyers hailed the […]

“There Will Be Blood”: S&P Warns Failure To Raise Debt Ceiling Would Be “More Catastrophic Than Lehman”

With just one month left until the Treasury “X-date”, or the moment when it would run out of cash without a debt-ceiling resolution…

… the time has come for dire, apocalyptic threats to spook Congress into action and specifically reaching a compromise on a debt ceiling resolution, and S&P – which infamously downgraded the US in 2011 during the last debt ceiling fiasco – is happy to be the source of bad news.

In a report published on Wednesday titled “With A Shutdown, There Will Be Blood”, U.S. chief economist at S&P, Beth Ann Bovino, writes that “failure to raise the debt limit would likely be more catastrophic to
the economy than the 2008 failure of Lehman Brothers and would erase
many of the gains of the subsequent recovery.

Not even bothering to focus too much on the implications of a debt-ceiling breach, which would result in a technical default of the US, and potentially imperil the reserve status of the US Dollar, Bovino instead analyses the other key event due in a month, the potential government shutdown and writes that If it began early in the quarter, a shutdown would shave at least $6.5 billion off of real 4Q GDP each week it continues. Her analysis is based in part on 1995-1996 government shutdown and 16-day shutdown in October 2013.

 

However, agreeing with Goldman’s analysis released earlier, the S&P analyst said that the likelihood of a federal shutdown in late September remains “slim” with the fallout from Harvey reducing the chances further.

Still, S&P is unwilling to assume a happy ending, with Bovino adding that “betting on a rational US government can be risky.” Judging by today’s latest blow out in the spread between September/October Bill yields, the market agrees.

The post “There Will Be Blood”: S&P Warns Failure To Raise Debt Ceiling Would Be “More Catastrophic Than Lehman” appeared first on crude-oil.news.