Forbes | How Donald Trump Shifted Kids-Cancer Charity Money Into His Business Forbes LIKE AUTUMN LEAVES, sponsored Cadillacs, Ferraris and Maseratis descend on the Trump National Golf Club in Westchester County, New York, in September for the Eric Trump Foundation golf invitational. Year after year, the formula is consistent: 18 holes ... |
Read the original:
How Donald Trump Shifted Kids-Cancer Charity Money Into His Business - Forbes
New York Times | London, Qatar, Donald Trump: Your Tuesday Briefing New York Times Two of the three suspects in the London attack have been identified. One, nicknamed Abs, had appeared in a TV documentary about jihadis in Britain. Click here for a short 360 video of the speech by Sadiq Khan, the mayor of London, at a vigil yesterday. |
Read more from the original source:
London, Qatar, Donald Trump: Your Tuesday Briefing - New York Times
President Donald Trump is by no means popularcompared with his predecessors, his approval rating has been remarkably low during his time in the White House. But there's some small solace for the president this week: His approval rating is, at least for the moment, a hair better then where President Bill Clintonstood at the same point in his first term.
Different polling outfits putTrump at varying levels of approval, but the RealClearPolitics average hadhim at 39.8 percent Tuesday, while the weighted average from FiveThirtyEight hadhim atexactly 39 percent. Not great numbers, but still better than Clinton. On Day 138 of his presidency, just 37.8 percent of Americans approved of the job he was doing, according to FiveThirtyEight.
If you compare where each president stood at this point in the Gallup tracking poll, however, the two are deadlocked. The most recent Gallup survey pegged Trump's approval at 37 percent, the exact same figure the polling company found for Clinton in early June1993. Trump's disapproval rating in the survey was far higher, however, outpacing Clinton at 57 percent to 49 percent.
Subscribe to Newsweek from $1 per week
A number of factors were blamed for Clinton's low approval at the time. The economy wasn't exactly humming along. There werethe beginnings of an ethics controversy over the White House travel office. Clintonalso allowed gay people to serve in the military under the "don't ask, don't tell" policy thatangered people, both for allowing gay people to serve and for not treating gay people equally.
"I never expected that I could take on some of these interests that I've taken on without being attacked," Clinton said about the approval polls at the time."And whenever you try to change things, there are always people there ready to point out the pain of change without the promise of it, and that's just all part of it. If I worried about the poll ratings, I'd never get anything done here."
Clinton's numbers soon turned around, and by the end of June, Gallup had him in the mid-40s. By the time he left office, 66 percent of the country approved of him.
Trump, meanwhile, has seen his approval rating decline steadily since he moved into the White House. The FBI investigation into his campaign's possible ties to Russiawhich, the U.S. intelligence community says,worked to get Trump electedcertainly hasn't helped the president's popularity.
A major event involvingthat controversy is scheduled for Thursday, when former FBI Directory James Comeywhom Trump firedis expected to testify before the Senate Intelligence Committee. Comey will almost certainly address a conversationwith Trump during which the president reportedly urged him to end theinvestigation into former National Security Adviser Michael Flynn.
Polls, meanwhile,have shownthat voters are concerned about the Russia investigationand how Trump has handled it. Meaning that it seems likely the president could trail Clinton again soon.
See the rest here:
Reality Leigh Winner, 25, was employed as a contractor with Pluribus International Corp., a government facility in Georgia from around February 13, according to an affidavit supporting her arrest. Her Twitter activity dropped significantly after that date.
The Justice Department announced charges Monday against Winner. She is accused of leaking classified information, used as the basis for an article The Intercept published Monday, detailing a classified National Security Agency memo.
She also uses her Twitter username @Reezlie on Instagram; however, her activity on the two platforms differed dramatically. On Instagram, she primarily posted selfies from the gym and pictures of food, while on Twitter she rarely posted about herself, focusing more on politics -- behavior not uncommon for people who use both social networks.
Winner follows 50 Twitter accounts, among them Edward Snowden, WikiLeaks, several with links to the group Anonymous and "alt" government agency accounts that became popular after President Donald Trump's inauguration, including AltFDA. None of the accounts appear to be personal connections.
Winner didn't hide her disdain for Trump. On Election Night, when it became apparent that Trump would win, she tweeted, "Well. People suck. #ElectionNight"
On February 11, she was particularly active on the social network, tweeting directly at the President, describing him as an "orange fascist."
Melania and I are hosting Japanese Prime Minister Shinzo Abe and Mrs. Abe at Mar-a-Lago in Palm Beach, Fla. They are a wonderful couple!
the most dangerous entry to this country was the orange fascist we let into the white house
Winner didn't appear to post explicitly about hacking or leaking but did retweet and like several tweets on the topic.
She "liked' a tweet from the hacking group Anonymous in November that hinted at hacking a Mac computer the then-President-elect was using.
Winner also favorited a February 15 tweet linking to an article about White House press secretary Sean Spicer's reported lax approach to his personal data security and also liked a WikiLeaks tweet linking to a Wall Street Journal reported headlined, "Spies Keep Intelligence From Donald Trump on Leak Concerns."
She follows several "rogue" Twitter accounts designed to look like they are run by federal agencies. Many of these accounts claim to be run by agency employees unhappy with the Trump administration.
She retweeted a post in January from the "Rogue NASA" account that attempted to explain why such accounts were becoming more popular.
Rogue Twitter accounts are fun, but gov't employees and scientists are very afraid of being fired if they speak out & share facts. #resist
Winner's Twitter activity slowed in mid-February, and the last time she appeared to tweet before her arrest Saturday was on March 5, when she tweeted at Anonymous, "what happened to the Feb 28th call for Trump to resign?"
Her mother, Billie Winner, said her daughter wasn't especially political and had not praised past leakers such as Snowden to her. "She's never ever given me any kind of indication that she was in favor of that at all," her mother said. "I don't know how to explain it."
Her court-appointed attorney, Titus Nichols, told CNN he was unable to confirm Tuesday that the Twitter account was Winner's.
Earlier, he said he believes the government has a political agenda by going after his client, whom he says is a low-level government employee. Nichols said he hasn't seen anything that would lead him to believe Winner is guilty of these charges.
CNN has reached out to Pluribus International to ask if it was aware of Winner's Twitter account.
CNN's Nick Valencia contributed to this report.
See the rest here:
Accused leaker Reality Winner called Trump an 'orange fascist' on Twitter - CNN International
Farage says Stone did no such thing.
David CornJun. 6, 2017 10:32 AM
Brent N. Clarke/AP
Last week, the Guardian published a report revealing a new and odd twist in the Trump-Russia scandal: Nigel Farage, the British politician who led the Brexit movement in Great Britain, is a person of interest in the FBI investigation of interactions between Trump associates and the Russian government. The newspaper reported that Farage was under FBI scrutiny because he had relationships with both the Trump camp and WikiLeaks, which disseminated Democratic emails swiped by Russian hackers in an effort to help Donald Trumps presidential campaign. Farage dismissed the story as hysteria and said he had not been contacted by the FBI. But Farage did meet with Trump during the campaign. And a source close to the Trump camp tells Mother Jones that a Trump-Farage meeting was set up by Roger Stone, the veteran political dirty-trickster and long-time Trump adviser who has come under investigation in the Trump-Russia inquiry.
That source is Stone himself.
In the months since the election, Stone has drawn the attention of investigators and reporters because he made statements during the campaign that implied he possessed inside information about WikiLeaks plans to release material stolen in the hack-and-leak covert operation mounted by Putins regime to subvert the 2016 campaign and assist Trump. In early Augustafter WikiLeaks had disseminated Democratic Party emails hacked by Russian intelligenceStone said at a Republican event in Florida, I actually have communicated with [WikiLeaks founder Julian] Assange. I believe the next tranche of his documents pertain to the Clinton Foundation, but theres no telling what the October surprise may be. On October 2, he tweeted, Wednesday@HillaryClinton is done. #Wikileaks. (This was five days before WikiLeaks released the emails of Clinton campaign CEO John Podesta, which were stolen by Russian hackers.) That month, Stone claimed he had a back-channel communication with Assange through a good mutual friend. During the campaign, Stone also communicated with Guccifer 2.0, the online persona that posted hacked Democratic emails, and Stone publicly insisted Guccifer 2.0 was not connected to the Russians.
Stones prescient statements about WikiLeaks anti-Clinton dumps and his claim of a connection with Assange naturally have raised questions about his role in the Trump-Russia scandal. And the Guardian report on Farage partly focused on the Brits ties to Stone. The story raised the possibility that Farage might have been Stones contact with WikiLeaks.
After the Guardian article was published, Mother Jones asked Stone if Farage was Stones mutual friend who had been his go-between with Assange. Stone replied, Dined with him once in Cleveland [during the GOP convention in July]. Got him a meeting with the candidate. Never spoke to him again.
So did Stone hook up Farage and Trump? The two politicians had a much-noticed rendezvous when Farage, then the leader of the UK Independence Party, appeared with Trump at a campaign rally in Mississippi in late August and declared, If I was an American citizen, I wouldnt vote for Hillary Clinton if you paid me. It was a moment when the conservative anti-European populism of England merged with Trumps anti-establishment American Firstism. Farage spoke of pro-Brexit voters supporting the referendum to withdraw Great Britain from the European Union so they could take back control of their country, take back control of their borders, and get back their pride and self-respect. Farage urged the American people to stand up against the establishment.
A book written by a Farage associate and published in October reported that Farages partnership with Trump came about because the British politician, while attending the GOP convention, had a chance encounter at 4:30 a.m. in his hotel bar with an aide to Mississippi Gov. Phil Bryant, a Republican. The aide suggested Farage visit Mississippi and subsequently sent him a formal invitation. A month later, Farage flew to Mississippi, just when Trump was scheduled to speak at a Republican fundraiser and a campaign rally. Farage had dinner with Bryant and regaled him and other guests with Brexit stories. Bryant suggested Farage speak at the Trump rally the following nightafter speaking at the GOP fundraiser. On a radio show the next morning, Farage announced he was in Mississippi to show his support for Trump. Steven Bannon, who had recently been named Trumps chief strategist, called Farage to check what Farage intended to say at the Republican dinner and the Trump rally. Hours later, Farage met Trump for the first time, according to this account, in a holding room at the Republican fundraiser. Trump strode across the room and gave the British politician a bear hug.
This account makes no mention of Stone. I asked Stone how his assertion that he had set up a meeting between Farage and Trump squared with this report. He replied, I suggested candidate [Trump] meet Farage immediately after the convention. Certain [Farage] asked others to secure a meeting. Dont recall when it happened only that it did. Its unclear whether the meeting Stone says he brokered was the same as the Mississippi get-together.
Stone added, You report so much bullshit why do you care about the facts?
The facts here are intriguing. If the FBI is indeed examining Farage for his ties to Assange and the Trump crew, Stones interactions with Farageand whether or not Stone really did connect him with Trumpcould be relevant. The brash and brassy Stone, who relishes publicity and mud-slinging and who has written a book claiming LBJ killed JFK, has been an enticing target for Democrats and investigators pursuing the various threads of the Russia-Trump scandal. With the Farage connection, the plot thickens.
Farage did not reply to a request for comment. Neither did the White House.
UPDATE:A spokesman for Farage says, Nigel met Roger Stone in a restaurant in Cleveland during the RNC purely by chance. They subsequently met each other in a hotel in Washington during Trumps inauguration, again without planning and by chance. He did not organise any meeting between Mr Trump and Mr Farage.
Mother Jones is a nonprofit, and stories like this are made possible by readers like you. Donate or subscribe to help fund independent journalism.
Read the original here:
Roger Stone: I Hooked Up Nigel Farage With Donald Trump - Mother Jones
Deadline | Donald Trump Rage Tweets Against Media For Taking Seriously His Tweets Deadline Donald Trump began his observation of D-Day accusing the media of trying to get him to stop using Twitter. TV news outlets this week are doing so by taking seriously Trump's tweets and expecting surrogates who appear on their TV programs to explain the ... This Man Is Turning Donald Trump's Tweets Into 'Official' Presidential Statements Pat Cunnane on Twitter: "For context - because he's President - all of Trump's Tweets should be mocked up in the ... |
Originally posted here:
Donald Trump Rage Tweets Against Media For Taking Seriously His Tweets - Deadline
Bebe Avoids Bankruptcy Filing With Real-Estate Deals Wall Street Journal (subscription) Bebe Stores Inc. has done what few other retailers have been able to do recentlyclose all of its stores without seeking bankruptcy protection. The mall-based retailer, which announced in April it would be closing all of its roughly 180 locations, was ... |
View original post here:
Bebe Avoids Bankruptcy Filing With Real-Estate Deals - Wall Street Journal (subscription)
A federal committee that reviews the national security implications of foreign entities doing business in the United States said it might investigate potential transactions in the Westinghouse Electric Co. bankruptcy that has put completion of the $14 billion V.C. Summer nuclear power project in doubt.
The Committee on Foreign Investment in the United States filed a letter late Monday with the U.S. bankruptcy court in New York stating that it could conduct an investigation into the possible sale of Westinghouse assets to foreign businesses. That investigation ultimately could be forwarded to President Donald Trump for further action, the letter states.
There are concerns in Washington, D.C., that Chinese investors might make a play for Westinghouse assets through the bankruptcy court, according to news reports. Westinghouse currently is a subsidiary of Japan-based Toshiba Corp., which has not announced any plans to sell the nuclear unit.
Mollie Gore, spokeswoman for V.C. Summer co-owner Santee Cooper, said the utility would not be surprised by such a review but doesn't expect it to impact an ongoing analysis of the nuclear plant's future. A spokeswoman with SCANA Corp., parent company to South Carolina Electric & Gas and the majority owner of V.C. Summer, did not respond to a request for comments.
Meanwhile, a report filed with the state's Office of Regulatory Staff says it could be months before Westinghouse makes a formal decision on whether to honor its contract with SCANA and Santee Cooper to build a pair of reactors at V.C. Summer. The two utilities, which co-own the Midlands power plant, are paying to keep construction on track under an interim agreement that expires June 26.
Southern Co. has a similar arrangement at Plant Vogtle in Georgia, where Westinghouse was building two reactors, but that agreement expires Friday.
If Westinghouse ultimately rejects the V.C. Summer contract as part of its bankruptcy reorganization, SCE&G and Santee Cooper would have to find a replacement contractor or build the reactors themselves. The utilities could try to recover financial damages from Westinghouse in court, but such litigation would be costly and time-consuming.
Santee Cooper's board of directors has called a special meeting to be held in closed session Wednesday to get legal advice on the nuclear project.
Several V.C. Summer contractors and vendors have filed liens against Westinghouse with the bankruptcy court. The Office of Regulatory Staff said there is no timeline for when creditors will be paid because there is no current deadline for Westinghouse to file a reorganization plan.
"It is generally understood that, in a case such as the Westinghouse case, payments to creditors hold pre-petition unsecured claims are not likely to commence for an extended period of time ...," the agency said in its report.
Westinghouse recently filed thousands of pages of documents outlining the company's financial condition, showing an estimated $5 billion in assets and $618 million in known liabilities. But breaking construction contracts at V.C. Summer and Vogtle could cost Westinghouse billions of dollars, according to a report in the Pittsburgh Post-Gazette. That newspaper said Fluor Corp. and Bechtel Corp., among the nation's largest engineering and construction firms, might be preparing bids to take over the projects.
The federal committee looking into a potential foreign buyer said in its letter that an investigation could delay progress in the bankruptcy case. Committee investigations can take up to 75 days, according to the letter.
"If (the commmittee) determines that the transaction poses national security concerns that cannot be resolved, it will refer the transaction to the president unless the parties choose to abandon the transaction," the letter states. "The president may suspend or prohibit the transaction."
The president's decision would not be subject to judicial review, according to the letter.
The committee is an inter-governmental agency that includes representatives from U.S. Treasury, Homeland Security, the Attorney General's office, the departments of defense, commerce and energy and other agencies.
The nearly decade-long V.C. Summer project has been beset by financial and construction problems. The current cost estimate for the reactors is 21.6 percent higher than an original $11.4 billion price tag, and analysts say the eventual cost could balloon to $19 billion if both reactors are built.
The construction contract between Westinghouse and the South Carolina utilities was made public late last month. It sheds little light on the cost overruns, showing nearly three dozen change orders totaling about $325 million a fraction of the $2.6 billion in cost overruns since the project was announced in 2008.
Construction also is years behind schedule, with a pre-bankruptcy estimate putting the first reactor online in April 2020 and completion of the second unit delayed to December 2020. The reactors have to be online by the end of 2020 to qualify for federal tax credits that could offset about $2.2 billion of construction costs that utility customers have been paying.
Cayce-based SCANA owns 55 percent of the V.C. Summer project while Moncks Corner-based Santee Cooper owns the other 45 percent. Under their current agreement with Westinghouse, the utilities are expected to decide by June 26 whether to proceed with construction of one or both reactors or to abandon the project altogether. If that happens, the utilities say they still would have to build some other type of generating plant to meet future electricity needs.
Reach David Wren at 843-937-5550 or on Twitter at @David_Wren_
Originally posted here:
Article Thesis
Valeant's (NYSE:VRX) huge net debt position and worsening operational performance mean that there is non-negligible credit risk for Valeant. It thus seems best to avoid the company's shares, especially since there is no catalyst in sight that could allow for an ongoing share price recovery.
Rationale
Valeant has been a high flyer for years, with its share price seemingly growing endlessly until, at one point, it didn't.
Valeant's fall, which decimated 95% of the company's share price, began in the second half of 2015, when the company's non-GAAP earnings story began to show some cracks. In the fourth quarter the company reported GAAP losses of $0.98 per share, whilst still claiming underlying earnings power (non-GAAP earnings) of $2.50 per share. The market since got wary of Valeant's adjusted earnings numbers, and rightfully so, the company has, however, reverted its use of big adjustments since, and GAAP number and non-GAAP numbers are now more in line with each other.
In the most recent quarter Valeant's GAAP results were actually better than the company's non-GAAP numbers:
As we can see, GAAP net income of $628 million is much higher than the non-GAAP bottom line number -- which Valeant does not include in its quarterly release. We can, however, calculate it by using the EBITA number of $766 million and adjusting it for interest expenses, taxes and amortization of intangible assets.
VRX Net Interest Income (Quarterly) data by YCharts
When we assume amortization costs to be zero, and calculate with interest expenses of $470 million, we get to pre-tax earnings of a little below $300 million, which, adjusted for taxes, means adjusted net earnings of $180 million.
VRX Effective Tax Rate (NYSE:TTM) data by YCharts
When we calculate with amortization expenses of $500 million, which is in line with the quarterly average over the last years, we don't get to any net earnings, however -- pre-tax losses would total $200 million quarterly.
Valeant is in too much debt
In order to determine the sustainability of Valeant's debt pile, we should look at its debt to EBITDA ratio:
Valeant points out that its debt position has shrunk from $32.3 billion at the end of the first quarter of 2016 to $28.9 billion one year later, but that is only part of the story.
Over the same twelve months, Valeant's adjusted EBITDA has declined by $1.1 billion, which means the debt to EBITDA ratio is now actually higher than it was one year ago: 6.95 versus 6.15, respectively.
Valeant's earnings power is shrinking at a much faster pace than its debt position, which means the debt pile is getting ever less sustainable.
When we annualize Q1's EBITDA of $860 million, we get to an estimate of $3.4 billion in EBITDA this year -- which could still be too high, as it does not account for further deterioration in Valeant's earnings power. In this case the debt to EBITDA multiple would stand at 8.4.
What happens when this is combined with rising interest rates, which makes Valeant's debt ever more expensive?
The Federal Funds rate is expected to grow to 3.0% over the next 18 months, an increase of 2.1 percentage points from the current level. If higher central interest rates are resulting in likewise higher interest rates for Valeant, the company could see its interest expenses rise by $610 million annually over the next one and a half years.
If, at the same time, Valeant's EBITDA continues to shrink at a 20% a year rate, the annual EBITDA run rate would total below $3 billion by the end of 2018.
VRX Net Interest Income (TTM) data by YCharts
As Valeant's interest expenses already total $1.9 billion, the total would stand at $2.5 billion -- barely covered by EBITDA. This does not include the impact of Valeant's ever-increasing debt to EBITDA ratio, which would likely push Valeant's interest expenses even higher -- this only calculates for sustained EBITDA declines and the increase in the Fed Funds rate.
It is difficult to forecast the additional impact of higher interest expenses due to investors shying away from Valeant's bonds if they are deemed too risky. But the fact that, even when we do not account for that, Valeant could be in a position where the company is just barely able to finance its interest expenses in one and a half years is a good reason for investors to think hard about whether it is a good idea to hold Valeant's shares.
The market cap has come down to a small level, and due to the huge volatility in Valeant's share price, it is very possible to make some short term gains. But in the long run, the outlook is not positive, and when we look a couple of years into the future, we see that Valeant could come into a position where it is no longer able to finance its debt.
I thus believe that it is best to stay away from this company's shares.
Takeaway
Valeant's non-GAAP shenanigans have ended, and for the most recent quarter it makes sense to look at the adjusted results. These spell trouble, however, as the company's earnings power is shrinking much faster than its debt levels.
Add in Federal Funds rate hikes that push interest rates higher, and the possibility of investors shying away from Valeant's bonds (which would increase interest rates further), and the risk for Valeant not being able to finance its debt any longer in a couple of years is not negligible any more.
Author's note: If you enjoyed this article and would like to read more from me, you can hit the "Follow" button to get informed about new articles.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
More:
Valeant: There Is Significant Bankruptcy Risk Here - Seeking Alpha
The Capitol building is seen in San Juan, Puerto Rico May 4, 2017. ALVIN BAEZ / Reuters
Puerto Rico has been under an economic recession for over 10 years, which has prompted more than 10 percent of its residents to move to the U.S. It's expected the islands recession will continue, given that the Boards fiscal plan expects to shrink the island's economy, at least for the next 2 years. This will most likely result in more Puerto Ricans continuing to migrate to the continental U.S.
There are now over 1 million Puerto Ricans living in the state of Florida alone, and it is almost certain that Florida and other states will see many more residents from the island arriving to their jurisdictions in search of work and a fresh start.
The U.S. Virgin Islands, another U.S. territory with just over 100,000 residents, is under a $2 billion debt. Consequently, they will be watching how Puerto Ricos court process unfolds to determine if it is in their interests to seek Congressional protection. Furthermore, states with high debt or pension obligations might look to Puerto Ricos Title III process to see if they can eventually have a similar remedy made available to them.
May 17 was a historic day for both Puerto Rico and the United States, as the U.S. District Court there held its first hearing on the island's bankruptcy, thus officially starting the first case under the
This law created a process combining elements of traditional Chapter 9 and 11 bankruptcies that will permit U.S. owned territories to adjust their debts. Previously, U.S. law did not give territories the remedy used by state municipalities such as Detroit to restructure their debts.
Puerto Rico, an island obtained by the United States after the 1898 Spanish American War, is the first territory to use this process, expected to have far reaching implications not only for the island and its inhabitants, but also across the U.S. financial markets and pension systems.
This process is regulated in Title III of PROMESA, and it's presided by New York district judge Laura Taylor Swain. She was appointed to the case by Supreme Court Chief Justice John Roberts, who, under PROMESA, is the person authorized to select the Judge.
The Title III process differs from a traditional bankruptcy case in several aspects. PROMESA establishes that a 7-person Oversight Board, whose members were recommended by Congress and officially selected by President Obama in 2016, will act as the islands representative.
However, this does not mean that the Board is required to act in the islands best interests, as PROMESA does not impose any fiduciary duties to it. It mainly requires the Board to develop a plan that helps Puerto Rico achieve fiscal responsibility and eventually regain access to capital markets.
Furthermore, PROMESA gave the Boards members immunity for all actions they carry under the Act, and they can override Puerto Ricos laws and elected officials.
Under Title III, the Board will work with Puerto Ricos creditors to renegotiate the islands debts. Once this is done, they will present a Debt Adjustment Plan to the court for approval. This Plan will be approved if it complies with the requirements set in Section 314 of PROMESA.
One requirement of note is the one in Section 314(b)(6), which establishes that the plan will be approved if it is feasible and in the best interests of creditors, which shall require the court to consider whether available remedies under the non-bankruptcy laws and constitution of the territory would result in a greater recovery for the creditors than is provided by such plan.
This section is likely to give Judge Taylor Swain more power over Puerto Rico than she would have in a traditional Chapter 9 bankruptcy process, under which a similar plan would be approved if it is in the best interests of creditors and is feasible. It is unknown why this additional requirement was added to Title III.
In order to protect the best interests of the creditors, the Court is authorized to allow the Oversight Board to interfere with Puerto Ricos political or governmental powers and alter its properties, revenues or the use of its income producing properties.
This Section gives powers to the Board that are unique in U.S. law, as, they appear to give it the ability to, for example, potentially dispose of Puerto Ricos assets and properties and have a say in the way the island government provides basic services to its 3.5 million residents, even though it was not elected to do so by the Puerto Rican people. Judge Swain seemed to be aware of this power during the hearing, when she remarked that this case must lead to a better future for Puerto Rico.
Judge Swain scheduled hearings through December. In addition, the Judge issued an order yesterday requiring Puerto Rico to file a Creditor Matrix by June 30, 2017, and to file a list of all its creditors by August 30, 2017.
However, this process is expected to last several years and become the largest municipal bankruptcy in U.S. history, easily surpassing Detroits $20 billion dollar default, and perhaps come close to matching Argentinas historic 2001 default of over $150 billion dollars.
Who will pay for this bankruptcy process estimated to cost tens of millions of dollars? It will come out of Puerto Rico's pockets, in a process that will fundamentally transform the future of the island, its obligations towards its residents and its relationship to the United States.
In sum, Puerto Rico finds itself in uncharted legal waters. As this case unfolds, it will be important to see how Judge Swain and the Board protect the islands residents and ensure that Puerto Rico can develop a sustainable economic plan to transform and grow its economy without jeopardizing its residents.
Furthermore, it will be essential that Judge Swain orders a full audit of the debt as part of this process, so there can be a clear understanding of which individuals, elected officials and businesses were responsible for this financial catastrophe so they can be held accountable.
Finally, in order to protect the best interests of both Puerto Ricos and US residents, it's vital that this process and the audit of the debt moves authorities to enact legal reforms that end any unscrupulous, unethical or illegal financial practices that led to this tragic situation.
Follow NBC News Latino on
View original post here:
4 Reasons Why Puerto Rico's 'Bankruptcy' Process Matters to US Residents - NBCNews.com
A high ranking committee consisting of White House cabinet members and possibly President Donald Trump himself are positioning themselves to weigh in on the Westinghouse bankruptcy case.
In court records filed late Monday, the Committee on Foreign Investments in the United States, or CFIUS, stated the potential sale of Westinghouse or its assets could be subject to the panel's review.
Consisting of various White House cabinet members, the CFIUS is authorized to review transactions which could result in foreign persons or entities acquiring U.S. businesses, according to the U.S. Treasury website.
CFIUS' mission is to determine if there are any national security issues resulting from said transactions, the treasury website states.
A subsidiary of Japanese-held Toshiba, Westinghouse filed for Chapter 11 bankruptcy protection on March 29.
Westinghouse is the lead contractor at financially struggling nuclear plants under construction in Fairfield County (V.C. Summer) and Burke County, Georgia (Plant Vogtle).
Documents filed May 31 with the S.C. Office of Regulatory Staff, or ORS, state Westinghouse's nuclear interests at V.C. Summer and Vogtle have become a "financial drain," eclipsing any profits Westinghouse is earning in other core areas of its business.
A CFIUS review of any potential Westinghouse transaction "could affect the transactions' timing, terms and ability to be completed," according to its June 5 court filing.
Folliwing CFIUS review, the matter could also be reviewed personally by President Donald Trump, the filing continues.
"Section 721 of the Defense Production Act of 1950 ... authorizes the President, acting through CFIUS, to review any merger, acquisition, or takeover 'which could result in foreign control of any person engaged in interstate commerce in the United States.'" court records state.
CFIUS consists of a who's who of White House cabinet members, including the Secretaries of the Treasury (who chairs the group), State, Defense, Commerce, Energy and Homeland Security, as well as the Attorney General and other federal officials, according to the court filing.
The Director of National Intelligence and Secretary of Labor are ex officio members, meaning they are nonvoting. Five White House officials also serve as observers.
Co-owners SCANA Corp. and Santee Cooper are temporarily funding day-to-day operations at V.C. Summer per an extension of an interim financing agreement that expires June 26.
A similar agreement at Vogtle that was set to expire June 3 and extended to June 5 has been extended again, this time to 5 p.m. Friday, June 9, Georgia Power spokesman Jacob Hawkins said Tuesday.
"Georgia Power continues work to complete its full-scale schedule and cost-to-complete analysis and work with the project Co-owners (Oglethorpe Power, MEAG Power and Dalton Utilities) and the Georgia Public Service Commission to determine the best path forward for customers," Hawkins said in a statement.
This is a developing story and will be updated throughout the day.
Visit link:
Washington weighs in on Westinghouse bankruptcy | News ... - Aiken Standard
TAGS: Marketing, Overseas
December 18, 2014
As some planters are still rolling and others are put away for the next season, crops are growing. Once concern on the minds of farmers is if prices and the farm economy will offer enough support to keep producers in business.
Ag bank Farmer Mac is answering that question in a new release. AgDay had an exclusive first look at its quarterly financial report, The Feed.
Bankruptcies is one of several topics explored by the report. Chapter 12 bankruptcy filings have remained relatively low during the last decade, but the agricultural downturn during the last three years has resulted in a small uptick in farm bankruptcy rates.
Its not systematicits not all located in one region or one commodity, said Jackson Takach, an economist with Farmer Mac. Weve seen maybe a very small uptick, but its not anywhere near what we saw in the Great Depression or after the 1980s farm crisis. That gives me a lot of good feelings about the ag economy.
According to The Feed, the average bankruptcy rate in the past decade has been roughly 2.3 farm bankruptcies per 10,000 farms.
Nebraska, eastern California, central Georgia, Kansas and Wisconsin are the areas where bankruptcies are most common. However, Iowa and Missouri have relatively fewer bankruptcies.
Read the rest here:
Farmer Mac Early Exclusive: Farm Bankruptcy Rates Low - AgWeb
Immunotherapy through clinical trials is becoming a promising treatment option for some mesothelioma patients.
Checkpoint inhibitor drugs, such as Keytruda, already have U.S. Food and Drug Administration (FDA) approval as first-line treatments for non-small cell lung cancer (NSCLC), edging immunotherapy drugs closer to becoming a viable second-line therapy for other thoracic cancers, including pleural mesothelioma.
However, overall response to immune therapies remains relatively low.
Researchers across the country are striving to enhance responsiveness to immunotherapy drugs. Leading that trend is viroimmunotherapy, or the process of combining cancer-killing (oncolytic) viruses with immunotherapy drugs.
Dr. Manish Patel, an assistant professor in the division of hematology, oncology and transplantation at the University of Minnesota, has studied the potential of virus therapy for mesothelioma for several years.
His research led to an ongoing clinical trial at the Mayo Clinic in Rochester, Minnesota, investigating the side effects and optimal dosage levels of using a genetically altered measles virus to kill mesothelioma tumor cells.
Patel and Dr. Alexander Dash of Macalester College in St. Paul, Minnesota, recently published a paper in the journal Biomedicines that analyzes measles and other oncolytic viruses as potential viroimmunotherapy treatments for pleural mesothelioma and other thoracic cancers.
As research continues, Patel believes the day of using viruses to increase the efficacy of immunotherapy drugs is not as far off as some may think.
I think as we go down the line of combining with checkpoint blockade and looking at different viruses, we may see that we start seeing more efficacy; however, for mesothelioma, that may take a few years, Patel told Asbestos.com. Weve got the measles virus that really is going to be in phase II testing now, and so I think if were able to demonstrate efficacy in that study, we may well be able to get an FDA indication in the next two to three years.
Immune checkpoint inhibitors, such as pembrolizumab (Keytruda), allow the immune system to fight cancer cells by negating the PD-L1 protein, which usually prevents an immune response.
A recent clinical trial showed significant tumor reduction in more than half of pleural mesothelioma patients given pembrolizumab as a second-line therapy. The FDA recently expanded approval for pembrolizumab after the drug nearly doubled the effectiveness in patients diagnosed with NSCLC.
I suspect that immune checkpoint blockade will be approved for mesothelioma as well once we get more information, Patel said. In fact, were already using [immune checkpoint inhibitors] as an off-label for many patients.
But, irrespective of tumor type, only a small percentage of patients can respond to the therapy.
Through immunotherapy results of melanoma and lung cancer, researchers have found that response likely depends on the ability of the patients own immune system to recognize the tumor as foreign.
Depending on which tumor type, its somewhere between 15 to 30 percent of patients who will respond to checkpoint blockade, Patel said. And if you do respond, usually that response is quite durable.
The goal now becomes getting a better response to immunotherapy.
As foreign pathogens, viruses can recreate the ability to recognize a tumor by bringing immune cells into the tumor microenvironment. Researchers also know that some viruses can directly kill cancer cells and stimulate an immune reaction around the cancer cells.
When tumors die, they release antigens that can be recognized by immune cells. So it increases the chance that you have a T-cell that now recognizes the tumor, Patel explained. Those are now tumor-specific immune responses that could potentially be long lived.
Viruses can also increase the cancer cell expression of PDL-1.
I think all of those things conspire together to show that this is probably going to be a good way to activate the immune system, making the immune cells recognize that theres a tumor there, Patel said. Then, if we block PDL-1, youll have a much better chance of getting an active immune response.
The concept of virotherapy, or using viruses to attack cancer cells, is nothing new. But Patel and other researchers are focused on finding viruses that kill tumor cells as well as induce an enhanced immune response to the cancerous tissue.
Although the measles virus is the most studied in this area, it presents some challenges. The virus was a serious problem in America until an infant vaccine eliminated much of the concern.
Because people have antibodies against the measles virus, its very difficult to get that virus to where you want it to go, Patel said.
In their recent study, Patel and Dash evaluated other viruses and their potential as a treatment against thoracic cancers, including vesicular stomatitis virus (VSV).
Part of the interest in that one is, unlike the measles virus, most people have never been exposed to VSV, Patel said. Its mainly a virus that affects animals, specifically livestock, so that whole problem with the antibodies is not really there with VSV.
A separate study showed VSV was not only effective in killing cancer cells in mice with mesothelioma tumors, but also raised the immune response of the mice against the tumors.
The activity of it was really dependent on the immune system, Patel said. So now you have a system in which the virus is not only directly killing the cells but also raising immune response. It is an exciting finding, particularly in todays oncology landscape.
The overarching challenge facing virotherapy and all potential mesothelioma treatments is how fast the cancer spreads.
Mesothelioma is often diagnosed in the later stages when tumors have spread outside the point of origin and possibly to other parts of the body.
Currently, Patel and his colleagues are focused on intratumoral injections, which involve inoculating the tumors with the viruses directly. The potential downside of this selective approach is if the tumors are widespread.
Is there enough infection going on? Is there enough replication going on? And is there enough viroimmune response to really get at the whole body burden of cancer? I think those are some questions were working on, Patel said. If a patient has a metastatic tumor, or widely spread cancer, you may infect just some of those cancer cells. And is that going to be enough to create a whole systemic response?
Another question being addressed is how to improve the delivery of a virus to a broad variety of spots affected.
Patel and other investigators are looking at using cells to help carry the virus.
We know for sure that theres another virus called Rio Virus that gets carried along with immune cells in the bloodstream, which we dont seem to see with some of these other viruses but at the same time there are potentially different strategies that could be used to deliver the virus to where we want it to go, Patel said.
Perhaps the biggest challenge facing researchers is the development process.
Developing new drugs is costly and time consuming. For mesothelioma, the rarity of the disease is a challenge in itself, as it is difficult to conduct a large enough clinical trial.
Anytime we make a change to the baseline virus, it has to go through the whole development pathway all over again. We have way more ideas than we have time to develop into a useful drug. So thats another major challenge to determine which viruses to stick with because the process is lengthy.
Follow this link:
Using Viruses to Boost Mesothelioma Immunotherapy - Asbestos.com
A calcium-binding protein called calretinin may provide the basis for a new kind of blood test for the asbestos-linked cancer, malignant mesothelioma.
Right now, there is no reliable way to detect the presence of a mesothelioma tumorbefore symptoms develop.
But scientists around the world are searching for ways to use certain compounds produced by tumors to diagnose mesothelioma earlier, allowing forearlier treatment and potentiallybetter outcomes.
Calretinin is one such compound. It is a protein involved in calcium signaling, a process that governs a number of critical cellular processes.
A team of scientists from Germany and Australia recently pitted calretinin against the more established mesothelioma biomarker, mesothelin, in a test to see which protein offered the best chance of identifying the asbestos cancer early.
The test involved 163 Australian men and 36 German men with malignant pleural mesothelioma. Another 163 Australians and 72 Germans who had non-malignant asbestos-associated conditions (asbestosis or pleural plaques) made up a control group.
Samples of blood serum and plasma had been collected from all the participants prior to therapy. These were tested for the presence of both calretinin and mesothelin.
Taking into consideration all the different factors that could potentially impact the concentrations of these markers in the blood, such as age, mesothelioma subtype, and how long their blood samples had been stored, the team estimated the diagnostic performance of both markers.
The scientists found that the calretinin-based blood test was able to correctly identify cases of epithelioid or biphasic mesothelioma 71 percent of the time. That is comparable to mesothelin, which correctly identified 69 percent of these mesothelioma cases correctly.
The news was even better when the two types of markers were used together. In that case, calretinin increased the sensitivity of mesothelin from 66 percent to 75 percent. Just as importantly, the combination test was able to correctly rule out mesothelioma with 97 percent accuracy.
The only downside of calretinin appeared to be the fact that the biomarkers effectiveness broke down when it came to identifying sarcomatoid mesothelioma, the rarest subtype.
The assay [blood test[ is robust and shows a performance that is comparable to that of mesothelin, writes lead author Georg Johnen, one of the developers of the calretinin-based blood test, in BMC Cancer. Molecular markers like calretinin and mesothelin are promising tools to improve and supplement the diagnosis of malignant mesothelioma and warrant further validation in a prospective study.
All subtypes of mesothelioma are caused by exposure to asbestos and are continuing to rise in the US, despite strict regulations. Because late-state mesothelioma rarely responds to conventional cancer treatments, earlier detection is keyto improving survival rates.
Source:
Johnen, G, et al, Calretinin as a blood-based biomarker for mesothelioma, May 30, 2017, BMC Cancer,
Read the rest here:
New Blood Test Could Mean Earlier Mesothelioma Diagnosis - Surviving Mesothelioma
Thoracic oncologists have been waiting for some positive data from checkpoint inhibitors in advanced mesothelioma for some time and this may have finally come in the form of the investigator-sponsored Maps-2 phase II study, presented at Asco on Monday. The Maps-2 study, which examined Bristol-Myers Squibb's (NYSE:BMY) Opdivo with/without Yervoy in second or third-line patients showed an impressive set of survival curves that may set a new bar for combinations in this patient group.
The median overall survival for the Opdivo/Yervoy combo was not reached but the Kaplan-Meier plot suggests it will, when mature, exceed 12 months, possibly by some margin, with a median progression-free survival for the combo of 5.6 months (see table below). Such figures are considered very impressive in this extremely poor prognosis disease.
Yervoy if you do
Furthermore, survival measures for the combo exceeded single agent Opdivo in all respects, suggesting an additive benefit for the CTLA4 antibody. This was also seen as an important finding, given the disappointing outcome of the Determine trial, which examined Astrazeneca's (NYSE:AZN) CTLA4 antibody, tremelimumab, against placebo in advanced mesothelioma last year.
With 125 patients enrolled, Maps-2 was of a sufficient size to give confidence in the robustness of the data. By contrast, most studies with checkpoint inhibitors in mesothelioma have been small as well as single arm, so outcome measures could be skewed. Compounding the problem is a well recognized difficulty of determining response in a disease where the tumor is located in the lining of the lungs.
A separate study largely of Merck & Co's (NYSE:MRK) Keytruda was also presented at Asco and showed a median overall survival of 8.0 months in advanced mesothelioma. But the study is more notable for the fact it highlighted large differences in response between PD-L1 positive and especially PD-L1 high patients, relative to those with negative expression, albeit based on a small sub-set. This suggests that PD-L1 testing is going to be required in this setting.
Larger studies in mesothelioma tend to be run by co-operative groups and there are two such under way with checkpoint inhibitors: Promise-Meso with Keytruda in first-line disease and Confirm with Opdivo in the third-line setting. Both test these agents as monotherapies.
The positive outcome from Maps-2 does provides some read-across to the Checkmate-743, the only industry-sponsored phase III study in this cancer type, which examines Opdivo/Yervoy combo directly against pemetrexed/cisplatin in the first-line setting.
However, KOLs discussing the data believe that checkpoint inhibitors should be most effective when used for either first-line maintenance or as second-line agents after progression. The scientific consensus in this indication remains that patients should be treated with chemo, potentially with targeted therapy, first line.
Vargatef in first line
This was reinforced by updated survival results presented at Asco with Boehringer Ingelheim's Vargatef from the Lume-Meso phase II trial in first-line mesothelioma. This small study tested pemetrexed/cisplatin with/without Vargatef and showed a trend in overall survival and a significant advantage in terms of PFS. The magnitude of the benefit was similar to that seen with the addition of Avastin to pem/cis in the larger Maps study - run by the same French cooperative group as Maps-2 - which is currently supporting an approval application for the Roche drug.
Boehringer noted the benefit for adding Vargatef was greatest in patients with epithelioid histology, which represent the majority and may become a key target for its kinase inhibitor.
Boehringer is conducting a large phase III study, also called Lume-Meso, designed to support a registration application.
But a hotly awaited readout in mesothelioma this year is that of a large, 248-patient phase II study with Bayer's antibody-drug conjugate anetumab ravtansine in second line, which is due in November. This study is sufficiently large that, if positive, it could support a registration application.
Go here to read the rest:
IO Strategy In Mesothelioma Finally Gets Mapped Out | Seeking Alpha - Seeking Alpha
The first Sunday of every June is marked as National Cancer Survivors Day, and this annual event celebrates those struggling with all types of cancers, including malignant mesothelioma. Though the days official name gives the impression that it is only meant for those who have lived a certain amount of time past remission, or who are deemed cancer free, the term cancer survivorship actually refers to far more than that. According to Dr. Namrata Patel, Medical Director of New York-Presbyterian Hudson Valley Hospitals Cheryl R. Lindenbaum Comprehensive Cancer Center and an Assistant Professor of Medicine at Columbia University Medical Center, the term actually refers to anyone with cancer from diagnosis through treatment and beyond. Survivorship also takes into consideration the people surrounding the patient spouses, family members, friends, and caregivers who are all affected and play a role in the patients health and well being.
People who have been diagnosed with mesothelioma, and those who make up their extended circle of family and friends, are significantly impacted as soon as the diagnosis has been made. The situation is immediately infused with a sense of urgency because the prognosis of mesothelioma is so grim most patients succumb to the disease within two years of the time that they are diagnosed. The emotions involved are also heightened by the overwhelming sense of loss and grief, and frequentlyof anger born of the news that the condition could have been prevented. Because mesothelioma is caused by exposure to asbestos, in most cases there are companies or employers who were aware of the dangers posed by a workplace or environment but who chose to put profits over people.
The most important thing that people can do to help support those suffering from mesothelioma is to ensure that in addition to medical treatment, they are also receiving the emotional support and resources that they need. At Mesothelioma.net, our Patient Advocates are dedicated to providing mesothelioma victims and their families with answers that can help improve quality of life. For more information, contact us at1-800-692-8608. Were here to help.
Terri Oppenheimer is an independent writer, editor, and proofreader. She graduated from the College of William and Mary with a degree in English. Her dreams of a writing career were diverted by a need to pay her bills. She spent a few years providing the copy for a major retailer, then landed a lucrative career in advertising sales. With college bills for all three of her kids paid, she left corporate America for a return to her original goal of writing. She specializes in providing content for websites and finds tremendous enjoyment in the things she learns while doing her research. Her specific areas of interest include health and fitness, medical research, and the law.
See the original post:
Methanol, or methyl alcohol, is a colorless solvent found in a variety of automotive products including windshield washer fluid, gasoline antifreeze and alternative fuels. It is also used as an industrial solvent for household products such as paint removers and rubbing alcohol.
While the toxicity of methanol to humans is well known, the compound is found naturally in the human body in small amounts. Certain fruits and vegetables contain it, and methanol may be produced as an unintended byproduct of the fermentation process.
Now, researchers at universities in Cameroon and Turkey are using the compound in an unusual way as a treatment against malignant mesothelioma cell lines.
Dr. Victor Kuete, a biochemist at the University of Dschang in Cameroon, led the research team that tested methanol extracts found in African plants on mesothelioma and four other cancers.
The results, published recently in the journal BMC Complementary and Alternative Medicine, are promising.
These data highlight the usefulness of these extracts in the fight against solid cancers, Kuete wrote in the study. This hypothesis is strengthened by the good selectivity index of the tested extract, which is compatible with their possible use in cancer chemotherapy.
Kuete has spent many years investigating the cytotoxicity, or toxicity to living cells, of compounds and extracts found in African plants.
In December 2016, Kuete discovered that an organic compound called rapanone caused cell death (apoptosis) in mesothelioma cell lines.
We found that rapanone likely induced apoptosis via loss of mitochondrial membrane potential, Kuete told Asbestos.com.
The latest naturally derived compound with success fighting mesothelioma cells comes from the leaves of Kalanchoe crenata, a perennial succulent shrub native to tropical regions of Africa.
Methanol extracts from Kalanchoe crenata leaves (KCL) were tested against five cancers: Mesothelioma, colon cancer, non-small cell lung cancer, hepatocellular carcinoma (liver cancer) and breast cancer.
KCL was most potent against mesothelioma cell lines, while it didnt have a significant effect against the other cancers tested.
Kuete noted that this is the first report on the anti-cancer activity of KCL. The plant is traditionally used in alternative medicine as a diabetic and anti-inflammatory drug.
Other medicinal plants tested in the study included:
Overall, the Elephantopus mollis extract was most effective against the five cancer cell lines.
Elephantopus mollis and Millettia macrophylla are traditionally used in the treatment of cancers, Kuete wrote. The two plants, [especially]mollis, had cytotoxic effects on the tested carcinoma cells, validating their traditional use in the management of malignancies.
Small-cell lung cancer was the least responsive to elephants foot and the least responsive cancer overall. Only KCL showed significant cell death against the lung cancer cell lines. The only cancer with better results from KCL was mesothelioma.
Despite the promising results, using organic compounds to treat mesothelioma is a novel therapy at this point, but Kuete hopes his continued work in the area will spark future investigations into using KCL and other plants as a basis for cytotoxic drugs.
For his latest study, Kuete and his team used untreated cells as a control and doxorubicin a popular chemotherapeutic agent used to treat a number of cancers, including mesothelioma as a drug control.
Of the five cancers in the study, doxorubicin was most effective against mesothelioma, followed by hepatocellular carcinoma.
All of the doxorubicin results were significantly better than any of the plant extracts, but the findings could give clinical researchers another option to possibly enhance the effectiveness of future cancer drugs.
This study provides evidences of the cytotoxicity of the tested plant extract and highlights the good activity of Elephantopus mollis and Kalanchoe crenata, Kuete wrote. They deserve more exploration to develop novel cytotoxic drugs.
Read the original post:
Methanol from African Plants Kills Mesothelioma Cells - Asbestos.com
CHICAGONew phase 2 data suggest immunotherapy could stall mesothelioma progressionand that when it comes to Bristol-Myers Squibbs checkpoint inhibitors, two might be better than one.
Early results unveiled Monday at the American Society of Clinical Oncology annual meeting showed that Bristols PD-1 med Opdivo and CTLA4 drug Yervoy slowed disease growth in patients with relapsed malignant pleural mesothelioma (MPM). At the 12-week mark, cancer hadnt worsened in 44% of patients treated with Opdivo and 50% of those treated with the Opdivo-Yervoy combo, Bristol said.
The two-drug combo edged Opdivo monotherapy elsewhere, too. Solo, Opdivo held off cancer progression for a median four months, while the tandem treatment staved off the advance of the disease for a median 5.6 months.And when it came to extending patients' lives, the Opdivo-only cohort posted a 10.4 month median overall survival, while patients taking theimmunotherapy duo hadnt yet hit the median.
RELATED: The top 15 best-selling cancer drugs in 2022- Opdivo
Those are big numbers, considering that MPM is a devastating disease that currently lacks treatment options, BMS oncology development head, Fouad Namouni, said in an interview.
I think its great news for patients and one more proof that combining agents and not being shy of tackling very difficult diseasesdiseases that I remember, back when, we called them the graveyard of drug developmentnow we are making them happen with combination therapies, he said.
RELATED:Adding Opdivo to Yervoy ups melanoma treatment efficacybut it ups rate of serious side effects, too
Opdivo and Yervoy already have one joint approval, and thats in inoperable or metastatic melanoma. Theyre under investigation together in other tumor types, though, too, including gastric cancer and bladder cancer.
I think we very early on at Bristol knew that its not going to be immunotherapy as a monotherapy that would bring the best survival benefits for patients, Namouni said. We very early on noticed that adding ... Yervoy to Opdivo will improve the response rates, improve the progression-free survival, and improve the survival, he said.
The key question for the one-two punch, though, is whether it can get the jobdone in first-line lung cancer.Now that Opdivo has failed in that setting as a monotherapyand rival med Keytruda has succeededtheres even more riding on the combo, which is now in testing as a first-line treatment,than there once was.
Follow this link:
Bristol-Myers Squibb's Opdivo, Yervoy put the brakes on mesothelioma in phase 2 - FiercePharma
June 5, 2017
Malignant pleural mesothelioma or MPM is a rare cancer, but its incidence has been rising. This cancer is usually associated with asbestos exposure, and patients have a median life expectancy of only 13-15 months. All patients relapse despite initial chemotherapy, more than 50% of them within six months after stopping treatment. There are currently no effective therapeutic options for patients with MPM.
Early findings from an ongoing phase II clinical trial in France, MAPS-2, show that immunotherapy may slow the growth of MPM after relapse. At 12 weeks, cancer had not worsened in 44% of patients who received nivolumab (Opdivo) and in 50% of those who received nivolumab with ipilimumab (Yervoy).
The study will be featured in a press briefing today and presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.
"Our findings suggest that immunotherapy may provide new hope to patients with relapsed mesothelioma," said lead study author Arnaud Scherpereel, MD, PhD, head of the Pulmonary and Thoracic Oncology Department at the University Hospital (CHU) of Lille in Lille, France. "This randomized phase II trial may be enough to support the use of immune checkpoint inhibitors in this setting, but it is too early to conclude whether nivolumab alone or the combination of nivolumab and ipilimumab is better."
About the Study
This multi-center clinical trial enrolled 125 patients with advanced MPM who had received up to two prior treatments, including standard platinum-based chemotherapy. The majority of patients (80%) were male, and the median age was 72 years. The patients were randomly assigned to treatment with nivolumab alone or nivolumab with ipilimumab until the cancer worsened; 70% of patients received at least 3 cycles of either treatment.
Key Findings
The authors report results from the first 108 patients treated on the study. The disease control rate or DCR, defined as the percentage of patients in which cancer either shrank or did not grow, was 44% among the patients who received nivolumab only and 50% among those who received nivolumab with ipilimumab (the 12-week DCR for all treatments previously tested in relapsed MPM was less than 30%). Tumors shrank in 17% of patients treated with nivolumab and 26% of those treated with nivolumab and ipilimumab.
After a mean follow-up of 10.4 months of the 125 patients, the median time until the cancer worsened (progression-free survival) was 4 months with nivolumab alone and 5.6 months with nivolumab and ipilimumab. The median overall survival was 10.4 months in the nivolumab group and not reached in the nivolumab with ipilimumab group (meaning that more than 50% were still alive at analysis). Mature quality-of-life data are not yet available.
The side effects were rather mild overall with the most common being thyroid problems, colon inflammation, and skin rash. Severe side effects were more common in the nivolumab plus ipilimumab group (18% vs. 10%), in which three treatment-related deaths occurred.
Next Steps
With 125 patients, MAPS-2 is the largest clinical trial of immune checkpoint inhibitors in mesothelioma to date, according to the authors. Many ongoing clinical trials are exploring nivolumab and other immune checkpoint inhibitors as second- or third-line treatments for MPM. In addition, several larger clinical trials investigating immune checkpoint inhibitors as initial therapy for MPM are already under way.
"Mesothelioma cells build a protective tumor microenvironment to shield themselves against the immune system's attacks and even act against anti-tumor immune response," said Dr. Scherpereel. "Therefore, therapies that shift the tumor microenvironment from a state of immune suppression to one of immune activation may hold promise in MPM."
About Mesothelioma
Malignant pleural mesothelioma is a cancer that begins in the lining of the lungs. This cancer is associated with occupational exposure to asbestos, which causes chronic inflammation. It typically takes 30 to 40 years from asbestos exposure to development of MPM.
The peak of asbestos use was between the 1960s and the 1980s. Although use of asbestos has been banned in the United States and many European countries, asbestos is still being used and extracted in many developing countries. "For these reasons, we expect to continue to see growing incidence of mesothelioma in the coming decades," said Dr. Scherpereel.
Explore further: Immunologic changes point to potential for clinical investigation of combination immunotherapy for deadly kidney cancer
More information: abstracts.asco.org/199/AbstView_199_187024.html
Immunologic changes observed in an early study of patients with metastatic renal cell carcinoma (MRCC) raised the possibility for a larger clinical study of combination immunotherapy, according to findings reported by researchers ...
New research suggests that some patients with head and neck cancers can benefit by continuing treatment with an immunotherapy drug after their tumors show signs of enlargement according to investigators at Dana-Farber Cancer ...
Rush University Medical Center is among the first hospitals in the nation, and the only one in Illinois, to provide patients fighting advanced kidney access to a new combination immunotherapy that targets different immune ...
Treatment with the immune checkpoint inhibitor nivolumab (Opdivo) yielded durable responses in some patients with advanced non-small cell lung cancer (NSCLC), with a five-year survival rate of 16 percent, according to data ...
White blood cell counts can predict whether or not lung cancer patients will benefit from immunotherapy, according to research presented at the European Lung Cancer Conference (ELCC).
Results from the CheckMate 040 study presented today found that nivolumab, an immuno-oncology drug which acts by modulating the immune system, produces durable responses with long-term survival rates, regardless of whether ...
Researchers at University of California San Diego School of Medicine report that cancer cells appear to communicate to other cancer cells, activating an internal mechanism that boosts resistance to common chemotherapies and ...
When you dine on curry and baked apples, enjoy the fact that you are eating something that could play a role starvingor even preventingcancer.
A research study led by University of Minnesota engineers gives new insight into how cancer cells move based on their ability to sense their environment. The discovery could have a major impact on therapies to prevent the ...
Scientists at Karolinska Institutet in Sweden report that cancer cells and normal cells use different 'gene switches' in order to regulate the expression of genes that control growth. In mice, the removal of a large regulatory ...
Doctors are reporting unprecedented success from a new cell and gene therapy for multiple myeloma, a blood cancer that's on the rise. Although it's early and the study is small35 peopleevery patient responded and all ...
Drugs are scoring big wins against common cancers, setting new standards for how to treat many prostate, breast and lung tumors. There's even a "uni-drug" that may fight many forms of the disease.
Please sign in to add a comment. Registration is free, and takes less than a minute. Read more
More:
Early research suggests first immunotherapy for mesothelioma on the horizon - Medical Xpress
March 6, this year marked 60 years since Ghana attained independence from British colonial rule.
Indeed, 60 years in the life of a nation calls for sober reflections on her socio-economic development and trajectories.
There is no gain-saying 60 years in the life of Ghana have been characterised by economic fortunes and misfortunes. In spite of the challenges confronting us as a nation, it was deemed necessary to celebrate our 60th independence anniversary with relative modesty. Several events were organised to add colour to the celebration. The 60th anniversary celebration saw the invitation of foreign dignitaries, including leaders from African countries such as Nigeria, Togo, Benin, Burkina Faso, La Cote dIvoire, Guinea, Sierra Leone, Liberia, Senegal, and Cape Verde, among others.
Benefits to Ghana
Barely two months after the 60th anniversary celebration, President Nana Addo Dankwa Akufo-Addo, embarked on official visits to some of the African leaders who were invited to the event. However, some social commentators have expressed concerns about the rationale behind the Presidents visits and their economic significance to the nation. The imminent question emanating from the ongoing debate is: What are the socio-economic benefits of President Akufo-Addos African tour to the Ghanaian economy? One could readily recount about four distinct and essential benefits of the Presidents foreign trips to the Ghanaian economy.
First, as tradition demands, it is imperative to reciprocate the kind gesture of your neighbours. To this end, it was important for the President of the Republic to visit these African leaders to express the people of Ghanas profound gratitude and thanks for their decision to take time off their busy national schedules to grace the celebration of Ghanas 60th independence anniversary; and to formally introduce himself as the current President of Ghana to the peoples of the touring African countries. Second, the Presidents visits would help to strengthen ties between Ghana and each of the African countries visited. The advent of improved technology such as Skype and telephone conversations has enhanced collaboration and relation among leaders; it has limited the extent to which ones physical presence is required to transact a business. These novel technological advancements notwithstanding, ones physical presence is inevitable in certain situations; the Presidents physical presence in the neighbouring African countries has created the enabling environment for discussions on matters of national importance. In countries where the international relations are under siege or on the verge of collapse, the visit afforded the leaders the opportunity to revive and strengthen those relations. For instance, President Akufo-Addos visits to Togo and La Cote dIvoire presented him with an opportunity to assure and reaffirm the Government of Ghanas commitment to curbing the debilitating effects of illegal mining on water bodies flowing across these countries.
Available statistics indicate that in 2013, trade volume between Ghana and Cape Verde amounted to $5 million; the volume of trade between the two countries in 2016 was less than $200,000. However, Ghanas bilateral relations with Cape Verde have been given a significant boost by President Akufo-Addos visit to President Jorge Fonseca; leaders of the two countries have renewed their commitment to strong economic relations for the mutual benefit of their citizens in the areas of job creation and increased income. Specifically, the leaders considered the establishment of a Permanent Joint Commission for Co-operation between Ghana and Cape Verde to facilitate direct flight and shipping arrangements between Accra (Ghana) and Praia (Cape Verde), among others.
Third, the leading marketer of the Ghanaian economy to foreign investors is the President. As a result, President Akufo-Addos visits to the neighbouring African countries presented an opportunity for him to showcase Ghanas investment opportunities; and outline measures put in place by the government to make Ghana a preferred destination for investors. Organising business fora during the visits made it possible for investors to ask pertinent questions; and to receive cogent responses on the investment climate in Ghana.
Ease of doing business
In 2017, the World Bank released statistics on the ease of doing business in 190 economies across the globe based on the following criteria: ease of doing business, starting a business, dealing with construction permits, getting electricity, registering property, getting credit, protecting minority investors, paying taxes, trading across borders, enforcing contracts, and resolving insolvency.
The statistics revealed Ghana ranks 108th in the world, 11th in Africa, and 1st in West Africa with regards to the ease of doing business. This implies that the necessary fundamental policies have been formulated to facilitate business transactions in the country. Perhaps, what requires constant improvement is efficiency in the registration of businesses; provision of infrastructural facilities such as good roads, adequate electricity and water supply to the nook and cranny of this country to ensure equitable distribution of companies and jobs to various areas in the economy.
Similar statistics released by the World Bank in 2016 on the ease of doing business revealed Ghana ranked 114th in the world, 9th in Africa and 1st in West Africa. A comparative analysis of the World Bank statistics for 2016 and 2017 reveals an improvement in Ghanas world rankings, a drop in the African rankings, and a consolidation of the West African rankings.
Finally, President Akufo-Addo was expected to meet and share the Government of Ghanas policies with Ghanaians resident in the touring African countries. It is necessary for Ghanaians abroad to be updated, constantly, on the countrys socio-economic developments. This plays a monumental role in their resolve to remit regularly, and to make a firm decision on returning home to contribute their quota to the edifice of our dear nation. The Presidents interactions with Ghanaians resident in the neighbouring African countries might have unravelled thoughts and ideas useful to the advancement of the nations economic cause. Indeed, knowledge and wisdom are not the preserve of an individual or a government; together, we can build a better Ghana.GB
The author is Lead Consultant/CEO, Eben Consultancy. Fellow, Chartered Economist & Council Member, ICEG. Email: [emailprotected] Website: http://www.ebenezerashley.com
See the original post:
Impact of Prez Akufo-Addo's W/A tour on economy - Graphic Online