Novartis immuno-oncology drug candidate fails skin cancer trial By Reuters


© Reuters. The logo of Swiss drugmaker Novartis is pictured at the French company’s headquarters in Rueil-Malmaison

ZURICH (Reuters) – Swiss drugmaker Novartis said on Saturday that its investigational spartalizumab immuno-oncology drug mixed with the approved medicines Tafinlar and Mekinist failed in a late-stage trial for a type of advanced skin cancer.

The drug did not improve progression-free survival in previously untreated patients with BRAF V600 mutation-positive cutaneous melanoma, compared to Tafinlar + Mekinist alone, Novartis said.

Despite the failure, Novartis is continuing development of spartalizumab, a so-called checkpoint inhibitor thought to help take the brakes off the immune system in fighting cancer, against other kind of tumors, the Basel-based company said.

Novartis has been late in developing such immuno-oncology drugs for its portfolio, a field now dominated by lucrative medicines including Merck’s Keytruda, Bristol-Myers Squibb (NYSE:)’s Opdivo, and to a lesser extent, Roche’s Tecentriq.

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Martin Shkreli fails to end FTC, New York lawsuit over Daraprim price hikes By Reuters


© Reuters. Former drug company executive Martin Shkreli arrives at U.S. District Court for the fifth day of jury deliberations in his securities fraud trial in the Brooklyn borough of New York City

By Jonathan Stempel

NEW YORK (Reuters) – A federal judge on Tuesday rejected Martin Shkreli’s effort to dismiss a lawsuit accusing the imprisoned former pharmaceutical executive of trying to monopolize the lifesaving drug Daraprim, whose price he raised more than 4,000% in one day.

U.S. District Judge Denise Cote denied requests by Shkreli and Vyera Pharmaceuticals, which he once ran, to dismiss all but one claim in a civil lawsuit by the Federal Trade Commission, New York Attorney General Letitia James and six other states.

The defendants were accused of scheming to block generic equivalents of Daraprim from entering the market, enabling them in 2015 to boost the drug’s cost overnight to $750 from $17.50.

Daraprim treats a potentially fatal infection known as toxoplasmosis.

Lawyers for Shkreli, Vyera, its parent Phoenixus AG and the defendant Kevin Mulleady, who like Shkreli was once Vyera’s chief executive, did not immediately respond to requests for comment.

Nicknamed “Pharma Bro” for eccentricities including his use of social media, Shkreli is serving a seven-year prison term following his 2017 conviction for cheating investors in two hedge funds and trying to prop up a biotechnology company’s stock price.

The 37-year-old remains best known for the Daraprim price hike, when Vyera was known as Turing Pharmaceuticals.

Cote, who sits in Manhattan, said the complaint plausibly alleged that the defendants violated federal antitrust law by blocking rivals from accessing Daraprim, including when Vyera went so far as to repurchase the drug at above-retail prices.

She also pointed to allegations that Shkreli and Mulleady “designed, implemented and negotiated the network of contracts” that blocked Daraprim generics, and may have “benefitted personally” from the illegality.

The case is FTC et al v Vyera Pharmaceuticals LLC et al, U.S. District Court, Southern District of New York, No. 20-00706.

Disclaimer: Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. All CFDs (stocks, indexes, futures) and Forex prices are not provided by exchanges but rather by market makers, and so prices may not be accurate and may differ from the actual market price, meaning prices are indicative and not appropriate for trading purposes. Therefore Fusion Media doesn`t bear any responsibility for any trading losses you might incur as a result of using this data.

Fusion Media or anyone involved with Fusion Media will not accept any liability for loss or damage as a result of reliance on the information including data, quotes, charts and buy/sell signals contained within this website. Please be fully informed regarding the risks and costs associated with trading the financial markets, it is one of the riskiest investment forms possible.





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U.K. reveals 59 countries exempt from quarantine rules — the U.S. fails to make the list


The U.K. government has scrapped a 14-day quarantine rule for visitors to England from 59 countries — but the U.S. has failed to make the list.

Passengers arriving in England from any of the 59 countries and territories will not be forced to self-isolate for 14 days on entering the country from July 10. The “travel corridors” will allow holidaymakers to visit the exempt countries and not have to isolate on their return, while overseas visitors from the 59 countries can also come to England without having to quarantine.

The list includes France, Germany, Italy and Spain, a number of other European countries, as well as Australia, New Zealand, South Korea, and Japan. Barbados, St Kitts and Nevis and St Lucia also made the full list, published on Friday.

However, the U.S., which also failed to make the European Union’s safe list, is not one of the exempt countries and nor is Canada or Sweden, which opted not to go into lockdown at the height of the pandemic. Portugal was another notable omission from the list. U.K. transport minister Grant Shapps confirmed earlier on Friday that the U.S. would not be included in the exemption, telling the BBC that America has “very high numbers of infection.” Ireland was already exempt from the measures. The list applies to England, and Scotland and Wales will release their own information shortly, the government said.

The controversial 14-day quarantine rule came into force at the beginning of June and required all travelers to the U.K. to self-isolate for two weeks on arrival. Travel operators, airlines and hotel owners urged the government to scrap the rule, fearing it would further damage industries already hard hit by the coronavirus pandemic. More than 70 travel firm bosses wrote to the government on in a joint letter last month.

British politicians, including many in Prime Minister Boris Johnson’s Conservative party criticized the quarantine measures, which were implemented as cases were falling across Europe. Conservative MP for Winchester Steve Brine said many people will think “it’s the right move at the wrong time,” while Ben Spencer, MP for Runnymede & Weybridge, called it “a very blunt tool” with many downsides and consequences for the aviation industry.

Home secretary Priti Patel defended the restrictions in early June and said the U.K. was vulnerable to infections being brought in from abroad. At the time Patel said air bridges, allowing tourists to avoid isolating, were being considered and the measures would be reviewed at the end of June. Following the review, the government published the list of 59 countries now exempt from quarantine measures on Friday.



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Move to ease small-business coronavirus loan conditions fails in Senate


A Republican effort to pass a bill easing terms for business owners who take out Paycheck Protection Program loans fell short Thursday as senators headed home for a weeklong Memorial Day break.

The bill, offered on the Senate floor by Sen. Susan Collins, a Maine Republican, and pushed hard by Florida Republican Sen. Marco Rubio, would have given loan recipients twice as much time in which to use the PPP loans.

While the bill had bipartisan support, trying to pass the bill in one day meant it faced an uphill battle of needing signoff by all 100 senators, which it was unable to garner.

But even attempting to move the bill marked something of an about-face by Republicans, who had resisted acting on new coronavirus-related bills until they were able to see how past efforts were faring. It also came after Democrats had criticized Republicans for inaction and new data showed more than 2 million new claimants for jobless benefits, indicating Senate Republicans are feeling the political heat for their stance favoring a pause in legislation.

Under the PPP, small businesses are able to get their loan amount forgiven if they maintain the same number of employees and do not cut their pay by more than 25% for eight weeks after the loan is made. The bill would increase that time to 16 weeks in total. That would give businesses additional time to wait for local COVID-19 lockdowns to end before trying to call workers back.

Collins also said the bill would extend the deadline for businesses to apply for loans from June 30 to Dec. 31, allow loan funds to be used for personal protective equipment and investments needed to reopen safely, and hold lenders harmless for changes in program guidance issued by the Small Business Administration and the Treasury Department.

The House is expected to take up similar, though not identical, legislation next week that would also extend the window in which businesses can use the money.

Rubio, who largely designed the PPP in March, told reporters Thursday at the U.S. Capitol he was unsure whether it would pass. “I expect us to offer it and what seems to be a pretty broad agreement, but you just never know when you ask 100 people’s opinion whether one is going to object to it for potentially unrelated reasons,” Rubio said.

The PPP, which aims to help small businesses hurt by the coronavirus crisis, was established in late March and has received $670 billion in funding through the $2.2 trillion CARES Act and April’s $484 billion relief package.

Restaurant executives on Monday pressed President Donald Trump to extend the deadline to 24 weeks from eight weeks, and he said their request was “very reasonable.”

Treasury Secretary Steven Mnuchin talked up an extension on Thursday in a live interview with The Hill, saying “that’s something we definitely want to fix — doesn’t cost us any more money and there is bipartisan support.” But he signaled he remains opposed to doing away with a rule that requires that 75% of a PPP loan’s proceeds go toward payroll expenses.

“Let me just remind people — it’s called the Paycheck Protection Program. It’s not called the Overhead Protection Program,” Mnuchin said. “We believe that the 75% was exactly consistent with the way the program was designed.”

House Democrats’ sweeping $3 trillion aid package that passed Friday includes an extension, an elimination of the 75% rule and other changes to the PPP, but that broad measure is overall a non-starter for Republican lawmakers.

Democratic Rep. Dean Phillips of Minnesota, who has co-sponsored the standalone House bill targeting the PPP with GOP Rep. Chip Roy of Texas, said last week that he agreed to vote for House Democrats’ $3 trillion package in part because he got a commitment that there would be a vote on his measure. Phillips and Roy’s bill is called the Paycheck Protection Flexibility Act, and it includes an extension, an elimination of the 75% rule and other changes.

Read more:Small businesses could get more time to spend emergency loans, as Democrats and Republicans back extension

Adding to pressure, the Labor Department on Thursday morning reported there were more than 2.4 million new applications for unemployment assistance last week, bringing the total since virus-related lockdowns began in mid-March to more than 35 million.

Republican senators had planned to head home without considering any additional legislation, a stance some said was encouraged by Trump in his lunch meeting with them Tuesday. Earlier Thursday, Majority Leader Mitch McConnell, a Kentucky Republican, had teased House Democrats about being absent this week, offering to send his colleagues to the other side of the Capitol “to collect their newspapers and water the plants.”

But cracks in Republicans’ party solidarity began to appear late Wednesday when Sen. Cory Gardner of Colorado and Collins said they would object to leaving for the weeklong Memorial Day break today unless there was action on a coronavirus bill.

Collins and Gardner are considered to have among the toughest routes to reelection this year.

“We’ve got more work to do. This is a major change if we get the agreement, but you know, we’re close,” Gardner said of the new PPP push.

House Speaker Nancy Pelosi said Thursday she was confident McConnell would move a broader bill, though she did not say when. “I think he will. I think he wants to put some things on the table,” she said.



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Intel fails to clear the clouds on its forecast


Intel Corp. announced what was generally expected Thursday — a boom in server and PC chips as more consumers work at home during the COVID-19 pandemic — but could not alleviate investors’ fears about the rest of 2020, resulting in declining values across the chip sector.

The first quarter demonstrated that Intel
US:INTC
managed to both catch up with its prior demand issues and meet the COVID-19 related surge in demand for PC and server chips. However, it also gave a mildly disappointing forecast for the second quarter, predicting profits lower than analysts expected due to the costs of moving new products to its next-generation 10-nanometer manufacturing process.

“Tailwinds are most evident in the first half of the year on strong demand for mobile compute and related infrastructure on the dynamics of sheltering in place,” Intel Chief Executive Bob Swan told analysts on a conference call. But he added that while the second quarter is expected to see strong demand in the data-center segment continue, the second half has a lot of potential problems.

“Headwinds include the impact of a global recession on [the Internet of Things business] and other markets, particularly industrial and retail, lower automotive production impacting Mobileye and slowing enterprise and government data-center demand,” he said.

In after-hours trading, shares of Intel fell more than 5%, and other chip stocks, including Advanced Micro Devices Inc.
US:AMD
, Microchip Technology Inc.
US:MCHP
and Applied Materials Inc.
US:AMAT
, declined more than 2%. Chip stocks had been outperforming the broader market so far this year: Intel’s shares are down just 1.4% this year and the PHLX Semiconductor Index
US:SOX
has declined 9.1%, compared to the S&P 500’s
US:SPX
steeper year-to-date decline of 13.4%. 

The world’s largest semiconductor maker did not really tell investors anything they were not already expecting, and kept its comments vague enough about the second half. Stacy Rasgon, a Bernstein Research analyst, had also expected demand to continue into the second quarter.

“It seems possible we may see some Q2 strength as channel inventories get replenished, but bringing the second half into question,” he wrote in a note ahead of Intel’s earnings.

Both Intel and Texas Instruments Inc.
US:TXN
, which reported earnings Tuesday, mentioned, respectively, they were “already seeing the impact of a recession” and that “we will approach a likely significant recession” in their conference calls.

So as the second half continues to remain a question — one that Intel and nearly every other company that has reported this week is not yet ready to answer — investors are left to wonder how bad things are going to get.



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