Merck’s PhIII liver cancer study for Keytruda fails on two key endpoints, just three months after the FDA gave it the green light – Endpoints News

In a rare setback, Merck has suffered a key Phase III failure for Keytruda that could put a crimp in its sales prospects.

Roy Baynes

The pharma giant reported after the market closed on Tuesday that Keytruda failed the KEYNOTE-240 study for hepatocellular carcinoma, the most common type of liver cancer. The trial missed on both overall survival as well as progression-free survival. That news arrived just 3 months after the FDA offered an accelerated approval on liver cancer based on their earlier mid-stage data for the drug. 

Staying on the market requires Merck to put up positive pivotal data. Questions about the drug’s future in liver cancer dinged Merck’s stock $MRK, which dropped slightly more than 1% after the release hit.

Merck was quick to note that it’s studying Keytruda in a range of other liver cancer studies, but the advantage here has clearly switched to Opdivo for now, which has been dragging steadily behind Keytruda after falling short on lung cancer, where Merck holds first-line advantage.

This wasn’t the only confirmatory Phase III study to flop. Just weeks ago Eli Lilly had to suspend marketing of Lartruvo after its pivotal for soft tissue sarcoma failed. These back-to-back setbacks, though, are unlikely to slow down the FDA, which has proved eager to hand out accelerated OKs — particularly for cancer drugs — in recent years.

“While we are disappointed KEYNOTE-240 did not meet its co-primary endpoints, the results for overall survival, progression-free survival and objective response rate are generally consistent with findings from the Phase II study, KEYNOTE-224, which led to the accelerated approval of KEYTRUDA for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.


Photo credit: AP Images.

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Elon Musk: Bitcoin Has ‘Quite Brilliant’ Structure, Paper Money is Going Away – Cointelegraph

Technology entrepreneur and Tesla CEO Elon Musk said that Bitcoin’s (BTC) structure is “quite brilliant” and that digital currency is “a far better way to transfer value than pieces of paper.” Musk made his remarks during an interview on advisory services firm ARK Invest’s podcast on Feb. 19.

In response to a question about whether Bitcoin becomes the only native cryptocurrency of the Internet, Musk said that “the Bitcoin structure was quite brilliant,” and that he thinks that “one of the downsides of crypto is that computationally it is quite energy intensive. So there have to be some kind of constraints on the creation of crypto. But it’s very energy intensive to create the incremental Bitcoin at this point.”

On this note, Musk stressed that “it would not be a good use of Tesla resources to get involved in crypto. We’re just really trying to accelerate the advance of sustainable energy.”

Musk continued saying that cryptocurrency “bypasses currency controls […] paper money is going away, and crypto is a far better way to transfer value than pieces of paper, that’s for sure.”

Last February, Musk tweeted that he only owned 0.25 BTC. He noted in the same tweet that apart from the 0.25 BTC a friend had given to him “many years ago”, he “literally own[s] zero cryptocurrency.”

Previously, major industry players also argued that Bitcoin occupies a unique place as a store of value or “digital gold.” Mike Novogratz, a former Goldman Sachs partner and founder of crypto merchant bank Galaxy Digital, said that “Bitcoin is going to be digital gold, a place where you have sovereign money, it’s not U.S. money, it’s not Chinese money, it’s sovereign. Sovereignty costs a lot, it should.”

Twitter co-founder and CEO Jack Dorsey — who is well known for his conviction that Bitcoin will become the “native currency of the Internet” — said earlier this month that “[Bitcoin] feels it’s the one that wants to be currency the most, versus others that are doing more general purpose things or distributed computing […] I think [the altcoin space] has generated some really amazing ideas, but I’m focused on currency and the transactional aspect.”

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MDU plans to close 3 coal fired electric generation units in ND, Montana – KFYR-TV

BISMARCK, N.D. – Montana Dakota Utilities plans to close three coal fired electric generation units at two locations in North Dakota and Montana.

MDU says the units will close within the next two to three years and a new simple cycle natural gas combustion turbine will be built.

The decision was made as part of the companies resource plan.

The unit at the Lewis and Clark Station in Sidney, Mont., is expected to close near the end of 2020. The two units at the Heskett Station in Mandan, N.D., are expected to close at the end of 2021.

MDU says the total cost of building and operating a new simple-cycle combustion turbine is expected to be about half the total cost of continuing to run both stations.

Montana-Dakota employs 77 people between the two coal stations and only 10 employees will be needed to operate the new units.

MDU says it will offer training to employees who wish to fill open positions in other areas of the company.

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Owens & Minor names new president and CEO – Richmond.com

A seasoned senior executive with experience in health care, pharmaceutical and biotechnology distribution industries has been named the new president and chief executive officer at Owens & Minor Inc.

The Hanover County-based medical products distributor named Edward A. Pesicka as its top executive, effective March 4.

Pesicka worked as an executive at biotechnology product development company Thermo Fisher Scientific, where he most recently served as its chief commercial officer and senior vice president. He was at Thermo Fisher for 15 years and then spent almost eight years before that with TRW Inc., the former aerospace and automotive company, where he held roles in corporate finance.

He replaces Robert C. Sledd, who was named Owens & Minor’s interim president and CEO in November when P. Cody Phipps left. Phipps had been chairman, president and CEO of Owens & Minor since 2015,

“Ed is a seasoned senior executive with a deep understanding of distribution, manufacturing and service within our industry,” said Sledd, who remains as the company’s board chairman. Sledd has been a board member since 2007.

“He also has a proven ability to lead performance improvement,” Sledd said. “During his time at Thermo Fisher Scientific, Ed was responsible for leading a portfolio of businesses focused on distribution, manufacturing and services. He demonstrated his sales and financial acumen and developed a reputation for providing outstanding customer service and driving strong financial results. We are pleased that our process resulted in identifying the ideal CEO.”

Pesicka joins Owens & Minor as the Fortune 500 company tries to steer its way through a difficult market environment, which has been particularly challenging for its legacy medical supplies distribution business.

For instance, the company faces pricing pressures driven in part by consolidation among customers in the health care industry, along with higher raw materials costs for some products it distributes, such as medical gloves.

The company reported a fourth-quarter loss of $261.8 million, after reporting a profit in the same period a year earlier. The results missed Wall Street expectations.

Pesicka will get a seat on Owens & Minor’s board.

Anne Marie Whittemore, a former McGuireWoods attorney who is the board’s lead director and member of its search committee, said in a statement that the board conducted a thorough search.

“The board believes we have found the right leader with practical management and people development skills that align with our strategy,” Whittemore said

During his 15-year tenure with Thermo Fisher, Pesicka ran an $8 billion portfolio of global distribution, manufacturing and service businesses. He also served as chief financial officer for multiple divisions.

At TRW, he served as divisional chief financial officer for the company’s Nelson Stud Welding division.

He began his career as an auditor at PricewaterhouseCoopers.

Pesicka holds an MBA from Case Western Reserve University and a bachelor’s degree in accounting and business administration from Muskingum College.

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Qualcomm says Apple’s iOS update fix shouldn’t prevent US ban on the iPhone – Phone Arena

On March 26th, the U.S. International Trade Commission (ITC) will decide on whether to issue an exclusion order against Apple, in effect banning certain iPhone models from being imported and sold in the U.S. Last week, Apple said that an update to iOS removed the power saving feature
that infringed on a Qualcomm patent according to an ITC judge. The company said that it didn’t think any earlier iPhone models infringed on the patent, but disseminated the update as a result of Qualcomm’s claims.
Apple has told the ITC that a ruling that prevents it from importing iPhone models with Intel modems will stop the competition between Qualcomm and Intel that is necessary for the development of 5G (as a side note,
Qualcomm did introduce a new 5G modem chip today). Intel says that an ITC exclusion ban against the iPhone will force it out of the modem market. Meanwhile,
as noted by Seeking Alpha, Qualcomm filed some paperwork with the ITC today. The document from the chip maker states that Apple’s iOS update workaround contradicts the latter’s argument that its phones should not be banned by the ITC.

Apple, obviously, has asked the ITC not to impose an exclusion order. Instead, it has asked the agency for six additional months to complete any changes needed for the iPhone to become “infringement-free,” and to have the changes examined by U.S. Customs.

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